A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
Phase: NA
Conditions: Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express 
written consent of Abbott. 
87173 CIP Posting Cover Page Ver C 
Template 
Page 1 of 1 
 
NCT Number: NCT02173379 
ABSORB IV RCT 
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the 
Treatment of Subjects With de Novo Native Coronary Artery Lesions 
Study Document No: 10-392 
Version 1.0 
Date: 16 August 2018 
 
 
Sponsor  
 
 
Abbott Cardiovascular Systems, Inc. 
        
 
 
 
3200 Lakeside Drive 
      
  
 
 
Santa Clara, CA 95054 
        
 
 
 
United States 
 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 2 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
TABLE OF CONTENTS 
Compliance Statement: ....................................................................................................................8 
PROTOCOL SUMMARY ...............................................................................................................9 
1. 
INTRODUCTION ................................................................................................................30 
2. 
BACKGROUND INFORMATION .....................................................................................32 
2.1 
Summary of Investigational Device ...............................................................................32 
2.1.1 Name of the Investigational Device ...........................................................................32 
2.1.2 Intended Indication ....................................................................................................32 
2.1.3 Absorb BVS Features ................................................................................................32 
2.1.4 Description of the Investigational Device ..................................................................34 
2.1.5 Description of the Control Device .............................................................................40 
2.1.6 Investigational Device Accountability .......................................................................41 
2.1.7 Summary of Pre-Clinical Studies ...............................................................................41 
2.1.8 Previous Clinical Studies ...........................................................................................43 
2.1.9 ABSORB TRIALS.....................................................................................................44 
2.1.10 SPIRIT TRIALS ........................................................................................................48 
2.1.11 Patient Reported Outcomes (PRO) ............................................................................49 
2.2 
Trial Rationale ...............................................................................................................49 
3. 
TRIAL OBJECTIVE ............................................................................................................50 
4. 
CLINICAL TRIAL/INVESTIGATION FLOW AND FOLLOW-UP SCHEDULE ...........50 
4.1 
Number of Subjects to be Registered .............................................................................50 
4.2 
ABSORB Physician Training ........................................................................................50 
4.3 
Lead-In Phase.................................................................................................................52 
4.4 
ABSORB III Treatment Flow and Lesion Selection .....................................................53 
4.5 
Measures Taken to Avoid and Minimize Bias ...............................................................55 
4.5.1 Randomization ...........................................................................................................56 
4.5.2 Blinding......................................................................................................................56 
4.6 
Early Termination of the Clinical Trial .........................................................................57 
5. 
ENDPOINTS ………………………………………………………………………………57 
5.1 
Primary Endpoint ...........................................................................................................57 
5.2 
Powered Secondary Endpoint(s) ....................................................................................57 
5.3 
Additional Secondary Endpoint(s) .................................................................................59 
5.4 
Informational Endpoints (Patient Reported Outcomes) .................................................62 
6. 
SUBJECT SELECTION AND WITHDRAWAL ................................................................62 
6.1 
Subject Population .........................................................................................................62 
6.2 
Subject Screening and Informed Consent ......................................................................63 
6.2.1 Subject Screening .......................................................................................................63 
6.2.2 Informed Consent.......................................................................................................63 
6.3 
Eligibility Criteria ..........................................................................................................64 
6.3.1 General Eligibility Criteria ........................................................................................64 
6.3.2 Angiographic Eligibility Criteria ...............................................................................67 
6.4 
Point of Registration ......................................................................................................69 
6.5 
Subject Discontinuation .................................................................................................69 
7. 
TREATMENT AND EVALUATION OF SAFETY AND EFFECTIVENESS ..................71 
7.1 
Baseline ..........................................................................................................................71 
7.1.1 Baseline Laboratory Assessments to Confirm Subject Eligibility .............................71 
7.1.2 Subject History...........................................................................................................71 
7.1.3 Patient-Reported Outcomes Assessment ...................................................................71 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 3 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
7.2 
Pre-Procedure .................................................................................................................72 
7.2.1 Pre-Procedure Laboratory Assessment ......................................................................72 
7.2.2 Dual Anti-Platelet Medications ..................................................................................72 
7.2.3 Anti-Coagulation Medications ...................................................................................73 
7.3 
Index Procedure .............................................................................................................73 
7.3.1 Baseline (Pre-Procedure) Angiography .....................................................................73 
7.3.2 Imaging Guidance Document ....................................................................................73 
7.3.3 Treatment of the Non-target Lesion(s) ......................................................................73 
7.3.4 Treatment Rules of the Target Lesion(s) ...................................................................74 
7.3.5 Bailout Stenting or Alternative Procedures ...............................................................80 
7.3.6 Final (Post-procedure) Angiography .........................................................................81 
7.3.7 Final (Post-procedure) IVUS and OCT .....................................................................81 
7.3.8 Imaging Assessment ..................................................................................................81 
7.4 
Post–procedure ...............................................................................................................83 
7.4.1 Post-procedure Information to be Recorded ..............................................................83 
7.4.2 Post-procedure Laboratory and Clinical Tests ...........................................................83 
7.4.3 Follow-up Antiplatelet Medications ..........................................................................84 
7.4.4 Other Chronic Concomitant Medications ..................................................................84 
7.5 
Clinical and Imaging Follow-up for All Subjects ..........................................................85 
7.6 
Additional Follow-up Visits for All Subjects ................................................................86 
8. 
ADVERSE EVENTS ............................................................................................................87 
8.1 
Definitions......................................................................................................................87 
8.1.1 Adverse Event ............................................................................................................87 
8.1.2 Serious Adverse Event ...............................................................................................87 
8.1.3 Device Deficiency/Product Experience .....................................................................88 
8.2 
Device Relationship .......................................................................................................88 
8.2.1 Unanticipated Serious Adverse Device Effect ...........................................................88 
8.3 
Adverse Event/Device Deficiency/Product Experience Reporting ...............................89 
8.3.1 Adverse Event and Serious Adverse Event Reporting ..............................................89 
8.3.2 UADE/USADE Reporting to Sponsor and IRB ........................................................90 
8.3.3 Device Deficiency/Product Experience Reporting ....................................................90 
8.3.4 Adverse Event Reporting to Country Regulatory Authorities by the Sponsor ..........90 
8.4 
Safety Monitoring by Data Safety Monitoring Board ...................................................90 
9. 
ADJUDICATION OF EVENTS ...........................................................................................91 
9.1 
The Clinical Events Committee (CEC) ..........................................................................91 
9.2 
Angiographic Core Laboratory ......................................................................................91 
10. STATISTICAL ANALYSIS ................................................................................................91 
10.1 Statistical Overview ...........................................................................................................91 
10.2 Analysis Populations ..........................................................................................................92 
10.2.1 Intent-to-Treat Population ...........................................................................................92 
10.2.2 Per Treatment Evaluable Population ..........................................................................92 
10.3 Sample Size Calculations and Assumptions ......................................................................93 
10.3.1 ABSORB III Primary Endpoint ..................................................................................93 
10.3.2 Powered Secondary Endpoints ...................................................................................94 
10.4 Statistical Analyses ............................................................................................................97 
10.4.1 Primary Endpoint Analysis .........................................................................................98 
10.4.2 Powered Secondary Endpoint Analyses .....................................................................98 
10.4.3 Secondary Endpoint Analyses ....................................................................................98 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 4 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
10.4.4 Additional Analyses ....................................................................................................98 
10.4.5 Exploratory Analyses .................................................................................................98 
10.4.6 Informational Endpoint Analyses ..............................................................................98 
10.4.7 Subgroup Analysis ......................................................................................................99 
10.4.8 Handling of Multiplicity Issues ..................................................................................99 
10.4.9 Criteria for Early Termination of the Trial for Effectiveness .....................................99 
10.4.10 Procedures for Accounting for Missing, Unused or Spurious Data..........................99 
10.4.11 Pooling Strategy ........................................................................................................99 
10.4.12 Deviations from the Original Statistical Plan ...........................................................99 
11. DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ...................................................99 
12. QUALITY CONTROL AND QUALITY ASSURANCE ..................................................100 
12.1 
Selection of Clinical Sites and Investigators ...............................................................100 
12.2 
Training ........................................................................................................................100 
12.2.1 Site Training.............................................................................................................100 
12.2.2 Training Required for the Use of the Test Device ...................................................100 
12.2.3 Training of Sponsor’s Monitors ...............................................................................100 
12.3 
Monitoring ...................................................................................................................100 
12.3.1 Designated Monitors .................................................................................................100 
12.3.2 Visits .........................................................................................................................101 
12.4 
Deviations from Protocol .............................................................................................101 
12.5 
Quality Assurance Audits ............................................................................................102 
12.6 
Sponsor Support to Clinical Trial/Investigation Site for Regulatory Body Inspection
 
102 
12.7 Committees ......................................................................................................................102 
12.7.1 Steering Committee .................................................................................................102 
12.7.2 Publications Committee ...........................................................................................102 
12.7.3  Data Safety Monitoring Board (DSMB) ..................................................................103 
12.7.4  Clinical Events Committee (CEC) ...........................................................................103 
13. DATA HANDLING AND RECORD KEEPING ..............................................................103 
13.1 
Source Documentation .................................................................................................103 
13.2 
Electronic Case Report Form Completion ...................................................................104 
13.3 
Record Retention .........................................................................................................104 
13.4  Investigational Devices ................................................................................................104 
13.4.1 Investigational Device Accountability ......................................................................104 
14. ETHICAL CONSIDERATION ..........................................................................................105 
14.1 
Institutional Review Board/Medical Ethics Committee Review .................................105 
15. PUBLICATION POLICY ..................................................................................................105 
16. RISK ANALYSIS ...............................................................................................................106 
16.1 
Potential Risk ...............................................................................................................106 
16.1.1 Cardiac Catheterization, Stenting and Percutaneous Transcatheter Coronary 
Angioplasty ..........................................................................................................................106 
16.1.2 Associated Risks of the Absorb BVS Polymer ........................................................106 
16.1.3 Everolimus ...............................................................................................................107 
16.1.4 Drug Interaction of Everolimus ...............................................................................107 
16.1.5  Carcinogenicity, Genotoxicity, and Reproductive Toxicity ...................................107 
16.1.6 Risks associated with Quantitative Imaging Modalities ...........................................108 
16.2 
Risk Management Procedure .......................................................................................109 
16.3 
Potential Benefit ...........................................................................................................110 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 5 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
17. Special Populations .............................................................................................................111 
Appendix I: ABBREVIATIONS AND ACRONYMS ................................................................113 
APPENDIX II: 
DEFINITIONS .............................................................................................116 
APPENDIX III: 
SCHEDULE OF EVENTS ...........................................................................133 
APPENDIX IV: 
ENROLLMENT AND REGISTRATION PROCESS .................................133 
APPENDIX V: 
VESSEL TREATMENT & RANDOMIZATION .......................................136 
APPENDIX VI: 
IMAGING FLOW AND SCHEDULE ........................................................139 
APPENDIX VII: 
evaluation of lead-in phase ...........................................................................140 
APPENDIX VIII: RISK STRATIFICATION OF Cardiac Catheterization, Stenting and 
Percutaneous Transcatheter Coronary Angioplasty ............................................................142 
APPENDIX IX: 
CONTACT INFORMATION ......................................................................143 
APPENDIX X: 
REFERENCES .............................................................................................144 
Addendum A: 
Pharmacokinetics Sub-study Synopsis .........................................................147 
PROTOCOL SUMMARY FOR ABSORB IV ............................................................................156 
1. 
INTRODUCTION ..............................................................................................................181 
2. 
BACKGROUND INFORMATION ...................................................................................182 
2.1.1 Name of the Investigational Device .........................................................................182 
2.1.2 Intended Indication ..................................................................................................182 
2.1.3 Background Information ..........................................................................................182 
2.1.4 Absorb GT1 ................................................................................................................182 
2.2 
Trial Rationale .............................................................................................................183 
3. 
TRIAL OBJECTIVE ..........................................................................................................183 
4. 
CLINICAL TRIAL/INVESTIGATION FLOW AND FOLLOW-UP SCHEDULE .........184 
4.1 
Number of Subjects to be Registered ...........................................................................184 
4.2 
ABSORB Physician Training ......................................................................................184 
4.3 
ABSORB IV Treatment Flow and Lesion Selection ...................................................184 
4.4 
Measures Taken to Avoid and Minimize Bias .............................................................186 
4.4.1 Randomization .........................................................................................................186 
4.4.2 Blinding....................................................................................................................187 
4.5 
Early Termination of the Clinical Trial .......................................................................188 
5. 
ENDPOINTS.. ....................................................................................................................188 
5.1 
Primary Endpoints .......................................................................................................188 
5.2 
ABSORB IV Major Secondary Endpoint ....................................................................188 
5.3 
Additional Secondary Endpoint(s) ...............................................................................189 
5.4 
Informational Endpoints ..............................................................................................190 
5.4.1 Patient Reported Outcomes......................................................................................190 
5.4.2 Health Economics ....................................................................................................190 
6. 
SUBJECT SELECTION AND WITHDRAWAL ..............................................................191 
6.1 
Subject Population .......................................................................................................191 
6.2 
Subject Screening and Informed Consent ....................................................................191 
6.2.1 Subject Screening and Informed Consent ................................................................191 
6.3 
Eligibility Criteria ........................................................................................................191 
6.4 
Point of Registration ....................................................................................................191 
6.5 
Subject Discontinuation ...............................................................................................191 
7. 
TREATMENT AND EVALUATION OF SAFETY AND EFFECTIVENESS ................192 
7.1 
Baseline ........................................................................................................................192 
7.1.1 Baseline Laboratory Assessments to Confirm Subject Eligibility ...........................192 
7.1.2 Subject History.........................................................................................................192 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 6 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
7.1.3 Patient-Reported Outcomes Assessment .................................................................192 
7.2 
Pre-Procedure ...............................................................................................................192 
7.2.1 Pre-Procedure Laboratory Assessment ....................................................................192 
7.2.2 Dual Anti-Platelet Medications ................................................................................193 
7.2.3 Anticoagulation Medications ...................................................................................195 
7.2.4 Statin Therapy ..........................................................................................................195 
7.3 
Index Procedure ...........................................................................................................195 
7.3.1 Baseline (Pre-Procedure) Angiography ...................................................................195 
7.3.2 Imaging Guidance Document ..................................................................................195 
7.3.3 Treatment Rules of the Target Lesion(s) .................................................................195 
7.3.4 Treatment Rules of Unplanned Non-Target Lesion(s) ............................................196 
7.3.5 Bailout Stenting or Alternative Procedures .............................................................196 
7.3.6 Final (Post-procedure) Angiography .......................................................................197 
7.3.7 Final (Post-procedure) IVUS and OCT ...................................................................197 
7.4 
Post–procedure .............................................................................................................197 
7.4.1 Post-procedure Information to be Recorded ............................................................197 
7.4.2 Post-procedure Laboratory and Clinical Tests .........................................................197 
7.4.3 Assessment of perception bias. ................................................................................198 
7.4.4 Follow-up Antiplatelet Medications ........................................................................199 
7.4.5 Other Chronic Concomitant Medications ................................................................199 
7.5 
Clinical Follow-up for All Subjects .............................................................................199 
7.6 
Additional Follow-up Visits for All Subjects ..............................................................200 
8. 
ADVERSE EVENTS ..........................................................................................................201 
8.1 
Definitions....................................................................................................................201 
8.1.1 Adverse Event .............................................................................................................201 
8.1.2 Serious Adverse Event ................................................................................................201 
8.1.3 Device Deficiency/Product Experience ......................................................................202 
8.2 
Device Relationship .....................................................................................................202 
8.2.1 Unanticipated Serious Adverse Device Effect (USADE) ........................................202 
8.3 
Adverse Event/ Device Deficiency/ Product Experience Reporting ...........................203 
8.3.1 Adverse Event and Serious Adverse Event Reporting ............................................203 
8.3.2. Unanticipated Serious Adverse Device Effect Reporting to Sponsor and IRB .........204 
8.3.3 Device Deficiency/Product Experience Reporting ..................................................204 
8.3.4 Adverse Event Reporting to Country Regulatory Authorities by the Sponsor ........204 
8.4 
Safety Monitoring by Data Safety Monitoring Board .................................................205 
9. 
ADJUDICATION OF EVENTS .........................................................................................205 
9.1 
The Clinical Events Committee (CEC) ........................................................................205 
9.2 
Angiographic Core Laboratory ....................................................................................205 
10. STATISTICAL ANALYSIS ..............................................................................................205 
10.1 
Statistical Overview .....................................................................................................205 
10.2 
Analysis Populations ....................................................................................................206 
10.2.1 Intent-to-Treat (ITT) Population ..............................................................................206 
10.2.2 As-Treated (AT) Population ....................................................................................206 
10.3.1 ABSORB IV Primary Endpoints .............................................................................206 
10.3.2 Powered Secondary Endpoint ...................................................................................207 
10.4 
Statistical Analyses ......................................................................................................208 
10.4.1 Primary Endpoint Analyses  ....................................................................................209 
10.4.2 Powered Secondary Endpoint Analysis ...................................................................209 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 7 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
10.4.3 Secondary Endpoint Analyses .................................................................................209 
10.4.4 Additional Analyses .................................................................................................210 
10.4.5 Informational Endpoint Analyses ............................................................................210 
10.4.6 Subgroup Analysis ...................................................................................................210 
10.4.7 Handling of Multiplicity Issues ................................. Error! Bookmark not defined. 
10.4.8 Criteria for Early Termination of the Trial for Effectiveness ..................................210 
10.4.10 Procedures for Accounting for Missing, Unused or Spurious Data.....................210 
10.4.11 Pooling Strategy ...................................................................................................210 
10.4.12 Deviations from the Original Statistical Plan ......................................................210 
11. ADDITIONAL PROTOCOL INFORMATION.................................................................210 
11.1 
Direct Access to Source Data/Documents Addendum ................................................210 
12. ABSORB-RESOLVe: REduction in iSchemia with BiOresorbale Vascular Scaffolds—An 
Imaging Sub-study to ABSORB IV ....................................................................................212 
12.1. Background ..................................................................................................................212 
12.1.1. Ischemia Assessment by SPECT .............................................................................212 
12.1.2. Coronary CT Angiography (CCTA) ........................................................................213 
12.1.3. CT Perfusion (CTP) .................................................................................................213 
12.1.4. FFRCT .......................................................................................................................214 
12.1.5. The Present Study ....................................................................................................214 
12.2. Rationale and Design of ABSORB-RESOLVe ...........................................................214 
12.3. ABSORB-RESOLVe Study Objectives: .....................................................................216 
12.3.1. Primary Objective (Myocardial Ischemia by SPECT). ............................................216 
12.3.2. Powered Secondary Objective (Myocardial Ischemia by CT). ...............................216 
12.3.3. Tertiary Objectives: .................................................................................................217 
12.4. ABSORB-RESOLVe Study Population and Clinical Site Participation .....................218 
12.4.1. Selection of Subjects ................................................................................................219 
12.4.2. Test Schedule and Subject Visits .............................................................................219 
12.4.3. Procedural Assessments and Treatment Strategy ....................................................226 
12.5. References ....................................................................................................................227 
Appendix I: ABBREVIATIONS AND ACRONYMS ................................................................231 
APPENDIX II: 
DEFINITIONS .............................................................................................232 
APPENDIX III: 
SCHEDULE OF EVENTS ...........................................................................236 
APPENDIX IV: 
ENROLLMENT AND REGISTRATION PROCESS .................................238 
APPENDIX V: 
VESSEL TREATMENT & RANDOMIZATION .......................................240 
APPENDIX VI: RISK STRATIFICATION OF CARDIAC CATHERIZATION, STENTING 
AND PERCUTANEOUS TRANSCATHETER CORONARY ANGIOPLASTY ............243 
APPENDIX VII: 
CONTACT INFORMATION ......................................................................244 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 8 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
COMPLIANCE STATEMENT:  
This trial will be conducted in accordance with this Protocol/Clinical Investigational Plan, the 
declaration of Helsinki, applicable good clinical practices and regulations (e.g., US 21 CFR Part 
50, 21 CFR Part 56, and 21 CFR Part 812, OUS ISO14155) and the appropriate local 
legislation(s). The most stringent requirements, guidelines or regulations must always be 
followed.  The conduct of the trial will be approved by the appropriate Institutional Review 
Board (IRB)/ Ethics Committee (EC) of the respective investigational site and by the applicable 
regulatory authorities (e.g., FDA, PMDA, MHRA, etc.) 
Sponsor Signatory Representative: 
Approval for this protocol and any subsequent amendments shall be obtained per Abbott 
Vascular Standard / Detailed Operating Procedure(s).

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 9 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
PROTOCOL SUMMARY 
Trial Name and 
Number 
ABSORB III Randomized Controlled Trial: 10-392 
Title  
THE ABSORB III RANDOMIZED CONTROLLED TRIAL 
(RCT) 
Investigational 
Device 
Absorb™ Bioresorbable Vascular Scaffold (BVS) System1: 
• Scaffold diameters: 2.5, 3.0 and 3.5 mm  
• Scaffold lengths2: 8, 12, 18, and 28 mm 
The 3.0 x 18 mm Absorb BVS will be used for the Lead-In.  
Control Device 
Commercially approved XIENCE Family Stent System, inclusive of 
XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, 
XIENCE Pro (OUS only),and XIENCE ProX (OUS only)3 
• Stent diameters:  2.5, 2.75, 3.0, 3.25*, 3.5 and 4.0 mm  
• Stent lengths: 8, 12, 15, 18, 23, and 28 mm 
XIENCE Family Stent System will hereinafter be called “XIENCE” in 
this study. 
*The 3.25 mm is only available for XIENCE Xpedition 
Objectives 
• ABSORB III Primary Objective: The pivotal trial to support the 
US pre-market approval (PMA) of Absorb BVS. ABSORB III will 
evaluate the safety and effectiveness of the Absorb BVS System 
compared to the XIENCE in the treatment of subjects, including 
those with diabetes mellitus, with ischemic heart disease caused by 
up to two de novo native coronary artery lesions in separate 
epicardial vessels.  
• ABSORB III Secondary Objectives: 
• Lead-In Phase Objective: To evaluate the applicability and 
transferability of the didactic Absorb BVS physician training 
plan to US clinical practice. 
• Imaging Cohort Objective: To evaluate long-term vascular 
function and patency of the Absorb BVS treated segments 
compared to XIENCE treated segments in the treatment of 
subjects with ischemic heart disease caused by up to two de 
 
1 The commercially approved CE marked device will be used in geographies where it is commercially available. 
2 Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm 
length will be available for the 3.5 mm diameter. The commercially approved CE marked 23mm Absorb BVS 
device will not be used in this study. 
3 For geographies where these devices are commercially available, the investigational sites may use only their 
locally approved devices. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 10 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
novo native coronary artery lesions in separate epicardial 
vessels. 
Study Design  
A prospective, randomized (2:1 Absorb BVS to XIENCE), single-
blind, multi-center trial, registering approximately 2250 subjects. 
• The primary endpoint data from this trial will support US premarket 
approval (PMA) of Absorb BVS and label claims of non-inferiority 
of Absorb BVS as compared to XIENCE in 1-year target lesion 
failure (TLF). 
The ABSORB III trial also includes a Lead-In Phase and an Imaging 
Cohort: 
• Lead-In Phase:  
A non-randomized, single-arm, open label group of up to 50 
subjects treated with Absorb BVS at up to 35 US sites. The Lead-In 
phase will enroll/register subjects prior to the randomization phase 
of ABSORB III. 
• Imaging Cohort:  
A prospective, randomized (2:1 Absorb BVS to XIENCE), single-
blind, multi-center trial, registering approximately 200 subjects. 
This includes 150 subjects for the angiographic/IVUS endpoints 
analysis and approximately 50 subjects for OCT endpoints analysis. 
The 200 subjects are separate from the 2000 subjects included in 
the primary analysis. 
The powered secondary endpoint data from this cohort will support 
label claims of superiority of Absorb BVS as compared to XIENCE 
specific to vasomotion and late lumen enlargement  
The Lead-In Group and Imaging Cohort will operate under the 
ABSORB III trial. The Lead-In Group will enroll/register first. After 
the completion of Lead-In, the rest of ABSORB III subjects (including 
Imaging Cohort) will start to enroll/register. All trial elements will 
apply to ABSORB III, including the Lead-In Group and the Imaging 
Cohort, unless otherwise specified. 
ABSORB III 
Primary Endpoint 
ABSORB III Primary Endpoint 
1. TLF at 1 year, non-inferiority (NI) against the control. 
• TLF is defined as composite of Cardiac Death, Myocardial 
Infarction attributable to Target Vessel (TV-MI), or Ischemia-
Driven Target Lesion Revascularization (ID-TLR). 
• This analysis will include ~2000 subjects.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 11 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Powered Imaging 
Cohort Secondary 
Endpoints 
Imaging secondary endpoints are based on the pooled subjects from the 
Imaging Cohort of ABSORB III (  
 angiographic subjects and 
 
IVUS subjects) and subjects from the ABSORB Japan RCT (  
 
angiographic subjects, and 
 IVUS subjects). 
1. The in-stent/scaffold mean lumen area change, from post-
procedure to 3 years by IVUS (mean lumen area measured after 
nitrate infusions, superiority test, 
 pooled subjects). 
2. The in-stent/scaffold mean lumen diameter change, between pre- 
and post-nitrate infusion at 3 years by angiography (superiority 
test, 
 pooled subjects). 
Powered 
Secondary 
Endpoint for 
Angina  
Angina at 1 year test for superiority of Absorb BVS to XIENCE. 
• Angina is defined as the first adverse event resulting in the site 
diagnosis of angina. 
• The analysis will exclude angina following the index procedure 
through discharge, not to exceed a period of 7 days  
This analysis will include ~2000 subjects.  
Powered 
Secondary 
Endpoint for All 
Revascularization 
All revascularization at 1 year test for superiority of Absorb BVS to 
XIENCE.  
This analysis will include ~2000 subjects.  
Powered 
Secondary 
Endpoint for 
Ischemia-Driven 
Target Vessel 
Revascularization 
Ischemia-driven target vessel revascularization at 1 year testing for 
superiority of Absorb BVS to XIENCE 
This analysis will include ~ 2000 subjects. 
Powered 
Secondary 
Endpoint for 
Diabetic Indication 
The powered secondary endpoint will be used to support a diabetic 
indication for Absorb BVS. 
Patient Reported 
Outcome (PRO) 
Informational 
Endpoints 
Patient-reported outcomes are informational endpoints to assess Health-
Related Quality of Life at baseline, 30 days, 1, 2, 3 and 5 years follow-
up. The following questionnaires will be used in this study:  
• EuroQoL 5D (EQ-5D) survey to assess overall health status  
• Seattle Angina Questionnaire (SAQ) to assess disease-specific 
Quality of Life 
• Rose Dyspnea Scale (RDS) to assess severity of dyspnea. 
• Generalized Anxiety Disorder scale (GAD-7) to assess anxiety. 
Notes:  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 12 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
PRO endpoints will be evaluated in the 2,000 primary analysis subjects 
of ABSORB III and not the lead-in or imaging subjects. 
At 5 years, only EQ-5D and SAQ will be administered. 
Subject 
Enrollment, 
Randomization 
and Registration 
• Subjects are considered enrolled in ABSORB III after signing 
the Informed Consent. 
• Subjects are considered randomized in ABSORB III after the 
interactive voice response system (IVRS) has been called and a 
device (Absorb BVS or XIENCE) has been assigned. 
• Subjects are considered registered in the ABSORB III upon 
randomization. 
• Enrolled subjects not randomized in the trial will be considered 
screen failures and will not be followed.  
• Lead-In subjects will be considered registered upon calling 
IVRS. 
Refer to Figure 1 in Appendix IV.  
Clinical Follow-Up 
All subjects in the ABSORB III (including the Lead-In and Imaging 
Cohort) will receive the following clinical follow-up: 
o 30 ± 7 days follow-up telephone contact/office visit 
o 180 ± 28 days follow-up telephone contact/office visit  
o 1 year ± 28 days office visit and electrocardiogram (ECG) 
o Annual visits: 2-5 years ± 28 days follow-up telephone contact/ 
office visit 
Imaging Follow-
Up for the Imaging 
Cohort  
A select number of sites with intravascular ultrasound (IVUS) only or 
IVUS and optical coherence tomography (OCT) capabilities will be 
selected to enroll the 200 subject Imaging Cohort. These subjects will 
have additional evaluations: 
o Post-procedure: angiography and IVUS (~150 subjects) or 
angiography and OCT (~50 subjects) 
o  3 years ± 28 days: angiography, IVUS and ECG for 
approximately 150 subjects, OR 
o 3 years ± 28 days: angiography, OCT and ECG for 
approximately 50 subjects  
All subjects in Imaging Cohort must have received the assigned device.  
Imaging Cohort subjects are required to undergo imaging at 3 years.  
Patient Reported 
Outcome (PRO) 
Follow-Up 
All 2,000 subjects in the primary analysis will receive the following 
PRO follow-up assessments: 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 13 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
o 30 ± 7 days follow-up telephone contact/office visit (EQ-5D, 
SAQ, RDS, GAD-7) 
o 1, 2 and 3 year ± 28 days office visit (EQ-5D, SAQ, RDS, 
GAD-7) 
o 5 year ± 28 days follow-up telephone contact/ office visit (EQ-
5D, SAQ) 
ABSORB III 
Primary Analysis 
Sample Size 
Justification 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
Imaging Cohort 
Analysis Sample 
Size Justification 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
Inclusion Criteria 
General Inclusion Criteria 
1. Subject must be at least 18 years of age. 
2. Subject or a legally authorized representative must provide 
written Informed Consent prior to any study related procedure, 
per site requirements. 
3. Subject must have evidence of myocardial ischemia (e.g., 
stable, unstable angina, post-infarct angina or silent ischemia) 
suitable for elective PCI.  Subjects with stable angina or silent 
ischemia and < 70% diameter stenosis must have objectives 
sign of ischemia as determined by one of the following, 
echocardiogram, nuclear scan, ambulatory ECG or stress ECG). 
In the absence of noninvasive ischemia, fractional flow reserve 
(FFR) must be done and indicative of ischemia. 
4. Subject must be an acceptable candidate for coronary artery 
bypass graft (CABG) surgery. 
5. Female subject of childbearing potential who does not plan 
pregnancy for up to 1 year following the index procedure. For a 
female subject of childbearing potential a pregnancy test must 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 14 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
be performed with negative results known within 7 days prior to 
the index procedure per site standard. 
6. Female subject is not breast-feeding at the time of the screening 
visit and will not be breast-feeding for up to 1 year following 
the index procedure. 
7. Subject agrees to not participate in any other investigational or 
invasive clinical study for a period of 1 year following the index 
procedure.4 
Angiographic Inclusion Criteria 
1. One or two de novo target lesions: 
a. If there is one target lesion, a second non-target lesion may 
be treated but the non-target lesion must be present in a 
different epicardial vessel, and must be treated first with a 
successful, uncomplicated result prior to randomization of 
the target lesion. 
b. If two target lesions are present, they must be present in 
different epicardial vessels and both must satisfy the 
angiographic eligibility criteria. 
c. The definition of epicardial vessels means the LAD, LCX 
and RCA and their branches. Thus, the patient must not have 
lesions requiring treatment in e.g. both the LAD and a 
diagonal branch. 
2. Target lesion(s) must be located in a native coronary artery with 
a visually estimated or quantitatively assessed %DS of ≥ 50% 
and < 100% with a TIMI flow of ≥ 1 and one of the following: 
stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow 
reserve, stress test), unstable angina or post-infarct angina.  
a. Lesion(s) must be located in a native coronary artery with 
RVD by visual estimation of   ≥ 2.50 mm and ≤ 3.75 mm.  
b. Lesion(s) must be located in a native coronary artery with 
length by visual estimation of ≤ 24 mm. 
c. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions 
(s) must be located in a native coronary artery with RVD by 
visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion 
length by visual estimation is ≥ 8 mm and ≤ 14 mm. 
Exclusion Criteria 
General Exclusion Criteria 
 
4 This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies 
that are non-invasive and do not require medication are allowed.  A subject who is taking part in the long-term 
follow-up phase of a trial, who has completed all medications and invasive procedures per protocol requirements, 
may continue to participate in that trial. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 15 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
1. Any surgery requiring general anesthesia or discontinuation of 
aspirin and/or an ADP antagonist is planned within 12 months 
after the procedure. 
2. Subject has known hypersensitivity or contraindication to 
device material and its degradants (everolimus, poly (L-lactide), 
poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, 
nickel, platinum, tungsten, acrylic and fluoro polymers that 
cannot be adequately pre-medicated. Subject has a known 
contrast sensitivity that cannot be adequately pre-medicated. 
3. Subject has known allergic reaction, hypersensitivity or 
contraindication to aspirin; or to clopidogrel and prasugrel and 
ticagrelor; or to heparin and bivalirudin, and therefore cannot be 
adequately treated with study medications. 
4. Subject had an acute myocardial infarction (AMI; STEMI or 
NSTEMI) within 72 hours of the index procedure and both CK 
and CK-MB have not returned to within normal limits at the 
time of index procedure; or subject with stable angina or silent 
ischemia has CK-MB that is greater than normal limits at the 
time of the index procedure.  
5. Subject is currently experiencing clinical symptoms consistent 
with new onset AMI (STEMI or NSTEMI), such as nitrate-
unresponsive prolonged chest pain with ischemic ECG changes. 
6. Subject has a cardiac arrhythmia as identified at the time of 
screening for which at least one of the following criteria is met:5 
a. Subject requires coumadin or any other agent for chronic 
oral anticoagulation.  
b. Subject is likely to become hemodynamically unstable due 
to their arrhythmia. 
c. Subject has poor survival prognosis due to their arrhythmia. 
7. Subject has a left ventricular ejection fraction (LVEF) < 30% 
assessed by any quantitative method, including but not limited 
to echocardiography, MRI, Multiple-Gated Acquisition 
(MUGA) scan, contrast left ventriculography, PET scan, etc. 
LVEF may be obtained within 6 months prior to the procedure 
for subjects with stable CAD. For subjects presenting with 
ACS, LVEF must be assessed during the index hospitalization 
(which may include during the index procedure by contrast left 
ventriculography) but prior to randomization in order to confirm 
the subject’s eligibility.   
8. Subject has undergone prior PCI within the target vessel during 
the last 12 months. Prior PCI within the non-target vessel or any 
peripheral intervention is acceptable if performed anytime >30 
 
5 Investigator should use discretion when enrolling subjects with high CHADS scores. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 16 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
days before the index procedure, or between 24 hours and 30 
days before the index procedure if successful and 
uncomplicated.  
9. Subject requires future staged PCI either in target or non-target 
vessels or subject requires future peripheral interventions < 30 
days after the index procedure 
10. Subject has received any solid organ transplants or is on a 
waiting list for any solid organ transplants. 
11. At the time of screening, the subject has a malignancy that is 
not in remission. 
12. Subject is receiving immunosuppressant therapy or has known 
immunosuppressive or severe autoimmune disease that requires 
chronic immunosuppressive therapy (e.g., human 
immunodeficiency virus, systemic lupus erythematosus, etc.). 
Note: corticosteroids are not included as immunosuppressant 
therapy. 
13. Subject has previously received or is scheduled to receive 
radiotherapy to a coronary artery (vascular brachytherapy), or 
the chest/mediastinum. 
14. Subject is receiving or will require chronic anticoagulation 
therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or 
any other agent for any reason).   
15. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 
cells/mm3.  
16. Subject has a documented or suspected hepatic disorder as 
defined as cirrhosis or Child-Pugh ≥ Class B. 
17. Subject has renal insufficiency as defined as an estimated GFR 
< 30 ml/min/1.73m2 or dialysis at the time of screening.6  
18. Subject is high risk of bleeding for any reason; has a history of 
bleeding diathesis or coagulopathy; has had a significant gastro-
intestinal or significant urinary bleed within the past six months. 
19. Subject has had a cerebrovascular accident or transient ischemic 
neurological attack (TIA) within the past six months, or any 
prior intracranial bleed, or any permanent neurologic defect, or 
any known intracranial pathology (e.g. aneurysm, arteriovenous 
malformation, etc.). 
20. Subject has extensive peripheral vascular disease that precludes 
safe 6 French sheath insertion. Note: femoral arterial disease 
does not exclude the patient if radial access may be used. 
 
6 Estimated GFR can be based on Modification of Diet in Renal Disease (MDRD) equation or Cockcroft-Gault 
equation (CCG).  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 17 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
21. Subject has life expectancy < 5 years for any non-cardiac cause 
or cardiac cause. 
22. Subject is in the opinion of the Investigator or designee, unable 
to comply with the requirements of the study protocol or is 
unsuitable for the study for any reason. This includes 
completion of Patient Reported Outcome instruments. 
23. Subject is currently participating in another clinical trial that has 
not yet completed its primary endpoint.7   
24. Subject is part of a vulnerable population who, in the judgment 
of the investigator, is unable to give Informed Consent for 
reasons of incapacity, immaturity, adverse personal 
circumstances or lack of autonomy.  This may include:  
Individuals with mental disability, persons in nursing homes, 
children, impoverished persons, persons in emergency 
situations, homeless persons, nomads, refugees, and those 
incapable of giving informed consent. Vulnerable populations 
also may include members of a group with a hierarchical 
structure such as university students, subordinate hospital and 
laboratory personnel, employees of the Sponsor, members of 
the armed forces, and persons kept in detention. 
 
Angiographic Exclusion Criteria 
All exclusion criteria apply to the target lesion(s) or target vessel(s).  
1. Lesion which prevents successful balloon pre-dilatation, defined 
as full balloon expansion with the following outcomes: 
 Residual %DS is a maximum < 40% (per visual 
estimation), ≤ 20% is strongly recommended. 
 TIMI Grade-3 flow (per visual estimation).  
 No angiographic complications (e.g. distal embolization, 
side branch closure). 
 No dissections NHLBI grade D-F.  
 No chest pain lasting > 5 minutes.   
 No ST depression or elevation lasting > 5 minutes. 
2. Lesion is located in left main. 
3. Aorto-ostial RCA lesion (within 3 mm of the ostium). 
4. Lesion located within 3 mm of the origin of the LAD or LCX. 
 
7 This includes clinical trials of medications and  invasive procedures. Questionnaire-based studies, or other studies 
that are non-invasive and do not require medication are allowed.  A subject who is taking part in the long-term 
follow-up phase of a trial, who has completed all medications and invasive procedures per protocol requirements, 
may continue to participate in that trial. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 18 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
5. Lesion involving a bifurcation with a:  
a. side branch ≥ 2 mm in diameter, or 
b. side branch with either an ostial or non-ostial lesion with 
diameter stenosis > 50%, or 
c. side branch requiring dilatation  
6. Anatomy proximal to or within the lesion that may impair 
delivery of the Absorb BVS or XIENCE stent:  
a. Extreme angulation (≥ 90°) proximal to or within the 
target lesion. 
b. Excessive tortuosity (≥ two 45° angles) proximal to or 
within the target lesion. 
c. Moderate or heavy calcification proximal to or within 
the target lesion. If IVUS used, subject must be excluded 
if calcium arc in the vessel prior to the lesion or within 
the lesion is ≥ 180°.   
7. Vessel contains thrombus as indicated in the angiographic 
images or by IVUS or OCT.  
8. Lesion or vessel involves a myocardial bridge. 
9. Vessel has been previously treated with a stent at any time prior 
to the index procedure such that the Absorb BVS or XIENCE 
would need to cross the stent to reach the target lesion. 
10. Vessel has been previously treated and the target lesion is within 
5 mm proximal or distal to a previously treated lesion. 
11. Target lesion located within an arterial or saphenous vein graft 
or distal to any arterial or saphenous vein graft. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 19 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Lesion Selection 
Prior to treatment with the assigned device (Absorb BVS or XIENCE), 
vessel sizing by visual estimation must be conducted to appropriately 
match the device to the size of the vessel. Quantitative methods such as 
on-line QCA, IVUS or OCT can be used if deemed necessary per 
physician discretion, but are not required. Details on the vessel sizing 
methods can be found in the Imaging Guidance Document. 
Table 1.0 provides the device sizes, the reference vessel diameter 
(RVD) and lesion length for ABSORB III.  
Table 1.0 Absorb BVS and XIENCE Sizes  
Device 
Lesion and Device Sizes 
RVD 1 
Lesion Length1 
Lead-In 
Absorb BVS 
(Target lesion) 
RVD ≥ 2.75 mm - ≤ 3.25 mm 
 
Scaffold diameter: 3.0 mm 
Lesion length ≥ 8-≤ 14 mm 
Scaffold length: 18 mm 
RCT Absorb 
BVS 
(Target lesion) 
RVD ≥ 2.50 mm - ≤ 3.75 mm 
 
Scaffold diameter: 2.5, 3.0 and 
3.5 mm 
Lesion length ≤ 24 mm 
Scaffold Length2: 8, 12, 18 and 
28 mm 3    
 
RCT 
XIENCE5  
(Target lesion) 
 
RVD ≥ 2.50 mm - ≤ 3.75 mm 
 
Stent diameter: 2.5, 2.75, 3.0, 
3.25 3.5, 4.0 mm 
Lesion length ≤ 24 mm 
Stent Length: 8, 12, 15, 18, 23 
and 28 mm 3  
 
XIENCE  
(Non-target 
lesion) 
Per IFU (RVD ≥ 2.25 mm - ≤ 
4.25 mm can be treated)  
All available sizes 
Per IFU (lesion ≤ 32 mm) 4  
All available sizes 
1 Reference vessel diameter (RVD) and lesion length are based on visual estimation.  
2 Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 diameter Absorb 
BVS.  Only the 12 mm length will be available for the 3.5 mm diameter. The 
commercially approved CE marked 23mm Absorb BVS device will not be used in 
this study. 
3 For target lesion, planned overlapping is not allowed (i.e. the lesion must be eligible 
for treatment with a single stent). However, bailout overlapping is allowed if required. 
4 For non-target lesion, planned overlapping allowed. 
5 XIENCE V, XIENCE Prime, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro, 
and XIENCE ProX are used in this study. 
A minimum of 2 mm (by visual estimation) of normal or nearly normal 
reference vessel at both proximal and distal edge should be covered by 
the device.  
Treatment 
Strategy 
• Treatment of a maximum of two de novo native coronary artery 
lesions, each in a different epicardial vessel. 
o If a single target lesion is treated, it must be treated by the 
assigned device (Absorb BVS or XIENCE). For Lead-In 
subject, the target lesion will be treated only with Absorb BVS. 
o If two lesions are treated, possible combinations are as follows: 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 20 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
o Two target lesions:  
 If both lesions satisfy angiographic inclusion/exclusion 
criteria, then both lesions must be treated by the same 
device that the subject was randomized to (test device: 
Absorb BVS or control device: XIENCE), 
 For Lead-In subjects, both target lesions will be treated 
with Absorb BVS 
OR 
o One target lesion and one non-target lesion: 
 If only one lesion satisfies angiographic inclusion and 
exclusion criteria then this lesion must be treated by the 
assigned device (test device: Absorb BVS or control 
device: XIENCE) as a target lesion and the other lesion 
must be treated by XIENCE as a non-target lesion per 
the instructions for use (IFU).  
 The non-target lesion must be treated first (before 
randomization) with a XIENCE and the patient may 
then only be randomized if treatment of the non-target 
lesion was successful and uncomplicated, defined as 
final diameter stenosis ≤ 10% with final TIMI-3 flow, 
with no residual dissection NHLBI grade ≥ type B, and 
no transient or sustained angiographic complications 
(e.g., distal embolization, side branch closure), no chest 
pain lasting > 5 minutes, and no ST segment elevation or 
depression lasting > 5 minutes. Refer to Figure 2 in 
Appendix V. 
 For Lead-In subjects, treatment of one target lesion and 
one non-target lesion is allowed. The target lesion must 
be treated by Absorb BVS, and the non-target lesion 
must be treated by XIENCE. The non-target lesion must 
be treated first and successfully (as defined above) 
before treating the target lesion with Absorb BVS. 
 
Access Site and Guide Catheter Size: 
• Either femoral or radial access may be used.  
• A minimum 6F guide catheter or greater must be used during the 
index procedure per requirements for Absorb BVS implantation 
(refer to IFU). 
o Minimum guiding catheter compatibility (inner diameter) for 
Absorb BVS is 0.070”/1.8 mm (6F). 
o Devices (i.e., guide sheaths such as the GuideLiner) that 
decrease the inner diameter of the guide catheter outside of the 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 21 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Absorb BVS minimum guide catheter compatibility must not be 
used with the Absorb BVS System. Do not insert a 5-in-6, or a 
6-in-7 guide sheath into a 6F or 7F guiding catheter, 
respectively, as doing so will result in an inner diameter that is 
too small for use with the Absorb BVS. 
o If a guide sheath is necessary, the inner diameter must meet or 
exceed the above minimum guiding catheter requirements for 
Absorb BVS (i.e., only the 7-in-8 GuideLiner provides an 
adequate inner diameter (0.071” ID), 8F guiding catheter would 
be required). 
o For XIENCE, please follow IFU for guiding catheter size. 
 
Baseline Angiogram and Identification of the potential target 
lesion: 
• Assessment of the potential target lesion(s) to be treated must be 
done to ensure angiographic criteria are met; this must occur prior 
to pre-dilatation and vessel sizing. 
 
Pre-dilatation of potential target lesion 
• Pre-dilatation of the potential target lesions(s) must be performed. 
• Pre-dilatation must be performed with an angioplasty balloon; 
cutting or scoring balloons may be used per physician discretion, if 
the lesion appears to be mildly calcified. 
• The pre-dilatation balloon should be sized 1:1 to the visually 
estimated RVD or 0.25 mm smaller than RVD. It cannot be more 
than 0.5 mm smaller than the visually estimated RVD of the target 
vessel. If the pre-dilatation balloon is sized 1:1 a non-compliant 
balloon is strongly recommended. 
The pre-dilatation balloon must be equal in length or shorter than 
the planned scaffold/stent length. 
Important: Full balloon expansion with the pre-dilatation balloon 
must be achieved before the patient is randomized into the study. If 
there is any question that the target lesion was not fully dilated or 
that any significant resistance to expansion from the lesion remains, 
the lesion should be re-dilated with a non-compliant balloon (sized 
1:1 to the RVD) at higher pressure. Absorb BVS or XIENCE must 
not be implanted in a lesion in which full balloon expansion has not 
been achieved. 
• The potential target lesion must continue to meet angiographic 
criteria following adequate pre-dilatation, to be regarded as 
“successful pre-dilatation”. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 22 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
o For randomized subjects, RVD remains ≥ 2.50 mm - ≤ 3.75 
mm, and length of the lesion that will be covered by the device 
(including any edge dissections) is still ≤ 24 mm. 
o For Lead-In subjects, RVD remains ≥ 2.75 mm - ≤ 3.25 mm, 
and length of the lesion that will be covered by the device 
(including any edge dissections) is still ≥8- ≤ 14 mm. 
o Residual %DS is a maximum of < 40% (per visual estimation), 
≤ 20% is strongly recommended. 
o TIMI Grade-3 flow (per visual estimation). 
o No angiographic complications (e.g. distal embolization, side 
branch closure). 
o No dissections NHLBI grade D-F. 
o No chest pain lasting > 5 minutes. 
o No ST depression or elevation lasting > 5 minutes. 
• For two potential target lesions, the lesion with the higher 
possibility of failing vessel sizing criteria (per investigator’s 
assessment) should be identified as the first target lesion and pre-
dilated first before randomization. 
o If pre-dilatation of the 1st target lesion fails, the patient may not 
be randomized, and the interactive voice response system 
(IVRS) must not be called. 
o If the 1st target lesion was successfully pre-dilated and vessel 
sizing criteria are still met, the IVRS is called to randomize the 
subject. Once the first lesion is successfully treated8 with the 
assigned device (and only at this time), the second target lesion 
must be pre-dilated, and then treated with the assigned device. 
o If the 1st target lesion was successfully pre-dilated but did not 
meet vessel sizing criteria, treat as a non-target lesion. Once the 
first lesion is successfully treated as a non-target lesion, the 
second lesion must be treated as the target lesion in which 
successful  pre-dilatation and vessel sizing criteria must be met 
after which IVRS must be called and the target lesion treated 
per assignment. If 2nd target lesion fails pre-dilatation and vessel 
sizing criteria, it should be treated as non-target lesion and 
subject must not be randomized. 
• Each target vessel and lesion should also be such that the operator 
believes either the Absorb BVS or XIENCE devices could be 
delivered to and cross the target lesion without additional lesion 
 
8 Successful lesion treatment is defined as final diameter stenosis ≤ 30% with final TIMI-3 flow, with no residual 
dissection NHLBI grade ≥ type B, and no transient or sustained angiographic complications (e.g. distal 
embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation or depression 
lasting > 5 minutes. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 23 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
preparation (e.g. absence of excessive vessel or lesion tortuosity or 
calcification). 
 
Vessel Sizing 
• Following the use of nitroglycerine (at least 100 µg intracoronary 
nitroglycerine, >150 µg preferred)9 and successful pre-dilatation of 
the potential target lesion(s), vessel sizing must be conducted by 
visual estimation. Quantitative methods such as on-line QCA, 
IVUS or OCT may be used per physician discretion but are not 
required, taking into account that QCA tends to under-estimate 
RVD compared to visual estimation, whereas IVUS tends to over-
estimate lumen RVD compared to visual estimation. Follow core 
laboratory guidelines for the use of each modality. 
• Prior to randomization, IVUS or OCT can be used to evaluate the 
vessel if there is question regarding the eligibility of the vessel 
either before or after pre-dilatation. 
• A subject must not be randomized in ABSORB III if: 
o Vessel size or lesion length before or after pre-dilatation does 
not satisfy eligibility criteria. 
o Moderate or heavy calcification, tortuosity or other conditions 
are present proximal or within the target segment, reducing the 
likelihood that the Absorb BVS or XIENCE can be either 
delivered to or expanded at the lesion. 
o Complications and/or adverse events were identified during 
IVUS or OCT usage (e.g. vessel dissection NHLBI grade D-
F).10 
• Table 2.0 provides the guidance of vessel and device sizing during 
the procedure, which are detailed as the following: 
o First, assess RVD based on visual estimation 
o Then, select a pre-dilatation balloon sized 1:1 to RVD or 0.25 
mm smaller than RVD. For example, for RVD of 2.5 mm, a 
pre-dilatation balloon of 2.25-2.5 mm should be used. 
o Use the size of the inflated pre-dilatation balloon, as well as the 
results after pre-dilatation, to reassess the RVD for appropriate 
vessel sizing for the scaffold or stent. If the reassessed RVD 
after pre-dilatation exceeds the specified range for a specific 
 
9 If the patient’s blood pressure is so low that ≥ 100 ug of nitroglycerine cannot be administered, the patient should 
not be randomized. It is suggested that ≥200 µg of nitroglycerine be administered if the systolic blood pressure is 
>140 mmHg. Timing of nitroglycerine administration and pre-dilatation is per physician discretion, but must be 
before randomization and assessment of scaffold or stent size. 
10 Examples of complications associated with IVUS or OCT: side-branch occlusion, persistent S-T abnormalities, 
prolonged chest pain, flow limiting dissections etc. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 24 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
BVS size, the next available size Absorb BVS can be used. For 
example, if the RVD is reassessed as 2.8 mm after pre-dilatation 
of a vessel that was believed to be 2.5 mm before pre-dilatation, 
then implant a 3.0 mm BVS. 
o Post-dilatation must always be a non-compliant balloon. 
Always make sure the non-compliant post-dilatation balloon has 
a length short enough so it is inflated within the scaffold 
margins to avoid edge dissection. 
Table 2.0 
Vessel and Device Sizing[1]  
Closest RVD 
by Visual 
Estimation 
Pre-dilatation 
Balloon Diameter 
Reassessed 
Closest RVD 
after Pre-
dilatation 
Absorb BVS 
Diameter 
2.5 mm 
2.25 or 2.5 mm 
2.5 mm 
2.5 mm 
2.75 mm 
2.25 – 2.75 mm 
2.75 mm 
3.0 mm 
3.0 mm 
2.5 – 3.0 mm 
3.0 mm 
3.0 mm 
3.25 mm 
2.75 – 3.25 mm 
3.25 mm 
3.5 mm 
3.5 mm 
3.0 – 3.5 mm 
3.5 mm 
3.5 mm 
3.75 mm 
3.25 – 3.75 mm 
3.75 mm 
3.5 mm 
 
Randomization 
• Upon successful treatment of the non-target lesion (if any) and 
completion of successful pre-dilatation and vessel sizing of the first 
target lesion, interactive voice response system (IVRS) can be 
called. 
• A subject is considered registered and in the ITT population at the 
time of randomization. 
• Lead-In subjects will not be randomized but are assigned to Absorb 
BVS treatment in target lesion(s). 
 
Lesion Treatment 
• The length of the Absorb BVS and XIENCE stent should be 
selected to allow at least 2 mm of normal or nearly normal 
reference vessel at each edge. 
• If the Absorb BVS cannot reach or cross the lesion or additional 
lesion preparation is required, the Absorb BVS must be removed 
and a new Absorb BVS must be introduced after subsequent pre-
dilatation(s) with the same sized or larger non-compliant balloon at 
higher pressure. Note: the Absorb BVS should not be “Dottered” 
across the lesion if it does not cross easily. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 25 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• If the Absorb BVS is unable to reach or cross the target lesion after 
multiple attempts (maximum of two Absorb BVS; including 
additional lesion preparation), a XIENCE stent must be used. 
• If XIENCE is unable to reach or cross the target lesion after 
multiple attempts (including additional lesion preparation), the 
investigator should treat the lesion per standard of care. 
• In the case of two target lesions assigned to the Absorb BVS, if the 
first lesion is unsuccessfully treated with the Absorb BVS the 
following must occur:  
o First target lesion must be treated with XIENCE. If the 
treatment of the 1st target lesion is successfully treated with 
XIENCE, treat the 2nd target lesion with Absorb BVS.  
o  If the treatment of the 1st target lesion is unsuccessfully treated 
with XIENCE, treat the 1st lesion and 2nd lesion per standard of 
care. The subject must not be treated with Absorb BVS.  
o Every attempt must be made that the two lesion treatments 
occur at the same index procedure as staged procedures are not 
allowed. However, if a staged procedure does occur, Absorb 
BVS must not be used.  
Successful lesion treatment is defined as final diameter stenosis ≤ 
30% with final TIMI-3 flow, with no residual dissection NHLBI 
grade ≥ type B, and no transient or sustained angiographic 
complications (e.g. distal embolization, side branch closure), no 
chest pain lasting > 5 minutes, and no ST segment elevation or 
depression lasting > 5 minutes.   
• For Absorb BVS, the scaffold should be deployed slowly, by 
pressurizing the delivery system in 2 atm increments each over 5 
seconds, until the scaffold is completely expanded. Pressure should 
be maintained for 30 seconds if tolerated by the patient. 
• For the Absorb BVS and XIENCE delivery balloon, do not exceed 
the rated burst pressure (RBP) per the IFU for the individual device. 
• Post-dilatation of target lesion or non-target lesion treated with 
XIENCE should be per standard of care. 
• If post-dilatation of the target lesion treated with Absorb BVS is 
necessary the following guidance is given: 
o A low profile, high pressure, non-compliant, balloon dilatation 
catheter that has not been previously inflated must be used. 
o The post-dilatation balloon length should be selected such that 
the balloon stays within the margins of the scaffold so as to 
avoid an edge dissection. 
o The expanded diameter of the post dilatation balloon must be 
within the allowable expansion limits of the scaffold. Do not 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 26 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
dilate the Absorb BVS beyond the dilatation limit which is 0.5 
mm above the nominal diameter. Doing so may result in 
scaffold damage. Thus, it is highly recommended that the 
compliance chart of the non-compliant balloon selected must be 
carefully reviewed prior to dilatation and an appropriate 
maximum pressure used to ensure that the scaffold is not over-
dilated. 
Table 3.0 
Scaffold Diameter and Maximum Diameter Limit 
Nominal Scaffold Diameter 
Post Dilatation Maximum 
Diameter Limit 
2.5 mm 
3.0 mm 
3.0 mm 
3.5 mm 
3.5 mm 
4.0 mm 
o The delivery balloon cannot be removed from the body and 
reinserted and used for post-dilatation. 
• During randomization, if a bailout device is required for a target 
lesion (e.g., for edge dissection), the same device as the implanted 
device must be used. 
o Absorb BVS if target lesion is treated with Absorb BVS. 
o XIENCE if target lesion is treated with XIENCE.  
o If a bailout with an Absorb BVS device cannot be delivered to 
the site of the lesion, the device should be carefully withdrawn 
and a XIENCE used. 
o If an appropriate size Absorb BVS is not available XIENCE can 
be used.  
• If during the Lead-In phase a bailout is required, the investigator 
should use an appropriately sized XIENCE stent and not an Absorb 
BVS. 
• Overlap of the bailout stent/scaffold with the implanted 
stent/scaffold should be 1-2 mm; gaps should be avoided.  
• IVUS or OCT guidance may be used as per standard of care in all 
patients.  
• Please refer to the physician training deck for user guidance in 
handling procedural issues (e.g., difficult in recrossing an implanted 
scaffold for purposes such as intravascular imaging or post-
dilatation if needed). 
 
Imaging Cohort  
If subject is in the Imaging Cohort (See Appendix VI and Imaging 
Guidance Document for further details):  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 27 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• Post-procedure angiography, IVUS and OCT are required based on 
respective imaging groups. 
• If post-dilatation was performed, post-procedure imaging must be 
conducted following last balloon inflation. 
• If two target lesions are treated, post-procedure imaging must be 
done on the first target lesion after its successful treatment, and then 
after successful treatment of the 2nd target lesion.    
Antiplatelet11 
Therapy 
Antiplatelet Medication Loading Dose: 
• Aspirin: Subjects must receive a loading dose of ≥ 300 mg of 
aspirin within 24 hours before the procedure, regardless of whether 
the patient was previously taking aspirin 
• Adenosine diphosphate (ADP) antagonist: either clopidogrel, 
prasugrel or ticagrelor may be used as per standard of care and per 
label indications. A loading dose of the ADP antagonist must be 
given within 24 hours prior to the index procedure (preferred) but in 
all cases no greater than 1 hour after the end of the procedure. 
o Clopidogrel: a peri-procedural loading dose 600 mg is 
required 
o Prasugrel: a peri-procedural loading dose of 60 mg is 
required 
o Ticagrelor: a peri-procedural loading dose of 180 mg is 
required.  
• For patients with recent ACS prior to admission, it is strongly 
recommended that the loading dose be given at least 6 hours before 
the procedure (clopidogrel 600 mg), or 1 hour prior to the procedure 
(prasugrel 60 mg or ticagrelor 180 mg), but in all cases no greater 
than 1 hour after the end of the procedure. 
• The prasugrel or ticagrelor loading dose may be omitted for those 
subjects on chronic prasugrel (5 or 10 mg daily) or ticagrelor (90 
mg twice daily) for ≥ 7 days prior to the index procedure. For 
patients maintained on chronic clopidogrel, the loading dose of the 
ADP antagonist must be administered. A loading dose of prasugrel 
or ticagrelor may be safely given to patients maintained on chronic 
clopidogrel therapy, or even in those in whom a clopidogrel loading 
dose was recently administered. 
• Ticlopidine may be used as a substitute at a dose in accordance with 
standard hospital practice only if the subject develops 
 
11  ABSORB III will allow the use of FDA approved P2Y12 inhibitors. Loading and maintenance dosages of all 
P2Y12 inhibitors should follow respective prescribing information. If outside the US, country specific approvals are 
allowed.  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 28 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
hypersensitivity or intolerance to clopidogrel, prasugrel, or 
ticagrelor.  
• Refer to respective prescribing information for ADP Antagonist for 
further details regarding loading practice.  
 
Antiplatelet Medication Post-Procedure Daily Dose: 
• All subjects will be maintained at a minimum of 75 mg of 
clopidogrel daily or 5 or 10  mg of prasugrel daily (10 mg preferred 
in most patients*) or 90 mg twice daily of ticagrelor for a minimum 
of 12 months following the procedure.  
• All subjects must receive ≥75 to ≤100 mg of aspirin daily through 5 
years follow-up during the study and should continue to take aspirin 
indefinitely.  
*For prasugrel subjects < 60 kg in weight or ≥ 75 years of age a 
maintenance dose of 5 mg per day for 12 months is allowable. Patients 
with prior stroke or TIA should receive clopidogrel or ticagrelor, not 
prasugrel. 
Refer to respective prescribing information for ADP antagonist for 
further details regarding maintenance dose.  
Cardiac 
Biomarker 
Collection 
Between Baseline and Discharge 
• Pre-procedure CK and CK-MB draw*  
• First post-procedure CK and CK-MB draw at 6 to 12 hours post-
procedure.  
• Second post-procedure CK and CK-MB draw at 18-24 hours post-
procedure, or at the time of discharge as long as discharge is at or 
after 16 hours post-procedure.** 
• If either of the post-procedure CK-MB levels are ≥ 3 x ULN, serial 
CK and CK-MB levels must be drawn until they are falling. 
• A 12 lead ECG must be obtained at baseline and between 30 and 90 
minutes post procedure 
* If the patient has stable coronary artery disease, the pre-procedure 
level can be obtained during procedure but prior to stent/scaffold 
deployment. If the patient has a recent acute coronary syndrome, the 
pre-procedure level must be obtained prior to the procedure and the 
CK-MB shown to be within normal limits prior to the patient being 
randomized.  
CK and CK-MB levels are required at all time points. If troponin is 
collected at the pre-procedure or post-procedure time points, this should 
also be documented in the electronic case report forms.   

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 29 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
** For hospitals required to discharge stable subjects prior to 16 hours, 
the subject may be discharged but will have to return to the enrolling 
institution for their second biomarker draw. 
Primary 
Analytical 
Population 
The primary analysis population will be the ITT population. 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 30 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
1. 
INTRODUCTION 
The ABSORB III Randomized Controlled Trial (RCT) evaluates the safety and effectiveness of 
the Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System12. The Absorb 
BVS System13 will be compared to the commercially approved, control stent XIENCE. 
ABSORB III also includes a Lead-In phase and an Imaging Cohort and includes a maximum of 
220 sites in the United States and outside the United States. The ABSORB III primary endpoint 
is target lesion failure (TLF) (cardiac death, target vessel myocardial infarction and ischemia-
driven target lesion revascularization) at 1 year.  
The Absorb BVS used in the ABSORB III trial is the Absorb BVS System manufactured in 
Temecula California [Absorb BVS System (mfg TEM)]13.  Clinical trials in the ABSORB 
Clinical Program have utilized the Absorb BVS System manufactured in Mountain View 
California (mfg MTV).  The Absorb BVS System (mfg TEM) introduces eight additional sizes to 
the Absorb BVS System product matrix for ABSORB III (Refer to Table 4.1).  Concurrent with 
the manufacturing site transfer, Abbott Vascular has implemented design and manufacturing 
enhancements to increase product robustness and product ease of use (Refer to Section 2.1.4.6). 
Hereinafter, Absorb BVS System (mfg TEM)13 will be known as Absorb BVS, unless specified.  
ABSORB III is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-
center trial, registering approximately 2250 subjects. This is the pivotal trial to support the US 
PMA approval of Absorb BVS. The primary objective of ABSORB III is to evaluate the safety 
and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of 
subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions 
in separate epicardial vessels. The primary endpoint data from this trial will be based on 
approximately 2000 subjects and will support label claims of non-inferiority of Absorb BVS as 
compared to XIENCE in 1-year TLF. The ABSORB III will also include a Lead-In Phase and an 
Imaging Cohort. The ABSORB III will also support a diabetes indication for Absorb BVS. 
Lead-In Phase 
A non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at 
up to 35 US sites. The objective of the Lead-In is to evaluate the applicability and transferability 
of the didactic Absorb BVS physician training plan to US clinical practice. The Lead-In Phase 
will enroll/register subjects prior to the randomization in ABSORB III.  
Imaging Cohort  
A prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center cohort, 
registering approximately 200 subjects. The 200 subjects are separate from the 2000 subjects 
included in the primary endpoint analysis. The objective of the Imaging Cohort is to evaluate 
long-term vascular function and patency of the Absorb BVS treated segments compared to 
XIENCE treated segments. Data from two powered secondary endpoints from this cohort will 
 
12 The commercially approved CE marked device will be used in geographies where it is commercially available. 
13 The Absorb™ Bioresorbable Vascular Scaffold (BVS) System is the trade name for this product. During the 
course of development, multiple product names were used to describe this product including, Bioresorbable 
Vascular Scaffold (BVS) System, Bioabsorbable Vascular Stent, BVS Everolimus Eluting Coronary Stent System 
(EECSS), Abbott Vascular Bioabsorbable Device (AVBD) EECSS, BVS Cohort A (used in the ABSORB Cohort A 
trial) and BVS Cohort B (used in the ABSORB Cohort B trial). 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 31 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
support label claims of superiority of Absorb BVS as compared to XIENCE specific to 
vasomotion and late lumen enlargement. 
After the completion of Lead-In Phase, enroll/registration of the 2000 subjects for the primary 
analysis and the 200 subjects in the Imaging Cohort will begin. All trial elements will apply to 
Lead-In Phase and the Imaging Cohort, unless otherwise specified. 
Figure 1.1 provides the complete ABSORB III design.  
  
Figure 1.1:  ABSORB III  Overall Design 
In addition, all 2,000 primary analysis subjects in ABSORB III will complete patient-reported 
outcome (PRO) self-administered questionnaires at baseline, 30 days, 1, 2 and 3 years (EQ-5D, 
SAQ, RDS, GAD-7) and at 5 years (EQ-5D, SAQ).  
The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in 
different epicardial vessels with RVD ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 
mm. All other subjects in ABSORB III unless specified will receive treatment of up to two de 
novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 
mm and lesion lengths ≤ 24 mm.  
All subjects (including Lead-In) will be screened per the protocol inclusion and exclusion criteria 
and registered subjects will have clinical follow-up at 30 days, 180 days, and 1, 2, 3, 4, and 5 
years. Subjects in the Imaging Cohort will receive imaging follow-up at 3 years for angiography 
and IVUS or OCT.  
ABSORB III 
Randomized 2:1 (BVS :XIENCE) 
N=2250   
Primary EP:1 yr TLF Non-inferiority of Absorb BVS vs. XIENCE
 
ABSORB 
Imaging  Cohort
                   
Randomized 2:1 (BVS :XIENCE) 
N=200
Powered Secondary EPs: Superiority of 
Absorb BVS to XIENCE at: 
1) 3 yrs with vasomotion (n=200)  
2) 3 yrs late lumen enlargement (n=150)
Descriptive assessment of target lesion by 
OCT (n=50)
Non-randomized: 
Absorb BVS only
Primary objective:                           
Evaluation of physician training
N= up to 50 subjects 
ABSORB Lead-In 
Group

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 32 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
2. 
BACKGROUND INFORMATION 
2.1 
Summary of Investigational Device 
2.1.1 Name of the Investigational Device 
The investigational device to be used in this trial is the Absorb BVS System14. In this protocol, 
the investigational scaffold or test device is referred to as “the Absorb BVS”. The Absorb BVS 
System is manufactured by Abbott Cardiovascular Systems, Inc., California, an affiliate of 
Abbott Vascular, Inc. 
2.1.2 Intended Indication 
The Absorb Bioresorbable Vascular Scaffold (BVS) is a temporary scaffold that will fully resorb 
over time and is indicated for improving coronary luminal diameter in patients, including those 
with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions 
(length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. 
2.1.3 Absorb BVS Features 
The Absorb BVS is a bioresorbable balloon-expandable scaffold with a drug and bioresorbable 
polymer coating. After implantation, the scaffold supports the vessel mechanically for an 
appropriate period. It is then resorbed in the body and the polymer material becomes 
undetectable over time. In contrast, currently available commercial coronary stents are made of 
metal, which resides permanently in the body. 
The first therapeutic catheterization for coronary artery stenosis was performed by Andreas 
Gruentzig in 1977. Percutaneous transluminal coronary angioplasty (PTCA) with a balloon was 
the first therapy which became commonly performed. After a vessel is treated by PTCA 
restenosis, which may require additional treatment, can occur due to 1) acute recoil, 2) 
remodeling, and/or 3) neointimal proliferation. A stent can minimize the occurrence of recoil and 
remodeling by mechanically supporting the vessel lumen. However, the vessel support is 
required only for approximately three - six months to prevent recoil and remodeling [2-4] , and 
an implanted stent after this period may no longer be necessary. 
 
 
  
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
  
  
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
14 The commercially approved CE marked device will be used in geographies where it is commercially available. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 33 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
   
 
  
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
 
 
 f 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
   
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
After the Absorb BVS becomes structurally discontinuous, it ceases to perform any scaffolding 
role and may be considered functionally inert.  The sole remaining design objective of the 
remaining implant is that it be resorbed in a benign fashion.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
  
 
  
  
   
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
    

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 34 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
2.1.4 Description of the Investigational Device 
The Absorb BVS System is a balloon-expandable, drug-eluting bioresorbable vascular scaffold, 
where the components of the Absorb BVS System include: 
• A bioresorbable poly(L-lactide) (PLLA) scaffold backbone. 
• A coating comprised of the active pharmaceutical ingredient everolimus and 
bioresorbable poly(D,L-lactide) (PDLLA). 
• Four platinum marker beads, two each embedded at the proximal and distal ends 
of the scaffold for radiopacity. 
• A delivery system similar in design, materials, and performance to that of the 
MULTI-LINK VISION® Rapid Exchange (RX) Coronary Stent System (CSS) 
and MULTI-LINK MINI VISION® CSS 
 
 
. 
2.1.4.1 
Polylactide 
Bioresorbable polymers have been the subject of extensive scientific research and commercial 
development in fields as diverse as food packaging and biomedical devices.  Polylactide (PLA) 
and its copolymers have a long history of use in medical devices starting with bioresorbable 
sutures in the 1960s. These polymers are now used in a wide range of bioresorbable implants, 
including:  orthopedic devices such as plates, pins and screws; drug delivery systems such as 
solid implants and gel based systems; suture anchors; peripheral bioabsorbable stents; and 
surgical mesh and clips. Prior experience with bioresorbable polymers in human applications 
includes the Angio-Seal™ vascular closure device (St. Jude Medical) [9], BioMatrix™ drug-
eluting stent (Biosensors International Ltd.) [10], the Bio-Corkscrew™ full-threaded suture 
anchor (Arthrex, Inc.) [11], (Longo) and the Igaki-Tamai® bioabsorbable stent (Kyoto Medical 
Planning Co Ltd.) [12].  The Angio-Seal device, fabricated in part from poly(lactide-co-
glycolide) (PLGA), reveals that the release of degradation products from a bioresorbable device 
is well tolerated by a blood vessel. The BioMatrix DES contains a PDLLA coating, which 
controls the drug release into the coronary tissue and bloodstream.  The Bio-Corkscrew suture 
anchor exemplifies the safe use of PDLLA to fix sutures (soft tissue) to bone in rotator cuff 
repair.  The Igaki-Tamai stent, made completely from PLLA, demonstrates the intrinsic safety of 
that material when used in coronary arteries, and this stent received CE mark for peripheral 
vascular application.  Finally, the Absorb BVS System is currently CE Marked as a temporary 
scaffold indicated for improving coronary luminal diameter that will eventually resorb and 
potentially facilitate normalization of vessel function in patients with ischemic heart disease due 
to de novo native coronary artery lesions. 
PLA is a member of the aliphatic polyester family of materials. The lactide monomer from which 
PLA is synthesized is a cyclic di-ester of lactic acid, which is a chiral molecule with two optical 
isomers, L-lactic acid and D-lactic acid.  When lactide is prepared from a racemic mixture of 
lactic acid, one obtains three isomers, namely D-lactide, L-lactide, and meso-lactide.  The meso-
lactide isomer is readily separated from the other two isomers.  Polymerization of pure L-lactide 
or D-lactide leads to the optically active and crystallizable PLLA and poly(D-lactide) (PDLA), 
respectively.  Polymerization of a racemic mixture of L-lactide and D-lactide leads to the 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 35 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
optically inactive and amorphous PDLLA, which is a random copolymer containing equal 
numbers of L- and D-lactide monomer subunits.  
PLLA is a semicrystalline polymer whose degree of crystallinity and crystalline microstructure 
are dependent upon the thermal and deformation history during processing.  The high tensile 
strength and modulus of PLLA make it suitable for load bearing applications.  PLLA has a 
maximum crystallinity of approximately 70%, a melting temperature (Tm) of 170 - 180°C, and a 
glass transition temperature (Tg) of 55 - 65°C [13, 14]. 
PDLLA is a random copolymer derived from an equimolar mixture of D- and L-lactide.  PDLLA 
is characterized by a lower tensile strength and higher elongation than PLLA due to its 
amorphous structure.  Because amorphous polymers lack crystalline structure, they do not have 
melting temperatures but instead begin to flow at temperatures in excess of Tg [13, 14].  
2.1.4.2 
PLLA Scaffold 
The Absorb BVS is a bioresorbable balloon-expandable scaffold with a drug and bioresorbable 
polymer coating.  
 
 
  
 
 
 
  
 
  
 f 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 f 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Two permanent platinum markers are embedded at each end 
ring to enable fluoroscopic visualization.  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 36 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
 
 
 
 
2.1.4.3 
Absorb BVS Bioresorbable Coating 
The Absorb BVS bioresorbable polymer drug coating is a single drug/polymer matrix layer 
comprised of the amorphous random copolymer PDLLA, which contains and controls the release 
of the drug, everolimus.  Everolimus is an anti-proliferative (Afinitor, Novartis Pharmaceuticals 
Corp.) that is blended with PDLLA in a 1:1 (w:w) proportion and applied to the entire surface 
(i.e., sidewalls, luminal and abluminal) of the PLLA scaffold. 
  
 
 
  
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
2.1.4.4 
Everolimus 
Everolimus [40-O-(2-hydroxyethyl)-rapamycin], which is provided to Abbott Vascular by 
Novartis Pharmaceuticals Corporation, is a novel semisynthetic macrolide immunosuppressant, 
 
15 RPT2068797 Drug Content Along the Length of BVS Stents 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 37 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
obtained through chemical modification of Rapamycin.  Rapamycin (INN: sirolimus) is a 
secondary macrolide metabolite that is produced by certain actinomycete strains.  The oral 
formulation of everolimus16 known as Certican® (Novartis Pharmaceuticals Corporation), 
outside the United States and as Zortress® in the U.S., is for the prevention of organ transplant 
rejection.  Novartis Pharmaceuticals Corporation has granted Abbott Vascular the right to 
reference Certican’s IND 52,003, NDA No. 21-560 and NDA No. 21-638.  Additionally, the oral 
formulation of everolimus known as Afinitor® (Novartis Pharmaceuticals Corporation) is 
approved as of March 30, 2009, in the U.S. for the treatment of patients with advanced renal cell 
carcinoma after failure of treatment with sunitinib or sorafenib.  Everolimus has also been used 
in similar dosing on the CE Marked and FDA approved XIENCE permanent vascular implants.   
The nominal drug dose per scaffold size of BVS and XIENCE is given in Table 2.1. 
 
 
 
16 AFINITOR Highlights of Prescribing Information, Novartis Pharma Stein AG, March 2009; Zortress Prescribing 
Information, Novartis Pharma Stein AG, 2010; Certican Investigator’s Brochure Novartis. October 2, 2009.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 39 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
2.1.4.5 
Delivery System 
The Absorb BVS delivery system is similar in design, materials, and performance to that of 
MULTI-LINK VISION RX CSS 
 
 
, which is commercially approved 
in more than 80 countries, including the United States, Canada and European Union. That 
delivery system is also similar to that of XIENCE V RX Stent System 
 and MULTI-
LINK RX ZETA CSS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  The overall length of the catheter is 143 cm. 
Two radiopaque balloon markers are located on the distal segment of the inner member and are 
positioned to mark the working length of the balloon.  The scaffold is mounted such that the 
markers reflect the expanded scaffold length.  The radiopaque markers aid in positioning the 
scaffold fluoroscopically and accurately positioning the delivery system for post-deployment 
dilation, if necessary.  Two non-radiopaque markers are attached to the proximal end of the shaft 
of the Absorb BVS delivery system, specifically 95 cm and 105 cm proximal to the distal tip.  
These two markers indicate when the distal tip of the catheter exits the tip of a brachial or 
femoral guiding catheter, respectively.  
A single arm adapter is attached to the proximal end of the catheter and accesses the 
inflation/deflation lumen.  The proximal shaft is thermally bonded to a nylon adaption cup, 
which is mechanically sealed to the single arm adapter with a polycarbonate nosepiece.  The 
nosepiece is threaded onto the single arm adapter, and these are bonded together with methylene 
chloride.  
A 0.014 inch (0.36 mm) or smaller diameter guide wire can be used in the guide wire lumen.  
The guide wire exits the guide wire lumen at the guide wire exit notch, which is formed at the 
junction of the mid-shaft and the intermediate shafts.  Proximal to this point, the guide wire runs 
externally alongside the proximal shaft of the catheter.  
2.1.4.6 
Absorb BVS Device Comparisons 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
  
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 40 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
  
 
  
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
  
 f 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
  
 
 
Table 2.2 
Absorb BVS System Product Size Matrix 
 
 
Product Length (mm) 
Product Diameter (mm) 
8 
12 
18 
28 
2.5 
X 
X 
X 
X 
3.0 
X 
X 
X 
X 
3.5 
 
X 
X 
X 
A = Anticipated additional size. 
X = Size currently available. 
 
Please note that the commercially approved CE marked 23mm Absorb BVS device will not be 
used in this study. 
2.1.5 Description of the Control Device  
The commercially available XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE 
Alpine, XIENCE Pro, and XIENCE ProX 17 Stent Systems will serve as the control device. 
Hereinafter, these devices will be called “XIENCE” in this trial. 
XIENCE Pro is a rebranding (re-labelling) of the commercially available XIENCE V and 
XIENCE PRIME. XIENCE ProX is a rebranding of the commercially available XIENCE 
Xpedition. XIENCE Pro and XIENCE ProX are only approved for use outside the US. 
The XIENCE is composed of a drug coated stent and balloon expandable delivery system. The 
drug coating is composed of two polymers and the anti-proliferative drug everolimus. The 
delivery system used in this trial utilizes the same principle of operation as other Abbott 
Vascular Rapid Exchange (RX) coronary stent systems and coronary dilation catheters. The 
XIENCE is fabricated from a single piece of medical grade L-605 Cobalt Chromium (CoCr) 
 
17 For geographies where these devices are commercially available, the investigational sites may use only their 
locally approved devices. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 41 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
alloy.  This alloy can be formed into thinner stent struts than traditional stainless steel stents, and 
provides a more flexible, low delivery system profile while maintaining adequate radiopacity and 
strength.  For more details on the XIENCE please refer to the XIENCE V, XIENCE PRIME, 
XIENCE Alpine, XIENCE Pro, and XIENCE ProX IFUs. 
2.1.6 Investigational Device Accountability 
The Sponsor will ship the investigational devices (Absorb BVS System) to the Primary 
Investigator (or designee) only at each site. In geographies using the commercially available CE 
marked device, the investigators will acquire the product through their normal commercial 
vendors. The Primary Investigator will maintain adequate records of the receipt and disposition 
of the investigational device, including part number and serial number, date implanted, patient 
identification [ID] number and implanting physician. An Inventory Accountability Report will be 
generated for this purpose. In geographies not using the commercially available CE marked 
device, any unused investigational devices will be returned to the Sponsor and a completed 
Inventory Accountability Report will be generated for the site when the enrollment phase of the 
study is complete. The Inventory Accountability Report must document the disposition of all 
investigational devices including those that have been returned to the Sponsor. Use of any 
investigational device outside of the protocol (e.g., compassionate use) is strictly forbidden and 
may constitute grounds for removal of the investigator/site from the study. In geographies using 
the commercially available CE marked device, the commercial device may be used in non-trial 
patients. The sites will manage the XIENCE and the commercially available CE marked Absorb 
BVS device supplies for this trial without sponsor oversight and the device should be used in 
accordance with the IFU. In sites using commercially available CE marked devices (XIENCE 
and Absorb BVS), the primary investigator will maintain records of device usage for the study 
subjects. The records will contain device part number and serial number, date implanted, patient 
identification number, and implanting physician. 
2.1.7 Summary of Pre-Clinical Studies 
A comprehensive series of animal studies have been conducted to demonstrate safety of the 
Absorb™ Bioresorbable Vascular Scaffold (BVS) System18.  
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
  
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Consistent 
preclinical safety has been demonstrated among the BVS Cohort A device (1 to 48 months), the 
 
18 The Absorb™ Bioresorbable Vascular Scaffold (BVS) System is the trade name for this product.  During the 
course of development, multiple product names were used to describe this product including, Bioresorbable 
Vascular Scaffold (BVS) System, Bioabsorbable Vascular Stent, BVS Everolimus Eluting Coronary Stent System 
(EECSS), Abbott Vascular Bioabsorbable Device (AVBD) EECSS, BVS Cohort A (Gen. 1.0) (used in the 
ABSORB Cohort A trial) and BVS Cohort B (Gen.1.1) (used in the ABSORB Cohort B trial). 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 42 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Absorb BVS (mfg MTV) (3, 28, 90, 180 days and 12, 18, 24, and 30 months), and the Absorb 
BVS (mfg TEM) (28, 90, and 180 days).   
Experience in the preclinical setting has been cumulative among these devices because of the 
similarities they share. Studies conducted using the Cohort A device include a 90-day 
pharmacokinetics study, a safety study at 28 and 90 days, a safety study from 1 to 48 months, 
and a degradation study at 10, 12, 18, 24 and 36 months. These studies were conducted in 
porcine coronary arteries. Additionally, a 3 to 36 months safety study was conducted in rabbit 
iliac arteries. Studies conducted for the Absorb BVS (mfg MTV) include an up to 90-day 
pharmacokinetics study; two safety studies with collective evaluations at 3, 28, 90, 180 days and 
12, 18, 24, and 30 months; a 28-day and a 90-day overlap safety study; and two in vivo 
degradation studies with collective evaluations at 28, 90, and 180 days and at 12, 18, 24, and 30 
months.  These studies were conducted in porcine coronary arteries.  Studies conducted for the 
Absorb BVS (mfg TEM) include an up to 90-days pharmacokinetics study and three safety 
studies (28, 90, and 180 days).  
With respect to pharmacokinetics, studies conducted demonstrate bioequivalence of Absorb BVS 
(mfg MTV) and Absorb BVS (mfg TEM) with 78-79% of everolimus being released at 28 days 
and 96% at 90 days.  Bioequivalence of the drug release profiles was not only demonstrated 
between the Absorb BVS (mfg MTV) and the Absorb BVS (mfg TEM), but also between the 
Absorb BVS (mfg MTV and mfg TEM) and the XIENCE V Everolimus Eluting Coronary Stent.  
Therapeutic concentrations of everolimus were maintained in target vessels for at least 28 days 
following implantation of Absorb BVS (mfg MTV and mfg TEM).  A systemic safety profile of 
Absorb BVS (mfg MTV and mfg TEM) was also demonstrated in the PK studies. 
Safety of the BVS Cohort A device was demonstrated in two studies in porcine coronary arteries 
using CYPHER (1 to 48 months) and VISION (28, 90 days) controls and in rabbit iliac arteries 
using a CYPHER control (3 to 36 months).  Safety of the Absorb BVS (mfg MTV) was 
confirmed in single configuration at 3, 28, 90, 180 days and at 12, 18, 24, and 30 months and in 
overlapping configuration at 28 and 90 days in porcine coronary arteries using XIENCE V 
(single and overlapping) as the respective control. Absorb BVS (mfg TEM) demonstrated safety 
in porcine coronary arteries at 28, 90, and 180 days. Collectively, comparable safety to the 
respective control device(s) was demonstrated through the maintenance of lumen patency, 
sequestration of struts in a benign neointima, near to complete endothelialization by 28 days 
(single) and 90 days (overlapping), and inflammation that was within pre-established safety 
acceptance criteria.  Luminal thrombosis, medial necrosis, and medial thinning were not 
observed in any of these studies.  From 24 to 48 months in arteries implanted with BVS Cohort 
A device, resorption sites representing pre-existing struts were benignly integrated into the 
arterial wall. Degradation studies conducted for Absorb BVS (mfg MTV) demonstrate up to 74% 
resorption by 30 months with no adverse responses, and Absorb BVS (mfg TEM) is expected to 
have similar jn vivo degradation based on the similar material composition and in vitro 
degradation rates through 180 days shared by Absorb BVS (mfg MTV) and Absorb BVS (mfg 
TEM).  
The Absorb Cohort A BVS System and the Absorb BVS (mfg MTV and mfg TEM) demonstrate 
commensurate safety and function at revascularization, which relates to both luminal support and 
everolimus suppression of neointimal hyperplasia. Collectively the results from this series of 
animal studies support the validity of commencing clinical studies using the Absorb BVS in this 
trial. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 43 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
2.1.8 Previous Clinical Studies 
While drug-eluting metallic stents have significantly reduced restenosis rates after PCI, longer 
treatment areas covered by metallic stents may preclude surgical revascularization.  Further, the 
absence of a permanent stent may favor maintained luminal patency associated with remodeling. 
Additionally, bioresorbable scaffolds can act as a vehicle for local therapy and are amenable to 
non-invasive cardiovascular imaging. There is angiographic and clinical evidence from a small 
number of recent studies demonstrating that the bioresorbable stent/scaffold is associated with 
low restenosis and adverse event rates.  However, due to the limited number of studies, small 
sample size, and short-term follow-up, long-term studies are warranted evaluating the 
bioresorbable scaffold.  
2.1.8.1 
Bioresorbable Stent/Scaffold 
Early Bioresorbable Stent/Scaffold Prototypes 
The first bioresorbable stent was developed at Duke University in the early 1980s. The stents 
made from PLLA were implanted in canine femoral arteries. The strut surface was completely 
endothelialized at 2 weeks and the vessels remained patent at 12 weeks post-implantation. No 
inflammatory response and no thrombosis were observed [15, 16]. This technology subsequently 
was acquired by Guidant Corporation, and now Abbott Vascular.  
Igaki-Tamai Stent 
Tamai et al were the first group to provide clinical investigation data with PLLA implant in 
humans.  A prospective, unblinded Clinical Investigation was carried out to assess the feasibility 
and safety of the Igaki-Tamai stents. Fifty subjects electively underwent percutaneous coronary 
artery intervention (PCI) for coronary artery stenosis with the Igaki-Tamai stent over a period of 
19 months. There were 63 lesions in Japan that were enrolled in the study from September 1998 
to April 2000 in which a total of 84 Igaki-Tamai stents were received. Angiographic follow-up 
was performed for the first 19 lesions at 3 months and 6 months and the percent diameter 
stenosis (%DS) was 33% at both of the follow-up time points [12]. This was comparable to the 
%DS at 6 months post-implantation of BMS (29.2% in VISION stent; 34.6% in TETRA stent). 
Clinical follow-up was performed at up to 4 years, and MACE rate at 4 years was reported as 
18%[17]. Stent struts were not visible during IVUS follow-up at three years [18]. Additionally, 
one subject was followed at 9 years and good patency was observed by optical coherence 
tomography OCT (Figure 2.3) [19]. Recently, 10 year plus follow-up data was presented on the 
50 patients that received Igaki-Tamai stents. Survival rates for freedom from all-cause death, 
cardiac death and MACE (all death, non-fatal MI and target lesion revascularization/target vessel 
revascularization (TLR/TVR)) were 87%, 98% and 50%, respectively [20]. The 10 year TLR 
rate was 28% and there were 2 cases of definite scaffold thromboses in which one was subacute 
and one was very late (10 years after implant) in which the patient had a sirolimus eluting stent 
proximal to two Igaki-Tamai stents. Angiographic data from 6 months to 3 years showed an 
increase in minimum lumen diameter (1.76±0.74 mm to 2.22±0.56 mm) and a decrease in % 
diameter stenosis (%) (38±22 to 25±18). IVUS evaluation of the target vessel found that after 36 
months the  Igaki-Tamai stents struts had disappeared and from 6 months to 3 years the 
minimum lumen area  (3.64±1.68 mm2 to 5.18±2.09 mm2) and the vessel area (external elastic 
membrane) increased.  The balloon-expandable (i.e., heating not required) Igaki-Tamai 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 44 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
peripheral stent was evaluated in the PERSEUS clinical trial [21], of which results supported 
approval for CE mark (November 29, 2007). 
 
Figure 2.3:  OCT Images of Igaki-Tamai Stent at 9 Years 
 
A: Proximal marker; C: Distal marker; B: Bifurcation 
The lumen was smooth and strut footprints were not observed. 
 
2.1.9 ABSORB TRIALS 
ABSORB Cohort A 
Since the development of the drug-eluting stent, there have been significant improvements in 
PCI clinical outcomes [22-27]. The next endeavor into PCI is the use of polymeric scaffolds, 
such as the Absorb BVS System.  Early evidence with the first iteration of the Absorb BVS 
System (Absorb Cohort A BVS System) demonstrates similar performance to that of DES, as 
well as similar physiological and functional changes to the treated region of the vessel. The First 
in Man ABSORB Cohort A Trial represents the first clinical evaluation of the safety and 
performance of the Absorb Cohort A BVS System. The ABSORB Cohort A Trial enrolled 30 
subjects from 4 clinical sites (the Netherlands, Poland, Denmark, and New Zealand) from March 
7, 2006 to July 18, 2006. Subjects with visually estimated nominal vessel diameters of 3.0 mm 
and lesion(s) length ≤ 14 mm were enrolled.  They received a single 3.0 x 12 mm or 3.0 x 18 mm 
Absorb Cohort A BVS System. The 6-month angiographic in-device late loss (LL) of the Absorb 
Cohort A BVS System was 0.43 mm, which was larger than the in-stent LL of the XIENCE V 
stent in the SPIRIT FIRST trial (0.10 mm), but superior to bare metal stents (0.85 mm). The 
greater late loss associated with the Absorb Cohort A BVS System device was due to scaffold-
area loss, suggesting that the scaffold may have prematurely lost the ability to provide luminal 
support [28] . Contrarily, neointimal proliferation observed in IVUS was smaller compared to the 
XIENCE V stent (mean neointimal area of the Absorb Cohort A BVS System: 0.30 ± 0.44 mm2 
vs. XIENCE V: 0.61 ± 0.75 mm2) [29]. Average lumen area significantly decreased between 
post-procedure and 6-month time points, while it significantly increased between 6-month and 2-
year time points. Vessel area between  baseline and the 6-month and 2-year time points remained 
constant demonstrating the absence of negative remodeling. Vasomotion measurements 
conducted at 2 years showed preliminary indications of restoration of vessel movement in the 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 45 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
treated segment as well as in the distal and proximal segments [30]. Currently, 5-year follow-up 
has been completed in the Cohort A and there have been no changes in the endpoint event rates 
between 6 months and 5 years, in which only one ischemic MACE event (NQMI) was reported 
in the first 6 months of the trial. No scaffold thromboses have occurred in the Cohort A through 
5 years of follow-up. 
ABSORB Cohort B 
Based upon the safety results of the BVS Cohort A device, Cohort B of the ABSORB trial was 
initiated on March 19, 2009 to evaluate Absorb BVS System (mfg MTV), and completed 
enrollment on November 6, 2009 with 101 subjects split into two groups: Group 1, n=45 
(imaging follow-up at 180 days and 2 years) and Group 2, n=56 (imaging follow-up at 1 year and 
3 years).  
 
 
 
 
 
 
  
  
 
  
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
.  Cohort B is a prospective, open-labeled, multi-center registry that enrolled 
subjects with up to two de novo native coronary artery lesions in separate epicardial vessels with 
visually estimated nominal vessel diameters of 3.0 mm and lesion(s) length ≤ 14 mm.  All 
subjects in Cohort B received a single 3.0 x 18 mm BVS Cohort B device per lesion treated. The 
6-month angiographic results from Cohort B Group 1 demonstrated a late loss of 0.19 mm which 
is similar to the 0.10 mm late loss of the 3.0 x 18 mm XIENCE V observed in the SPIRIT FIRST 
trial and compares favorably with the 0.43 mm late loss from Cohort A. At 180 days, the IVUS 
results from Cohort B Group 1 showed limited intra-scaffold neo-intimal hyperplasia, the 
volume obstruction (VO) was 1.2% and the neointimal hyperplasia (NIH) area was 0.08 mm2. 
These results compare favorably with XIENCE V in SPIRIT FIRST (VO of 8.0% and NIH area 
of 0.56 mm2) and with Cohort A (VO of 5.3% and NIH area of 0.29 mm2).  As observed in 
Cohort A, the 6-month IVUS results showed a significant reduction in the average lumen area 
(6.60 ± 1.22 mm2 after procedure vs. 6.37 ± 1.12 mm2 at 180-day, p=0.0048). This was much 
lower than that found for the Cohort A BVS System (6.08± 1.13 mm2 after procedure vs. 5.07± 
1.22 mm2, p=0.0001, at 180-day).  The vessel area remained comparable between baseline and 
180-day follow-up (14.22 ± 3.75 mm2 vs. 14.49 ± 3.67 mm2) demonstrating the absence of 
negative remodeling. 
QCA and IVUS results from baseline, post procedure and 2 year are available for the patients in 
Cohort B Group 1. The 2-year angiographic results from Cohort B Group 1 demonstrated a late 
loss of 0.27 mm which compares well to the SPIRIT II XIENCE V 2 year late loss of 0.33 mm. 
Furthermore, in Cohort B Group 1 (n=33) IVUS data demonstrated lumen, scaffold and vessel 
enlargement between 6 months and 2 years (Table 2.3).  
Table 2.3: 
ABSORB Cohort B Group 1: IVUS Results through 2 Years 
 
Post-procedure 
6 Months 
2 years 
p-value post 
vs. 2 years 
p-value 6 m vs. 
2 years 
Average vessel area 
(mm2) 
14.04 ± 3.80 
14.44 ± 3.82 
15.35 ± 
4.05 
< 0.0001 
< 0.0001 
Average scaffold 
area (mm2) 
6.53 ± 1.23 (33) 
6.42 ± 1.17 
7.08 ± 1.73 
0.0035 
< 0.0001 
Average lumen 
area 
6.53 ± 1.24 
6.36 ± 1.18 
6.85 ± 1.78 
0.3515 
0.0105 
Based on paired analysis. P-values from Wilcoxon signed rank test.   

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 46 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Table 2.4 shows clinical outcomes through 2 years for all subjects (n=100)19 in the ABSORB 
Cohort B Trial. There have been no cardiac deaths through 1 year and the MI rate has remained 
low at 3% from 180 days to 2 years, in which all were non-Q wave MIs. There have been 6 
TLRs, resulting in an overall 2-year MACE rate of 9%. As of 2 years no scaffold thromboses 
have been reported.   
Table 2.4: 
ABSORB Cohort B clinical endpoint event rates through 2 Years 
 
30 Days 
6 Months 
12 Months 
24 Months 
 
N=101 
N=101 
N=101 
N=100 
Cardiac Death %  
0 
0 
0 
0 
Myocardial Infarction 
% (n) 
2.0(2) 
3.0(3) 
3.0(3) 
3.0(3) 
 Q-wave MI 
0 
0 
0 
0 
 Non Q-wave MI (n) 
2.0(2) 
3.0(3) 
3.0(3) 
3.0(3) 
Ischemia driven TLR 
%  
0 
2.0(2) 
4.0(4) 
6.0(6) 
  CABG 
0 
0 
0 
0 
  PCI (n) 
0 
2.0(2) 
4.0(4) 
6.0(6) 
Hierarchical MACE % 
(n) 
2.0 (2) 
5.0 (5) 
6.9 (7) 
9.0 (9) 
MACE: Cardiac death, MI, ischemia-driven TLR 
TVF: Cardiac death, MI, ischemia-driven TLR, ischemia-driven TVR 
MI per protocol definition used in SPIRIT III and SPIRIT IV 
Three year results for ABSORB Cohort B Group 1 (N=44) have been presented at TCT 2012.20  
At 3 years, the MACE rate was 6.8%, the MI rate was 2.3%, and the ID-TLR rate was 4.5%; all 
of these were unchanged from 2 years, reflecting that there were no new MACE in this 
population between 1 year and 3 years.  In addition, there were no scaffold thrombosis events by 
ARC or protocol definitions, and there were no cardiac death.  There was one new non-TLR 
TVR between 2 and 3 years that contributed to a 3 year hierarchical TVF rate of 9.1%.  
Vasomotion measurements conducted at 1 year (Cohort B Group 2, N = 32) and at 2 years 
(Cohort B Group 1, N = 33) showed preliminary indications of restoration of vessel movement in 
the treated segment.21  
ABSORB EXTEND 
ABSORB EXTEND is an open label, single-arm, continuous access trial targeted to enroll 
approximately 1000 patients in up to 100 worldwide sites across Europe, Asia-Pacific, Latin 
America, and Canada.  This is a safety and performance trial aimed at enrolling a large clinical 
cohort with some exclusion criteria, and with minimal interventional imaging follow-up except 
for an approximate 50 subject OCT subset involving only planned overlapping cases. In addition 
there is a subset of 100 patients with noninvasive MSCT imaging.  ABSORB EXTEND is the 
first of the ABSORB trials to allow planned overlapping of two Absorb BVS System (mfg 
MTV). Subjects registered can be treated with a maximum of two de novo native coronary artery 
lesions each located in different epicardial vessels; the target lesion length must be  ≤ 28 mm and 
 
19 One subject did not complete the 2 year follow-up.  
20 Smits, P. et. al. ABSORB Cohort B Trial: Evaluation of the Absorb Everolimus Eluting Bioresorbable Vascular 
Scaffold (Absorb BVS) in the treatment of patients with de novo native coronary artery lesions, in TCT 2012. 2012 
(presentation): Miami, FL. 
21 1 year vasomotion data from Serruys P.W ACC 2011 oral presentation and 2 year vasomotion data from Ormiston 
and Serruys TCT 2011 poster presentation 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 47 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
reference vessel sizes must be suitable to be treated with an Absorb BVS System (mfg MTV).  
The device sizes used thus far in the study that have generated data summarized here have been 
the 3.0 x 18 mm, 3.0 x 28 mm and 2.5 x 18 mm scaffolds.  
Clinical follow-up will be conducted on all subjects registered in the trial for up to 3 years.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 Data out to 30 days were available for 451 
subjects in ABSORB EXTEND as of 11-January-2012. The MACE rate for ABSORB EXTEND 
through 11-January-2012 was 2.2% (10/451) out to 30 days, which was driven by MI. The 
hierarchical and non-hierarchical MI rates were the same at 30 days; both were 2.2% (10/451). 
There were no cardiac deaths through 30 days and the ID-TLR rate during the 30-day period was 
0.2% (1/451). The scaffold thrombosis rate out to 30 days, as defined using the ARC definition 
in which the subacute (1-30 days) and acute/subacute (0-30 days) rates were both 0.4% (2/451) 
according to the definite + probable ARC definitions. Data out to 6-months were available for 
269 subjects in ABSORB EXTEND as of 11-January-2012. The MACE rate was 3.0% (8/269) 
[1 cardiac death and 7 MI] at 6 months. The one cardiac death was with a subject that did not 
receive an Absorb BVS. The 6 month ID-TLR rate was 0.4% (1/269) and the overall (0-194 
days) scaffold thrombosis rate was 0.7% (2/268) according to the definite + probable ARC 
definitions. Data out to 1 year was available for 120 subjects in ABSORB EXTEND as of 11-
January-2012. The MACE rate was 5.0% (6/120) [1 cardiac death, 4 MI, and 1 ID-TLR] at 1 
year.  The overall (0-393 days) scaffold thrombosis rate was 0.8% (1/119) according to the 
definite + probable ARC definitions.  
Six month follow-up data were available for 500 subjects and 1 year follow-up data were 
available for 250 subjects through 18-September-2012.  The MACE rate was 3.0% (15/500) at 6 
months and 4.4% (11/250) at 1 year.  The overall MI rate was 2.8% (14/500) at 6 months and 
2.8% (7/250) at 1 year.  The cardiac death rate was 0.2% (1/500) at 6 months and 0.4% (1/250) 
at 1 year, this cardiac death included the subject that did not receive the Absorb BVS. The 6 
month ID-TLR rate was 0.6% due to the occurrence of three ID-TLR events and the 1 year ID-
TLR rate was 2.0% due to the occurrence of 5 ID-TLR events. The overall 6 month  scaffold 
thrombosis rate was 0.6%, and the overall 1 year scaffold thrombosis rate was 0.8% according to 
the definite + probable ARC definitions.  
ABSORB II 
ABSORB II is a post-approval RCT occurring outside the United States (OUS) that will be the 
first comparison of the Absorb BVS System against an active control of a metallic DES 
(XIENCE PRIME).  The ABSORB II trial is the first to have powered, co-primary endpoints 
evaluating both the morphological and functional responses at 2 or 3 years when the device has 
resorbed (depending on the results of the ABSORB Cohort B trial 3-year imaging follow-up 
data). The ABSORB II RCT will enroll approximately 501 subjects at approximately 40 
investigational sites OUS.   
 
22 ABSORB EXTEND Annual Progress Report, report dated March 14, 2012. 
23 Bartorelli, A. L. et. al., ABSORB EXTEND: An interim report on the 6 month clinical outcomes from the first 
500 patients registered, in TCT 2012. 2012, (presentation): Miami, FL; Bartorelli, A. L. et. al., ABSORB EXTEND: 
An interim report on the 12 month clinical outcomes from the first 250 patients registered, in TCT 2012. 2012, 
(presentation): Miami, FL.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 48 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
ABSORB PHYSIOLOGY 
The ABSORB PHYSIOLOGY trial will evaluate one of the key potential benefits of the Absorb 
BVS System, which is coronary vessel functionality after bioresorption.  The trial will be 
dedicated to comparing the vascular responses of Absorb BVS treated vessel segments versus 
metallic DES (XIENCE V or XIENCE PRIME) treated segments, to measure how the vessel 
accommodates changes in blood flow following physiological stimuli.   
2.1.10 SPIRIT TRIALS 
The SPIRIT Family of trials is composed of SPIRIT FIRST, SPIRIT II, SPIRIT III, SPIRIT IV 
and SPIRIT Small Vessel, all of which demonstrated the safety and effectiveness of XIENCE V, 
which uses the same drug (Everolimus) and has the same drug density (100 µg/cm2) and release 
profile (80%/28 days) as the Absorb BVS.  
The pivotal SPIRIT III trial, which supported the US approval of XIENCE V, was a 2:1 RCT 
with the primary endpoint of in-segment LL at 240 days. XIENCE V was found to be non-
inferior (p<0.0001) and superior (p=0.0037) to TAXUS in this primary endpoint, with values of 
0.14±0.41 (301) and 0.28±0.48 (134), respectively. The 1-year MACE rates were 6.0% (39/655) 
and 10.3% (33/319) for the XIENCE V arm and TAXUS arm, respectively, and the stent 
thrombosis rates (definite/probable per ARC) were 1.1% for XIENCE V and 0.6% TAXUS 
(p=NS).  The SPIRIT III RCT has continued to demonstrate safety and efficacy of XIENCE V 
through 5 years.  
The SPIRIT IV clinical trial was a 2:1 randomized clinical trial against TAXUS designed to 
continue to evaluate the safety and efficacy of the XIENCE V. At 1 year, the XIENCE V arm 
demonstrated non-inferiority and superiority to the TAXUS arm in terms of TLF (4.2% and 
6.8%, respectively, PNI  < 0.0001, PSUP = 0.0012), and the stent thrombosis rates per ARC 
(definite/probable) were lower in the XIENCE V arm (0.3%)  compared to the TAXUS arm 
(1.1%; p=0.04). SPIRIT IV continues to demonstrate the safety and efficacy of XIENCE V 
through 3 years.  
The SPIRIT PRIME trial, which supports the US approval of XIENCE PRIME, was a 
prospective, open-label, non-randomized study consisting of two registries with approximately 
500 subjects at up to 75 global sites: the Core Size Registry (stent diameters 2.25. 2.5, 3.0, 3.5, 
4.0 mm with stent length 8, 18, and 28 mm) and the Long Lesion Registry (stent diameters 2.5, 
3.0, 3.5, 4.0 mm with stent lengths 33 and 38 mm). Each subject was to receive treatment in up 
to two de novo native coronary lesions, each lesion in a different epicardial vessel. SPIRIT 
PRIME Core Size and Long Lesion Registries met all pre-specified PGs with statistical 
significance. The observed TLF rate at one year was 4.5% (18/399) (per protocol-defined MI) 
and 6.5% (26/399) (per ARC-defined MI) in the Core Size Registry, and 7.7% (8/104) (per 
protocol-defined MI) and 12.5% (13/104) (per ARC-defined MI) in the Long Lesion Registry, 
respectively.   
Further details on the SPIRIT Family of trials can be found in the XIENCE V IFU and XIENCE 
PRIME IFU. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 49 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
2.1.11 Patient Reported Outcomes (PRO) 
In clinical trials, patient reported outcome instruments can be used to measure the impact of an 
intervention on several aspects of patient health status and quality of life.  Since improvements in 
clinical measures may not necessarily correlate with how the patient feels or functions, 
understanding the patient perspective on treatment effectiveness can be extremely valuable. 
Obtaining the patient’s perspective may also provide additional information that may not be fully 
captured through clinician-centered evaluations. 
In addition, as health expenditures have continued to rise, it is no longer sufficient for new 
therapies to simply demonstrate efficacy in order to be accepted into mainstream medical practice. 
Today, physicians, payers, and policy-makers have become increasingly interested in 
understanding the overall value of therapies. Patients’ self-reported health-related quality of life 
outcomes help to determine the full impact of treatment benefit and serve as key inputs when 
assessing the value of this impact.   
Patient Reported Outcome instruments will be incorporated in the 2,000 primary analysis subjects 
in ABSORB III to provide a complementary evaluation of the effectiveness of the Absorb BVS 
system. The following instruments will be administered during this study at pre-implantation, 30 
days, 1, 2, 3 and 5 years follow-up:  
• EuroQoL 5D (EQ-5D) survey to assess overall health status  
• Seattle Angina Questionnaire (SAQ) to assess disease-specific QoL 
• Rose Dyspnea Scale (RDS) to assess severity of dyspnea* 
• Generalized Anxiety Disorder scale (GAD-7) to assess anxiety* 
*RDS and GAD-7 will only be used through 3 years. 
2.2 
Trial Rationale  
As mentioned in Section 2.1.9, the Absorb BVS System is being evaluated in ABSORB Cohort 
B and ABSORB EXTEND, all single arm, non-randomized clinical trials. Currently, only 
retrospective descriptive comparisons provide insight into the performance of the Absorb BVS 
System (mfg MTV) compared to XIENCE V. In the Cohort B trial, Absorb BVS System (mfg 
MTV) showed a similar 1-year (BVS 0.27 mm and XIENCE V 0.23 mm) and 2-year LL 
measurement (BVS 0.27 mm and XIENCE V 0.33 mm) compared to XIENCE V and the 1- year 
(6.9%), 2-year (8.9%) and 3-year (8.9%) MACE rates (Kaplan Meier estimate) for Absorb BVS 
System (mfg MTV) were comparable to the 3.0 x18 mm XIENCE V 1-year (7.5%), 2-year 
(8.5%) and 3-year (11.4%) MACE rates (Kaplan Meier estimate) from pooled SPIRIT data 
(SPIRIT FIRST, SPIRIT II and SPIRIT III RCT). ABSORB III provides the first robust head-to-
head comparisons of the Absorb BVS to XIENCE, and is designed to demonstrate non-
inferiority for the 1-year clinical endpoint of TLF with Absorb BVS compared to XIENCE. 
Furthermore, ABSORB III will provide the opportunity to evaluate the long term benefits of 
Absorb BVS compared to XIENCE in regards to potential functional as well as dynamic (i.e., 
vessel movement) and morphological (i.e., late lumen enlargement) changes to the treated vessel.    

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 50 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
3. 
TRIAL OBJECTIVE 
ABSORB III Primary Objective: The pivotal trial to support the US pre-market approval 
(PMA) of Absorb BVS.  ABSORB III will evaluate the safety and effectiveness of the Absorb 
BVS System compared to the XIENCE in the treatment of subjects, including those with 
diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery 
lesions in separate epicardial vessels.  
ABSORB III Secondary Objectives:  
• Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic 
Absorb BVS physician training plan to US clinical practice. 
• Imaging Cohort Objective: To evaluate long-term vascular function and patency of the 
Absorb BVS treated segments compared to XIENCE treated segments in the treatment of 
subjects with ischemic heart disease caused by up to two de novo native coronary artery 
lesions in separate epicardial vessels. 
4. 
CLINICAL TRIAL/INVESTIGATION FLOW AND 
FOLLOW-UP SCHEDULE 
4.1 
Number of Subjects to be Registered 
Approximately 2250 subjects will be registered in ABSORB III. Of this total number, up to 50 
subjects will be registered in the Lead-In phase, 2000 subjects will support the primary endpoint 
analysis and 200 subjects will be registered in the Imaging Cohort.  
4.2 
ABSORB Physician Training 
The ABSORB III training program is a two-phased approach that will combine 1) didactic 
learning and 2) vessel sizing test-runs with corresponding retrospective core laboratory analysis.  
All investigators (primary investigators and sub-investigators) will be required to undergo 
didactic training.  The didactic learning will involve both self-learning of provided materials, 
meeting-based peer to peer learning or site learning conducted by Abbott Vascular trained staff.  
The investigators will receive an Absorb BVS training package that will include the training on 
the following elements:  1) technology overview, which includes the rationale and goals for a 
bioresorbable scaffold and the description of the Absorb BVS, with specifics on the polymer, 
delivery system and the three phases of functionality (revascularization, resorption and 
restoration) associated with Absorb BVS.  2) Update on the most current ABSORB program pre-
clinical and clinical data.  3) Patient and lesion selection which includes the indication, 
contraindications and warnings for the use of Absorb BVS.  There will also be a review of the 
general and angiographic inclusion and exclusion criteria, with emphasis on the avoidance of 
specific lesion criteria that could result in adverse outcomes.  4) Lesion preparation and 
treatment strategy, which will detail the ABSORB III protocol-required criteria on the 
appropriate preparation of the potential target lesion and sizing of the vessel prior treatment.  5) 
Case reviews specific to lessons learned from the previous ABSORB trials.  6) Device usage and 
logistics which includes details on device storage, sheath removal and general instructions for 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 51 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
use.  The section will also include information on packaging, product handling, storage and 
shelf-life and device accountability.  
The ABSORB III site primary investigators and sub-investigators attending the investigator 
meeting will receive peer-to-peer learning which will include, an update on the most recent 
Absorb BVS clinical and pre-clinical data and current clinical practice, Absorb BVS 
characteristics and differences compared to metallic DES, patient and lesion selection, 
appropriate techniques to size the vessel, practical recommendations on how to implant Absorb 
BVS and the indications for Absorb BVS based on ABSORB III. There will also be case review 
discussions by physicians that have treatment experience with Absorb BVS and the dos and 
don’ts of treatment.  The ABSORB III didactic learning phase was developed from the learning 
and strategies used in the ABSORB Cohort B, ABSORB EXTEND and ABSORB II trials. 
At the investigator meeting, the didactic training will also include hands-on training through the 
use of simulated arterial models (SAM), in which there will be learning on the device handling 
outside of and within the model coronary vasculature.  The SAM training will be conducted by 
Abbott Vascular employees well trained in the handling and delivery of the Absorb BVS.  The 
physicians will be educated on the scaffold, the delivery system, the scaffold profile differences 
as compared to XIENCE, and direction on the removal of the Absorb BVS’ protective sheath.  
Physicians will have an opportunity to undergo exercises that will allow them to experience the 
differences in the delivery and deployment between XIENCE and Absorb BVS in an in vitro 
model.  Discussions will be held regarding proper lesion preparation and specific techniques that 
have been used by physicians with prior experience implanting Absorb BVS in patients. In the 
SAM training, physicians will also be able to undergo exercises to understand the expansion 
capabilities of the Absorb BVS.   
For those investigators not attending the investigator meeting, Abbott Vascular (AV) staff 
trained on the use of Absorb BVS will provide detailed training at site initiations.  The training 
will include the topics mentioned above, including but not be limited to, the investigational plan, 
investigational device usage, clinical investigation plan requirements, electronic case report form 
completion, and clinical investigation personnel responsibilities. Specific to the device usage, the 
clinical research associate (CRA) will train the investigators on appropriate use of the device, 
including (but not limited to) reintroduction of the device, dwell time in the body, use of 
adjunctive devices, removal of the device and expansion/post dilatation guidelines.  
All investigator/clinical investigation personnel that are trained must sign a training log.  No 
investigator/clinical investigation personnel will perform any clinical investigation-related 
procedures prior to signing a training log.  Furthermore, the site primary investigator (or 
designee) that attended the investigator meeting will be asked to serve as the site physician 
expert to provide feedback to his/her sub-investigators on their experience with the hands-on 
training with Absorb BVS and any further learning.  However, if investigators at the site need 
further training regarding Absorb BVS, AV will provide this service. 
Prior to enrollment in ABSORB III, two angiographic test runs that provide a visual estimation 
of RVD on non-study PCI patients must be completed by the Investigators.  Visual RVD 
estimates can be sent to the Angiographic Core Laboratory for review to correlate the 
investigator’s visual estimation of RVD with quantitative angiographic readings by the Core 
Laboratory. The test runs can be performed prior to the clinical sites trial start-up or using 
retrospective PCI cases in which the non-study patient has given consent for the data to be used. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 52 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Investigators will be required to complete a minimum of two visually estimated cases and both 
must meet the specified sizing requirements as assessed by the core laboratory. If an investigator 
has participated in AV coronary trials, visually estimated RVD data and the corresponding core 
laboratory assessment can also be used for the test run. All test run data must have been 
completed no earlier than June 2009. Complete details on the test-runs can be found in the 
physician training slides and the imaging guidance document that will be distributed to each site. 
Supplemental quantitative information from on-line quantitative angiography, intravascular 
ultrasound, or optical coherence tomography can be used to confirm measurements of the vessel, 
if the clinical site chooses. Please review the Imaging Guidance Document for further details. 
4.3 
Lead-In Phase 
ABSORB III will include a Lead-In Phase that will provide an opportunity to evaluate whether 
the Absorb physician training, developed from the ABSORB programs outside the US, can be 
applied to US clinical practice. 
The Lead-In Phase will enroll/register subjects prior to the randomization of the 2000 subjects 
supporting the primary analysis.  The objective of the Lead-In Phase will be the evaluation of the 
applicability and transferability of the didactic Absorb BVS physician training plan to US 
clinical practice.  The primary area of learning in the usage of Absorb BVS includes the vessel 
sizing, lesion preparation, device delivery and deployment, as these variables reflect the change 
in practice that occurs with the use of a polymeric scaffold compared to a metallic stent.  The 
Lead-In Phase will involve up to 35 US sites and up to 50 subjects treated with Absorb BVS. 
There will be four key areas of evaluation of the Lead-In Phase, 1) angiographic 
inclusion/exclusion, 2) vessel sizing meeting protocol required criteria, 3) treatment strategy per 
protocol requirements and 4) device success.  Each of these variables will provide a measure of 
adherence to the physician training program.  The data for each registered subject will be 
collected through the electronic case report forms (eCRFs).  The outcomes will determine 
whether the physician training requires further modification to meet the needs of the US 
physicians. Details on how the sponsor will evaluate the Lead-In Phase can be found in 
Appendix VII.  
The first Absorb BVS case for each investigator participating in the Lead-In will be attended by 
an Abbott Vascular (AV) CRA. The objective of the CRA-attended cases is to provide an 
opportunity for the investigator to receive guidance on and reinforcement of the Absorb BVS 
teachings (detailed in Section 4.2) during their Absorb BVS enrollment.  The CRA field group 
will be trained on Device Handling Fundamentals and all elements of the protocol.  At the time 
of the procedure, the CRA attendant will be available to provide review of the key protocol 
requirements and device usage elements prior to the start or during the index procedure.  The 
sponsor CRA will make every attempt to ensure that the first Absorb BVS case is attended in 
person. However, a diagnostic angiogram is often not performed on a separate date prior to PCI 
for pre-screening. In these instances, since the diagnostic catheterization (qualifying cardiac 
catheterization) and the intervention are done at the same setting (with limited amount of time in-
between), AV would be unable to travel to the site and attend in person.  For these sites, AV 
personnel will be available to provide telephone guidance and reinforcement prior to the start of 
the index procedure.   

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 53 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Prior to the index procedure, the CRA will review the 4 variables with the enrolling physician:  
1) angiographic inclusion/exclusion criteria requirements; 2) vessel treatment strategy; 3) 
appropriate vessel sizing and scaffold selection; and 4) appropriate device preparation and usage.  
If the CRA is at the site in person, once this information is reviewed and the index procedure has 
occurred, the CRA will complete the Lead-In checklist for the investigator and submit this 
information to AV for filing.  If the CRA is not present, the site will be requested to complete the 
eCRF within 1-2 business days of the procedure, which will be remotely monitored by the CRA 
within 1-2 business days of data entry.  If the CRA is present at the time of the index procedure, 
the site will have 2 business days to enter the subject data into the eCRF.  
In addition to the CRA guidance provided onsite or via telephone, during the site initiation visit, 
the site will be provided with a similar checklist and reference tools in order to ensure that they 
have the necessary information readily available to ensure appropriate subject selection, vessel 
treatment strategy, vessel sizing and Absorb BVS selection as well as appropriate device 
preparation and usage. 
Angiograms should be submitted to the core laboratory within 2 business days following the 
procedure for analysis to ensure appropriate vessel sizing and scaffold usage (for details on 
imaging uploading refer to Imaging Guidance Document).  This feedback will be provided to 
the site within 72 hours of submitting the angiogram.  If discrepancies are identified by the 
angiographic core laboratory specific to vessel sizing and the %DS required for analyzing device 
success (< 30%), the angiographic core laboratory and the CRA, respectively, will contact the 
investigator to discuss the issue and any corrective measures necessary to avoid the issue in 
future cases. Investigators not meeting all four criteria (CRA assessed and core laboratory 
assessed), will be retrained on the missed elements by the AV CRAs and/or core laboratory if 
necessary prior to their next Absorb BVS case.  Depending on the elements missed, the CRA 
may attend the next Absorb BVS case to ensure criteria are met.  At any time during the Lead-In 
phase, if AV or the site determines that further site/investigator training is required, such training 
will be arranged.  
4.4 
ABSORB III Treatment Flow and Lesion Selection 
The same treatment flow and lesion selection applies to all subjects in ABSORB III (including 
the Lead-In Phase and the Imaging Cohort).  Either one or two target lesions in two separate 
epicardial vessels will be treated. If only one target lesion is intended, a second non-target lesion 
in a different epicardial coronary artery than the target lesion may also be treated prior to the 
target lesion. For the Lead-In Phase, only Absorb BVS will be used for target lesion (s).  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 54 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Figure 4.1 shows the lesion treatment for subjects in the Lead-In Phase. 
Single Lesion 
Single Target 
Lesion 
Absorb BVS 
Two Lesions 
Two Target Lesions 
One Target lesion 
and one Non-target 
lesion
Absorb BVS 
Target
Non-Target
Lead-In Phase
Up to 50 subjects
Absorb BVS 
Absorb BVS 
XIENCE
 
Figure 4.1 Lesion Treatment 
 
Figure 4.2 shows the lesion treatment for the 2200 randomized subjects. 
Single Lesion 
Single Target 
Lesion 
Test: Absorb BVS or 
Control: XIENCE 
Two Lesions 
Two Target Lesions 
One Target lesion 
and one Non-target 
lesion
Non-Target
XIENCE 
2000 subjects
&
200 Imaging Subjects
Test: Absorb BVS or 
Control: XIENCE 
Test: Absorb 
BVS or Control: 
XIENCE 
Target
Test: Absorb BVS or 
Control: XIENCE 
 
Figure 4.2 Lesion Treatment 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 55 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
If a non-target lesion is present, the non-target lesion must be successfully treated first with a 
XIENCE stent. Despite the allowance of two lesion treatment, planned staged procedures are not 
allowed in ABSORB III.  
Prior to treatment with the assigned device (Absorb BVS or XIENCE), vessel sizing by visual 
estimation must be conducted to appropriately match the device to the size of the vessel. 
Quantitative methods such as on-line QCA, IVUS or OCT may be used if deemed necessary per 
physician discretion, but are not required. Details on the vessel sizing methods can be found in 
Imaging Guidance Document (detailed in Section 7.3.2).  
Table 4.1 provides the device sizes, RVD and lesion length for ABSORB III.  
Table 4.1 
 Absorb BVS and XIENCE Sizes  
Device 
Lesion and Device Sizes 
RVD 1 
Lesion Length1 
Lead-In Absorb 
BVS 
(Target lesion) 
RVD ≥ 2.75 mm - ≤ 3.25 mm 
Scaffold diameter: 3.0 mm 
Lesion length ≥ 8-≤ 14 mm 
Scaffold length: 18 mm 
RCT Absorb BVS 
(Target lesion) 
RVD ≥ 2.50 mm - ≤ 3.75 mm 
Scaffold diameter: 2.5, 3.0 and 3.5 mm 
Lesion length ≤ 24 mm 
Scaffold Length2: 8, 12, 18 and 28 mm 3  
 
RCT XIENCE5  
(Target lesion) 
 
RVD ≥ 2.50 mm - ≤ 3.75 mm 
Stent diameter: 2.5, 2.75, 3.0, 3.25, 3.5, 
4.0 mm 
Lesion length ≤ 24 mm 
Stent Length: 8, 12, 15, 18, 23 and 28 mm 3 
 
XIENCE  
(Non-target lesion) 
Per IFU (RVD ≥ 2.25 mm - ≤ 4.25 mm 
can be treated)  
All available sizes 
Per IFU (lesion ≤ 32 mm) 4  
All available sizes 
1 Reference vessel diameter (RVD) and lesion length based on visual estimation  
2 Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 diameter Absorb BVS. Only the 12 mm length 
will be available for the 3.5 mm diameter. The commercially approved CE marked 23 mm Absorb BVS device will 
not be used in this study. 
3 For target lesion, planned overlapping is not allowed (i.e., the lesion must be eligible for treatment with a single 
stent). However, bailout overlapping is allowed if required. 
4 For non-target lesion, planned overlapping allowed. 
5 XIENCE V, XIENCE Prime, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro, and XIENCE ProX are used in 
this study. 
The commercially approved CE marked 23mm Absorb BVS device will not be used in this 
study. 
A minimum of 2 mm (by visual estimation) of minimally diseased tissue should be covered by 
the device at both the proximal and distal edges.  
Planned overlap of the target lesion is not allowed. Overlap in the case of bailout is allowed for 
both the target and non-target lesion. Please refer to Section 7.3.5 for details regarding bailout. 
4.5 
Measures Taken to Avoid and Minimize Bias 
In ABSORB III there will be several measures taken to avoid and minimize bias such as 
randomization and blinding. This process has been detailed in the following sections. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 56 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
4.5.1 Randomization 
Stratified Randomization: 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
Timing of Randomization: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
  
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
  
 
  
 
  
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
  
 
 
  
 
 
 
  
 
 
  
 
 
 
 
  
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
4.5.2 Blinding 
   
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
  
 
 
 
   
 
 
  
 
  
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 57 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
4.6 
Early Termination of the Clinical Trial 
Sponsor reserves the right to discontinue the Clinical Investigation at any stage, with suitable 
written notice to the investigator. The investigator may also discontinue participation in the 
Clinical Investigation with suitable written notice to Sponsor.  Should either of these events 
occur, the investigator shall return all documents and devices to the Sponsor, provide a written 
statement as to why the premature termination has taken place, and notify the Ethics Committee 
and the regulatory authority (if applicable).  All applicable Clinical Investigation documents 
shall be subject to the same retention policy as detailed in the Section 13.0 Data Handling and 
Record Keeping. 
All subjects registered up to the point of trial discontinuation will continue to be followed up per 
protocol requirements. 
5. 
ENDPOINTS 
5.1 
Primary Endpoint 
ABSORB III Primary Endpoint 
1. TLF at 1 year, non-inferiority (NI) against the control. 
• TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-
defined MI definition, Appendix II) attributable to Target Vessel (TV-MI), or Ischemia-
Driven Target Lesion Revascularization (ID-TLR). 
• This analysis will include ~2000 subjects.  
5.2 
Powered Secondary Endpoint(s) 
Imaging Cohort Powered Secondary Endpoints  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 58 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Imaging Cohort Powered Secondary Endpoints are based on the pooled subjects from the 
Imaging Cohort of Absorb III (  
 angiographic subjects and 
 IVUS subjects) and 
subjects from the Absorb Japan RCT (  
 angiographic subjects, and 
 IVUS subjects). 
One of the key attributes that differentiates Absorb BVS from metallic stents is the progressive 
mechanical weakening of the scaffold with polymer degradation over time, which allowed for 
vessel movement and gradual outward remodeling (positive) to accommodate any increases in 
the in-scaffold intimal hyperplasia that may limit blood flow.  In both the Absorb Cohort A and 
Cohort B trials, Absorb BVS treated vessels have shown evidence of vessel movement and late 
lumen and scaffold enlargement, providing anatomic indication that the vessel can adapt and 
enable the natural Glagov process.24  
The vasomotion endpoint assesses the ability of the in-scaffold segment to move when the vessel 
is no longer mechanically constrained. Angiography will be used for the vasomotion assessment.  
The assessment of late lumen enlargement will be evaluated by the in-stent/scaffold mean lumen 
area change (ΔMLA) from post-procedure to 3 years by IVUS.  
1. The in-stent/scaffold mean lumen area change, from post-procedure to 3 years by IVUS 
(mean lumen area measured after nitrate infusions, superiority test, 
 pooled subjects). 
2. The in-stent/scaffold mean lumen diameter change, between pre- and post-nitrate infusion at 
3 years by angiography (superiority test, 
 pooled subjects). 
Powered Secondary Endpoint for Angina  
This powered secondary endpoint is intended to assess angina at 1 year and test for superiority of 
Absorb BVS to XIENCE. 
• Angina is defined as the first adverse event resulting in the site diagnosis of angina. 
• The analysis will exclude angina following the index procedure through discharge, not to 
exceed a period of 7 days. 
This analysis will include ~2000 subjects. 
Powered Secondary Endpoint for All Revascularization  
This powered secondary endpoint is intended to assess all revascularization at 1 year and test for 
superiority of Absorb BVS to XIENCE. 
This analysis will include ~2000 subjects. 
Powered Secondary Endpoint for Ischemia-Driven Target Vessel Revascularization 
This powered secondary endpoint is intended to assess ischemia-driven target vessel 
revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. 
 
24Glagov S, Weisenber W, Zarins CK et al. Compensatory enlargement of human atherosclerotic coronary arteries. 
N Engl J Med. 1987; 316: 1371-1375.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 59 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
This analysis will include ~ 2000 subjects. 
Powered Secondary Endpoint for Diabetic Indication  
The powered secondary endpoint will be to support a diabetic indication for Absorb BVS.  
5.3 
Additional Secondary Endpoint(s) 
In ABSORB III the following clinical secondary endpoints will be analyzed. Secondary imaging 
endpoints will be analyzed in the Imaging Cohort.  
• Acute Success: (Combined Clinical/Angiographic Endpoint)  
o Device success (Lesion level analysis) 
o Procedural success (Subject level analysis) 
• Clinical Endpoint in hospital and at each follow-up point (30 days; 180 days; 1, 2, 3, 4 
and 5 years). 
o Component 
 Death (Cardiac, Vascular, Non-cardiovascular) 
 Myocardial Infarction   
- Attributable to target vessel (TV-MI)  
- Not attributable to target vessel (NTV-MI) 
 Target Lesion Revascularization (TLR) 
- Ischemia driven TLR (ID-TLR)  
- Non ID TLR (NID-TLR) 
 Target Vessel Revascularization (TVR,) 
- ID TVR  
- Non ID TVR 
 All coronary revascularization 
o Composite Endpoints 
 Death/All MI 
 Cardiac Death/All MI 
 Cardiac Death/TV-MI/ID-TLR (TLF) 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 60 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 Cardiac Death/All MI/ID-TLR (MACE) 
 Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) 
 Death/All MI/All revascularization  
o Scaffold-Thrombosis / Stent Thrombosis (per ARC definition)  
 Timing (acute, sub-acute, late and very late) 
 Evidence (Definite and Probable) 
• Imaging Endpoints:  
Imaging endpoints will be analyzed on Imaging Cohort subjects only.  
o Angiography:  
All angiographic endpoints will be collected post-procedure and at 3 years  
 In-segment25 late loss (LL) 
 In-device26 LL 
 Proximal LL (proximal defined as 5 mm of tissue proximal to the device 
placement) 
 Distal LL (distal defined as 5 mm of tissue distal to the device placement) 
 In-device/in-segment/proximal/distal minimum lumen diameter  
 In-device/in-segment/proximal/distal %Diameter Stenosis (DS) 
 In-device/in-segment/proximal/distal angiographic binary restenosis 
 In-device net gain (change in minimum lumen diameter between 3 years and post-
procedure) 
 The magnitude of in-stent/scaffold mean lumen diameter change (absolute value) 
at 3-years follow-up from pre-nitrate to post-nitrate 
 The normalized in-stent/scaffold mean lumen diameter change at 3-years follow-
up from pre-nitrate to post-nitrate, defined as, 
 
 
25 In-device refers to the margins of the stent or scaffold. Segment refers to the margins of the stent or scaffold and 5 
mm proximal and 5 mm distal to the stent or scaffold.  
26 Device throughout the protocol summary refers to XIENCE or Absorb BVS System 
%
100
change)/2
Diameter 
Lumen 
Mean 
 
Distal
 
 
change
Diameter 
Lumen 
Mean 
 
(Proximal
change
Diameter 
Lumen 
Mean 
 
fold
Stent/Scaf
-
In
×
+

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 61 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
where both proximal and distal mean lumen diameter changes are at 3-years 
follow-up from pre-nitrate to post-nitrate 
 Change in minimum lumen diameter, within treated segment, at 3 years follow-up 
from pre-nitrate to post-nitrate  
 Change in in-device %DS at 3 years follow-up from pre-nitrate to post-nitrate  
o IVUS (Grey scale): 
All IVUS endpoints will be collected post-procedure and at 3 years (as applicable) and 
within the device and within the treated segment:  
 Minimal Lumen Area  
 Percentage of subjects with late gain without incomplete apposition by IVUS 
(IVUS minimum lumen area post- procedure post-nitrate - IVUS minimum lumen 
area 3 years follow-up post-nitrate)   
 %  change in the tissue area/volume between lumen and external elastic lamina 
(EEL)   
 Absolute change in tissue area/volume between lumen and EEL  
 Mean/minimal vessel diameter/area/volume 
 Mean/minimal device diameter/area/volume; if analyzable in respect to Absorb 
BVS 
 Mean/minimal lumen diameter/area/volume, including change in minimum lumen 
area between post-procedure and follow-up 
 Mean/maximal neointima hyperplasia area/volume/percentage at 3 years; if 
analyzable in respect to Absorb BVS 
 Incomplete apposition (post-implantation), persisting incomplete apposition, late 
acquired incomplete apposition and resolved incomplete apposition at 3 years; if 
analyzable in respect to Absorb BVS  
• OCT: 
All OCT endpoints will be collected post-procedure and 3 years, and for within the 
device and within the treated segment:  
 Descriptive analysis of strut, lesion and vessel morphology  
 Mean neointimal area (NIA)  
- 
Apposed to the vessel wall with neointimal coverage 
- 
Apposed to vessel wall without neointimal coverage 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 62 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
- 
Incomplete apposition to vessel wall with neointimal coverage 
- 
Incomplete apposition to vessel wall without neointimal coverage 
 Lumen area/volume stenosis % 
 Mean/minimal device area 
 Mean/minimal luminal area/volume 
 Mean strut area/volume   
 Persisting incomplete apposition, late incomplete apposition at 3 years (if 
analyzable) 
 OCT analysis for subjects with jailed side branch 
 Descriptive analyses from 3-dimensional OCT reconstructions 
5.4 
Informational Endpoints (Patient Reported Outcomes) 
In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes 
will be analyzed as informational endpoints.  
• Overall Health Status in hospital (baseline) and at the specified follow-up contacts (30 
days; 1, 2, 3 and 5 years) assessed using the EuroQoL 5D (EQ-5D) 
• Disease-Specific Quality of Life in hospital (baseline) and at the specified follow-up 
contacts (30 days; 1, 2, 3 and 5 years) assessed using the Seattle Angina Questionnaire 
(SAQ) 
• Dyspnea severity in hospital (baseline) and at the specified follow-up contacts (30 days; 
1, 2 and 3 years) assessed using the Rose Dyspnea Scale (RDS) 
• Anxiety in hospital (baseline) and at the specified follow-up contacts (30 days; 1, 2 and 
3years) assessed using the Generalized Anxiety Disorder scale (GAD-7) 
6. 
SUBJECT SELECTION AND WITHDRAWAL  
6.1 
Subject Population 
Subjects registered into this Clinical Investigation will be male and female subjects derived from 
the general interventional cardiology population.  The Clinical Investigation will register 
approximately 2250 subjects, with a maximum of two de novo native coronary artery lesions in 
separate epicardial vessels, who meet all eligibility criteria, have provided written Informed 
Consent and have been registered in the trial. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 63 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
6.2 
Subject Screening and Informed Consent  
6.2.1 Subject Screening 
Subjects planned to be admitted for a percutaneous coronary artery revascularization procedure 
should be screened for Clinical Investigation eligibility by a member of the research team 
previously trained to the Clinical Investigation Plan.   
Subjects that have signed an Informed Consent (Refer to Appendix IV, Enrollment and 
Registration Process) are considered enrolled in ASBORB III.  Subjects who do not satisfy the 
general angiographic inclusion and exclusion criteria and/or have unsuccessful pre-dilatation 
and/or vessel sizing are considered screen failures and will not proceed further in the trial.  These 
subjects will be entered into the eCRF screening log (as applicable; in addition, the reason for 
screen failure as well as supporting data will be entered into the log).  
6.2.2 Informed Consent 
The Investigator or designee, who has been trained on the protocol, will explain the nature and 
scope of the trial, potential risks and benefits of participation, and answer questions for the 
subjects. All subjects (or legally authorized subjects’ representatives, if applicable) must sign and 
date the Institutional Review Board (IRB) /Medical Ethics Committee (MEC) approved 
informed consent prior to any clinical trial/investigation-specific procedures. No patients 
belonging to a vulnerable population will be enrolled. Vulnerable population is defined as 
subject whose willingness to volunteer in a clinical investigation could be unduly influenced by 
the expectation, whether justified or not, of benefits associated with participation or of retaliatory 
response from senior members of a hierarchy in case of refusal to participate.  Examples of 
populations which may contain vulnerable subjects include: Individuals with lack of or loss of 
autonomy due to immaturity or through mental disability, persons in nursing homes, children, 
impoverished persons, subjects in emergency situations, ethnic minority groups, homeless 
persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable 
subjects include, for example, members of a group with a hierarchical structure such as 
university students, subordinate hospital and laboratory personnel, employees of the sponsor, 
members of the armed forces, and persons kept in detention.   
Obtaining of the consent, provision of a copy to the subject, along with the date must be 
documented in the subject’s medical records. The informed consent form must be signed by an 
investigator or designate trained on the protocol. In addition, the signed informed consent must 
be kept in the subject’s medical records/research chart and a copy must be given to the subject or 
the legally authorized representative. 
In addition, an authorization for use and disclosure of the subjects’ protected health information, 
in accordance with the Health Insurance Portability and Accountability Act (HIPAA), must be 
obtained from the subject or their legally authorized representative (US only). 
For Live cases at congresses the patients need to sign a specific Live Case ICF, approved by the 
IRB/EC and by Abbott Vascular, as well as by the competent authorities (e.g., FDA), as 
applicable. The investigator must request Abbott Vascular approval prior to, performing a Live 
Case. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 64 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
6.3 
Eligibility Criteria  
Eligibility criteria are the same for all subjects in ABSORB III, unless specified. 
6.3.1 General Eligibility Criteria 
Assessment for general eligibility criteria is based on the medical records of the site and 
interview with a candidate subject. Clinical and laboratory test of the eligibility assessment shall 
be per site standard of care. If some of these tests are not included in the site’s standard tests, 
they must be done, but after written Informed Consent has been obtained. Subjects must meet 
ALL of the inclusion criteria to be considered for the clinical evaluation. If ANY of the 
exclusion criteria are met, the subject is excluded from the clinical evaluation and cannot be 
registered.  
6.3.1.1 
General Inclusion Criteria  
1. Subject must be at least 18 years of age. 
2. Subject or a legally authorized representative must provide written Informed Consent 
prior to any study related procedure, per site requirements. 
3. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-
infarct angina or silent ischemia) suitable for elective PCI.  Subjects with stable angina or 
silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as 
determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or 
stress ECG). In the absence of noninvasive ischemia, FFR must be done and indicative of 
ischemia.  
4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) 
surgery. 
5. Female subject of childbearing potential who does not plan pregnancy for up to 1 year 
following the index procedure. For a female subject of childbearing potential a pregnancy 
test must be performed with negative results known within 7 days prior to the index 
procedure per site standard. 
6. Female subject is not breast-feeding at the time of the screening visit and will not be 
breast-feeding for up to 1 year following the index procedure. 
7. Subject agrees to not participate in any other investigational or invasive clinical study for 
a period of 1 year following the index procedure.27 
 
27 This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies 
that are non-invasive and do not require medication are allowed.  A subject who is taking part in the long-term 
follow-up phase of a trial, who has completed all medications and invasive procedures per protocol requirements, 
may continue to participate in that trial. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 65 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
6.3.1.2 
General Exclusion Criteria 
1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP 
antagonist is planned within 12 months after the procedure. 
2. Subject has known hypersensitivity or contraindication to device material and its 
degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and 
cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be 
adequately pre-medicated. Subject has a known contrast sensitivity that cannot be 
adequately pre-medicated. 
3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to 
clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore 
cannot be adequately treated with study medications. 
4. Subject had an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours 
of the index procedure and both CK and CK-MB have not returned to within normal 
limits at the time of index procedure; or subject with stable angina or silent ischemia has 
CK-MB that is greater than normal limits at the time of the index procedure.  
5. Subject is currently experiencing clinical symptoms consistent with new onset AMI 
(STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic 
ECG changes.  
6. Subject has a cardiac arrhythmia as identified at the time of screening for which at least 
one of the following criteria is met:28 
a. Subject requires coumadin or any other agent for chronic oral anticoagulation  
b. Subject is likely to become hemodynamically unstable due to their arrhythmia 
c. Subject has poor survival prognosis due to their arrhythmia 
7. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any 
quantitative method, including but not limited to echocardiography, MRI, Multiple-Gated 
Acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be 
obtained within 6 months prior to the procedure for subjects with stable CAD. For 
subjects presenting with ACS, LVEF must be assessed during the index hospitalization 
(which may include during the index procedure by contrast left ventriculography) but 
prior to randomization in order to confirm the subject’s eligibility. 
8. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior 
PCI within the non-target vessel or any peripheral intervention is acceptable if performed 
anytime >30 days before the index procedure, or between 24 hours and 30 days before 
the index procedure if successful and uncomplicated. 
 
28 Investigator should use discretion when enrolling subjects with high CHADS scores. 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 66 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
9. Subject requires future staged PCI either in target or non-target vessels or subject requires 
future peripheral interventions < 30 days after the index procedure. 
10. Subject has received any solid organ transplants or is on a waiting list for any solid organ 
transplants. 
11. At the time of screening, the subject has a malignancy that is not in remission.  
12. Subject is receiving immunosuppressant therapy or has known immunosuppressive or 
severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., 
human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: 
corticosteroids are not included as immunosuppressant therapy. 
13. Subject has previously received or is scheduled to receive radiotherapy to a coronary 
artery (vascular brachytherapy), or the chest/mediastinum. 
14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, 
dabigatran, apixaban, rivaroxaban or any other agent for any reason).   
15. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.  
16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-
Pugh ≥ Class B. 
17. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or 
dialysis at the time of screening.29  
18. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or 
coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within 
the past six months. 
19. Subject has had a cerebrovascular accident or transient ischemic neurological attack 
(TIA) within the past six months, or any prior intracranial bleed, or any permanent 
neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous 
malformation, etc.). 
20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath 
insertion. Note: femoral arterial disease does not exclude the patient if radial access may 
be used. 
21. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause. 
22. Subject is in the opinion of the Investigator or designee, unable to comply with the 
requirements of the study protocol or is unsuitable for the study for any reason. This 
includes completion of Patient Reported Outcome instruments. 
 
29 Estimated GFR can be based on Modification of Diet in Renal Disease (MDRD) equation or Cockcroft-Gault 
equation (CCG).  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 67 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
23. Subject is currently participating in another clinical trial that has not yet completed its 
primary endpoint.30   
24. Subject is part of a vulnerable population who, in the judgment of the investigator, is 
unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal 
circumstances or lack of autonomy.  This may include:  Individuals with mental 
disability, persons in nursing homes, children, impoverished persons, persons in 
emergency situations, homeless persons, nomads, refugees, and those incapable of giving 
informed consent. Vulnerable populations also may include members of a group with a 
hierarchical structure such as university students, subordinate hospital and laboratory 
personnel, employees of the Sponsor, members of the armed forces, and persons kept in 
detention. 
6.3.2 Angiographic Eligibility Criteria 
Assessment of angiographic eligibility is per visual assessment by an investigator both for 
qualitative and quantitative variables. IVUS, OCT or on-line QCA may be used if deemed 
necessary by investigators.  
6.3.2.1 
Angiographic Inclusion Criteria  
1. One or two de novo target lesions: 
a. If there is one target lesion, a second non-target lesion may be treated but the non-
target lesion must be present in a different epicardial vessel, and must be treated first 
with a successful, uncomplicated result prior to randomization of the target lesion. 
b. If two target lesions are present, they must be present in different epicardial vessels 
and both must satisfy the angiographic eligibility criteria. 
c. The definition of epicardial vessels means the LAD, LCX and RCA and their 
branches. Thus, the patient must not have lesions requiring treatment in e.g. both the 
LAD and a diagonal branch. 
2. 
Target lesion(s) must be located in a native coronary artery with a visually estimated 
or quantitatively assessed %DS of ≥ 50% and < 100% with a TIMI flow of ≥1 and 
one of the following: stenosis ≥ 70%, an abnormal functional test (e.g. fractional flow 
reserve, stress test), unstable angina or post-infarct angina.  
a. Lesion(s) must be located in a native coronary artery with RVD by visual estimation 
of ≥ 2.5 mm and ≤ 3.75 mm.  
b. Lesion(s) must be located in a native coronary artery with length by visual estimation 
of ≤ 24 mm. 
 
30 This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies 
that are non-invasive and do not require medication are allowed.  A subject who is taking part in the long-term 
follow-up phase of a trial, who has completed all medications and invasive procedures per protocol requirements, 
may continue to participate in that trial. 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 68 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
c. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesion(s) must be located in a 
native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. 
The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm. 
6.3.2.2 
Angiographic Exclusion Criteria 
All exclusion criteria apply to the target lesion(s) or target vessel(s).  
1. Lesion which prevents successful balloon pre-dilatation, defined as full balloon 
expansion with the following outcomes: 
 Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly 
recommended. 
 TIMI Grade-3 flow (per visual estimation).  
 No angiographic complications (e.g. distal embolization, side branch closure). 
 No dissections NHLBI grade D-F.  
 No chest pain lasting > 5 minutes.   
• No ST depression or elevation lasting > 5 minutes  
2. Lesion is located in left main. 
3. Aorto-ostial RCA lesion (within 3 mm of the ostium). 
4. Lesion located within 3 mm of the origin of the LAD or LCX. 
5. Lesion involving a bifurcation with a:  
a. side branch ≥ 2 mm in diameter, or 
b. side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or 
c. side branch requiring dilatation. 
6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or 
XIENCE stent:  
a. Extreme angulation (≥ 90°) proximal to or within the target lesion. 
b. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion. 
c. Moderate or heavy calcification proximal to or within the target lesion. If IVUS used, 
subject must be excluded if calcium arc in the vessel prior to the lesion or within the 
lesion is ≥ 180°.   
7. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 70 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• A minimum of two telephone calls to contact the subject should be recorded in the source 
documentation, including date, time, and initials of site personnel trying to make contact; 
• If these attempts are unsuccessful, a certified letter should be sent to the subject. 
Subject Discontinuation: 
Every subject should remain in the Clinical Investigation until completion of the required follow-
up period, however, a subject’s participation in any Clinical Investigation is voluntary and the 
subject has the right to withdraw at any time without penalty or loss of benefit. Conceivable 
reasons for discontinuation may include, but not be limited to, the following: 
• Subject Withdrawal:  Subject participation in a Clinical Investigation is voluntary and 
the subject may discontinue participation (refuse all subsequent testing/follow-up) at any 
time without loss of benefits or penalty. 
• Investigator Termination:  Investigator may terminate the subject’s participation 
without regard to the subject’s consent if the Investigator believes it is necessary. 
Reasons for an investigator’s termination of a subject include the following but are not 
limited to:  
o Per the investigator’s discretion, a subject is unable to be compliant with the 
protocol requirement (e.g., medical conditions such as terminal cancer; subject 
moved out of the country, etc.) 
o Per the investigator’s discretion, the follow-up study requirements (i.e., 
medications or procedures) may put the subject at risk. 
• Lost-to-Follow-up:  Subject does not complete the scheduled follow-up visits but has not 
‘officially’ withdrawn from the clinical investigation.   
Sponsor must be notified of the reason for subject discontinuation. The site will record this 
information on the eCRF and source documents.  Investigators must also report this to their 
ethics committee (EC) or IRB as defined by their institution’s procedure.  Subjects will not be 
replaced. 
The subject is considered to have completed the study upon Clinical Investigation completion of 
the 5-year follow-up. 
However, if a subject withdraws from the study due to problems related to the investigational 
device safety or performance, the investigator shall ask for the subject's permission to follow 
his/her status/condition outside of the clinical investigation. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 71 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
7. 
TREATMENT AND EVALUATION OF SAFETY AND 
EFFECTIVENESS 
7.1 
Baseline  
7.1.1 Baseline Laboratory Assessments to Confirm Subject Eligibility 
Subject preparation will be in accordance with standard hospital policy for the care of 
interventional cardiology subjects.  
7.1.2 Subject History 
Subject history will include demographics (e.g., age, gender)31, cardiac history including but not 
limited to Canadian Cardiovascular Society (CCS) and Braunwald classification of angina, 
history of myocardial infarction, diabetes mellitus, hypertension, hypercholesterolemia, previous 
CABG and PCI, and concomitant cardiovascular medications (Refer to Appendix II for 
Definitions).  In addition, measurements of weight, height, and resting blood pressure will be 
collected. 
7.1.3 Patient-Reported Outcomes Assessment 
All 2,000 primary analysis subjects in ABSORB III will complete the following Patient Reported 
Outcome questionnaires in person at the clinical site prior to the index procedure*. 
• EuroQoL 5D (EQ-5D) survey to assess overall health status.  The EQ-5D is a self-
administered two-part instrument.  The first part consists of 5 questions to assess current 
health state in 5 dimensions (mobility, self care, usual activities, pain/discomfort and 
anxiety/depression).  The second part is a 20 cm visual analog scale that ranges from 0 
(worst imaginable health state) to 100 (best imaginable health state [31].   
• Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life.  The SAQ 
is a self-administered 19-item instrument designed to measure the physical and emotional 
effects of coronary artery disease across five dimensions (physical limitation, angina 
stability, angina frequency, treatment satisfaction, and disease perception)[32]. 
• Rose Dyspnea Scale (RDS) to assess severity of dyspnea.  The RDS is a self-
administered 4-item instrument designed to assess impact of dyspnea on health-related 
quality of life [33]. 
• Generalized Anxiety Disorder scale (GAD-7) to assess anxiety.  The GAD-7 is a self-
administered 7-item instrument designed to assess severity of patient’s general anxiety 
disorder[34]. 
*Every effort should be made to have subjects complete all four patient reported outcomes 
questionnaires prior to the procedure.  However, in situations where this is absolutely not 
 
31 Demographics include age, gender, post-menopausal status, date of birth, race/ethnicity, highest level of 
education, employment status and household income.  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 72 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
possible, subjects may complete them post-procedure, prior to discharge. Subjects who complete 
their questionnaires post-procedure should base their responses on their condition prior to the 
procedure.  
7.2 
Pre-Procedure  
7.2.1 Pre-Procedure Laboratory Assessment 
The following laboratory assessments need to be obtained prior to the index procedure or at the 
time of the index procedure depending on the assessment and condition of the subject. 
Table 7.1  
Baseline Laboratory Assessment 
Within 21 days prior to 
procedure† 
Within 7 days prior to 
procedure 
Within 48 hours prior to procedure€ 
• 
Platelet and White Blood 
Count 
• 
Hemoglobin 
• 
Serum Creatinine 
• 
HbA1c‡ 
• 
Estimated GFR* 
• 
Pregnancy test (if 
applicable) 
• 
12-lead ECG (within 24 hours 
preferred) 
• 
Creatine kinase (CK) 
• 
Creatine kinase myocardial-band 
isoenzyme (CK-MB) 
†The 21 day labs must be known prior to index procedure.  
‡ HbA1c is to be collected in diabetic subjects only, and its result is not needed prior to the index procedure. 
€Within 24 hours must be done in cases in which there is evidence of acute or recent (<7 days) myocardial infarction 
(MI) or unstable angina; in these cases CK and CK-MB must be < ULN prior to the index procedure.  For stable 
angina or silent ischemia, CK and CK-MB < ULN within 48 hours prior to index is acceptable.  For stable angina 
subjects, if CK is > ULN but CK-MB is < ULN, with no signs of MI or unstable angina, the patient maybe enrolled.  
If the subject does not have a known diagnosis of MI or unstable angina within 96 hours prior to the index 
procedure, assessment of cardiac enzymes may be obtained from arterial blood drawn after the start of the index 
procedure but prior to device implantation.  However, if CK-MB comes back elevated a protocol deviation will be 
issued. 
* Glomerular Filtration Rate 
 
Both CK and CK-MB must be measured pre-procedure and used to assess subject’s eligibility 
criteria.  
7.2.2 Dual Anti-Platelet Medications 
Subjects selected for treatment with Absorb BVS or XIENCE must receive a loading dose of ≥ 
300 mg of aspirin within 24 hours, regardless of whether the patient was previously taking 
aspirin. Subjects are also required to receive a loading dose of an ADP antagonist within 24 
hours prior to the index procedure (preferred), but in all cases no greater than 1 hour after the end 
of the procedure.  ADP antagonist administered must include one of the following, a peri-
procedural loading dose of 600 mg of clopidogrel bisulfate, or 60 mg of prasugrel or 180 mg of 
ticagrelor. For patients with a recent ACS prior to admission, it is strongly recommended that the 
loading dose be given at least 6 hours before the procedure (clopidogrel 600 mg), or 1 hour prior 
to the procedure (prasugrel 60 mg or ticagrelor 180 mg), but in all cases no greater than 1 hour 
after the end of the procedure. 
The prasugrel loading dose may be omitted for those subjects on chronic prasugrel therapy (5 or 
10 mg daily, or according to prescribing information) for ≥ 7 days prior to the index procedure; 
however, it is recommended that a loading dose (≥ 30 mg) be re-administered. The ticagrelor 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 73 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
loading dose may be omitted for those subjects on chronic ticagrelor therapy (90 mg twice daily).  
For patients maintained on chronic clopidogrel, the loading dose of an ADP antagonist must be 
administered. A loading dose of prasugrel or ticagrelor may be safely given to patients 
maintained on chronic clopidogrel therapy, or even in those in whom a clopidogrel loading dose 
was recently administered. Ticlopidine may be used as a substitute at a dose in accordance with 
standard hospital practice only if the subject develops hypersensitivity or intolerance to 
clopidogrel, prasugrel, or ticagrelor.   
Refer to respective prescribing information for ADP antagonist for further details regarding 
loading practice.  
7.2.3 Anti-Coagulation Medications 
Subjects must receive appropriate anticoagulation and other therapy according to standard 
hospital practice. Either unfractionated heparin or bivalirudin may be used for procedural 
anticoagulation, as per the discretion of the investigator. Subjects having been treated with low 
molecular weight heparin (LMWH) prior to the procedure must receive their last dose more than 
8 hours prior to the index procedure. LMWH and fondaparinux are not permitted as procedural 
anticoagulants in this protocol.  
Use of glycoprotein IIb/IIIa inhibitors will be at the discretion of the investigator. Any change in 
medication regime performed per the protocol, and not as routine hospital practice, can only 
occur after obtaining Informed Consent. 
7.3 
Index Procedure 
7.3.1 Baseline (Pre-Procedure) Angiography 
Baseline angiography of the target vessel(s) will be completed as per the Angiographic Core 
Laboratory Protocol. 
7.3.2 Imaging Guidance Document 
The Imaging Guidance Document will provide specific details and instructions from the 
angiographic, IVUS and OCT core laboratory regarding vessel sizing, and post-procedure and 
follow-up imaging with each respective modality. This document will be separate from the 
protocol.  
7.3.3 Treatment of the Non-target Lesion(s) 
In addition to target lesion, one additional non-target lesion in a different epicardial vessel can be 
treated by the specific country’s regulatory-approved XIENCE stent (e.g., FDA-approved/CE-
marked stent/Therapeutic Goods Administration (TGA)). A non-target lesion can be treated in 
the case that there are two lesions and one lesion does not meet the angiographic 
inclusion/exclusion criteria. The non-target lesions must be treated first, prior to randomization, 
and the subject may then only be randomized if treatment of the non-target lesion was successful 
and uncomplicated, defined as final diameter stenosis ≤ 10% with final TIMI-3 flow, with no 
residual dissection NHLBI grade ≥ type B, and no transient or sustained angiographic 
complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 74 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
and no ST segment elevation or depression lasting > 5 minutes. The non-target lesion will not be 
considered in the primary analysis.  
7.3.4 Treatment Rules of the Target Lesion(s) 
Prior to use, the Absorb BVS System or XIENCE should be inspected and prepared according to 
the IFU. The Absorb BVS System and XIENCE should be delivered and deployed per the IFU. 
The treatment strategy applies to all subjects in ABSORB III, including the Lead-In Phase and 
the Imaging Cohort. 
• Treatment of a maximum of two de novo native coronary artery lesions, each in a different 
epicardial vessel. 
o If a single target lesion is treated, it must be treated by the assigned device (Absorb BVS 
or XIENCE). For Lead-In subjects, the target lesion will be treated only with Absorb 
BVS. 
o If two lesions are treated, possible combinations are as follows: 
o Two target lesions:  
 If both lesions satisfy angiographic inclusion/exclusion criteria, then both lesions 
must be treated by the same device that the subject was randomized to (test 
device: Absorb BVS or control device: XIENCE), 
 For Lead-In subjects, both target lesions will be treated with Absorb BVS 
OR 
o One target lesion and one non-target lesion: 
 If only one lesion satisfies angiographic inclusion and exclusion criteria then this 
lesion must be treated by the assigned device (test device: Absorb BVS or control 
device: XIENCE) as a target lesion and the other lesion must be treated by 
XIENCE as a non-target lesion per the instructions for use (IFU).  
 The non-target lesion must be treated first (before randomization) with a 
XIENCE, and the patient may then only be randomized if treatment of the non-
target lesion was successful and uncomplicated, defined as final diameter stenosis 
≤ 10% with final TIMI-3 flow, with no residual dissection NHLBI grade ≥ type B, 
and no transient or sustained angiographic complications (e.g., distal 
embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST 
segment elevation or depression lasting > 5 minutes. Please refer to Figure 2 in 
Appendix V. 
 For Lead-In subjects, one target lesion and one non-target lesion treatment is 
allowed. The target lesion must be treated by Absorb BVS, and the non-target 
lesion must be treated by XIENCE. The non-target lesion must be treated first and 
successfully (as defined above) before treating the target lesion with Absorb BVS. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 75 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Access Site and Guide Catheter Size: 
• Either femoral or radial access may be used.  
• A minimum 6F guide catheter or greater must be used during the index procedure per 
requirements for Absorb BVS implantation.  
o Minimum guiding catheter compatibility (inner diameter) for Absorb BVS is 0.070”/1.8 
mm (6F) (refer to IFU).   
o Devices (i.e., guide sheaths such as the GuideLiner) that decrease the inner diameter of 
the guide catheter outside of the Absorb BVS minimum guide catheter compatibility must 
not be used with the Absorb BVS System. Do not insert a 5-in-6, or a 6-in-7 guide sheath 
into a 6F or 7F guiding catheter, respectively, as doing so will result in an inner diameter 
that is too small for use with the Absorb BVS. 
o If a guide sheath is necessary, the inner diameter must meet or exceed the above 
minimum guiding catheter requirements for Absorb BVS (i.e., only the 7-in-8 GuideLiner 
provides an adequate inner diameter (0.071” ID), 8F guide catheter would be required). 
• For XIENCE, please follow IFU for the guiding catheter size. 
Baseline Angiogram and Identification of the potential target lesion: 
• Assessment of the potential target lesion(s) to be treated must be done to ensure angiographic 
criteria are met; this must occur prior to pre-dilatation and vessel sizing. 
Pre-dilatation of potential target lesion 
• Pre-dilatation of the potential target lesions(s) must be performed.  
• Pre-dilatation must be performed with an angioplasty balloon; cutting or scoring balloons 
may be used per physician discretion, if the lesion appears to be mildly calcified.  
• The pre-dilatation balloon should be sized 1:1 to the visually estimated RVD or 0.25 mm 
smaller than RVD. It cannot be more than 0.5 mm smaller than the visually estimated RVD 
of the target vessel.  If pre-dilatation balloon is sized 1:1, a non-compliant balloon is strongly 
recommended.  
The pre-dilatation balloon must be equal in length or shorter than the planned scaffold/stent 
length.   
Important: Full balloon expansion with the pre-dilatation balloon must be achieved before the 
patient is randomized into the study. If there is any question that the target lesion was not 
fully dilated or that any significant resistance to expansion from the lesion remains, the lesion 
should be re-dilated with a non-compliant balloon (sized 1:1 to the RVD) at higher pressure. 
Absorb BVS or XIENCE must not be implanted in a lesion in which full balloon expansion 
has not been achieved.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 76 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• The potential target lesion must continue to meet angiographic criteria following adequate 
pre-dilatation, to be regarded as “successful pre-dilatation”. 
o For randomized subjects, RVD remains ≥ 2.50 mm - ≤ 3.75 mm, and length of the lesion 
that will be covered by the device (including any edge dissections) is still ≤ 24 mm. 
o For Lead-In subjects, RVD remains ≥ 2.75 mm - ≤ 3.25 mm, and length of the lesion that 
will be covered by the device (including any edge dissections) is still ≥8- ≤ 14 mm. 
o Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly 
recommended.  
o TIMI Grade-3 flow (per visual estimation).  
o No angiographic complications (e.g. distal embolization, side branch closure).  
o No dissections NHLBI grade D-F. 
o No chest pain lasting > 5 minutes.   
o No ST depression or elevation lasting > 5 minutes. 
• For two potential target lesions, the lesion with the higher possibility of failing vessel sizing 
criteria (per investigator’s assessment) should be identified as the first target lesion and pre-
dilated first before randomization. 
o If pre-dilatation of the 1st target lesion fails, the patient may not be randomized, and the 
interactive voice response system (IVRS) must not be called. 
o If the 1st target lesion was successfully pre-dilated and vessel sizing criteria are still met, 
the IVRS is called to randomize the subject. Once the first lesion is successfully treated32 
with the assigned device (and only at this time), the second target lesion must be pre-
dilated, and then treated with the assigned device.   
o If the 1st target lesion was successfully pre-dilated but did not meet vessel sizing criteria, 
treat as a non-target lesion. Once the first lesion is successfully treated as a non-target 
lesion, the second lesion must be treated as the target lesion in which successful  pre-
dilatation and vessel sizing criteria must be met after which IVRS must be called and the 
target lesion treated per assignment. If 2nd target lesion fails pre-dilatation and vessel 
sizing criteria, it should be treated as non-target lesion and subject must not be 
randomized. 
•  Each target vessel and lesion should also be such that the operator believes either the Absorb 
BVS or XIENCE devices could be delivered to and cross the target lesion without additional 
lesion preparation (e.g., absence of excessive vessel or lesion tortuosity or calcification).  
 
32 Successful lesion treatment is defined as final diameter stenosis ≤ 30% with final TIMI-3 flow, with no residual 
dissection NHLBI grade ≥ type B, and no transient or sustained angiographic complications (e.g. distal 
embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation or depression 
lasting > 5 minutes. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 77 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Vessel Sizing 
• Following the use of nitroglycerine (at least 100 µg intracoronary nitroglycerine, >150 µg 
preferred)33 and successful pre-dilatation of the potential target lesion(s), vessel sizing must 
be conducted by visual estimation. Quantitative methods such as on-line QCA, IVUS or OCT 
may be used per physician discretion but are not required; taking into account that QCA 
tends to under-estimate RVD compared to visual estimation, whereas IVUS tends to over-
estimate lumen RVD compared to visual estimation. Follow core laboratory guidelines for 
the use of each modality. 
• Prior to randomization, IVUS or OCT can be used to evaluate the vessel if there is question 
regarding the eligibility of the vessel either before or after pre-dilatation.  
• A subject must not be randomized in ABSORB III if 
o Vessel size or lesion length before or after pre-dilatation does not satisfy eligibility 
criteria. 
o Moderate or heavy calcification, tortuosity or other conditions are present proximal or 
within the target segment, reducing the likelihood that the Absorb BVS or XIENCE can 
be either delivered to or expanded at the lesion. 
o Complications and/or adverse events were identified during IVUS or OCT usage (e.g., 
vessel dissection NHLBI grade D-F).34   
• Table 7.2 provides the guidance of vessel and device sizing during the procedure, which are 
detailed as the followings: 
o First, assess RVD based on visual estimation 
o Then, select a pre-dilatation balloon sized 1:1 to RVD or 0.25 mm smaller than RVD. For 
example, for RVD of 2.5 mm, a pre-dilatation balloon of 2.25-2.5 mm should be used. 
o Use the size of the inflated pre-dilatation balloon, as well as the results after pre-
dilatation, to reassess the RVD for appropriate vessel sizing for the scaffold or stent. If 
the reassessed RVD after pre-dilatation exceeds the specified range for a specific BVS 
size, the next available size Absorb BVS can be used. For example, if the RVD is 
reassessed as 2.8 mm after pre-dilatation of a vessel that was believed to be 2.5 mm 
before pre-dilatation, then implant a 3.0 mm BVS. 
o Post-dilatation must always be a non-compliant balloon. Always make sure the non-
compliant post-dilatation balloon has a length short enough so it is inflated within the 
scaffold margins to avoid edge dissection. 
 
33 If the patient’s blood pressure is so low that ≥ 100 ug of nitroglycerine cannot be administered, the patient should 
not be randomized. It is suggested that ≥200 µg of nitroglycerine be administered if the systolic blood pressure is 
>140 mmHg. Timing of nitroglycerine administration and pre-dilatation is per physician discretion, but must be 
before randomization and assessment of scaffold or stent size.  
34 Examples of complications associated with IVUS or OCT: side-branch occlusion, persistent S-T abnormalities, 
prolonged chest pain, flow limiting dissections etc. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 78 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Table 7.2 
Vessel and Device Sizing  
Closest RVD by 
Visual Estimation 
Pre-dilatation 
Balloon Diameter 
Reassessed Closest RVD 
after Pre-dilatation 
Absorb BVS Diameter 
2.5 mm 
2.25 or 2.5 mm 
2.5 mm 
2.5 mm 
2.75 mm 
2.25 – 2.75 mm 
2.75 mm 
3.0 mm 
3.0 mm 
2.5 – 3.0 mm 
3.0 mm 
3.0 mm 
3.25 mm 
2.75 – 3.25 mm 
3.25 mm 
3.5 mm 
3.5 mm 
3.0 – 3.5 mm 
3.5 mm 
3.5 mm 
3.75 mm 
3.25 – 3.75 mm 
3.75 mm 
3.5 mm 
 
Randomization 
• Upon successful treatment of the non-target lesion (if any) and completion of successful pre-
dilatation and vessel sizing of the first target lesion, interactive voice response system (IVRS) 
can be called. 
• A subject is considered registered and in the ITT population at the time of randomization.  
• Lead-In subjects will not be randomized but are assigned to Absorb BVS treatment in target 
lesion(s). 
Lesion Treatment 
• The length of the Absorb BVS and XIENCE stent should be selected to allow at least 2 mm 
but less than 4 mm of normal or nearly normal reference vessel at each edge. 
• If the Absorb BVS cannot reach or cross the lesion or additional lesion preparation is 
required, the Absorb BVS must be removed and a new Absorb BVS must be introduced after 
subsequent pre-dilatation(s) with the same sized or larger non-compliant balloon at higher 
pressure. Note: the Absorb BVS should not be “Dottered” across the lesion if it does not 
cross easily. 
• If the Absorb BVS is unable to reach or cross the target lesion after multiple attempts 
(maximum of two Absorb BVS; including additional lesion preparation), a XIENCE stent 
must be used.  
• If XIENCE is unable to reach or cross the target lesion after multiple attempts (including 
additional lesion preparation), the investigator should treat the lesion per standard of care. 
• In the case of two target lesions assigned to the Absorb BVS, if the first lesion is 
unsuccessfully treated with the Absorb BVS the following must occur:  
o First target lesion must be treated with XIENCE. If the treatment of the 1st target lesion is 
successfully treated with XIENCE, treat the 2nd target lesion with Absorb BVS.  
o If the treatment of the 1st target lesion is unsuccessful treated with XIENCE, treat the 1st 
lesion and 2nd lesion per standard of care. The subject must not be treated with a BVS.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 79 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
o Every attempt must be made that the two lesion treatment occur at the same index 
procedure as staged procedures are not allowed. However, if a staged procedure does 
occur BVS must not be used.  
• Successful lesion treatment is defined as final diameter stenosis ≤ 30% with final TIMI-3 
flow, with no residual dissection NHLBI grade ≥ type B, and no transient or sustained 
angiographic complications (e.g. distal embolization, side branch closure), no chest pain 
lasting > 5 minutes, and no ST segment elevation or depression lasting > 5 minutes.   
• For Absorb BVS, the scaffold should be deployed slowly, by pressurizing the delivery 
system in 2 atm increments each, over 5 seconds, until the scaffold is completely expanded. 
Pressure should be maintained for 30 seconds if tolerated by the patient. 
• For the Absorb BVS and XIENCE delivery balloon, do not exceed the rated burst pressure 
(RBP) per the IFU for the individual device. 
• Post-dilatation of target lesion or non-target lesion treated with XIENCE should be per 
standard of care. 
• If post-dilatation of the target lesion treated with Absorb BVS is necessary the following 
guidance is given: 
o A low profile, high pressure, non-compliant, balloon dilatation catheter that has not been 
previously inflated must be used. 
o The post-dilatation balloon length should be selected such that the balloon stays within 
the margins of the scaffold so as to avoid an edge dissection.  
o The expanded diameter of the post dilatation balloon must be within the allowable 
expansion limits of the scaffold. Do not dilate the Absorb BVS beyond the dilatation 
limit which is 0.5 mm above the nominal diameter. Doing so may result in scaffold 
damage. Thus, it is highly recommended that the compliance chart of the non-compliant 
balloon selected must be carefully reviewed prior to dilatation and an appropriate 
maximum pressure used to ensure that the scaffold is not over-dilated. 
Table 3.0 Scaffold Diameter and Maximum Diameter Limit  
Nominal Scaffold Diameter 
Post Dilatation Maximum 
Diameter Limit 
2.5 mm 
3.0 mm 
3.0 mm 
3.5 mm 
3.5 mm 
4.0 mm 
o The delivery balloon cannot be removed from the body and reinserted and used for post-
dilatation 
• IVUS or OCT guidance may be used as per standard of care.  
• Please refer to the physician training deck for user guidance in handling procedural issues 
(e.g., difficult in recrossing an implanted scaffold for purposes such as intravascular imaging 
or post-dilatation if needed). 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 80 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Imaging Cohort  
If subject is in the Imaging Group (See Appendix VI and Imaging Guidance Document for 
further details):  
• Post-procedure angiography, IVUS and OCT are required based on respective imaging 
groups. 
• If post-dilatation was performed, post-procedure imaging must be conducted following last 
balloon inflation. 
If two target lesions are treated, post-procedure imaging must be done on the first target lesion 
after its successful treatment, and then after successful treatment of the 2nd target lesion. 
7.3.5 Bailout Stenting or Alternative Procedures 
Bailout procedures may be performed if the subject experiences: 
• Dissection requiring intervention 
• Occlusive complication as evidenced by a decrease in target vessel flow 
• Chest pain or ischemic changes measured by ECG that do not respond to repeat balloon 
inflations, medical therapy or lytic agents 
• Unplanned additional device is required to cover the target lesion 
In the randomized subjects, if a bailout device is required for a target lesion (e.g., for edge 
dissection), the same device as the implanted device must be used. Overlap of the bailout 
stent/scaffold with the implanted stent/scaffold should be 1-2 mm. Gaps should be avoided. 
ο Use Absorb BVS if target lesion is treated with Absorb BVS. 
ο Use XIENCE if target lesion is treated with XIENCE.  
ο If a bailout with an Absorb BVS device cannot be delivered to the site of the lesion, the 
device should be carefully withdrawn and a XIENCE used. 
ο If an appropriate size Absorb BVS is not available XIENCE can be used.  
If during the Lead-In phase a bailout is required, the investigator should use an appropriately 
sized XIENCE stent and not an Absorb BVS. 
The Imaging Cohort subjects that receive metallic stent bailout of an Absorb BVS treated lesion 
will be required to complete imaging follow-up at the protocol specified time points of 3 years 
for IVUS or  OCT, depending on which imaging group the subject is in. However, the subject’s 
imaging data will not be included in the imaging study analysis and will not be counted towards 
the associated powered secondary endpoints analysis. These subjects may be replaced by another 
subject that received an Absorb BVS without metallic stent overlap. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 81 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
IMPORTANT:  It is required that the bailout device be placed so that there is no visible gap 
between the Absorb BVS and the bailout device.  In such a case, at least 1 mm (minimum) to 2 
mm (maximum) overlap is required. 
IMPORTANT: In the rare event of acute occlusion following Absorb BVS placement, the 
bailout device should be XIENCE and deployed within the Absorb BVS such that the Absorb 
BVS is completely covered by the bailout device if this is believed to be in the best interest of 
the patient.  
Although a bailout procedure is not considered a major adverse cardiac event (MACE) unless the 
subject sustains death, emergent CABG, PCI or MI, such procedures should be avoided unless 
required for safe subject management.  
7.3.6 Final (Post-procedure) Angiography 
Angiographic imaging will also be performed after the Absorb BVS or XIENCE stent 
deployment.  Physicians should follow accepted hospital imaging practice to ensure good 
apposition of the Absorb BVS or XIENCE to the vessel wall.  For angiographic imaging, post-
implantation images should be captured the same orthogonal views that were used for the pre-
procedure images. Intracoronary nitroglycerine should be re-administered before final 
angiography. 
7.3.7 Final (Post-procedure) IVUS and OCT 
For subjects not required to have post-procedure imaging, IVUS and OCT may be performed 
post-procedure if the investigator believes there is incomplete apposition of the device. The 
procedure will be performed according to the site’s standard. However, if malapposition is seen 
and post-dilatation required, a non-compliant balloon should be used and in the case of Absorb 
BVS, do not dilate the Absorb BVS beyond the dilatation limit which is 0.5 mm above the 
nominal diameter. Repeat angiography in orthogonal views must be performed after any 
additional inflations. 
7.3.8 Imaging Assessment 
Subjects from the Imaging Cohort will receive angiography (includes vasomotion assessment), 
IVUS and OCT at pre-specified time-points (Section 7.5). Imaging assessments should be 
conducted per core lab guidelines in the Imaging Guidance Document distributed to each site. 
Intracoronary nitroglycerine should be given before all imaging runs to avoid spasm and afford 
maximal luminal dimensions. 
Any Imaging Cohort subject that did not receive the assigned Absorb BVS or XIENCE stent will 
not receive follow-up imaging procedures. These subjects will be clinically followed under the 
study. If an Imaging Cohort subject had a TLR prior to the imaging follow-up, the imaging data 
at the time of TLR and at the protocol specified later imaging time points will be analyzed but 
not included in the imaging endpoint analysis. If an Imaging Cohort subject had a TVR or 
angiogram prior to the imaging follow-up, the subject will continue to have the protocol 
specified imaging follow-up and will not be replaced. If an Imaging Cohort subject has two 
target lesions but only one target lesion was successfully treated with the assigned device, the 
unsuccessfully treated target lesion must be imaged post-treatment and at the specified follow-up 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 82 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
times only if the assigned study device was implanted for lesion treatment. Imaging Cohort 
subjects that receive metallic stent bailout of an Absorb BVS treated lesion will be required to 
complete imaging follow-up at the protocol specified time points of 3 years for IVUS or OCT, 
depending on which imaging group the subject is in. However, the subject’s imaging data will 
not be included in the imaging study analysis and will not be counted the associated powered 
secondary endpoints. These subjects may be replaced by another subject that received an Absorb 
BVS without metallic stent overlap. 
7.3.8.1 
 
QCA of Target Vessel 
• QCA will be performed pre-procedure, post-procedure and at the 3-year follow-up for the 
imaging study subjects. 
• Angiography must be performed per the angiographic core laboratory guidelines. 
7.3.8.2  IVUS Pull-back of Target Vessel 
• IVUS pullback (20 MHz or 40-45 MHz catheter can be used) is required post-procedure 
and at 3-year follow-up for the imaging study subjects. 
• Pullback of the IVUS catheter should be performed from the distal reference to the 
guiding catheter, per IVUS core laboratory guidelines. 
• If IVUS reveals any findings such that additional PCI is performed, an additional IVUS 
run must be performed after the last intervention.  
• Caution:  It is important to place the IVUS transducer in the center of the lumen to avoid 
lifting or disturbing the device struts during pullback.  
7.3.8.3  OCT of the Target Vessel 
• OCT pullback is required post-procedure and at 3-year follow-up for the imaging study 
subjects. 
• OCT pullback should contain at least one recognizable landmark, usually a major side 
branch. 
• Caution:  It is important to place the OCT transducer in the center of the lumen to avoid 
lifting or disturbing the device struts during pullback. 
7.3.8.4  Vasomotion Assessment 
• At the 3-year follow-up, assessment of vessel movement in response to nitroglycerin 
infusion will be conducted. Please see the Imaging Guidance Document for the details of 
this assessment. 
• Vasomotion assessment should not be assessed under the following conditions, and those 
subjects may be replaced for the imaging analysis: 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 83 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
o Target lesion treated with Absorb BVS with metallic stent overlap 
o Target lesion undergoing other PCI procedures prior to 3-year imaging follow-up 
o If target lesion has ≥ 50% stenosis at the time of the 3-year assessment and does 
not clearly require revascularization, FFR should be conducted to determine if 
lesion is flow limiting. If the lesion is flow limiting and requires revascularization, 
vasomotion assessment should not be done. 
• Details regarding the angiographic assessment of the vessel and timing of nitroglycerine 
infusion are further detailed in the Imaging Guidance Document.   
7.4 
Post–procedure  
7.4.1 Post-procedure Information to be Recorded 
The following information needs to be obtained between 12 hours following the index procedure 
and hospital discharge (in-hospital stay is considered to be a maximum of 7 days following the 
index procedure).  
Between 12 hours post-procedure and discharge 
• Date of discharge 
• Antiplatelet medications  
• Chronic concomitant medications  
• Adverse Events, if any  
7.4.2 Post-procedure Laboratory and Clinical Tests 
The following laboratory assessments need to be obtained between post-index procedure and 
hospital discharge. Hospital discharge cannot occur prior to 16 hours to ensure complete post-
procedure cardiac enzyme collection. 
IMPORTANT:  These tests must be performed whether or not they are considered part of the 
Investigator’s standard of clinical practice. 
Post-procedure and discharge 
• A 12-lead ECG must be obtained between 30-90 minutes post procedure.  
• Both Creatine kinase (CK) and Creatine kinase myocardial-band isoenzyme (CK-MB) must 
be obtained for ALL registered subjects as it will be used for cardiac assessment of subjects 
post-index procedure 
o Pre-procedure CK and CK-MB draw*  
o First post-procedure CK and CK-MB draw at 6 to 12 hours post-procedure.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 84 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
o Second post-procedure CK and CK-MB draw at 18-24 hours post-procedure, or at the 
time of discharge as long as discharge is at or after 16 hours post-procedure**. 
o If either of the post-procedure CK-MB levels are ≥ 3 x ULN, serial CK and CK-MB 
levels must be drawn until they are falling. 
* If the patient has stable coronary artery disease, the pre-procedure level can be obtained during 
procedure but prior to stent/scaffold deployment. If the patient has a recent acute coronary 
syndrome, the pre-procedure level must be obtained prior to the procedure and the CKMB shown 
to be within normal limits prior to the patient being randomized. 
** For hospitals required to discharge stable subjects prior to 16 hours, the subject may be 
discharged but will have to return to the enrolling institution for their second biomarker draw. 
CK and CK-MB levels are required at all time points. If troponin is collected at the pre-procedure 
or post-procedure time points, this should also be documented in the electronic case report forms  
7.4.3 Follow-up Antiplatelet Medications 
All subjects will be maintained at a minimum of 75 mg of clopidogrel daily or 5 or 10 mg of 
prasugrel daily (10 mg preferred in most patients)  or 90 mg twice daily of ticagrelor for a 
minimum of 12 months following the procedure. For prasugrel subjects < 60 kg in weight or ≥75 
years of age, a maintenance dose of 5 mg per day for 12 months is allowable. Patients with prior 
stroke or TIA should receive clopidogrel or ticagrelor, not prasugrel. All subjects must receive 
between ≥75 to ≤ 100 mg of aspirin daily through 5 years follow-up during the study and should 
continue to take aspirin indefinitely.  
Refer to respective prescribing information for ADP antagonist for further details regarding 
maintenance dose.  
The start of anti-platelet medications, any changes or discontinuation of the medications, as well 
as the reasons for those change will be documented in the eCRF. 
7.4.4 Other Chronic Concomitant Medications 
Administration of concomitant medications other than any approved ADP antagonist and aspirin 
are not required in this protocol/CIP. Subjects may receive other medications as needed per 
physician’s discretion. These concomitant medications must be recorded if the medications are 
expected to continue for more than 3 months. However, antiplatelet medications must be 
recorded regardless of duration.  
The use and changes for the following classes of chronic concomitant medications, including 
dosage, frequency and route of administration should be recorded.  
• Cardiovascular Medications: Angiotensin converting enzyme inhibitors and angiotensin 
receptor blockers, renin inhibitor, beta blockers, calcium channel blockers, diuretics, 
coumadin, other chronic anticoagulants or anti-platelet agents (e.g. rivaroxaban, apixaban, 
dabigatran, cilostazol), vasodilators, statins, and other lipid lowering agents 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 85 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• Non-cardiovascular Medications: Systemic anti-inflammatory medications, hormone 
replacement therapy and diabetic medications 
7.5 
Clinical and Imaging Follow-up for All Subjects 
Clinical follow-up will be performed periodically at the following intervals for all subjects:  
o 30 ± 7 days follow-up telephone contact/office visit 
o 180 ± 28 days follow-up telephone contact/office visit 
o 1 year ± 28 days office visit and ECG35 
o 2 years ± 28 days follow-up telephone contact/office visit  
o 3 years ± 28 days follow-up telephone contact/office visit 
o 4 years ± 28 days follow-up telephone contact/office visit 
o 5 years ± 28 days follow-up telephone contact/office visit  
Registered subjects must be clinically followed even if no assigned device is implanted. Clinical 
follow-up visits can also be conducted by a blinded Nurse Practitioner or Physician Assistant that 
has been trained to the protocol.  
For the 2,000 primary analysis subjects of ABSORB III, Patient Reported Outcome follow-up 
assessments will be conducted as the followings:  
o 30 ± 7 days follow-up, in-person, mail, or phone (EQ-5D, SAQ, RDS, GAD-7) 
o 1 year ± 28 days office visit (EQ-5D, SAQ, RDS, GAD-7) 
o 2 years ± 28 days follow-up, in-person, mail, or phone (EQ-5D, SAQ, RDS, GAD-7) 
o 3 years ± 28 days follow-up, in-person, mail, or phone (EQ-5D, SAQ, RDS, GAD-7) 
o 5 years ± 28 days follow-up, in-person, mail, or phone (EQ-5D, SAQ) 
The questionnaires will be mailed to the subject for completion or can be completed during the 
phone or office visit. If questionnaires are mailed to the subjects, the subjects must mail the 
questionnaires back to the clinical site.  
 
35 ECG can be obtained outside of the investigational site but must be reviewed by one of the site investigators and 
obtained within the protocol visit window. If an investigator suspects that a subject, with a negative ECG, will 
require a diagnostic angiogram due to possible cardiac symptoms, a functional study must be performed prior to the 
angiogram to confirm whether the patient has ischemia. This must be done whether or not it is a site standard, due to 
the use of the ARC definition to adjudicate ischemia driven revascularization.  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 86 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
In addition to the clinical follow-up, imaging follow-up will be performed at the following 
intervals for the Imaging Cohort:  
 Post-procedure: angiography and IVUS (~150 subjects) or angiography and OCT 
(~50 subjects) 
 3 years ± 28 days follow-up office visit and ECG: subjects in the Imaging Cohort 
(n=150) will receive follow-up angiography and IVUS. 
 3 years ± 28 days follow-up office visit and ECG: subjects in the Imaging Cohort 
(n=50) will receive follow-up angiography and OCT.   
Imaging Cohort subjects are required to undergo only one of the imaging follow-up time-points.  
The following information will be collected at each of the time points: 
• Any adverse events*, medications, laboratory tests and 12-lead ECGs, if performed; 
• Any repeat coronary angiography and results of such, if applicable; 
• Details of any subsequent coronary interventions (e.g., repeat PCI or CABG); 
• Use and compliance of medications per clinical investigation plan; 
• Use and changes in concomitant cardiovascular medications. 
* All adverse events must be collected up to and including to the 1 year follow up for all 2250 
subjects. Following the 1-year follow-up, it is mandatory to collect information on cardiac 
adverse events, device related adverse events and on serious adverse events. 
7.6 
Additional Follow-up Visits for All Subjects  
Additional subject visits, such as unscheduled visits, may occur as clinically warranted. The 
following information will be collected:  
• Assessment of angina status 
• Adverse events  
• Details of any subsequent coronary interventions (e.g., repeat PCI or CABG)  
• Use and compliance to protocol medications (aspirin and prasugrel/clopidogrel/ 
ticagrelor/ticlopidine)  
• Use and changes in chronic concomitant medications (Refer to Appendix II for 
definition)  
For unscheduled visits for suspected ischemic cardiac events, sites should make reasonable 
efforts to obtain cardiac enzymes (Troponin I or T), CK and CK-MB, and/or ECG if the site is 
aware of the visit at the time of its occurrence. In all other scenarios (i.e., site does not become 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 87 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
aware until after the fact), no protocol deviation will be issued if Troponin I or T, CK and CK-
MB, and/or ECG were not obtained at the time of the unscheduled visit. 
All efforts must be made to obtain follow-up information on subjects who have undergone 
procedures or have been treated for adverse events in a non-trial-related hospital(s). 
All coronary revascularizations must be classified prospectively by the investigator as ischemia-
driven or not ischemia-driven (Refer to Appendix II for definition). If a subject has a coronary 
revascularization, all clinical information such as symptoms or lack of symptoms of ischemia, 
and possible relations with the target lesion/vessel should be fully recorded in the source 
documents prior to angiogram. 
8. 
ADVERSE EVENTS 
8.1 
Definitions 
To comply with worldwide standards and guidelines on clinical trial adverse event reporting, AV 
has developed the below definitions to be used and adhered to by the investigators. The exact 
definitions as referenced in these standards and guidelines are included in appendix II. 
8.1.1 Adverse Event 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device. 
NOTE 1: This definition includes events related to the investigational medical device or the 
comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to investigational 
medical devices. 
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a medicinal (investigational) 
product, whether or not related to the medicinal (investigational) product. 
8.1.2 Serious Adverse Event 
If the adverse event meets any of the criteria below, it is regarded as a serious adverse event 
(SAE): 
a. led to death, 
b. led to serious deterioration in the health of the subject, that either resulted in 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 88 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
3. in-patient or prolonged hospitalization, or 
4.  medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
c. led to fetal distress, fetal death or a congenital abnormality or birth defect 
An important medical event that may not result in death, be life-threatening, or require 
hospitalization but may be considered serious when, based upon appropriate medical judgment, 
may jeopardize the subject and/or may require intervention to prevent one of the outcomes listed 
in this definition. 
NOTE 1: This includes device deficiencies that might have led to a serious adverse event if a) 
suitable action had not been taken or b) intervention had not been made or c) if circumstances 
had been less fortunate. These are handled under the SAE reporting system. 
NOTE 2: A planned hospitalization for pre-existing condition, or a procedure required by the 
Clinical Investigation Plan, without a serious deterioration in health, is not considered to be a 
serious adverse event. 
8.1.3 Device Deficiency/Product Experience 
Device deficiency (DD) is defined as an inadequacy of a medical device related to its identity, 
quality, durability, reliability, safety or performance, such as malfunction, misuse or use error 
and inadequate labeling. This includes the failure of the device to meet its performance 
specifications or otherwise perform as intended.  Note: performance specifications include all 
claims made in the labeling of the device. 
Product Experience (PE) is defined as any expression of customer concern or dissatisfaction, 
including adverse events and patient issues that occurred during or after the use of a 
commercially available medical device. 
8.2 
Device Relationship 
Determination of whether there is a reasonable possibility that an investigational product or 
device caused or contributed to an AE is to be determined by the Investigator and recorded on 
the appropriate CRF form. Determination should be based on assessment of temporal 
relationships, biologic plausibility, association (or lack of association) with underlying disease 
and presence (or absence) of a more likely cause. 
8.2.1 Unanticipated Serious Adverse Device Effect  
Unanticipated serious adverse device effect (USADE) refers to any serious adverse device effect 
on health or safety or any life-threatening problem or death caused by, or associated with, a 
device, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 89 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
8.3 
Adverse Event/Device Deficiency/Product Experience Reporting 
8.3.1 Adverse Event and Serious Adverse Event Reporting 
All AEs will be collected on each registered subject through the 1-year follow-up visit. After 1 
year, only the following will be collected: 
• All serious AEs  
• All cardiovascular events regardless of seriousness or device relationship 
• All trial device-related events and events for which the relationship to the trial device is 
unknown  
• All unanticipated adverse device effects  
• All Cerebral Vascular Accidents (CVAs) 
The Investigator will monitor the occurrence of adverse events for each registered subject during 
the course of the clinical trial/investigation. Adverse Events reported by the subject, observed by 
the Investigator, or documented in medical records should be recorded on the adverse event 
eCRF, whether believed by the Investigator to be related or unrelated to the investigational 
device implant as required by this protocol. 
A fax form will be made available to allow the investigator to report SAEs and device 
deficiencies in the event the entry cannot be made in the EDC (FRM2073001 SAE Notification 
Form). This does not replace the EDC reporting system, however, all information must still be 
entered in the EDC system as soon as feasible. 
For all registered patients, AEs (any new event/experience that was not present at baseline or 
worsening of an event present at baseline) will be collected as required by this protocol. The 
reporting of AEs will start  when the guiding catheter enters the subject’s vasculature.  Reported 
AEs will be monitored through the course of the trial.  Additional information with regards to an 
AE should be updated within the appropriate case report form. 
Unchanged, chronic, non-worsening or pre-existing conditions are not adverse events and should 
not be recorded on the adverse event eCRF. 
The investigator should report all SAEs to the Sponsor as soon as possible but no later than 
outlined below. 
Study site 
Reporting timelines 
All Study Sites 
SAEs must be reported no later than 3 calendar days from the day the study 
personnel becoming aware of the event or as per the investigative site’s local 
requirements if the requirement is more stringent than those outlined. 
The date the site staff became aware that the event met the criteria of a serious adverse event 
must be recorded in the source document.  The investigator will further report the event to the 
IRB/EC according to the institution’s IRB/EC reporting requirements. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 90 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Serious adverse events that occurred in the user or persons other than the study subject should 
not be entered in the EDC system. However they need to be reported on the SAE Notification 
Form (FRM2073001).   
Serious adverse events should be reported on the SAE Notification Form in the occurrence that 
the EDC System is not available.  This does not replace the EDC reporting system.  All 
information must still be entered in the EDC system once the system is back to normal function. 
8.3.2 UADE/USADE Reporting to Sponsor and IRB 
Abbott Vascular requires the Investigator to report any USADE to the sponsor within 3 calendar 
days of the investigator’s knowledge of the event, unless local requirements are more stringent, 
and to the IRB/EC per IRB/EC requirements. 
8.3.3 Device Deficiency/Product Experience Reporting 
All device deficiencies/product experiences should be reported within the EDC System on the 
appropriate eCRF. A fax form will be made available to allow the investigator to report device 
deficiencies in the event that the entry cannot be made in the EDC (FRM2073000 Device 
Deficiency Report Form). This does not replace the EDC reporting system. However, all 
information must still be entered in the EDC system as soon as feasible. In case a device 
deficiency occurred before the patient ID and randomization number has been assigned, the 
device deficiency should be reported to the sponsor via a Device Deficiency Report Form 
(FRM2073000). 
The investigator should report all DDs/PEs to the Sponsor as soon as possible but no later than 
outlined below. 
Study sites 
Reporting timelines 
All Study Sites 
DDs/PEs must be reported no later than 3 calendar days from the day the 
study personnel becoming aware of the event or as per the investigative 
site’s local requirements if the requirement is more stringent than those 
outlined. 
The device, if not implanted or not remained in the subject, should be returned to Abbott 
Vascular.   
Device deficiencies should be reported to the IRB/EC per the investigative site’s local 
requirements. 
8.3.4 Adverse Event Reporting to Country Regulatory Authorities by the Sponsor  
The Sponsor will report the SAEs and DDs/PEs to the country regulatory authority, per local 
requirements. 
8.4 
Safety Monitoring by Data Safety Monitoring Board 
The Data Safety Monitoring Board (DSMB) will serve in an advisory role to Abbott Vascular to 
ensure safety by reviewing cumulative data from the clinical trial at pre-scribed intervals for the 
purpose of safeguarding the interests of trial participants. The composition, guiding policies, and 
operating procedures governing the DSMB are described in a separate DSMB charter.  Based on 
safety data, the DSMB may consider a recommendation for modifications or termination of the 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 91 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
trial based on any perceived safety concerns regardless of statistical significance. The 
recommendations of the DSMB are not binding, and all final decisions related to trial 
modifications rest with Abbott Vascular. 
9. 
ADJUDICATION OF EVENTS 
9.1 
The Clinical Events Committee (CEC) 
The Clinical Events Committee is comprised of qualified physicians who are not investigators in 
the trial.  The Clinical Events Committee is responsible for adjudicating specified clinical 
endpoints based on the specific criteria used for the categorization of clinical events in the trial. 
The composition, guiding policies, and operating procedures governing the CEC are described in 
a separate CEC Manual of Operations.  
9.2 
Angiographic Core Laboratory 
The angiographic core laboratory will be responsible for reviewing all available follow-up 
coronary angiograms for registered subjects, to determine if a revascularization was performed 
by PCI, and if so, whether or not the revascularization was related to the target lesion, target 
vessel or non-target vessel. The data from angiographic core laboratory will be provided to CEC 
for adjudicate stent thrombosis events with angiographic follow-up. 
10. STATISTICAL ANALYSIS  
10.1 Statistical Overview  
The ABSORB III trial is powered based on the primary endpoint of TLF at 1-year. TLF is 
defined as a per-subject hierarchical count of cardiac death, target vessel Q-wave or non-Q-wave 
MI (per protocol-defined MI definition, Appendix II), or ischemia-driven target lesion 
revascularization (ID-TLR).  
The primary endpoint of TLF at 1 year will be evaluated using the difference in event rates in the 
ITT population.  The hypothesis test is designed to show non-inferiority of Absorb BVS to 
XIENCE for the primary endpoint with a one-sided alpha of 0.025.  
 
 
 
 
 
 
 
 
  
   
   
 
  
   
   
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 93 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 f 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
 
 
 
   
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
10.3 Sample Size Calculations and Assumptions  
10.3.1 ABSORB III Primary Endpoint 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
  
 
 
 
  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 94 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
  
  
 
 
   
 
 
   
 
  
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
   
 
 
 
 
 
 
 
 
 
 
   
The primary endpoint will be assessed on all 2000 randomized subjects in ABSORB III. 
10.3.2 Powered Secondary Endpoints 
When the non-inferiority test of the primary endpoint TLF at 1 year is passed, superiority tests of 
the Powered Secondary Endpoints will be performed based on a pre-specified testing sequence.  
The pre-specified testing sequence will ensure the control of study wise type-I error rate at 0.05.  
For further details refer to the statistical analysis plan (SAP). 
Imaging Cohort Powered Secondary Endpoint 1 
The in-stent/scaffold mean lumen area change (ΔMLA) from post-procedure to 3 years by IVUS 
(mean lumen area is to be measured after nitrate infusions) will be evaluated using the difference 
between the two means of the two treatment arms in the pooled subjects from the Imaging 
Cohort of ABSORB III and ABSORB Japan. Superiority testing will be performed with a two-
sided alpha of 0.05.  
 
 
 
 
 
 
 
 
 
 
 
 
  
   
    
  
   
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
   
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
   
 
 
 
 
 
  
  
 
  
 
 
 
 
 
 
 
 
   
 
 
 
 
  
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
   
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 95 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Imaging Cohort Powered Secondary Endpoint 2 
The in-stent/scaffold mean lumen diameter change (ΔMLD) between pre- and post-nitrate 
infusion at 3 years by angiography will be evaluated using the difference between the means of 
the two treatment arms in the pooled subjects from the Imaging Cohort of ABSORB III and 
ABSORB Japan. Superiority testing will be performed with a two-sided alpha of 0.05.  
 
 
 
 
 
 
 
 
 
 
 
 
  
   
    
  
   
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
   
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
   
 
 
 
 
 
  
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
   
 
 
 
 
  
  
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 96 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Powered Secondary Endpoint for Angina 
Angina at 1 year (exclude angina following the index procedure through discharge, not to exceed 
a period of 7 days) will be evaluated using the difference between the angina rates of the two 
treatment arms. Superiority test will be performed with a two-sided alpha of 0.05   
 
 
 
 
 
 
 
 
 
 
 
 
  
  
    
  
  
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
   
  
 
 
 
 
 
 
  
   
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Powered Secondary Endpoint for All Revascularization 
All revascularization at 1 year will be evaluated using the difference between the all 
revascularization rates of the two treatment arms. Superiority test will be performed with a two-
sided alpha of 0.05.  
 
 
 
 
 
 
 
 
 
 
 
 
  
  
    
  
  
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
   
  
 
 
 
 
 
 
  
   
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Powered Secondary Endpoint for ID-TVR 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 97 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
ID-TVR at 1 year will be evaluated using the difference between ID-TVR rates of the two 
treatment arms. Superiority test will be performed with a two-sided alpha of 0.05.  
 
 
 
 
 
 
 
 
 
 
 
 
  
  
    
  
  
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
   
  
 
 
 
 
 
 
  
   
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Powered Secondary Endpoint for Diabetic Indication 
To assess the performance of Absorb BVS in the diabetic subgroup by testing against the 
corresponding pre-specified analysis. 
To support this powered secondary endpoint, Abbott Vascular intends to pool ABSORB family 
studies. Refer to SAP for details. 
10.4 Statistical Analyses  
Non-inferiority testing of the primary endpoints will be one-sided and performed at a 0.025 
significance level for the comparison of the Absorb BVS arm with the XIENCE arm. Superiority 
tests on the powered secondary endpoints will be performed at a two-sided 0.05 significance 
level.  Analyses of other secondary endpoints will be descriptive in nature.  
For binary variables such as TLF, TLR, and clinical procedure success, counts, percentages, and 
95% confidence intervals will be calculated, and p-values may be presented for hypothesis 
generating purposes. Pearson’s Chi-squared test or Fisher’s exact test will be performed when 
appropriate. In addition, logistic regression will be performed to determine whether the baseline 
characteristics exhibit any trends in predicting TLF.  
For continuous variables such as age, means, standard deviations, and 95% confidence intervals 
for the mean will be calculated and p-values may be presented for hypothesis generating 
purposes. For time-to-event variables, such as time to TLF, survival curves will be constructed 
using Kaplan-Meier estimates, and log rank test results will be displayed. Unless specified, 
analyses will be performed with pooled data across all study sites. 
For further details refer to the statistical analysis plan (SAP). 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 98 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
10.4.1 Primary Endpoint Analysis  
The ABSORB III primary endpoint of TLF at 1-year follow up will be analyzed for the ITT and 
the PTE populations.  The primary analysis will be based on the ITT population. The non-
inferiority hypothesis testing will be performed using a non-inferiority test statistic by Farrington 
and Manning. Non-inferiority of Absorb BVS to XIENCE will be established if the p-value for 
the non-inferiority test is less than 0.025.  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
10.4.2 Powered Secondary Endpoint Analyses  
Analysis of the Powered Secondary Endpoints for angina, for all revascularization, for ID-TVR, 
and for diabetic indication will include subjects from the primary analysis group. Pearson’s Chi-
square test will be used for superiority testing based on the ITT and PTE populations for the 
powered secondary endpoint for angina. Fisher’s exact test will be used for superiority testing 
based on the ITT and PTE populations for the powered secondary endpoints for all 
revascularization and for ID-TVR. Analysis of the Imaging Cohort Secondary Endpoints 1 and 2 
will include pooled subjects from the Imaging Cohort of ABSORB III and ABSORB Japan. Two 
sample t-test will be used for superiority testing based on the ITT and PTE populations.  
Details of the analyses for the powered secondary endpoints can be found in the statistical 
analysis plan (SAP).  
10.4.3 Secondary Endpoint Analyses  
Secondary endpoints other than the powered endpoints described above will be summarized 
descriptively for the ITT population. For further details refer to the statistical analysis plan 
(SAP).  
10.4.4 Additional Analyses  
Adverse Events related to stent/scaffold thrombosis, vascular complications or bleeding 
complications, and their relation with antiplatelet therapies used in the trial will be investigated 
between the two treatment groups, if applicable.  
Descriptive analyses will be provided for the Lead-In subjects. 
For further details refer to the SAP. 
10.4.5 Exploratory Analyses  
Details on pre-specified exploratory analyses can be found in the SAP.     
10.4.6 Informational Endpoint Analyses  
Patient Reported Outcomes for the 2,000 primary analysis subjects in ABSORB III will be 
analyzed for informational purpose. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 99 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
10.4.7 Subgroup Analysis 
Pre-specified subgroups such as diabetes, sex, age will be examined. Further details can be found 
in the SAP.  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
10.4.8 Handling of Multiplicity Issues  
Methods to handle multiplicity are specified, in the SAP.  
10.4.9 Criteria for Early Termination of the Trial for Effectiveness  
No formal statistical rule for early termination of the trial for effectiveness is defined.  
10.4.10 Procedures for Accounting for Missing, Unused or Spurious Data 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
10.4.11 Pooling Strategy  
Details on pooling strategy can be found in the SAP.  
10.4.12 Deviations from the Original Statistical Plan 
Any major changes to the statistical plan (available upon request) will be documented in an 
amendment to the statistical plan.  Less significant changes to the planned analyses will be 
documented in the final report. 
11. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The Investigator/institution will permit direct access to source data/documents for trial-related 
monitoring, audits, IRB/MEC review, and regulatory inspections. 
Subjects providing Informed Consent agree to allow the Sponsor or designee access and copying 
rights to pertinent information in their medical records relevant to trial participation (the 
Investigator should ensure patient identifiers are removed for medical records that are copied). 
The Investigator will obtain, as part of the Informed Consent, permission for trial monitors or 
regulatory authorities to review at the investigative site, in confidence, any records identifying 
the subjects in this clinical trial/investigation. This information may be shared with regulatory 
agencies; however, the Sponsor undertakes not to otherwise release the subject's personal and 
private information as per local data protection laws.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 100 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
12. QUALITY CONTROL AND QUALITY ASSURANCE 
12.1 Selection of Clinical Sites and Investigators 
The sponsor will select Investigators who are qualified by training and experience and are legally 
entitled to perform clinical research and to participate in the investigation of the assigned device. 
Sites will be selected based upon review of a recent site assessment and the qualifications of the 
Primary Investigator at the site.  
12.2 Training 
12.2.1 Site Training 
All Investigators/trial personnel are required to attend Sponsor training sessions, which may be 
conducted at an Investigator's meeting, a site initiation visit or other appropriate training 
sessions. Over-the-phone training may take place as required. Training of Investigators/trial 
personnel will include, but is not limited to, the protocol requirements, investigational device 
usage, electronic case report form completion and trial personnel responsibilities. All 
Investigators/trial personnel that are trained must sign a training log (or an equivalent) upon 
completion of the training. Prior to signing the training log, Investigator/trial personnel must not 
perform any trial-related activities that are not considered standard of care at the site.  
12.2.2 Training Required for the Use of the Test Device 
Investigators will be trained on the use of the Absorb BVS System.  Please refer to Section 4.2 
ABSORB Physician Training. 
12.2.3 Training of Sponsor’s Monitors 
Sponsor and/or designated monitors will be trained to the protocol, eCRFs and investigational 
device usage (as appropriate).  Documentation of this training will be according to written 
procedures. 
12.3 Monitoring 
Sponsor and/or designee will monitor the trial over its duration according to the pre-specified 
monitoring plan which will include the planned extent of source data verification 
12.3.1 Designated Monitors 
Study monitors are individuals who are designated to oversee the progress of a study. These 
individuals are appropriately trained and qualified to monitor the progress of a clinical study. 
The study sponsor may designate additional monitors at any time during the study. The Sponsor 
should be contacted for additional information on the person(s) responsible for monitoring 
activities. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 101 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
12.3.2 Visits 
Prior to initiating any procedure, the sponsor monitor (or delegate) will visit each investigator to 
ensure that the following criteria are met:  
The Investigator understands and accepts the obligation to conduct the research study according 
to the protocol and applicable regulations, and has signed the Investigator Agreement or the 
Clinical Study Agreement.  
The Investigator and his staff have sufficient time and facilities to conduct the study and that 
they have access to an adequate number of appropriate subjects to conduct the study.  
Source documentation must be available to substantiate proper Informed Consent procedures, 
adherence to protocol procedures, adequate reporting and follow-up of Adverse Events, accuracy 
of data collected on Case Report Forms, and device information.  
The Investigator/site will permit access to such records. A monitoring visit sign-in log will be 
maintained at the site. The Investigator will agree to dedicate an adequate amount of time to the 
monitoring process. The Investigator and/or Research Coordinator will be available for 
monitoring visits. It is expected that the Investigator will provide the study monitor with a 
suitable working environment for review of study-related documents. 
12.4 Deviations from Protocol 
It is the Investigator's responsibility to ensure that there are no deviations from the protocol 
without prior notification and approval of the sponsor and that all actions are in full 
compliance with all established procedures of the IRB/EC or equivalent committee. The 
Investigator will not deviate from the protocol for any reason without prior written approval from 
Sponsor except in cases of medical emergencies, when the deviation is necessary to protect the 
life or physical well-being of the subject or eliminate an apparent immediate hazard to the 
subject. In that event, the Investigator will notify Sponsor immediately by phone or in writing. 
All deviations must be reported to the Sponsor. In subject-specific deviations from the protocol, 
a Protocol Deviation Case Report Form will be completed. The occurrence of protocol deviations 
will be monitored by the Sponsor for evaluation of investigator compliance to the protocol and 
regulatory requirements and dealt with according to written procedures. Investigators will inform 
their IRB/EC or equivalent committee of all Protocol Deviations in accordance with their 
specific IRB/EC or equivalent committee reporting policies and procedures.  
In the event that an Investigator does not comply with the Investigator Agreement or the Clinical 
Study Agreement or protocol, the Investigator will be notified of the site’s non-compliance.  
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s monitor or 
company representative will attempt to secure compliance by one or more of the following (and 
not limited to):  
• Visiting the Investigator  
• Telephoning the Investigator  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 102 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• Corresponding with the Investigator  
Repeated non-compliance with the signed agreement, the protocol or any other conditions of the 
study may result in further escalation in accordance with the Sponsor’s written procedures 
including securing compliance or, at its sole discretion, the Sponsor may terminate the 
Investigator's participation in the study.  
12.5 Quality Assurance Audits 
The Sponsor may conduct periodic Quality Assurance audits (on-site audits) at various clinical 
trial/investigation sites. A Sponsor representative or designee may request access to all trial 
records, including source documentation, for inspection and duplication during a Quality 
Assurance audit. The Investigator and Research Coordinator must be available to respond to 
reasonable requests and queries made during the audit process.  
12.6 Sponsor Support to Clinical Trial/Investigation Site for Regulatory Body 
Inspection 
In the event that an Investigator is contacted by a Regulatory Agency in relation to this clinical 
trial/investigation, the Investigator will notify the Sponsor immediately and IRB/MEC as 
appropriate. The Investigator and Research Coordinator must be available to respond to 
reasonable requests and inspection queries made during the inspection process. The Investigator 
must provide the Sponsor with copies of all correspondence that may affect the review of the 
current clinical trial/investigation (e.g., Form FDA 483, Inspectional Observations, and warning 
letters). The Sponsor may provide any needed assistance in responding to regulatory inspections. 
12.7 Committees 
12.7.1 Steering Committee 
The Steering Committee is assigned by the Sponsor and comprises the Study Chairman and 
Principal Investigators, as specified on the cover page of this protocol. Other physician scientists 
may be added to the steering committee. The Sponsor will be represented by at least one person 
each from the Clinical Science and Clinical Program Management groups. The directors of the 
core laboratories and other Sponsor’s personnel may also participate in the Committee meetings 
if appropriate. Meeting minutes from this committee will be filed with the Sponsor. 
The Steering Committee is responsible for overseeing the scientific and operational aspects of 
the study. This committee will meet regularly to monitor patient enrollment, general data 
collection and non-compliance with the investigation plan at individual centers, to review and act 
upon recommendations of the Data and Safety Monitoring Board, to review operational issues 
that may arise and warrant a protocol amendment or other corrective action and to determine 
policy regarding any publications arising from data generated from the performance of the study. 
12.7.2 Publications Committee 
The Publication Committee is composed of representatives from Abbott Vascular Clinical 
Research, Steering Committee, Investigators, and other personnel as determined by the Steering 
Committee. This team will oversee presentation and/or publication aspects of the study. The 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 103 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Publication Committee will determine policy and strategies regarding individual presentations 
and/or publications arising from study generated data. The committee will also review all 
external requests for accessing study related data and strategies aligning with Abbott Vascular 
presentation and publication team expectations. The committee will also follow Abbott Vascular 
applicable policies and Standard Operating Procedures. 
12.7.3  Data Safety Monitoring Board (DSMB) 
The Data Safety Monitoring Board (DSMB) is an independent multidisciplinary group that does 
not have any affiliation with Abbott Vascular, the Investigators or core laboratories.  Details 
regarding the DSMB were reported earlier in Section 8.4. 
12.7.4  Clinical Events Committee (CEC) 
The Clinical Events Committee (CEC) is an independent adjudication body comprised of 
qualified physicians who are not participants in the trial.  Details regarding the CEC were 
reported earlier in Section 9.1. 
13. DATA HANDLING AND RECORD KEEPING 
Abbott Vascular Data Management will perform all data management activities including 
documentation of the systems and procedures to be used. All eCRF data collection will be 
performed through a secure web portal and all authorized personnel with access to the electronic 
data capture (EDC) system must use an electronic signature access method to enter, review or 
correct data.  Electronic signature procedures shall comply with the CFR Title 21 Part II and the 
ICH Guidelines for Good Clinical Practice (GCP) (Topic E6, April 2000) Section 5.5.3.  
Passwords and electronic signatures will be strictly confidential. 
All eCRF data will be downloaded from the EDC system and reformatted into a data structure 
acceptable to Abbott Vascular.   The data will be subjected to consistency and validation checks 
within the EDC system and will be subject to supplemental validation following download.  
Completed eCRF images with the date-and-time stamped electronic audit trail indicating the 
user, the data entered, and any reason for change (if applicable) will be archived at the 
Investigator’s site and a backup copy archived with Abbott Vascular 
For the clinical trial/investigation duration, the Investigator will maintain complete and accurate 
documentation including but not limited to medical records, clinical trial/investigation progress 
records, laboratory reports, electronic Case Report Forms, signed Informed Consent Forms, 
device accountability records, correspondence with the IRB/MEC and clinical trial/investigation 
monitor/Sponsor, Adverse Event reports, and information regarding subject discontinuation or 
completion of the clinical trial/investigation. 
13.1 Source Documentation 
Regulations and GCP require that the Investigator maintain information in the subject’s medical 
records that corroborates data collected on the Case Report Forms. In order to comply with these 
regulatory requirements/GCP, the following information should be included in the subject’s 
record, at a minimum, and if applicable to the investigation: 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 104 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• Medical history/physical condition of the subject before involvement in the trial 
sufficient to verify protocol entry criteria 
• Dated and signed notes on the day of entry into the trial referencing the sponsor, protocol 
number, subject ID number and treatment assigned (does not apply to blinded 
randomized trials) and a statement that informed consent was obtained 
• Dated and signed notes from each subject visit (for specific results of procedures and 
exams) 
• Adverse Events reported and their resolution including supporting documents such as 
discharge summaries, catheterization laboratory reports, ECGs, and lab results including 
documentation of site awareness of SAEs and of Investigator’s device relationship 
assessment of SAEs 
• Study-required laboratory reports and 12-lead ECGs, signed and dated for review and 
annotated for clinical significance of out of range results 
• Notes regarding protocol-required and prescription medications taken during the trial 
(including start and stop dates) 
• Subject’s condition upon completion of or withdrawal from the trial 
• Any other data  required to substantiate data entered into the eCRF 
13.2 Electronic Case Report Form Completion 
Primary data collection based on source-documented hospital and /or clinic chart reviews will be 
performed clearly and accurately by site personnel trained on the protocol and eCRF completion. 
eCRF data will be collected for all patients that are registered into the trial. 
13.3 Record Retention 
The sponsor will archive and retain all documents pertaining to the study for the lifetime of the 
device under evaluation. 
The Investigator must obtain permission from Sponsor in writing before destroying or 
transferring control of any clinical trial/investigation records. 
13.4  Investigational Devices 
13.4.1 Investigational Device Accountability 
Abbott Vascular ships investigational devices (Absorb BVS System) only to the Principal 
Investigator (the responsible leader of the investigational site) or his/her legal designee of each 
site. In geographies using the commercially available CE marked device, the investigators will 
acquire the product through their normal commercial vendors. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 105 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
The Investigator will maintain adequate records of the receipt and disposition of the 
investigational device, including part number and serial number, date used, patient ID number 
and treating physician.  An Inventory Accountability Log supplied by the Sponsor will be used. 
The Inventory Accountability Report must document the disposition of all investigational 
devices including those that have been returned to Sponsor. In sites using commercially available 
CE marked devices (XIENCE and Absorb BVS), the primary investigator will maintain records 
of device usage for the study subjects. The records will contain device part number and serial 
number, date implanted, patient identification number, and implanting physician. 
Use of any investigational device outside of the protocol is strictly forbidden because the 
Investigator has access to other commercially available PCI catheters and may constitute grounds 
for removal of the Investigator/site from the clinical trial/investigation. In geographies using the 
commercially available CE marked device, the commercial device may be used in non-trial 
patients. 
All investigational devices that are associated with a device failure or device deficiencies must 
be returned immediately to the Sponsor. 
14. ETHICAL CONSIDERATION 
14.1 Institutional Review Board/Medical Ethics Committee Review 
Institutional Review Board (IRB)/Medical Ethics Committee (MEC) approval for the protocol 
and Informed Consent Form /other written information provided to the patient will be obtained 
by the Principal Investigator at each investigational site prior to participation in this clinical 
trial/investigation. The approval letter must be signed by the IRB/MEC Chairman or authorized 
representative prior to the start of this clinical trial/investigation and a copy must be provided to 
the Sponsor. No changes will be made to the protocol or Informed Consent Form or other written 
information provided to the patient without appropriate approvals, including IRB/MEC, the 
Sponsor, and/or the regulatory agencies.  
Until the clinical trial/investigation is completed, the Investigator will advise his/her IRB/MEC 
of the progress of this clinical trial/investigation, per IRB/MEC requirements. Written approval 
must be obtained annually from the IRB/MEC to continue the clinical trial/investigation, 
according to each institution’s IRB/MEC requirements (US studies only). Further, any 
amendments to the protocol as well as associated Informed Consent Form changes will be 
submitted to the IRB/MEC and written approval obtained prior to implementation, according to 
each institution’s IRB/MEC requirements. 
No investigative procedures other than those defined in this protocol will be undertaken on the 
registered subjects without the written agreement of the IRB/MEC and the Sponsor. 
15. PUBLICATION POLICY 
The data and results from the trial are the sole property of the Sponsor. The Sponsor shall have 
the right to access and use all data and results generated during the clinical trial. The 
Investigators will not use the clinical trial/investigation-related data without the written consent 
of the Sponsor for any other purpose than for clinical trial/investigation completion or for 
generation of publication material, as referenced in the clinical trial/investigation Site 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 106 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Agreement. The publication and/or presentation of results from a single clinical 
trial/investigation site are not allowed until publication and/or presentation of the multi-center 
results. The Sponsor acknowledges that the trial’s Principal Investigators intend to publish a 
multi-center publication regarding the clinical trial/investigation results, and numerous secondary 
publications. The Sponsor must receive any proposed publication and/or presentation materials at 
least 60 days prior to the proposed date of the presentation or the initial submission of the 
proposed publication in order for the materials to be reviewed by the Sponsor in compliance with 
the Sponsor’s publication policy set forth in the clinical trial/investigation Site Agreement. 
The Sponsor will be responsible for determining whether to register the Clinical Investigation on 
www.clinicaltrials.gov <<http://www.clinicaltrials.gov>> or any other clinical investigations, in 
accordance with the International Committee of Medical Journal Editors guidelines, or any other 
applicable guidelines. In the event Sponsor determines that the trial should be registered, 
Sponsor shall be responsible for any such registration and results posting as required by Clinical 
Trials.gov. Institution and/or Principal Investigator(s) shall not take any action to register the 
trial. 
16. RISK ANALYSIS 
16.1 Potential Risk 
16.1.1 Cardiac Catheterization, Stenting and Percutaneous Transcatheter Coronary 
Angioplasty  
Refer to Investigator Brochure and/or Instructions for Use for this section for both Absorb BVS 
and XIENCE for the associated risks.  
Refer to APPENDIX VIII: for the Risk stratification of Cardiac Catheterization, Stenting and 
Percutaneous Transcatheter Coronary Angioplasty 
16.1.2 Associated Risks of the Absorb BVS Polymer 
The Absorb BVS is composed of a backbone fabricated from poly (L-lactide) and a drug-eluting 
coating layer which is a mixture of poly (DL-lactide) and the drug, everolimus.  These polymer 
materials were selected based on their long history of use in approved medical devices and their 
mechanical properties. Examples of currently approved bioabsorbable polymers used for clinical 
vascular applications include the Angio-Seal vascular closure device and the Igaki-Tamai 
bioabsorbable stent.  In addition, PLA is widely used in orthopedic implants and cosmetic 
treatment. 
The Angio-Seal device is composed of a plug of collagen sponge and an absorbable polymer 
anchor that are connected by an absorbable positioning suture.  The Angio-Seal device leaves the 
polymer anchor inside the vessel at the end of the procedure.  The anchor is held in place against 
the vessel wall by the absorbable suture.  The polymer anchor is manufactured from a 50/50 
copolymer of DL-lactide and glycolide.  The Angio-Seal device has a much more rapid 
degradation profile than the Absorb BVS, and has a much higher mass than the Absorb BVS.  
Thus, it is an excellent example supporting the fact that the polymer and its degradation products 
are well tolerated by blood vessels [21, 35]. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 107 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
The Igaki-Tamai bioabsorbable stent was the first to provide clinical trial data with 
biodegradable PLLA stent in humans [12].  The stent is manufactured from a monofilament poly 
(L-lactide) fiber wound into a helical pattern.  The long-term safety data presented by this 
clinical study demonstrates that the PLLA is a safe polymer for use in intravascular applications 
[17, 19]. Igaki-Tamai peripheral stent was evaluated in the PERSEUS clinical trial [21], of which 
results supported approval for CE mark (November 29, 2007). 
The coating polymer, poly (D,L-Lactide), is the same polymer used for the Abbott Vascular 
Champion drug eluting stent project and in the FUTURE I and FUTURE II human clinical trials 
conducted by BioSensors.  Safety of this polymer was demonstrated in the FUTURE I and 
FUTURE II trials [36-38],   The Champion project also collected a substantial body of evidence 
that demonstrated the coating polymer is safe to use in a vascular application. 
Systemic reaction possibly caused by PLLA orthopedic implant was rarely reported [39]. 
Local/regional/systemic delayed adverse effects caused by PLLA injection in cosmetic treatment 
was infrequent [40]. 
In summary, safety and biocompatibility of the Absorb BVS has been demonstrated based upon 
biocompatibility testing per ISO 10993-1, numerous preclinical animal safety studies, and the 
long use of these polymers in medical implants.  While the long-term outcome of the Absorb 
BVS is unknown at present, follow-up through 5 years from the ABSORB Cohort A and 2-year 
follow-up from ABSORB Cohort B, has shown a low occurrence of clinical events. 
16.1.3 Everolimus 
Refer to Investigator Brochure and/or Instructions for Use for this section for both Absorb BVS 
and XIENCE for the associated risks.  
16.1.4 Drug Interaction of Everolimus 
Refer to Investigator Brochure and/or Instructions for Use for this section for both Absorb BVS 
and XIENCE for the associated risks.  
16.1.5  Carcinogenicity, Genotoxicity, and Reproductive Toxicity 
The carcinogenicity, genotoxicity, and reproductive toxicity of Absorb BVS have not been 
evaluated; however, long term carcinogenicity and teratology studies were performed with the 
XIENCE V, a similar Everolimus-eluting coronary stent system. In the carcinogenicity studies, 
XIENCE V was implanted subcutaneously in transgenic mice. Based on the results of this 
study, XIENCE V does not appear to be carcinogenic when implanted in transgenic mice for 
26 weeks. In the reproductive toxicity studies XIENCE V was implanted in rats and showed no 
effect on their fertility or reproductive capability. Additionally, there were no teratogenic 
effects in the offspring in this study.  
There is no carcinogenicity, genotoxicity, and reproductive toxicity in PLA, lactide, and lactic 
acid. 
Pregnancy/Fertility 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 108 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
There are no adequate studies in pregnant women or men intending to father children regarding 
the safety of everolimus or the Absorb BVS. Everolimus when administered at oral doses of 0.1 
mg/kg and above showed effects on pre- and post-natal rat development limited to slight body 
weight changes and fetal survival without any specific toxic potential.  
Therefore, pregnant and nursing subjects and those planning pregnancy up to one year following 
the index procedure are excluded from this study. Female subjects with childbearing potential 
enrolled in this study must have a negative pregnancy test done within 7 days prior to the index 
procedure. If a female subject does get pregnant, the risks to the fetus are unknown. Effective 
contraception must be used before implanting an Absorb BVS. The method of contraception is a 
personal choice but needs to be made with respect to the subject’s values with adequate medical 
information on the effectiveness and safety of the method. Except for surgical removal of the 
uterus and ovaries or total abstinence, all methods of birth control have a failure rate. Intrauterine 
devices (IUD), hormonal contraceptives (birth control pills, injections or implants), tubal ligation 
or partner’s vasectomy and barrier contraceptives (condoms, diaphragms, and cervical caps) are 
available means of birth control. The primary care provider or a gynecologist should be 
consulted concerning the best birth control method for the subject given his/her medical history 
and lifestyle choices. 
Lactation 
It is unknown whether everolimus is distributed in human milk. Everolimus pharmacokinetic and 
safety profiles have not been determined in infants. Consequently, mothers should be advised of 
potential serious adverse reactions to everolimus in nursing infants. Prior to the implantation of 
Absorb BVS, a decision should be made regarding whether to discontinue nursing or conduct an 
alternate percutaneous coronary intervention procedure. 
16.1.6 Risks associated with Quantitative Imaging Modalities 
Subjects registered in ABSORB III may receive IVUS or OCT during the index procedure. 
Complication rates of IVUS range from 1 to 3%, transient spasm being the most common which 
is treated with intracoronary nitroglycerin. The rate of major complications, dissection or MI, is 
less than 0.5%. Examination of imaged vessels compared with non-imaged vessels shows no 
significant damages or disease progression at 1 year follow-up [41, 42]. Other complications 
include bleeding at the entry puncture site, injury to the vascular wall, thrombosis of the vessel, 
and peripheral embolization. Retrospective studies of cardiac patients show no increase in 
complications between non-imaged vessels and imaged vessels and IVUS is demonstrated to be 
safe for multiple uses (up to 6) after sensitive procedures [42].  
OCT is not commonly associated with major adverse events; most events can be minimized 
through appropriate training. Procedural planning and full education of risks associated with 
investigating vulnerable plaques will further minimize risk [43].   
Intracoronary nitroglycerin will be used during the index procedure in ABSORB III. 
Intracoronary nitroglycerin (NTG) is usually routinely administered to these patients in order to 
prevent coronary spasm for optimum imaging results. It has been shown that coronary dilatation 
occurs with as little as 5 μg of intracoronary NTG and that moderate doses of 50-200 μg can still 
produce vasodilatation without systemic effects such as hypotension or reflex tachycardia [44]. 
The known contraindications to nitroglycerin include among others hypersensitivity, recent use 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 109 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
of phosphodiesterase-5 inhibitors like sildenafil (Viagra), narrow angle glaucoma, and 
symptomatic hypotension. Further information about the risks of nitroglycerin can be found in its 
Summary of Product Characteristics (SPC). 
16.2 Risk Management Procedure 
The risks and benefits of PCI with the control device, XIENCE, are well understood and 
documented in the XIENCE IFU.  The XIENCE will remain in the coronary artery lesion 
indefinitely unless it is surgically removed. The adverse events and potential device issues 
associated with the test device, the Absorb BVS System, are not fully understood. The safety of 
the Absorb BVS for the treatment of coronary artery disease has been studied in ABSORB 
Cohort A and ABSORB Cohort B trials.  Although ABSORB Cohort A and ABSORB Cohort B 
did not compare the treatment of Absorb BVS to XIENCE, the data provides preliminary support 
that the safety of implanting Absorb BVS is no different than the safety of implanting the control 
device as long as the IFUs for both devices is followed. With the use of the Absorb BVS, there is 
the potential for device issues and adverse events not previously identified to occur. 
The long term safety and the efficacy of Absorb BVS in the treatment of coronary artery disease 
has also been evaluated in ABSORB Cohort A and ABSORB Cohort B. Currently, there is no 
long-term data comparing Absorb BVS to XIENCE, however a descriptive comparison between 
the ABSORB Cohort B outcomes and the SPIRIT FIRST trial using data from the 3.0x18 mm 
XIENCE V only, have shown similar results between Absorb BVS and XIENCE V (Section 
2.2). Further studies are needed to confirm this. The long term pathology of the coronary artery 
lesion after treatment with the Absorb BVS continues to be evaluated and the long-term benefits 
of Absorb BVS are not fully understood and continue to be evaluated. 
Subjects will receive 75 mg of clopidogrel bisulfate (Plavix®) daily or 10 mg of prasugrel daily 
or 90 mg twice daily of ticagrelor (or according to prescribing information [45]) for a minimum 
of 1 year to reduce the risk of thrombosis and to provide extended protection to compensate for 
potentially delayed endothelialization after implant. Subjects will also receive aspirin ≥ 75 to ≤ 
100 mg to be taken indefinitely. The side effects from aspirin are well documented and 
commonly include allergic reactions; gastrointestinal irritation such as stomach pain, dyspepsia, 
gastritis; and bleeding. 
Prasugrel [46] can cause significant, sometimes fatal bleeding.  The use of prasugrel in subjects 
at increased risk of bleeding should only be considered when the benefits in terms of prevention 
of ischemic events are deemed to outweigh the risk of serious bleedings. This concern applies 
especially to subjects who:  have a propensity to bleed, are ≥ 75 years of age, a body weight < 60 
kg, have concomitant use of medications that increase the risk of bleeding, or are likely to 
undergo urgent coronary artery bypass graft surgery.  Compared to patients weighing ≥ 60 kg, 
patients weighing < 60 kg have an increased exposure to the active metabolite of prasugrel and 
an increased risk of bleeding on a 10 mg once daily maintenance dose. The label recommends 
that patients weighing < 60 kg be placed on a maintenance dose 5 mg daily.  Prasugrel is 
contraindicated for subjects who have:  hypersensitivity to the active substance or to any of the 
excipients, active pathological bleeding, history of stroke or transient ischaemic attack (TIA), or 
severe hepatic impairment (Child-Pugh class C).  Further information about the risks of prasugrel 
can be found in its Summary of Product Characteristics (SPC).   

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 110 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Ticagrelor [47] can cause significant, sometimes fatal bleeding. Compared to clopidogrel, 
ticagrelor increased the overall risk of bleeding to a somewhat greater extent. In general, risk 
factors for bleeding include older age, a history of bleeding disorders, performance of 
percutaneous invasive procedures, and concomitant use of medications that increase the risk of 
bleeding (e.g., anticoagulant and fibrinolytic therapy, higher doses of aspirin, and chronic 
nonsteroidal anti-inflammatory drugs).  The increase in bleeding risk was seen for non-CABG-
related bleeding, but not for CABG-related bleeding.  Fatal and life-threatening bleeding rates 
were not increased. Dyspnea was reported more frequently with ticagrelor than with clopidogrel.  
Ticagrelor is contraindicated for subjects who have: history of intracranial hemorrhage, active 
pathological bleeding, and severe hepatic impairment.  Further information about the risks of 
ticagrelor can be found in its Summary of Product Characteristics. 
Prasugrel and ticagrelor are indicated for patients with acute coronary syndrome. The use of 
these medications outside the approved conditions may be associated with risks. Subjects will be 
monitored closely throughout the trial duration. 
The device should only be used by physicians who have been trained in interventional 
cardiology. The selected investigators will be trained on the device prior to participating in the 
study. In addition, they and other hospital personnel who are participating in a clinical trial will 
be trained on the IFU and clinical trial protocol.  
The patients will be screened against the inclusion and exclusion criteria before enrollment in the 
trial. The patients will be evaluated clinically with or without imaging at pre-determined time 
points per clinical trial protocol requirements to assess their clinical status.  
Corrective and preventative actions will be implemented by Abbott Vascular, as necessary, if 
deviations from recommendations in the protocol or IFU are observed.  
All device deficiencies, commercial complaints, and adverse events from clinical trials are 
monitored internally by Abbott Vascular. An independent Data Safety Monitoring Board 
(DSMB) will monitor safety throughout the clinical trial. Stopping rules will be discussed with 
the DSMB and applied for subject safety through enrollment. 
16.3 Potential Benefit 
The Absorb BVS is intended to revascularize the vessel like a conventional metallic stent, 
provide controlled elution of anti-proliferative drug to minimize neointimal growth and then 
resorb naturally into the body after vessel healing and remodeling are complete.   
The imaging and vasomotion data from ABSORB Cohort A at 2 years and ABSORB Cohort B at 
1 year showed the potential for vessel movement with the ABSORB BVS in response to 
pharmacological stimuli (Section 2.1.9). Lumen patency was maintained as shown with an 
increase in IVUS average lumen area in ABSORB Cohort A at 2 years and maintained average 
lumen area in ABSORB Cohort B at 2 years (Section 2.1.9).  
Another benefit of Absorb BVS is that non-invasive imaging can be done using multislice 
computed tomography (MSCT) to evaluate stenosis of treated lesion. The Absorb BVS scaffold 
is radiolucent and was undetected by MSCT apart from the platinum markers at each end of the 
scaffold.  In 24 subjects of ABSORB Cohort A, the scaffolded vessel segment at 2 years were 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 111 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
qualitatively patent. The 18-month clinical and MSCT results for the full ABSORB Cohort B 
trial (Cohort B1 and B2, 101 patients) were reported at the TCT congress in November, 2011. 
Unlike metal stents, on MSCT scans at 18 months it was possible to assess quantitatively the 
scaffolded segment in 61 of the 72 scans performed. These results provided an early indication 
that non-invasive imaging is feasible with the Absorb BVS System, which could reduce patient 
burden. 
17. SPECIAL POPULATIONS 
Women and minorities in the US are known to have low PCI utilization [48] . Recent statistics 
show that from 1984 to 2004, despite an increase in PCI utilization followed by a plateau, 
women have lower PCI utilization compared to men [48]. There are also data to support that 
women have a higher risk of PCI related mortality compared to men [49, 50] . The poorer 
outcomes among women have been related to delayed onset of disease, co-morbidities, vessel 
size associated with smaller body surface area, and premature coronary artery disease [49]. 
However, in the advent of advanced PCI technology, outcomes have improved among women 
and benefits of stenting can be applied to both women and men [49, 51, 52]. In SPIRIT III trial 
gender sub-analysis women treated with XIENCE V and TAXUS had worse MACE outcomes 
compared to men [52].  However, the difference in 1 year MACE rates between women and men 
was not significant in the XIENCE arm (p=0.146) but was significant in the TAXUS arm 
(p=0.019) [52].  A recent XIENCE V USA gender sub-analysis, which consisted of a larger 
population than SPIRIT III, found comparable ARC stent thrombosis (0.85% vs. 0.82%), cardiac 
death and MI (3.7% vs. 2.9%), and TLR (5.0% vs. 4.2%) rates among women compared to men 
treated with XIENCE V.  
Certain minority populations are found to have a higher rate of heart disease and associated risk 
compared to whites in the US. The prevalence of coronary heart disease (CHD) and MI is 
highest in black males and females compared to white males and other minority groups [53] . 
Among the US minority population, blacks and Hispanics compared to whites and Asian, have 
the lowest PCI utilization rates [48]. Blacks and  Hispanics that undergo PCI are found to be 
younger, and have co-morbidities such as diabetes, hypertension, obesity, and renal failure, 
compared to whites [54]. There has been some limited evidence that indicated these differences 
did not result in different angioplasty outcomes across minority groups [54]. However, a recent 
retrospective analysis in a small population (n=1438) which was 47.4% black, reported a higher 
MACE (death, MI and TVR) rate (21.7%) at 2.9 years compared to non-blacks (13.6%) [55]. 
Furthermore, after adjusting for age, comorbidities and socioeconomic status, black race 
remained an independent predictor of MACE [55].  
Overall women and minorities in the US have been identified as populations shouldering a 
greater coronary artery disease burden but ironically lower PCI utilization. However, there is 
evidence, albeit limited, to demonstrate that these populations may have poorer outcomes 
compared to other groups, while still benefiting from PCI utilization. Based on the discordance 
between disease burden and PCI utilization, it becomes imperative for PCI clinical trials to 
increase women and minority participation.   
To increase recruitment of special populations in ABSORB III, Abbott Vascular will implement 
several strategies. The first being a recruitment brochure that will educate patients on heart 
disease risk and the difference in heart disease burden across ethnicity and genders. This 
brochure will also inform patients that they can speak to their physician about whether they are 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 112 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
eligible to enroll in ABSORB III. Patients interested in the trial will also be shown a detailed 
flip-chart, presented by the site explaining the procedure and possible treatments received if they 
enroll in the trial.   
A second recruitment strategy will be compensation to subjects for their participation in 
ABSORB III (US only). Abbott Vascular will provide payments to subjects in order to 
compensate them for their time and effort in returning to the hospital or otherwise responding to 
Trial-related follow-up questions. Subjects’ participation in-person in the visits at the time points 
indicated below will be compensated as set forth below.  Payment will be made to Institution as a 
pass-thru to the subject on a per-subject per-time point basis, following completion of all eCRF 
data entry for the given procedure or receipt of imaging films at the core laboratory, depending 
on the nature of the visit, receipt of an invoice from Institution and evidence of the payment by 
Institution to the applicable subject.  Institution will make payment by check to each eligible 
subject.  This reimbursement is subject to IRB approval.  All subjects at the baseline visit will be 
paid $50.00.  Subjects who complete the 1-year follow-up will receive $100.  IVUS imaging 
subjects who complete the 3-year follow-up will receive $500.  OCT imaging subjects who 
complete the 3-year follow-up will receive $500. 
Lastly, subjects enrolled in the trial identified by the Institution or the Primary Investigator as 
having a financial hardship will be reimbursed for the protocol-required antiplatelet 
(Clopidogrel, Prasugrel, Ticagrelor, or Ticlopidine) regimen.   
Abbott Vascular believes these strategies may aid in the recruitment of patients from special 
populations that may not traditionally participate in a clinical trial.  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 113 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX I: ABBREVIATIONS AND ACRONYMS 
Acronym or Abbreviation 
Complete Phrase or Definition 
%DS 
percent diameter stenosis 
ACS 
Acute Coronary Syndrome 
AE 
adverse event 
AMI 
acute myocardial infarction 
BVS 
bioresorbable vascular scaffold 
CABG 
coronary artery bypass graft 
CAD 
coronary artery disease 
CCS 
Canadian Cardiovascular Society (Canada) 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CI 
clinically-indicated 
CIP 
Clinical Investigation Plan (EU) 
CK 
creatine kinase 
CK-MB 
creatine kinase myocardial-band isoenzyme 
CoCr 
cobalt chromium 
CRA 
Clinical Research Associate 
CRF 
case report form 
CSA 
cyclosporine A 
CSS 
coronary stent system 
CVA 
cerebrovascular accident (or stroke) 
DES 
drug eluting stent 
DLPLA 
poly (DL-lactide) 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee (EU) 
ECG 
Electrocardiogram 
eCRF 
electronic CRF 
EECS 
everolimus eluting coronary stent  
EECSS 
everolimus eluting coronary stent system   
EQ-5D 
Euro-QoL 5D 
FDA 
Food and Drug Administration 
F/U 
follow up (verb); follow-up (noun, adjective) 
GAD-7 
Generalized Anxiety Disorder scale 
GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practice 
GI 
gastrointestinal 
HbA1C 
glycosylated hemoglobin 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 114 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Acronym or Abbreviation 
Complete Phrase or Definition 
HCT 
hematocrit 
ICF 
Informed Consent Form  
ID 
ischemia-driven 
IFU 
Instructions for Use 
IRB 
Institutional Review Board (US and Japan) 
ITT 
Intent-to-Treat 
IVRS 
interactive voice response service 
IVUS 
intravascular ultrasound 
LAD 
left anterior descending coronary artery 
LCX 
left circumflex coronary artery 
LL 
late loss 
LVEF 
left ventricular ejection fraction 
MACE 
major adverse cardiac event 
MEC 
Medical Ethics Committee (EU) 
µg 
microgram 
Mg 
milligram 
MI 
myocardial infarction 
mL 
milliliter 
ML 
MULTI-LINK 
MLD 
minimum lumen diameter 
MLA 
mean lumen area 
mm 
millimeter 
N 
sample size; also N 
NIH 
neointimal hyperplasia 
NQMI 
non-Q wave myocardial infarction 
OUS 
Outside United States 
PCI 
percutaneous coronary intervention 
PK 
pharmacokinetics 
PLA 
poly lactic acid 
PLLA 
poly (L-lactide) 
PMA 
pre-marketing approval 
PTCA 
percutaneous transluminal coronary angioplasty 
PTE 
per treatment evaluable 
PRO 
patient reported outcomes 
QCA 
quantitative coronary angiography 
QOL 
quality of life 
RBC 
red blood cell 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 115 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Acronym or Abbreviation 
Complete Phrase or Definition 
RC 
Research Coordinator 
RCA 
right coronary artery 
RCT 
randomized controlled trial  
RDS 
Rose Dyspnea Scale 
RVD 
reference vessel diameter 
RX 
Rapid Exchange 
SAE 
serious adverse event 
SAP 
statically analysis plan 
SAQ 
Seattle Angina Questionnaire 
SMC 
smooth muscle cell 
TIA 
transient ischemic attack 
TGA 
Therapeutic Goods Administration 
TIMI 
thrombolysis in myocardial infarction 
TLR 
target lesion revascularization 
TVF 
target vessel failure 
TVR 
target vessel revascularization 
UADE 
unanticipated adverse device effect 
ULN 
upper limit of normal 
US 
United States 
USADE 
unanticipated serious adverse device effect 
VO 
volume obstruction 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 116 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX II: DEFINITIONS 
CLINICAL ENDPOINT DEFINITIONS 
DEATH (Per ARC Circulation 2007; 115: 2344-2351) 
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. 
Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac 
disease (e.g. cancer, infection) should be classified as cardiac.  
Cardiac death (CD):  
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), 
unwitnessed death and death of unknown cause, all procedure related deaths including those 
related to concomitant treatment. 
Vascular death: 
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary 
embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. 
Non-cardiovascular death: 
Any death not covered by the above definitions such as death caused by infection, malignancy, 
sepsis, pulmonary causes, accident, suicide or trauma. 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 117 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
MYOCARDIAL INFARCTION (MI)  
Protocol MI Definition 
Classification 
Biomarker Criteria 
Additional Criteria 
Periprocedural PCI 
CK-MB > 5 x ULN  
Baseline value* < ULN; see also 
** 
Periprocedural CABG 
CK-MB > 10 x ULN 
Baseline value* < ULN; see also 
**  
Spontaneous 
Troponin >ULN or CK-MB > ULN 
One or more of the following must 
also be present: 
- Symptoms of ischemia;   
- ECG changes  indicative of new 
ischemia -  (new ST-T changes or 
new LBBB),   
- Development of pathological Q 
waves;   
 - Imaging evidence of a new loss 
of  viable myocardium or a new 
regional wall  motion abnormality 
Reinfarction (not 
related to a procedure) 
If the Troponin or CKMB values are stable 
or decreasing on 2 consecutive samples > 6 
hours, a 20% or greater increase 3 to 12 
hours after second sample is required to 
diagnose recurrent MI. 
 
 
If biomarkers are increasing or 
peak not reached then insufficient 
data to diagnose recurrent MI. In 
this case at least two of the 
following three conditions must be 
present:   
- ECG changes  indicative of new 
ischemia -  (new ST-T changes or 
new LBBB),   
- Development of pathological Q 
waves 
- Imaging evidence of a new loss of  
viable myocardium or a new 
regional wall  motion abnormality 
ULN=Upper limits of the local laboratory normal (will be collected from each hospital laboratory prior 
to study commencement);  
LBBB=Left Bundle-branch Block 
* Baseline CKMB value is required before study procedure and presumes a typical rise and fall post 
procedure to diagnose a peri procedure MI 
** Whenever at least one baseline and one post procedure CK-MB measure are available, adjudication 
of MI will be based solely on these biomarker values. If the patient has stable ischemic heart disease 
and the baseline CK-MB measure are not available, they will be assumed to be within normal limits 
and MI will be adjudicated by the CEC solely according to the post procedure CK-MB measures. 
TROPONINS WILL NOT BE USED TO DIAGNOSE PERI-PROCEDURAL MI.  
If the patient had an elevated CK-MB at baseline (protocol violation), and/or no post procedure CK-
MB measures are available (protocol violation), adjudication of a post procedure MI will be based on 
presence of two of the following three:  
1) New ST elevation or ST depression ≥0.1mV in ≥2 contiguous leads on ECG ≥30 min. and ≤48 hrs. 
post-PCI (Note: ST elevation should be measured at the J point, and ST depression must be horizontal 
or down-sloping), Or New pathological Q-waves in ≥2 contiguous leads, or new LBBB; 
2) Post procedure TIMI 0/1 flow in a coronary artery or a side branch with reference vessel diameter 
≥2.0 mm which had TIMI 2-3 flow at baseline, or TIMI 2 flow in a major coronary artery or a side 
branch with reference vessel diameter ≥3.0 mm which had TIMI 3 flow at baseline (core laboratory 
assessed); 
3) Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality. 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 118 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Note: Patients with stable coronary artery disease syndromes may have the baseline CKMB drawn 
from the arterial sheath during the PCI procedure. If this value is elevated (expected in 1-2% of 
patients with stable CAD, a post-PCI MI will be diagnosed if the post-procedure CK-MB shows a 20% 
or greater CK-MB increase on the second sample drawn 3 to 12 hours post procedure (meeting the 
threshold of CKMB > 5 x ULN), and at least 1 of the following are present:  
1) ECG changes  indicative of new ischemia -  (new ST-T changes or new LBBB),   
2) Development of pathological Q waves;  
3) Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality. 
In the absence of any of the above evidence, a > 50% increase in CK-MB over the baseline value, 
meeting the threshold of CKMB > 5 x ULN, will also qualify for a periprocedural MI. 
• Periprocedural MI After PCI:  
The periprocedural period includes the first 48 hours after PCI. 
• Periprocedural MI After CABG:  
The periprocedural period includes the first 48 hours after coronary artery bypass grafting 
(CABG). 
• Spontaneous MI:  
MI after the periprocedural period may be secondary to late stent complications or 
progression of native disease. Performance of ECG and angiography supports 
adjudication to either a target or non-target vessel in most cases.  
With the unique issues and pathophysiological mechanisms associated with these later 
events as well as the documented adverse impact on short and long-term prognosis, a 
more sensitive definition than for periprocedural MI of any elevation of troponin or 
CKMB above the 99th percentile of the upper range limit (or ULN if URL is not 
available) is used. All late events that are not associated with a revascularization 
procedure will be considered simply as spontaneous. 
Myocardial infarctions will also be adjudicated based on the following classification:  
• Q wave MI  
Development of new, pathological Q wave on the ECG (≥ 0.04 seconds in duration and ≥ 
1 mm in depth) in ≥ 2 contiguous precordial leads or ≥ 2 adjacent limb leads) 
• Non-Q wave MI  
Those MIs which are not Q-wave MI. 
Myocardial infarctions will also be adjudicated as to their relation to the Target Vessel 
All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be 
considered related to the target vessel. 
Universal Myocardial Infarction Definition. As a secondary analysis, MI will be adjudicated 
according to the 2012 Universal Definition. Thygesen K et al. Eur Heart J. August 24, 2012 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 119 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
Modified World Health Organization (WHO) MI Definition. As a secondary analysis, MI 
will be adjudicated according to the modified WHO MI definition. 
• Q wave MI  
 
Development of new, pathological Q wave on the ECG  
• Non-Q wave MI  
o Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated 
CK-MB in the absence of new pathological Q waves 
o Non-Q wave MI definition will be used for both peri-procedural MI definition (≤ 48 
hours post-procedure) and spontaneous (> 48 hours post-procedure).  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 120 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
REVASCULARIZATION (Per ARC Circulation 2007; 115: 2344-2351) 
Target Lesion Revascularization (TLR)  
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of 
the target vessel performed for restenosis or other complication of the target lesion. All TLR 
should be classified prospectively as ischemia driven or not ischemia driven by the investigator 
prior to repeat angiography. An independent angiographic core laboratory should verify that the 
severity of percent diameter stenosis meets requirements for clinical indication and will overrule 
in cases where investigator reports are not in agreement. The target lesion is defined as the 
treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent. 
Target Vessel Revascularization (TVR) 
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the 
target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal 
to the target lesion which includes upstream and downstream branches and the target lesion 
itself. The above two definitions will be used in this protocol. 
The above two definitions will be used for CEC adjudication.  
Non Target Lesion Revascularization (Non-TLR) 
Any revascularization in the target vessel for a lesion other than the target lesion is considered a 
non-TLR. 
Non Target Vessel Revascularization (Non-TVR) 
Revascularization of the vessel identified and treated as the non-target vessel at the time of the 
index procedure.  
Non-Treated Vessel 
Vessel not treated at the time of the index procedure. 
Non-Treated Vessel Revascularization 
Revascularization of the non-treated vessel.  
Ischemia Driven [ID] Revascularization (TLR/TVR) 
A revascularization is considered ischemia driven if associated with any of the following: 
• Positive functional ischemia study including positive FFR 
• Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA 
• Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or 
positive functional study 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 121 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
CORONARY ARTERY BYPASS GRAFT SURGERY [CABG] 
Acute CABG is defined as immediate transfer from the cath lab to the operative room for 
emergent bypass surgery during the initial treatment phase. 
CABG during follow-up is only considered as a Clinical-indicated Target Lesion 
Revascularization if coronary angiography indicates a diameter of stenosis greater than 50% of 
the stented coronary segment (core lab QCA assessment) associated with one of the following 
conditions: 
• A positive history of recurrent angina pectoris presumably related to the target vessel.  
• Objective signs of ischemia (12-lead ECG, exercise test or equivalent) presumably 
related to the target vessel, 
• Abnormal results of any invasive functional diagnostic test (e.g. Doppler flow velocity 
reserve, fractional flow reserve).  
• A TLR/TVR with a diameter stenosis ≥70% (core lab QCA assessment) in the absence of 
the above mentioned ischemic signs or symptoms. 
STENT THROMBOSIS (Per ARC Circulation 2007; 115: 2344-2351) 
Stent Thrombosis should be reported as a cumulative value at the different time points and with 
the different separate time points. Time 0 is defined as the time point after the guiding catheter 
has been removed and the subject left the Catheterization lab.  
Timing:  
Acute stent thrombosis*:  
 
0 - 24 hours post stent implantation  
Subacute stent thrombosis*:  >24 hours . 30 days post stent implantation  
Late stent thrombosis†:  
 
30 days - 1 year post stent implantation  
Very late stent thrombosis†:  >1 year post stent implantation  
*  
Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 
30 days) - this definition is currently used in the community.  
† 
Including “primary” as well as “secondary” late stent thrombosis; “secondary” late stent 
thrombosis is a stent thrombosis after a target segment revascularization.  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 122 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Categories (Definite, Probable, and Possible): 
Definite stent thrombosis 
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic 
confirmation. 
Angiographic confirmation of stent thrombosis* 
The presence of a thrombus† that originates in the stent or in the segment 5 mm proximal 
or distal to the stent and presence of at least 1 of the following criteria within a 48-hour 
time window:  
o Acute onset of ischemic symptoms at rest  
o New ischemic ECG changes that suggest acute ischemia  
o Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous MI)  
o Nonocclusive  thrombosis 
o Thrombus Intracoronary thrombus is defined as a (spheric, ovoid, or 
irregular) noncalcified filling defect or lucency surrounded by contrast 
material (on 3 sides or within a coronary stenosis) seen in multiple 
projections, or persistence of contrast material within the lumen, or a 
visible embolization of intraluminal material downstream.  
o Occlusive thrombus  
o TIMI 0 or TIMI 1 intrastent or proximal to a stent up to the most adjacent 
proximal side branch or main branch (if originates from the side branch). 
Pathological confirmation of stent thrombosis  
Evidence of recent thrombus within the stent determined at autopsy or via examination of 
tissue retrieved following thrombectomy.  
* The incidental angiographic documentation of stent occlusion in the absence of 
clinical signs or symptoms is not considered a confirmed stent thrombosis (silent 
occlusion). 
† Intracoronary thrombus. 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 123 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Probable stent thrombosis 
Clinical definition of probable stent thrombosis is considered to have occurred after 
intracoronary stenting in the following cases: 
o Any unexplained death within the first 30 days‡  
o Irrespective of the time after the index procedure, any MI that is related to 
documented acute ischemia in the territory of the implanted stent without 
angiographic confirmation of stent thrombosis and in the absence of any other 
obvious cause  
‡ For studies with ST-elevation MI population, one may consider the exclusion of 
unexplained death within 30 days as evidence of probable stent thrombosis. 
Possible stent thrombosis 
Clinical definition of possible stent thrombosis is considered to have occurred with any 
unexplained death from 30 days after intracoronary stenting until end of trial follow-up. 
For the present study the principal definition of stent thrombosis will be ARC definite or 
probable stent thrombosis. 
ANGIOGRAPHIC ENDPOINT DEFINITIONS 
ANGIOGRAPHIC BINARY RESTENOSIS (ABR) 
Re-narrowing of the artery defined as %DS ≥ 50%.   
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 124 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
ACC/AHA Classification Scheme of Coronary Lesions: Lesion-Specific Characteristics 
Type A Lesions (High Success, >85%; Low Risk) 
• 
Discrete (< 10 mm length) 
• 
Little or no calcification 
• 
Concentric 
• 
Less than totally occlusive 
• 
Readily accessible 
• 
Not ostial in location 
• 
Nonangulated segment, < 45° 
• 
No major branch involvement 
• 
Smooth contour 
• 
Absence of thrombus 
Type B Lesions* (Moderate Success, 60-85%; Moderate risk) 
• 
Tubular (10-20 mm length) 
• 
Moderate-to-heavy calcification 
• 
Eccentric 
• 
Total occlusions < 3 mo old 
• 
Moderate tortuosity of proximal segment 
• 
Ostial in location 
• 
Moderately angulated segment, > 45°, < 90° 
• 
Bifurcation lesions requiring double guide 
wires 
• 
Irregular contour 
• 
Some thrombus present 
* Type B1 lesions: One adverse characteristic 
* Type B2 lesions: ≥ two adverse characteristics 
Type C Lesions (Low Success, <60%; High Risk) 
• 
Diffuse (> 2 cm length) 
• 
Total occlusions > 3 mo old 
• 
Excessive tortuosity of proximal segment 
• 
Inability to protect major side branches 
• 
Extremely angulated segments > 90° 
• 
Degenerated vein grafts with friable lesions 
 
CHRONIC OCCLUSION  
Total Occlusion: 
An occlusion with no antegrade filling of contrast to the distal segment (TIMI grade 0) 
Sub-total Occlusion: 
TIMI grade 1, and with collateral filling of the distal segment  
MAXIMUM DIAMETER (Dmax)  
Dmax refers to maximum lumen diameter evaluated after pre-dilatation within the boundaries of 
intended scaffold segment.  
IN-STENT 
Within the margins of the stent. 
IN-SCAFFOLD 
Within the margins of the scaffold. 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 125 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
IN-SEGMENT 
Within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or 
scaffold. 
LATE LOSS (LL) 
General definition: Calculated as MLD post-procedure – MLD at follow-up 
• In-segment Late Loss: in-segment MLD post-procedure – in segment MLD at follow-up 
• Proximal Late Loss: proximal MLD post-procedure – proximal MLD at follow-up 
(proximal defined as within 5 mm of healthy tissue proximal to the device placement) 
• Distal Late Loss: distal MLD post-procedure – distal MLD at follow-up (distal defined as 
within 5 mm of healthy tissue distal to the device placement) 
• In-device Late Loss: in-device MLD post-procedure – in-device MLD at follow-up 
PERCENT DIAMETER STENOSIS [%DS] 
The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views 
(when possible) by QCA. 
REFERENCE VESSEL DIAMETER [RVD]  
Average diameter of proximal and distal healthy segments by QCA. 10 mm “normal” reference 
segments are selected proximal and distal to the stenosis and averaged to define the reference 
vessel diameter (User defined method).  A computer-defined interpolated normal segment will 
be used to calculate percent diameter stenosis. 
RESTENOSIS 
Re-narrowing of the artery following the removal or reduction of a previous narrowing.  
TIMI (THROMBOSIS IN MYOCARDIAL INFARCTION) FLOW GRADES  
0. No contrast flow through the stenosis. 
1. A small amount of contrast flows through the stenosis but fails to fully opacify the artery 
beyond. 
2. Contrast material flows through the stenosis to opacify the terminal artery segment. 
However, contrast enters the terminal segment perceptibly more slowly than more 
proximal segments. Alternatively, contrast material clears from a segment distal to a 
stenosis noticeably more slowly than from a comparable segment not preceded by a 
significant stenosis. 
3. Anterograde flow into the terminal coronary artery segment through a stenosis is as 
prompt as anterograde flow into a comparable segment proximal to the stenosis. Contrast 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 126 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
material clears as rapidly from the distal segment as from an uninvolved, more proximal 
segment. 
ACUTE SUCCESS DEFINITIONS 
Clinical Device Success (Lesion Basis) 
Successful delivery and deployment of the study scaffold/stent at the intended target lesion and 
successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual 
stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout 
scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment 
is not one of the criteria for device success. 
Clinical Procedure Success (Patient Basis) 
Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual 
estimation if QCA unavailable) with successful delivery and deployment of at least one study 
scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for 
all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during 
the hospital stay (maximum of 7 days). In dual target lesion setting both lesions must meet 
clinical procedure success criteria to have a patient level procedure success. 
 
Successful 
Deployment 
No Device 
Deficiencies 
QCA requirement 
In-hospital 
AE 
Device Success 
Yes* 
Yes 
In-stent %DS < 30% 
Not applicable 
Procedure 
Success** 
Yes 
Yes 
In-segment %DS < 30% 
No TLF 
* Deployment success with any device is a condition of device success, as “can’t cross the lesion” is 
regarded as device deficiencies 
** Patient basis. If a patient has multiple lesions, all the lesions must satisfy the success criteria. 
 
DEVICE DEFICIENCY [ISO14155 3.15] 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety 
or performance ISO14155 3.15 
Note: Device deficiencies include malfunctions, use errors, and inadequate labeling  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 127 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
ADVERSE EVENT DEFINITIONS 
General Definition 
ADVERSE EVENT [AE] 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device.   
UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT 
Unanticipated serious adverse device effect (USADE) refers to any serious adverse device effect 
which by its nature, incidence, severity or outcome has not been identified in the current version 
of the risk analysis report (BS EN ISO 14155:2011).  
SERIOUS ADVERSE EVENT [SAE] 
If the adverse event meets any of the criteria below, it is regarded as serious adverse event 
(SAE).  
a. led to death, 
b. led to serious deterioration in the health of the subject, that either resulted in 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient or prolonged hospitalization, or 
4.  medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
c. led to fetal distress, fetal death or a congenital abnormality or birth defect 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
ANTICIPATED ADVERSE EVENT 
Any undesirable experience (sign, symptom, illness, abnormal laboratory value, or other medical 
event) occurring to a patient, whether or not considered related to the investigational product(s) 
or drug regimen prescribed as part of the protocol, predefined in the protocol and/or IFU, that is 
identified or worsens or occurs in frequency that is not considered normal during a clinical trial.  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 128 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
ADVERSE DEVICE EFFECT 
An adverse device effect is defined as any untoward and unintended response to a medical 
device. This definition includes any event resulting from insufficiencies or inadequacies in the 
IFU, device deployment, and user error. 
SERIOUS ADVERSE DEVICE EFFECT 
Adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event or that might have led to any of these consequences if suitable action had not been 
taken or intervention had not been made or if circumstances had been less opportune. 
UNANTICIPATED ADVERSE DEVICE EFFECT 
Any serious adverse effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects (21 CFR 812.3).  
SPECIFIC EVENT DEFINITIONS (ALPHABETIC ORDER) 
ANGINA PECTORIS 
Braunwald Classification of Unstable Angina: 
I. New onset of severe or accelerated angina. Patients with new onset (< 2 months in 
duration) exertional angina pectoris that is severe or frequent (> 3 episodes/day) or patients 
with chronic stable angina who develop accelerated angina (that is, angina distinctly more 
frequent, severe, longer in duration, or precipitated by distinctly less exertion than 
previously) but who have not experienced pain at rest during the preceding 2 months. 
II. Angina at rest, subacute. Patients with one or more episodes of angina at rest during the 
preceding month but not within the preceding 48 hours. 
III. Angina at rest, acute. Patients with one or more episodes of angina at rest within the 
preceding 48 hours. 
Canadian Cardiovascular Society [CCS] Classification of Stable Angina: 
I. Ordinary physical activity does not cause angina; for example walking or climbing stairs, 
angina occurs with strenuous or rapid or prolonged exertion at work or recreation. 
II. Slight limitation of ordinary activity; for example, angina occurs walking or stair 
climbing after meals, in cold, in wind, under emotional stress or only during the few 
hours after awakening, walking more than two blocks on the level or climbing more than 
one flight of ordinary stairs at a normal pace and in normal conditions. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 129 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
III. Marked limitation of ordinary activity; for example, angina occurs walking one or two 
blocks on the level or climbing one flight of stairs in normal conditions and at a normal 
pace. 
IV. Inability to carry on any physical activity without discomfort - angina syndrome may be 
present at rest. 
CEREBROVASCULAR ACCIDENT/STROKE 
Stroke is defined as a sudden onset of focal neurological deficits due to vascular lesions of the 
brain that persists >24 hours. Any neurological symptom that lasts < 24 hours is classified as 
TIA. Stroke results from either of two types of cerebral vascular disturbance: ischemia or 
hemorrhage. 
DISCONTINUITY 
Use when geometry of an implanted Absorb BVS has perceived or observed discontinuities 
(such as gaps, breaks or misalignment) on or after (≥) 6 months post-procedure. Expected by 
design due to resorption process. 
Fracture 
When break is suspected to have occurred or reported during use or prior to (<) 6 months post-
procedure (whichever is earliest) 
DISSECTION  
• National Heart, Lung, and Blood Institute [NHLBI] Dissection Classification 
System: 
A. Minor radiolucencies within the lumen during contrast injection with no 
persistence after dye clearance. 
B. Parallel tracts or double lumen separated by a radiolucent area during contrast 
injection with no persistence after dye clearance. 
C. Extraluminal cap with persistence of contrast after dye clearance from the lumen. 
D. Spiral luminal filling defects. 
E. New persistent filling defects. 
F. Non-A-E types that lead to impaired flow or total occlusion. 
Note: Type E and F dissections may represent thrombus. 
VASCULAR COMPLICATIONS (Am Heart J 2003; 145: 1022-9) 
Access site injury requiring invasive treatment associated with protocol required procedures and 
unscheduled cardiac catheterizations. A vascular complication may include access site 
hematoma, pseudoaneurysm, arteriovenous fistula, peripheral ischemia or nerve injury.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 130 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
OTHER PROTOCOL SPECIFIC DEFINITIONS 
ANGINA 
The first adverse event resulting in the site diagnosis of angina. 
ASSIGNED DEVICE 
In ABSORB III the assigned device for subjects in the Lead-In group is the investigational 
device Absorb BVS. For subjects in the randomized portion of ABSORB III (including the 
Imaging Cohort), the assigned device will be either the investigational Absorb BVS or the FDA 
approved XIENCE V, based on a 2:1 randomization.    
BLEEDING CLASSIFICATION   
Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) 
Major Bleeding endpoint will be defined by the GUSTO classification of “Severe” or “Moderate” as 
defined below: 
Severe or life-
threatening 
Either intracranial hemorrhage or bleeding that causes 
hemodynamic compromise and requires intervention 
Moderate 
Bleeding that requires blood transfusion but does not result in 
hemodynamic compromise 
Mild 
Bleeding that does not meet criteria for either severe or moderate 
bleeding 
Bleeding events that are medically important, but that do not meet the severe or moderate levels (e.g. 
require laboratory testing, evaluation by a physician, ER visit, or cessation of either study medication 
or other antithrombotic therapies) will be collected. Bleeding complications will be site reported.  
CHRONIC CONCOMITANT MEDICATIONS 
Chronic concomitant medication refers to the following:  
a) medication that has been prescribed or is over the counter, that has been taken or will 
continue to be taken regularly for at least a period of 3 months; or 
b) medication that is required to be taken indefinitely by the patient; or  
c) medication that has been prescribed or taken multiple times (each time for at least 3 
months). 
ENROLLED SUBJECT  
Subject has signed the Informed Consent.  
DWELL TIME  
Start date and time the device was inserted into the sheath. Start date and time the device was 
deployed. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 131 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Family History of Coronary Artery Disease (CAD) 
Family history of CAD is defined as CAD occurring in male 1st degree relatives (father, 
brothers) < 55 years old, and female 1st degree relatives (mother, sisters) < 65 years old.  
INTENT TO TREAT [ITT] POPULATION 
The ITT population is defined as the subjects registered in the study at the point of 
randomization.  
LEGAL AUTHORIZED REPRESENTATIVE 
An individual or judicial or other body authorized under applicable law to consent on behalf of a 
prospective subject to the subject’s participation in the procedure(s) involved in the research. (21 
CFR Part 50.3) 
MAJOR EPICARDIAL VESSELS 
• Left anterior descending artery [LAD] with septal and diagonal branches; 
• Left circumflex artery [LCX] with obtuse marginal and/or ramus intermedius branches; 
• Right coronary artery [RCA] and any of its branches. 
NO-REFLOW 
An acute reduction in coronary flow (TIMI grade 0-1) in the absence of dissection, thrombus, 
spasm, or high-grade residual stenosis at the original target lesion.  
PERCUTANEOUS CORONARY INTERVENTION [PCI] 
Refers to all interventional cardiology methods for treatment of coronary artery disease. 
PRINCIPAL INVESTIGATOR 
A physician-specialist, related to the study, who is responsible for the overall conduct of the trial 
at all sites and compliance with protocol and relevant.  
PRIMARY INVESTIGATOR 
A physician responsible for conducting the clinical trial at each investigational site. 
PROCEDURE START DATE AND TIME 
Procedure start date and time is recorded as the date and time the first guiding catheter was 
inserted into the subject. 
PROCEDURE END DATE AND TIME 
Procedure end date and time is recorded as the time the last guiding catheter was removed from 
the subject. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 132 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
SUCCESSFUL PRE-DILATATION 
Pre-dilatation has been successfully completed without complications if all of the following 
apply: 
o For randomized subjects: RVD remains ≥ 2.50 mm - ≤ 3.75 mm and length of the lesion 
that will be covered by the device (including any edge dissections) is still ≤ 24 mm 
o For Lead-In subjects: RVD remains ≥ 2.75 mm - ≤ 3.25 mm and length of the lesion that 
will be covered by the device (including any edge dissections) is still ≥ 8 mm - ≤ 14 mm 
o Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly 
recommended. 
o TIMI Grade-3 flow (per visual estimation),  
o No angiographic complications (e.g. distal embolization, side branch closure),  
o No dissections NHLBI grade D-F  
o No chest pain lasting > 5 minutes   
o No ST depression or elevation lasting > 5 minutes. 
TARGET LESION (Analysis Definition) 
The target lesion is defined as the lesion that has met the angiographic inclusion and exclusion 
criteria in a registered subject upon calling IVRS.  
Under these conditions, the lesion will be considered the target lesion regardless of the device 
implantation and treatment actually received. 
TARGET VESSEL 
The entire epicardial vessel in which the target lesion is located. 
RANDOMIZED SUBJECT  
Subject is considered randomized after the interactive voice response system (IVRS) has been 
called and a device (Absorb BVS or XIENCE) has been assigned.  
REGISTERED SUBJECT  
Subject is considered registered upon randomization. Lead-In subjects will be considered 
registered upon calling IVRS. 
UNSTABLE CARDIAC ARRYTHMIA 
Any irregularity in the heart's natural rhythm associated with hemodynamic instability that has 
not been controlled in spite of treatment.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 134 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX IV: ENROLLMENT AND REGISTRATION 
PROCESS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 135 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
r
  
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
   
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
p
  
 
 
 
 
 
 
  
 
 
   
  
 
 
  
 
  
 
 
 
 
 
  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 137 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
  
 
 
 
 
  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 138 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
  
  
 
   
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
  
 
  
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
p
 
 
 
 
 
 
  
 
  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 139 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 APPENDIX VI: 
IMAGING FLOW AND SCHEDULE 
 
Note: 
1 Use  IVUS or OCT depending on what modality available at the site.  
Refer to core laboratory guidelines in the Imaging Guidance Document regarding imaging requirements.  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 140 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX VII: 
EVALUATION OF LEAD-IN PHASE 
The ABSORB III Lead-In Phase will begin immediately prior to the randomization phase of the 
ABSORB III.  The main objective of the Lead-In Phase will be the evaluation of the applicability 
and transferability of the didactic Absorb BVS physician training plan to US clinical practice.  
The primary area of learning in the usage of Absorb BVS is in the vessel sizing, lesion 
preparation, and device delivery and deployment, as these variables reflect the change in practice 
that occurs with the use of a polymeric scaffold compared to a metallic stent.  The Lead-In Phase 
will involve up to 35 sites and up to 50 subjects treated with Absorb BVS. Each site will be 
allowed to register 5 subjects. The participating sites will not have had previous experience with 
Absorb BVS, therefore will be limited to US sites only.  As the Absorb physician training will be 
used to train all physicians in the usage of Absorb BVS, and the Lead-In Phase is intended to 
evaluate the training program, 35 sites are deemed sufficient.  
During the Lead-In phase, there will be four key areas specific to lesion/vessel selection, lesion 
preparation and device delivery and deployment that will be measured during the time of and 
following the index procedure.  The four variables are as follows: 
1. Angiographic inclusion/exclusion: At the time of the index procedure all angiographic 
inclusion/exclusion must be met. Selection of the appropriate target vessel and lesion 
criteria has been found to be important in the proper delivery and deployment of Absorb 
BVS. 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
  
 
 f 
 
 
 
 
 
 
 
 
 
 
 
 
  
2.  Vessel sizing met protocol required criteria: Retrospective analysis will be completed 
by the angiographic core laboratory.  Appropriate vessel sizing is important in the 
selection of the correct Absorb BVS diameter.  The RVD will be visually assessed by 
investigators at the time of the index procedure, and will be sent to angiographic core 
laboratory to assess if vessel sizing was done appropriately. The targeted Dmax 36 range 
as assessed by the angiographic core laboratory is ≥ 2.5 to ≤ 3.3 mm, with an acceptable 
range between 2.25 to ≤ 3.3 mm. This criterion is based on ABSORB EXTEND data in 
which an angiographic core laboratory retrospective analysis conducted on 108 target 
lesions  that were selected by ABSORB EXTEND investigators using on-line QCA 
(Quantitative Coronary Angiography) [56]. 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
  
 
  
 
 
 Furthermore, 
preliminary analysis from ABSORB Cohort B has demonstrated that the placement of the 
3.0 mm Absorb BVS in a vessel < 2.5 mm has not resulted clinical and angiographic 
differences as compared to vessels > 2.5 mm [57].  
3. Treatment strategy followed per the protocol: All treatment strategy requirements 
must be met at the time of the index procedure.  Proper delivery and deployment of the 
Absorb BVS is also dependent on variables such as appropriate guide catheter choice, 
 
36 Dmax is defined as the maximum lumen diameter of the vessel within the target lesion segment 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 141 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
pre-dilatation strategy, inflation timing and potential post-dilatation strategy. 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
                            
4. Device success: The device success criteria will be based on the protocol definition that 
is detailed in Appendix II.  
 
 
 
 
 
 
  
Each of these variables can be evaluated acutely and will provide the sponsor with a measure of 
adherence to the physician training program.  Subject registration will be conducted in 5 sets of 
10 subjects. After each subject is registered in the trial, the core laboratory will be review the 
angiographic data within 3 business days and monitoring of the data will occur within 1-2 
business days. After the registration of each subject set, AV will evaluate the four criteria for all 
10 subjects to determine whether they met the above criteria. Communication to the sites will be 
conducted to indicate a short pause in enrollment to evaluate each subject set. If there are 
deviations to the above criteria, modification to the training plan and retraining of identified 
elements will be conducted at the sites. Furthermore, AV will communicate to the sites when the 
continuation of subject enrollment/registration to the sites can occur.  Regarding the vessel sizing 
criteria, after the first missed vessel sizing by an investigator, they will receive immediate 
feedback from the sponsor and core laboratory, and retraining if needed.  
The data for each enrolled subject will be collected through the electronic case report forms 
(eCRFs).  
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 f 
 
 
 Identified trends may require for modification in training or retraining of 
investigators, which will be implemented immediately.  Modifications will not be required of 
those elements that exceed the criteria set.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  If the mean outcomes meet the criteria detailed 
above, randomization will resume immediately.  The 50 subjects will receive annual follow-up 
through 5 years and the sponsor will provide clinical data to the FDA through 5 years.  
The outcomes from the lead-in phase will determine whether the physician training requires 
further modification to meet the needs of the US physicians.  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
  
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 142 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX VIII: RISK STRATIFICATION OF CARDIAC 
CATHETERIZATION, STENTING AND PERCUTANEOUS 
TRANSCATHETER CORONARY ANGIOPLASTY  
Potential risks associated with the study device and everolimus were described in the original 
protocol. Based on additional clinical and commercial experience, Abbott Vascular has updated 
the BVS IDE IFU. The below section provides a consolidated list of anticipated adverse events 
and, in alignment with ISO14155:2011 requirements, the estimated frequencies of those risks. 
There is extensive clinical and commercial experience worldwide with cardiac catheterization 
and interventional procedures. It is expected that the risks will not be significantly different with 
the use of the Absorb BVS and XIENCE V stent in this trial.  The incidence rates of the known 
complications that may arise from a stenting procedure were obtained from the pooled XIENCE 
V trials  conducted by AV (Spirit First, Spirit II, Spirit III RCT, Spirit III JPN, Spirit III 4.0 mm, 
Spirit IV, Spirit V Diabetic, Spirit V Registry, Spirit Women, XV USA, XV DAPT, and XV 
India using MedDRA Preferred Terms of site-reported 1 year adverse events regardless of 
relationship to device or procedure ) and were classified using the frequency categories as below. 
Death and stent thrombosis within 1 year have been observed in < 2.0% of the patients enrolled 
in these trials.  
1. Very common: ≥ 10%: Unstable or stable angina pectoris 
2. Common: ≥ 1.0% to < 10%: Cardiac, pulmonary or renal failure; access site 
complications including pain, hematoma, or hemorrhage; vascular complication including 
at the entry site, which may require vessel repair; coronary artery dissection; arrhythmia 
including atrial and ventricular; myocardial infarction, including acute myocardial 
infarction; nausea and vomiting; hypotension; hypertension; restenosis 
3. Uncommon: ≥ 0.1% to < 1.0%: Cardiac arrest; emergent or non-emergent surgery; 
allergic or hypersensitivity reactions to contrast agent or platinum, polymer poly (L-
lactide) (PLLA), polymer poly (D,L-lactide) (PDLLA), and drug reactions to everolimus, 
antiplatelet drugs or contrast agent; bleeding complications which may require 
transfusion; coronary artery spasm; distal emboli; fever; catheter site infection or pain; 
myocardial ischemia; palpitations; coronary artery perforation; pericarditis, peripheral 
ischemia (due to vascular injury); pseudoaneurysm; pulmonary edema; stroke/CVA/TIA; 
total occlusion of coronary artery; ventricular tachycardia; ventricular fibrillation; vessel 
dissection 
4. Rare: ≥ 0.01% to < 0.1%: Arteriovenous fistula; cardiac tamponade; coronary artery 
embolism; arterial injury; procedural nausea; shock; peripheral artery dissection; 
peripheral nerve injury; renal insufficiency; pericardial effusion 
5. Very Rare: < 0.01% (including not reported AEs): Abrupt coronary artery closure; 
coronary artery aneurysm; arterial rupture; everolimus IFU risks. 
Some IFU risks, including everolimus risks have not been observed in Abbott Vascular clinical 
studies. These risks are listed in the very rare category. There may be risks related to the device 
that are unknown at present. Likewise the exact frequency of the risk might be unknown. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 143 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX IX: 
CONTACT INFORMATION 
A list of investigational site co-ordinates can be obtained upon request from the Clinical Project 
Manager for the study. The Clinical Project Manager can be reached at 
.  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 144 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX X: REFERENCES 
 
1. 
Gomez-Lara, J., et al., Serial analysis of the malapposed and uncovered struts of the new 
generation of everolimus-eluting bioresorbable scaffold with optical coherence tomography. 
Jounal of the American College of Cardiology: Cardiovascular Interventions, 2011. 4(9): p. 992-
1001. 
2. 
Kimura, T., et al., Three-year follow-up after implantation of metallic coronary-artery stents. The 
New England Journal of Medicine, 1996. 334(9): p. 561-566. 
3. 
Nobuyoshi, M., et al., Restenosis after successful percutaneous transluminal coronary 
angioplasty: serial angiographic follow-up of 229 patients. Journal of the American College of 
Cardiology, 1988. 12(3): p. 616-623. 
4. 
Serruys, P.W., et al., Incidence of restenosis after successful coronary angioplasty: a time-related 
phenomenon. A quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 
months. Circulation, 1988. 77(2): p. 361-371. 
5. 
Pietrzak, W.S., M.L. Verstynen, and D.R. Sarver, Bioabsorbable fixation devices: status for the 
craniomaxillofacial surgeon. Journal of Craniofacial Surgery, 1997. 8(2): p. 92-96. 
6. 
Gladden, L.B., Lactate metabolism: a new paradigm for the third millennium. Journal of 
Physiology, 2004. 558(Pt 1): p. 5-30. 
7. 
Philp, A., A.L. Macdonald, and P.W. Watt, Lactate--a signal coordinating cell and systemic 
function. Journal of Experimental Biology, 2005. 208: p. 4561-4575. 
8. 
Robergs, R.A., F. Ghiasvand, and D. Parker, Biochemistry of exercise-induced metabolic 
acidosis. American Journal of Physiology, 2004. 287(3): p. R502-R516. 
9. 
Lupattelli, T., et al., Efficacy and safety of antegrade common femoral artery access closure 
using the Angio-Seal device: experience with 1889 interventions for critical limb ischemia in 
diabetic patients. Journal of Endovascular Therapy, 2010. 17(3): p. 366-375. 
10. 
Barlis, P., et al., An optical coherence tomography study of a biodegradable vs. durable polymer-
coated limus-eluting stent: a LEADERS trial sub-study. European Heart Journal, 2010. 31(2): p. 
165-176. 
11. 
Longo, U.G., et al., The low-profile Roman bridge technique for knotless double-row repair of 
the rotator cuff. Archives of Orthopaedic and Trauma Surgery, 2011. 131(3): p. 357-361. 
12. 
Tamai, H., et al., Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents 
in humans. Circulation, 2000. 102(4): p. 399-404. 
13. 
Garlotta, D., A literature review of poly(lactic acid). Journal of Polymers and the Environment, 
2001. 9(2): p. 63-84. 
14. 
Perego, G., G.D. Cella, and C. Bastioli, Effect of molecular weight and crystallinity on poly(lactic 
acid) mechanical properties. Journal of Applied Polymer Science, 1996. 59(1): p. 37-43. 
15. 
Chapman, G.D., et al., A bioabsorbable stent: Initial experimental results. Circulation, 1990. 
1990(82 (Suppl II)): p. III - 541. 
16. 
Gammon, R.S., et al., Mechanical features of the Duke biodegradable stent. Journal of the 
American College of Cardiology, 1991. 1991(17): p. 235A. 
17. 
Tsuji, T., et al., Four-year follow-up of the biodegradable stent (IGAKI-TAMAI Stent). 
Circulation Journal, 2004. 68(Suppl 1): p. 135. 
18. 
Tsuji, T., et al., Three-year clinical follow-up results of the Igaki-Tamai biodegradable stent. 
Circulation Journal, 2003. 67(Suppl. I): p. 351. 
19. 
Onuma, Y., et al., Ten-year follow-up of the IGAKI-TAMAI stent. A posthumous tribute to the 
scientific world of Dr. Hideo Tamai. EuroIntervention Supplement, 2009. 5(Suppl. F): p. F109-
F111. 
20. 
Nishio, S., et al., Long-Term (>10 Years) clinical outcomes of first-in-human biodegradable poly-
l-lactic acid coronary stents: Igaki-Tamai stents. Circulation, 2012. 125(19): p. 2343-53. 
21. 
Biamino, G. and D. Schreinhert, Treatment of SFA lesions with PLLA biodegradable stents: 
results of the PERSEUS study. Journal of Endovascular Therapy, 2005. 12(Suppl. I): p. 5. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 145 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
22. 
Colombo, A., et al., Randomized study to assess the effectiveness of slow- and moderate-release 
polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation, 2003. 108(7): p. 
788-794. 
23. 
Morice, M.C., et al., A randomized comparison of a sirolimus-eluting stent with a standard stent 
for coronary revascularization. The New England Journal of Medicine, 2002. 346(23): p. 1773-
1780. 
24. 
Moses, J.W., et al., Sirolimus-eluting stents versus standard stents in patients with stenosis in a 
native coronary artery. The New England Journal of Medicine, 2003. 349(14): p. 1315-1323. 
25. 
Serruys, P.W., et al., A randomised comparison of an everolimus-eluting coronary stent with a 
paclitaxel-eluting coronary stent: the SPIRIT II trial. EuroIntervention, 2006. 2(3): p. 286-294. 
26. 
Stone, G.W., et al., A polymer-based, paclitaxel-eluting stent in patients with coronary artery 
disease. The New England Journal of Medicine, 2004. 350(3): p. 221-231. 
27. 
Stone, G.W., et al., Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in 
patients with coronary artery disease: a randomized trial. Journal of the American Medical 
Association, 2008. 299(16): p. 1903-1913. 
28. 
Tanimoto, S., et al., Comparison of in vivo acute stent recoil between the bioabsorbable 
everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: 
insights from the ABSORB and SPIRIT trials. Catheterization and Cardiovascular Interventions, 
2007. 70(4): p. 515-523. 
29. 
Ormiston, J.A., et al., A bioabsorbable everolimus-eluting coronary stent system for patients with 
single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet, 2008. 
371(9616): p. 899-907. 
30. 
Serruys, P.W., et al., A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-
year outcomes and results from multiple imaging methods. Lancet, 2009. 373(9667): p. 897-910. 
31. 
Schweikert, B., H. Hahmann, and R. Leidl, Validation of the EuroQol questionnaire in cardiac 
rehabilitation. Heart, 2006. 92(1): p. 62-7. 
32. 
Spertus, J.A., et al., Development and evaluation of the Seattle Angina Questionnaire: a new 
functional status measure for coronary artery disease. J Am Coll Cardiol, 1995. 25(2): p. 333-41. 
33. 
Arnold, S.V., et al., The impact of dyspnea on health-related quality of life in patients with 
coronary artery disease: results from the PREMIER registry. American Heart Journal, 2009. 
157(6): p. 1042-9 e1. 
34. 
Spitzer, R.L., et al., A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch 
Intern Med, 2006. 166(10): p. 1092-7. 
35. 
Aksoy, M., et al., The safety and efficacy of angioseal in therapeutic endovascular interventions. 
European Journal of Vascular and Endovascular Surgery, 2006. 32(1): p. 90-93. 
36. 
Grube, E., et al., Six- and twelve-month results from first human experience using everolimus-
eluting stents with bioabsorbable polymer. Circulation, 2004. 109(18): p. 2168-2171. 
37. 
Storger, H., et al., Clinical experiences using everolimus-eluting stents in patients with coronary 
artery disease. Journal of Interventional Cardiology, 2004. 17(6): p. 387-390. 
38. 
Grube, E. FUTURE II: Multicenter evaluation of the bioabsorbable polymer-based everolimus-
eluting stent. 2003. 
39. 
Mastrokalos, D.S. and H.H. Paessler, Allergic reaction to biodegradable interference poly-L-
lactic acid screws after anterior cruciate ligament reconstruction with bone-patellar tendon-bone 
graft. Arthroscopy, 2008. 24(6): p. 732-733. 
40. 
Alijotas-Reig, J., V. Garcia-Gimenez, and M. Vilardell-Tarres, Late-onset immune-mediated 
adverse effects after poly-L-lactic acid injection in non-HIV patients: clinical findings and long-
term follow-up. Dermatology, 2009. 219(4): p. 303-308. 
41. 
Nissen, S.E. and P. Yock, Intravascular ultrasound: novel pathophysiological insights and 
current clinical applications. Circulation, 2001. 103(4): p. 604-616. 
42. 
Ramasubbu, K., et al., Repeated intravascular ultrasound imaging in cardiac transplant 
recipients does not accelerate transplant coronary artery disease. Journal of the American 
College of Cardiology, 2003. 41(10): p. 1739-1743. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 146 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
43. 
Barlis, P., et al., A multicentre evaluation of the safety of intracoronary optical coherence 
tomography. EuroIntervention, 2009. 5(1): p. 90-95. 
44. 
Feldman, R.L., et al., Analysis of coronary responses to various doses of intracoronary 
nitroglycerin. Circulation, 1982. 66(2): p. 321-327. 
45. 
Partnership, B.-M.S.S.P., Plavix Highlights of Prescribing Information. 2011. 
46. 
Daiichi Sankyo, I. and E.L.a. Company, Effient Highlights of Prescribing Information. 2009. 
47. 
AstraZeneca, Brilinta Highlights of Prescribing Information. 2011. 
48. 
Movahed, M.R., et al., Nationwide trends in the utilisation of percutaneous coronary intervention 
(PCI) in the United States of America based on gender and ethnicities. EuroIntervention, 2009. 
5(3): p. 343-348. 
49. 
Lansky, A.J., Outcomes of percutaneous and surgical revascularization in women. Progress in 
Cardiovascular Diseases, 2004. 46(4): p. 305-319. 
50. 
Singh, M., et al., Mortality differences between men and women after percutaneous coronary 
interventions. A 25-year, single-center experience. Journal of the American College of 
Cardiology, 2008. 51(24): p. 2313-2320. 
51. 
Abbott, J.D., et al., Gender-based outcomes in percutaneous coronary intervention with drug-
eluting stents (from the National Heart, Lung, and Blood Institute Dynamic Registry). American 
Journal of Cardiology, 2007. 99(5): p. 626-31. 
52. 
Lansky, A.J., et al., Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent 
system: clinical and angiographic results from the SPIRIT III randomized trial. Catheterization 
and Cardiovascular Interventions, 2009. 74(5): p. 719-727. 
53. 
Lloyd-Jones, D., et al., Heart disease and stroke statistics--2009 update: a report from the 
American Heart Association Statistics Committee and Stroke Statistics Subcommittee. 
Circulation, 2009. 119(3): p. e21-e181. 
54. 
Minutello, R.M., et al., Impact of race and ethnicity on inhospital outcomes after percutaneous 
coronary intervention (report from the 2000-2001 New York State Angioplasty Registry). 
American Heart Journal, 2006. 151(1): p. 164-167. 
55. 
Napan, S., et al., Racial difference in cardiovascular outcomes following percutaneous coronary 
intervention in a public health service patient population. Journal of Invasive Cardiology, 2010. 
22(4): p. 168-173. 
56. 
Farooq, V., et al., Proximal and distal maximal luminal diameters as a guide to appropriate 
deployment of the ABSORB everolimus-eluting bioresorbable vascular scaffold: a sub-study of 
the ABSORB Cohort B and the on-going ABSORB EXTEND Single Arm Study. Catheterization 
and Cardiovascular Interventions, 2012. 79(6): p. 880-888. 
57. 
Diletti, R., et al., 6-month clinical outcomes following implantation of the bioresorbable 
everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm. Journal of the 
American College of Cardiology, 2011. 58(3): p. 258-264. 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 148 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Study Name  
ABSORB III PK Sub-study: 10-392 
Investigational 
Device 
Absorb™ Bioresorbable Vascular Scaffold (BVS) System:  
• Scaffold diameters: 2.5, 3.0 and 3.5 mm  
• Scaffold lengths: 8, 12, 18, and 28 mm  
Objective 
To determine the pharmacokinetics of everolimus delivered by the 
Absorb BVS in a separate and non-randomized cohort of subjects who 
only receive Absorb BVS with a maximum of two de novo native 
coronary artery lesions after implantation of the Absorb BVS.  (Note: 
The ABSORB III PK subjects will not contribute to the determination of 
the ABSORB III RCT primary endpoint.) 
Sub-study 
Design 
A prospective, open-label, non-blinded study enrolling approximately 12 
subjects in up to 5 US sites. 
Subject Number 
Total number of patients: Approximately 12 (as distributed below) 
Table 1: Drug Content in Absorb BVS 
Absorb BVS Diameter 
(mm) 
Absorb BVS Length 
(mm) 
Drug Dose 
(µg) 
2.5, 3.0 
8 
76 
2.5, 3.0 
12 
114 
2.5, 3.0 
18 
181 
2.5, 3.0 
28 
276 
3.5 
12 
135 
3.5 
18 
197 
3.5 
28 
308 
Table 2: Treatment Group and Drug Dosage 
Treatment Groups 
Drug Dose (µg) 
Single Scaffold 
76-308 
≥ 2 Scaffolds+ 
≥ 152++ 
+Two lesions in two separate vessels or bailout 
++Minimum dosage a subject can receive based on use of two of the smallest 
scaffold sizes (2.5/3.0 x 8 mm) 
To ensure the PK measurements reflect everolimus exposure due to 
Absorb BVS only, the PK sub-study will not allow non-target lesion 
treatment.   
Subjects will be included in the PK analysis only if all intended Absorb 
BVS are implanted and no other device is used/implanted. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 149 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Blood Sampling 
Timing 
• Pre-Absorb BVS implantation: Baseline 
• Baseline is defined as prior to implantation of the first Absorb 
BVS; the blood sample will be drawn on the day of the index 
procedure either through a heparin lock, venous sheath, or 
venipuncture. 
• Post-Absorb BVS implantation: 10 and 30 minutes, 1 hr, 2 hrs, 4 hrs, 
6 hrs , 12 hrs, 24 hrs (1 day), 48 hrs (2 days), 72 hrs (3 days), 96 hrs 
(4 days), 120 hrs (5 days), 168 hrs (7 days), 336 hrs (14 days), and 
720 hrs (30 days)  
• Post-implantation blood samples will be drawn at the time 
intervals stated above; timing of the post-implantation sampling 
will begin when the last Absorb BVS is deployed, i.e. last Absorb 
BVS delivery catheter is removed from the body. 
Follow-up 
• Refer to Section 7.5 Clinical and Imaging Follow-Up for All Subjects 
• Note: Follow-up for PK sub-study subjects will not include 
administration of the PRO tools nor imaging follow-up. 
PK Parameters 
• tmax 
• Cmax 
• AUC0-24h 
• AUC0-t 
• AUC0-∞ 
• λz  
• t1/2term  
• CL 
Safety 
Monitoring 
Refer to Section 9.0 Adverse Events 
Subject 
Enrollment  
Unlike the ABSORB III primary analysis group and Imaging cohort, 
IVRS will not be called for PK subjects until after a) successful pre-
dilatation and b) completion of the index procedure. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 150 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Exclusion from 
Analysis and 
Follow-up 
• Subjects in whom an Absorb BVS enters the body but is not 
implanted will be excluded from the sub-study analysis and will 
require 30-day safety follow-up. 
• Subjects in whom an Absorb BVS and a non-Absorb BVS device are 
implanted will be excluded from the sub-study analysis and will 
require the full 5-year follow-up as described in Section 7.5 Clinical 
and Imaging Follow-Up for All Subjects.  (Note: Completion of the 
PRO tools and imaging follow-up will not be required.) 
• In all of the above cases, subjects will be replaced in the PK sub-
study. 
Inclusion 
Criteria 
General Inclusion Criteria: Refer to Section 6.3.1.1 General Inclusion 
Criteria for complete list 
Angiographic Inclusion Criteria  
1. One or two de novo target lesions: 
a. If two target lesions are present, they must be present in 
different epicardial vessels and both must satisfy the 
angiographic eligibility criteria. 
b. The definition of epicardial vessels means the LAD, LCX and 
RCA and their branches. Thus, the patient must not have 
lesions requiring treatment in e.g. both the LAD and a 
diagonal branch.  
2. Target lesion(s) must be located in a native coronary artery with a 
visually estimated or quantitatively assessed %DS of ≥ 50% and < 
100% with a TIMI flow of ≥ 1 and one of the following: stenosis 
≥ 70%, an abnormal functional test (e.g., fractional flow reserve, 
stress test), unstable angina or post-infarct angina.  
a. Lesion(s) must be located in a native coronary artery with 
RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.  
b. Lesion(s) must be located in a native coronary artery with 
length by visual estimation of ≤ 24 mm. 
Exclusion 
Criteria 
General Exclusion Criteria: Refer to Section 6.3.1.2. General 
Exclusion Criteria for the complete list; the following 
change/modification applies to criterion #8: 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 151 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
8. Subject has undergone prior PCI within the target vessel(s) during 
the last 12 months. 
a. Prior PCI to a non-target vessel not using drug-eluting/coated 
devices (e.g. balloon, stent) is acceptable if performed 
anytime > 30 days before the index procedure.   
b. Prior PCI to a non-target vessel using drug-eluting/coated 
devices is acceptable if performed >6 months before the index 
procedure. 
c. Peripheral interventions not using drug-eluting/coated devices 
are acceptable if performed anytime > 30 days before the 
index procedure or between 24 hours and 30 days before the 
index procedure if successful, uncomplicated. 
d. Peripheral interventions using drug-eluting/coated devices are 
acceptable if performed > 6 months before the index 
procedure.  
Angiographic Exclusion Criteria: Refer to Section 6.3.2.2 
Angiographic Exclusion Criteria for the complete list 
Lesion Selection 
Refer to Section 4.4 ABSORB III Treatment Flow and Lesion Selection 
(Please note again that non-target lesion treatment is not allowed in the 
PK sub-study.) 
Treatment 
Strategy 
Refer to Section 7.3.4 Treatment Rules of the Target Lesion(s) with the 
following exceptions: 
• In the PK sub-study, all target lesions are to be treated with the 
Absorb BVS only 
• Subjects in the PK sub-study will not be randomized; any 
references to randomization should be disregarded 
Cardiac 
Biomarker 
Collection 
Refer to Section 7.4.2 Post-procedure Laboratory and Clinical Tests for 
complete details 
 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 153 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
TABLE OF CONTENTS 
PROTOCOL SUMMARY FOR ABSORB IV ............................................................................156 
1. 
INTRODUCTION ..............................................................................................................181 
2. 
BACKGROUND INFORMATION ...................................................................................182 
2.1.1 Name of the Investigational Device .........................................................................182 
2.1.2 Intended Indication ..................................................................................................182 
2.1.3 Background Information ..........................................................................................182 
2.2 
Trial Rationale .............................................................................................................183 
3. 
TRIAL OBJECTIVE ..........................................................................................................183 
4. 
CLINICAL TRIAL/INVESTIGATION FLOW AND FOLLOW-UP SCHEDULE .........184 
4.1 
Number of Subjects to be Registered ...........................................................................184 
4.2 
ABSORB Physician Training ......................................................................................184 
4.3 
ABSORB IV Treatment Flow and Lesion Selection ...................................................184 
4.4 
Measures Taken to Avoid and Minimize Bias .............................................................186 
4.4.1 Randomization .........................................................................................................186 
4.4.2 Blinding....................................................................................................................187 
4.5 
Early Termination of the Clinical Trial .......................................................................188 
5. 
ENDPOINTS ……………………………………………………………………………..188 
5.1 
Primary Endpoints .......................................................................................................188 
5.2 
ABSORB IV Major Secondary Endpoint ....................................................................188 
5.3 
Additional Secondary Endpoint(s) ...............................................................................189 
5.4 
Informational Endpoints ..............................................................................................190 
5.4.1 Patient Reported Outcomes......................................................................................190 
5.4.2 Health Economics ....................................................................................................190 
6. 
SUBJECT SELECTION AND WITHDRAWAL ..............................................................191 
6.1 
Subject Population .......................................................................................................191 
6.2 
Subject Screening and Informed Consent ....................................................................191 
6.2.1 Subject Screening and Informed Consent ................................................................191 
6.3 
Eligibility Criteria ........................................................................................................191 
6.4 
Point of Registration ....................................................................................................191 
6.5 
Subject Discontinuation ...............................................................................................191 
7. 
TREATMENT AND EVALUATION OF SAFETY AND EFFECTIVENESS ................192 
7.1 
Baseline ........................................................................................................................192 
7.1.1 Baseline Laboratory Assessments to Confirm Subject Eligibility ...........................192 
7.1.2 Subject History.........................................................................................................192 
7.1.3 Patient-Reported Outcomes Assessment .................................................................192 
7.2 
Pre-Procedure ...............................................................................................................192 
7.2.1 Pre-Procedure Laboratory Assessment ....................................................................192 
7.2.2 Dual Anti-Platelet Medications ................................................................................193 
7.2.3 Anticoagulation Medications ...................................................................................195 
7.2.4 Statin Therapy ..........................................................................................................195 
7.3 
Index Procedure ...........................................................................................................195 
7.3.1 Baseline (Pre-Procedure) Angiography ...................................................................195 
7.3.2 Imaging Guidance Document ..................................................................................195 
7.3.3 Treatment Rules of the Target Lesion(s) .................................................................195 
7.3.4 Treatment Rules of Unplanned Non-Target Lesion(s) ............................................196 
7.3.5 Bailout Stenting or Alternative Procedures .............................................................196 
7.3.6 Final (Post-procedure) Angiography .......................................................................197 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 154 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
7.3.7 Final (Post-procedure) IVUS and OCT ...................................................................197 
7.4 
Post–procedure .............................................................................................................197 
7.4.1 Post-procedure Information to be Recorded ............................................................197 
7.4.2 Post-procedure Laboratory and Clinical Tests .........................................................197 
7.4.3 Assessment of perception bias. ................................................................................198 
7.4.4 Follow-up Antiplatelet Medications ........................................................................199 
7.4.5 Other Chronic Concomitant Medications ................................................................199 
7.5 
Clinical Follow-up for All Subjects .............................................................................199 
7.6 
Additional Follow-up Visits for All Subjects ..............................................................200 
8. 
ADVERSE EVENTS ..........................................................................................................201 
8.1 
Definitions....................................................................................................................201 
8.1.1 Adverse Event .............................................................................................................201 
8.1.2 Serious Adverse Event ................................................................................................201 
8.1.3 Device Deficiency/Product Experience ......................................................................202 
8.2 
Device Relationship .....................................................................................................202 
8.2.1 Unanticipated Serious Adverse Device Effect (USADE) ........................................202 
8.3 
Adverse Event/ Device Deficiency/ Product Experience Reporting ...........................203 
8.3.1 Adverse Event and Serious Adverse Event Reporting ............................................203 
8.3.2. Unanticipated Serious Adverse Device Effect Reporting to Sponsor and IRB .........204 
8.3.3 Device Deficiency/Product Experience Reporting ..................................................204 
8.3.4 Adverse Event Reporting to Country Regulatory Authorities by the Sponsor ........204 
8.4 
Safety Monitoring by Data Safety Monitoring Board .................................................205 
9. 
ADJUDICATION OF EVENTS .........................................................................................205 
9.1 
The Clinical Events Committee (CEC) ........................................................................205 
9.2 
Angiographic Core Laboratory ....................................................................................205 
10. STATISTICAL ANALYSIS ..............................................................................................205 
10.1 
Statistical Overview .....................................................................................................205 
10.2 
Analysis Populations ....................................................................................................206 
10.2.1 Intent-to-Treat (ITT) Population ..............................................................................206 
10.2.2 Per Treatment Evaluable Population .......................................................................206 
10.3.1 ABSORB IV Primary Endpoints .............................................................................206 
10.3.2 Powered Secondary Endpoint ...................................................................................207 
10.4 
Statistical Analyses ......................................................................................................208 
10.4.1 Primary Endpoint Analyses .....................................................................................209 
10.4.2 Powered Secondary Endpoint Analysis ...................................................................209 
10.4.3 Secondary Endpoint Analyses .................................................................................209 
10.4.4 Additional Analyses .................................................................................................210 
10.4.5 Informational Endpoint Analyses ............................................................................210 
10.4.6 Subgroup Analysis ...................................................................................................210 
10.4.7 Handling of Multiplicity Issues ................................. Error! Bookmark not defined. 
10.4.8 Criteria for Early Termination of the Trial for Effectiveness ..................................210 
10.4.10 Procedures for Accounting for Missing, Unused or Spurious Data.....................210 
10.4.11 Pooling Strategy ...................................................................................................210 
10.4.12 Deviations from the Original Statistical Plan ......................................................210 
11. ADDITIONAL PROTOCOL INFORMATION.................................................................210 
11.1 
Direct Access to Source Data/Documents Addendum ................................................210 
12. ABSORB-RESOLVe: REduction in iSchemia with BiOresorbale Vascular Scaffolds—An 
Imaging Sub-study to ABSORB IV ....................................................................................212 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 155 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
12.1. Background ..................................................................................................................212 
12.1.1. Ischemia Assessment by SPECT .............................................................................212 
12.1.2. Coronary CT Angiography (CCTA) ........................................................................213 
12.1.3. CT Perfusion (CTP) .................................................................................................213 
12.1.4. FFRCT .......................................................................................................................214 
12.1.5. The Present Study ....................................................................................................214 
12.2. Rationale and Design of ABSORB-RESOLVe ...........................................................214 
12.3. ABSORB-RESOLVe Study Objectives: .....................................................................216 
12.3.1. Primary Objective (Myocardial Ischemia by SPECT). ............................................216 
12.3.2. Powered Secondary Objective (Myocardial Ischemia by CT). ...............................216 
12.3.3. Tertiary Objectives: .................................................................................................217 
12.4. ABSORB-RESOLVe Study Population and Clinical Site Participation .....................218 
12.4.1. Selection of Subjects ................................................................................................219 
12.4.2. Test Schedule and Subject Visits .............................................................................219 
12.4.3. Procedural Assessments and Treatment Strategy ....................................................226 
12.5. References ....................................................................................................................227 
Appendix I: ABBREVIATIONS AND ACRONYMS ................................................................231 
APPENDIX II: 
DEFINITIONS .............................................................................................232 
APPENDIX III: 
SCHEDULE OF EVENTS ...........................................................................236 
APPENDIX IV: 
ENROLLMENT AND REGISTRATION PROCESS .................................238 
APPENDIX V: 
VESSEL TREATMENT & RANDOMIZATION .......................................240 
APPENDIX VI: RISK STRATIFICATION OF CARDIAC CATHERIZATION, STENTING 
AND PERCUTANEOUS TRANSCATHETER CORONARY ANGIOPLASTY ............243 
APPENDIX VII: 
CONTACT INFORMATION ......................................................................244 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 156 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
PROTOCOL SUMMARY FOR ABSORB IV 
 
Investigational 
Device 
Absorb™ Bioresorbable Vascular Scaffold (BVS) System37: 
• Scaffold diameters: 2.5, 3.0 and 3.5 mm 
• Scaffold lengths38: 8, 12, 18, and 28 mm 
Once Absorb GT1™ BVS System is commercially available, it can 
also be used in the ABSORB IV trial (see section 2.1.4 for available 
sizes). 
Control Device 
Commercially approved XIENCE Family Stent System, inclusive of 
XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, 
XIENCE Pro (OUS only), and XIENCE ProX (OUS only)39. 
• Stent diameters:  2.5, 2.75, 3.0, 3.25*, 3.5 and 4.0 mm  
• Stent lengths: 8, 12, 15, 18, 23, and 28 mm 
XIENCE Family Stent System will hereinafter be called “XIENCE” in 
this study. 
*The 3.25 mm is only available for XIENCE Xpedition. 
Objectives 
• ABSORB IV Primary Objectives:  
o 
To evaluate 30-day clinical outcomes of the Absorb BVS 
compared to XIENCE in the treatment of subjects with ischemic 
heart disease caused by up to three de novo native coronary 
artery lesions in a maximum of two epicardial vessels, with a 
maximum of two lesions per epicardial vessel. 
o 
To evaluate long-term clinical outcomes of Absorb BVS 
compared to XIENCE in the treatment of subjects with ischemic 
heart disease caused by up to three de novo native coronary 
artery lesions in a maximum of two epicardial vessels, with a 
maximum of two  lesions per epicardial vessel. 
• ABSORB IV Secondary Objectives: 
 
37 The commercially approved CE marked device will be used in geographies where it is commercially available. 
38 Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm 
length will be available for the 3.5 mm diameter. The commercially approved CE marked 23mm Absorb BVS 
device will not be used in this study. 
39 For geographies where these devices are commercially available, the investigational sites may use only their 
locally approved devices. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 157 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• To evaluate 1-year clinical outcomes of the Absorb BVS 
compared to XIENCE in the treatment of subjects with ischemic 
heart disease caused by up to three de novo native coronary 
artery lesions in a maximum of two epicardial vessels, with a 
maximum of two lesions per epicardial vessel. 
o 
To evaluate the incidence of angina occurring within 1 year, 
with treatment of Absorb BVS compared to XIENCE. 
Study Design  
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to 
XIENCE), single-blind, multi-center study, registering approximately 
2600 subjects at approximately 140 sites.  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
Primary Endpoint 
TLF through 30-day, tested for non-inferiority of Absorb BVS to 
XIENCE. 
• This analysis will consist of ~2600 subjects in ABSORB IV. 
Powered 
Secondary 
Endpoints  
1. TLF through 1 year, tested for non-inferiority of Absorb BVS to 
XIENCE. 
2. Angina Powered Secondary Endpoint: The percentage of patients 
who experienced angina within 1 year, tested first for non-inferiority of 
Absorb BVS to XIENCE with reflex testing to superiority. 
• Angina is defined as any angina or angina equivalent symptoms 
determined by the physician and/or research coordinator after 
interview of the patient, and as adjudicated by a clinical events 
committee (CEC).   
• This analysis will exclude angina or angina equivalent 
symptoms that occurred following the index procedure through 
hospital discharge or 7 days, whichever occurs first.    
o For subjects who receive a planned staged procedure to 
treat one or more target lesions, the analysis will exclude 
angina or angina equivalent symptoms that occurred 
following the original index procedure through hospital 
discharge or 7 days after the final procedure, whichever 
occurs first. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 158 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
These analysis will consist of ~2600 subjects in ABSORB IV 
Patient Reported 
Outcome (PRO) 
Informational 
Endpoints 
Patient-reported outcomes (PRO) are informational endpoints to assess 
Health-Related Quality of Life. PRO assessments will be conducted at 
baseline, 1 and 6 months, and at 1, 3 and 5 years. The following 
questionnaires will be used in this study:  
• Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-
specific Quality of Life 
• EuroQoL 5D (EQ-5D) survey to assess overall health status  
(Note: PRO endpoints will be evaluated in the ~2600 subjects of 
ABSORB IV) 
The PROs will be analyzed to evaluate the relationship between quality 
of life and cardiovascular events that occurred post-PCI and to 
substantiate the clinical impact of the angina events identified in the 
trial. 
Health Economics 
Informational 
Endpoints 
The primary analysis is to compare the resource utilization and costs 
between the two treatment groups at 1, 2 and 3 years.  If the rates of 
angina, hospitalizations or revascularizations are different between the 
two arms, a cost effectiveness analysis will be performed evaluating the 
cost of angina, hospitalizations or revascularizations avoided.  
Subject 
Enrollment, 
Randomization 
and Registration 
• Subjects are considered enrolled in ABSORB IV after signing 
the Informed Consent. 
• Subjects are considered randomized in ABSORB IV after the 
interactive voice response system (IVRS) has been called and a 
device (Absorb BVS or XIENCE) has been assigned. 
• Subjects are considered registered in the ABSORB IV upon 
randomization. 
• Enrolled subjects not randomized in the trial will be considered 
screen failures and will not be followed.   
Clinical Follow-Up 
All registered subjects in ABSORB IV will receive the following 
clinical follow-up: 
o 30 ± 7 days follow-up telephone contact/office visit 
o 90 ± 14 days follow-up telephone contact/office visit 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 159 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
o 180 ± 28 days follow-up telephone contact/office visit  
o 270 ± 28 days follow-up telephone contact/office visit 
o 1 year ± 28 days follow-up telephone contact/office visit  
o 2 years ± 28 days follow-up telephone contact/office visit 
o 3 years ± 28 days follow-up telephone contact/office visit 
o 4 years ± 28 days follow-up telephone contact/office visit 
o 5 years ± 28 days follow-up telephone contact/office visit  
Patient Reported 
Outcome (PRO) 
Assessments 
All registered subjects of ABSORB IV will receive the following PRO 
assessments: 
o Baseline: SAQ-7, EQ-5D 
o 30 ± 7 days: SAQ-7, EQ-5D 
o 180 ± 28 days: SAQ-7, EQ-5D 
o 1 year ± 28 days: SAQ-7, EQ-5D 
o SAQ-7, EQ-5D will also be administered to all registered 
subjects at 3 and 5 years (± 28 days) visits. 
Primary Analysis 
Sample Size 
Justification 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
Inclusion Criteria 
General Inclusion Criteria 
1. Subject must be at least 18 years of age. 
2. Subject or a legally authorized representative must provide 
written Informed Consent prior to any study related procedure, 
per site requirements. 
3. Subject must have evidence of myocardial ischemia (e.g., silent 
ischemia, stable or unstable angina, non-ST-segment elevation 
MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). 
Patients with stable coronary syndromes can be enrolled any 
time after symptom onset if eligibility criteria are otherwise 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 160 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
met. Patients with acute coronary syndrome can be enrolled 
under the following conditions: 
a. Unstable angina or NSTEMI within 2 weeks of the 
index procedure. 
b. STEMI > 72 hours ≤ 2 weeks prior to the index 
procedure.  
Note: Subjects with UA or NSTEMI or STEMI occurring > 2 
weeks of the index procedure can be included in the trial but 
should be categorized based on their current angina class. 
4. Subjects must be suitable for PCI.  Subjects with stable angina 
or silent ischemia and < 70% diameter stenosis must have 
objective signs of ischemia as determined by one of the 
following: abnormal stress echocardiogram, nuclear scan, ECG, 
PET, MRI, and/or fractional flow reserve (FFR). 
(Note: subject with silent ischemia must have a prior history 
of typical angina, angina-equivalent symptoms, or atypical 
angina within the past year to be included in the trial.) 
5. Subject must be an acceptable candidate for coronary artery 
bypass graft (CABG) surgery. 
6. Female subject of childbearing potential who does not plan 
pregnancy for up to 1 year following the index procedure. For a 
female subject of childbearing potential a pregnancy test must 
be performed with negative results known within 7 days prior to 
the index procedure per site standard. 
7. Female subject is not breast-feeding at the time of the screening 
visit and will not be breast-feeding for at least 1 year following 
the index procedure. 
8. Subject agrees to not participate in any other investigational or 
invasive clinical study for a period of 5 years following the 
index procedure.40 
Angiographic Inclusion Criteria  
Treatment of up to three de novo lesions in a maximum of two 
epicardial vessels, with a maximum of two lesions per epicardial 
 
40 This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies 
that are non-invasive and do not require medication are allowed.  A subject who is taking part in the long-term 
follow-up phase of a trial, who has completed all medications and invasive procedures per protocol requirements, 
may continue to participate in that trial. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 161 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
vessel41. If only a single lesion is to be treated, it must be a target 
lesion. Up to one non-target lesion can be treated. Non-target lesion 
treatment can occur only in a non-target vessel.  
If there are two target lesions within the same epicardial vessel, the two 
target lesions must be at least 15 mm apart per visual estimation; 
otherwise this is considered as a single target lesion for lesion (and 
stent) length determination and must be treated with a single study 
device. 
1. Target lesion(s) must be located in a native coronary artery with 
a visually estimated or quantitatively assessed %DS of  ≥50% 
and < 100%, with a TIMI flow of ≥ 1, and one of the following: 
stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow 
reserve ≤0.80 AND/OR a positive stress test), or presentation 
with an acute coronary syndrome (unstable angina or NSTEMI 
within 2 weeks of index procedure, or STEMI >72 hours but ≤ 2 
weeks prior to the index procedure).  
a. Target lesion(s) must be located in a native coronary artery 
with RVD by visual estimation of   ≥ 2.50 mm and ≤ 3.75 
mm.*  
b. Target lesion(s) must be located in a native coronary artery 
with length by visual estimation of ≤ 24 mm. 
Note: Subjects with UA or NSTEMI or STEMI occurring > 2 
weeks of the index procedure can be included in the trial but 
should be categorized based on their current angina class. 
*Note: To exclude enrollment of excessively small vessels, if  
the operator believes that  based on visual angiographic 
assessments, the distal reference vessel diameter is ≤ 2.75 mm 
such that the plan is to implant a 2.5 mm device (stent or 
scaffold) in a target lesion, it is strongly recommended that 
either on-line QCA or intravascular imaging (ultrasound or 
optical coherence tomography) is used and demonstrates that the 
measured distal RVD for this target lesion is ≥ 2.50 mm (by at 
least one of these imaging modalities). This measurement may 
be performed before or after pre-dilatation, but before 
randomization. If the distal RVD measures <2.5 mm, that lesion 
IS NOT ELIGIBLE for randomization. Such a lesion may be 
treated as a non-target lesion.  
 
 
41 The definition of epicardial vessels means the LAD, LCX and RCA and their branches. 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 162 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Exclusion Criteria 
General Exclusion Criteria 
1. Any surgery requiring general anesthesia or discontinuation of 
aspirin and/or a P2Y12 receptor inhibitor is planned within 12 
months after the procedure. 
2. Subject has known hypersensitivity or contraindication to 
device material and its degradants (everolimus, poly (L-lactide), 
poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, 
nickel, platinum, tungsten, acrylic and fluoro polymers that 
cannot be adequately pre-medicated. Subject has a known 
contrast sensitivity that cannot be adequately pre-medicated. 
3. Subject has known allergic reaction, hypersensitivity or 
contraindication to any of the following: aspirin; or clopidogrel 
and prasugrel and ticagrelor; or heparin and bivalirudin, and 
therefore cannot be adequately treated with study medications. 
4. Subject had an acute STEMI (appropriate clinical syndrome 
with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) 
within 72 hours of the index procedure.  
5. Subject has a cardiac arrhythmia identified at the time of 
screening for which at least one of the following criteria is 
met:42 
a. Subject requires coumadin or any other agent for 
chronic oral anticoagulation.  
b. Subject is likely to become hemodynamically unstable 
due to their arrhythmia. 
c. Subject has poor survival prognosis due to their 
arrhythmia. 
6. Subject has a left ventricular ejection fraction (LVEF) < 30% 
assessed by any quantitative method, including but not limited 
to echocardiography, MRI, multiple-gated acquisition (MUGA) 
scan, contrast left ventriculography, PET scan, etc. LVEF may 
be obtained within 6 months prior to the procedure for subjects 
with stable CAD. For subjects presenting with ACS, LVEF 
must be assessed within 1 week of the index procedure and after 
ACS presentation, which may include contrast left 
ventriculography during the index procedure but prior to 
randomization in order to confirm the subject’s eligibility.   
 
42 Investigator should use discretion when enrolling subjects with high CHADS scores. 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 163 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
7. Subject has undergone prior PCI within the target vessel during 
the last 12 months. Prior PCI within the non-target vessel or any 
peripheral intervention is acceptable if performed anytime >30 
days before the index procedure, or between a minimum of 24 
hours and 30 days before the index procedure if successful and 
uncomplicated.  
8. Subject requires future staged PCI of any lesion other than a 
target lesion identified at the time of index procedure; or subject 
requires future peripheral vascular interventions < 30 days after 
the index procedure. 
9. Subject has received any solid organ transplants or is on a 
waiting list for any solid organ transplants. 
10. At the time of screening, the subject has a malignancy that is not 
in remission.  
11. Subject is receiving immunosuppressant therapy or has known 
immunosuppressive or severe autoimmune disease that requires 
chronic immunosuppressive therapy (e.g., human 
immunodeficiency virus, systemic lupus erythematosus, etc.). 
Note: corticosteroids are not included as immunosuppressant 
therapy. 
12. Subject has previously received or is scheduled to receive 
radiotherapy to a coronary artery (vascular brachytherapy), or 
the chest/mediastinum. 
13. Subject is receiving or will require chronic anticoagulation 
therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban, 
edoxaban or any other related agent for any reason).   
14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 
cells/mm3.  
15. Subject has a documented or suspected hepatic disorder as 
defined as cirrhosis or Child-Pugh ≥ Class B. 
16. Subject has renal insufficiency as defined as an estimated GFR 
< 30 ml/min/1.73m2 or dialysis at the time of screening.43  
17. Subject is high risk of bleeding for any reason; has a history of 
bleeding diathesis or coagulopathy; has had a significant 
 
43 Estimated GFR can be based on Modification of Diet in Renal Disease (MDRD) equation or Cockcroft-Gault 
equation (CCG).  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 164 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
gastrointestinal or significant urinary bleed within the past six 
months. 
18. Subject has had a cerebrovascular accident or transient ischemic 
neurological attack (TIA) within the past six months, or any 
prior intracranial bleed, or any permanent neurologic defect, or 
any known intracranial pathology (e.g. aneurysm, arteriovenous 
malformation, etc.). 
19. Subject has extensive peripheral vascular disease that precludes 
safe 6 French sheath insertion. Note: femoral arterial disease 
does not exclude the patient if radial access may be used. 
20. Subject has a life expectancy <5 years for any non-cardiac or 
cardiac cause. 
21. Subject is in the opinion of the Investigator or designee, unable 
to comply with the requirements of the study protocol or is 
unsuitable for the study for any reason. This includes 
completion of Patient Reported Outcome instruments. 
22. Subject is currently participating in another clinical trial that has 
not yet completed its primary endpoint.44   
23. Subject is part of a vulnerable population who, in the judgment 
of the investigator, is unable to give Informed Consent for 
reasons of incapacity, immaturity, adverse personal 
circumstances or lack of autonomy.  This may include:  
Individuals with a mental disability, persons in nursing homes, 
children, impoverished persons, persons in emergency 
situations, homeless persons, nomads, refugees, and those 
incapable of giving informed consent. Vulnerable populations 
also may include members of a group with a hierarchical 
structure such as university students, subordinate hospital and 
laboratory personnel, employees of the Sponsor, members of the 
armed forces, and persons kept in detention. 
Angiographic Exclusion Criteria 
All exclusion criteria apply to the target lesion(s) or target vessel(s).  
 
44 This includes clinical trials of medications and  invasive procedures. Questionnaire-based studies, or other studies 
that are non-invasive and do not require medication are allowed.  A subject who is taking part in the long-term 
follow-up phase of a trial, who has completed all medications and invasive procedures per protocol requirements, 
may continue to participate in that trial. 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 165 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
1. Unsuccessful pre-dilatation, defined as the presence of one or 
more of the following (note: successful pre-dilatation of at least 
one target lesion is required prior to randomization):  
a. Residual %DS after pre-dilatation is ≥ 40% (per visual 
estimation). Note: achieving a %DS ≤ 20% prior to 
randomization is strongly recommended. 
b. TIMI flow grade <3 (per visual estimation).  
c. Any angiographic complication (e.g. distal embolization, 
side branch closure). 
d. Any dissection NHLBI grade D-F.  
e. Any chest pain lasting > 5 minutes.   
f. Any ST-segment depression or elevation lasting > 5 
minutes. 
2. Lesion is located in left main or there is a ≥30% diameter 
stenosis in the left main (unless the left main lesion is a 
protected left main (i.e. a patent bypass graft to the LAD and/or 
LCX arteries is present), and there is no intention to treat the 
protected left main lesion). 
3. Aorto-ostial RCA lesion (within 3 mm of the ostium). 
4. Lesion located within 3 mm of the origin of the LAD or LCX. 
5. Lesion involving a bifurcation with a:  
a. side branch ≥ 2 mm in diameter, or 
b. side branch with either an ostial or non-ostial lesion with 
diameter stenosis >50%, or 
c. side branch requiring dilatation  
6. Anatomy proximal to or within the lesion that may impair 
delivery of the Absorb BVS or XIENCE stent:  
a. Extreme angulation (≥ 90°) proximal to or within the 
target lesion. 
b. Excessive tortuosity (≥ two 45° angles) proximal to or 
within the target lesion. 
c. Moderate or heavy calcification proximal to or within 
the target lesion. If IVUS used, subject must be excluded 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 166 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
if calcium arc in the vessel prior to the lesion or within 
the lesion is ≥ 180°.   
7. Lesion or vessel involves a myocardial bridge. 
8. Vessel has been previously treated with a stent and the target 
lesion is within 5 mm proximal or distal to a previously stented 
lesion. 
9. Target lesion located within an arterial or saphenous vein graft 
or distal to any arterial or saphenous vein graft. 
 
Lesion Selection 
Prior to treatment with the assigned device (Absorb BVS or XIENCE), 
vessel sizing by visual estimation must be conducted to appropriately 
match the device to the size of the vessel. Quantitative methods such as 
on-line QCA, IVUS or OCT may be used if the site is experienced with 
these techniques. Specifically, use of pre-PCI and post-PCI IVUS or 
OCT is strongly recommended to optimize device sizing and results. 
Details on the vessel sizing methods can be found in the Imaging 
Guidance Document. Table 1.0 provides the device sizes, the reference 
vessel diameter (RVD) and lesion length for ABSORB IV.  
Table 1.0 Absorb BVS and XIENCE Sizes in ABSORB IV 
Device 
Lesion and Device Sizes 
RVD 1 
Lesion Length1 
 
 
 
Absorb BVS 
(Target lesion) 
RVD ≥ 2.50 mm - ≤ 3.75 mm 
 
Scaffold diameter: 2.5, 3.0 and 
3.5 mm 
Lesion length ≤ 24 mm 
Scaffold Length2: 8, 12, 18 and 
28 mm 3    
 
XIENCE4  
(Target lesion) 
 
RVD ≥ 2.50 mm - ≤ 3.75 mm 
 
Stent diameter: 2.5, 2.75, 3.0, 
3.25 3.5, 4.0 mm 
Lesion length ≤ 24 mm 
Stent Length: 8, 12, 15, 18, 23 
and 28 mm 3  
 
1 Reference vessel diameter (RVD) and lesion length are based on visual estimation.  
2 Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 diameter Absorb 
BVS.  Only the 12 mm length will be available for the 3.5 mm diameter. The 
commercially approved CE marked 23mm Absorb BVS device will not be used in 
this study. 
3 For target lesion, planned overlapping is not allowed (i.e. the lesion must be eligible 
for treatment with a single stent). However, bailout overlapping is allowed if required. 
4 XIENCE V, XIENCE Prime, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro, 
and XIENCE ProX will be used in this study. 
It is highly recommended that a minimum of 2 mm (by visual 
estimation) of normal or nearly normal reference vessel at both 
proximal and distal edge be covered by the device. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 167 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Treatment 
Strategy 
• Treatment of up to three de novo lesions in a maximum of two 
epicardial vessels, with a maximum of two lesions per 
epicardial vessel45.  
•  If only a single lesion is to be treated, it must be a target lesion, 
treated with the assigned device (Absorb or XIENCE). 
• Non-target lesion treatment can occur only in a non-target 
vessel.  
• The treatment possibilities are: 
o Single target lesions 
o Two or three target lesions 
o One target lesion and one non-target lesion 
o Two target lesions and one non-target lesion 
• All target lesions must meet angiographic inclusion/exclusion 
criteria. 
• The non-target lesion must be treated first with a XIENCE, 
before randomization, per the instructions for use (IFU). A non-
target lesion cannot be considered for a staged procedure.  The 
patient may then only be randomized if treatment of the non-
target lesion was successful and uncomplicated, defined as: 
 
o  final diameter stenosis ≤ 10% with final TIMI-3 flow,  
o with no residual dissection NHLBI grade ≥ type B, and  
o no transient or sustained angiographic complications 
(e.g., distal embolization, side branch closure),  
o no chest pain lasting > 5 minutes, and  
o no ST segment elevation or depression lasting > 5 
minutes.  
• If there are two target lesions within the same epicardial vessel, 
the two target lesions must be at least 15 mm apart; otherwise 
this should be considered a single target lesion for lesion (and 
stent) length determination and must be treated with a single 
study device.  
 
Access Site and Guide Catheter Size: 
• Either femoral or radial access may be used.  
 
45 The definition of epicardial vessels means the LAD, LCX and RCA and their branches. 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 168 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• A minimum 6F guide catheter or greater must be used during 
the index procedure per requirements for Absorb BVS 
implantation (refer to IFU).  
o Minimum guiding catheter compatibility (inner 
diameter) for Absorb BVS is 0.070”/1.8 mm (6F). 
o Devices (i.e., guide sheaths such as the GuideLiner) that 
decrease the inner diameter of the guide catheter outside 
of the Absorb BVS minimum guide catheter 
compatibility must not be used with the Absorb BVS 
System. Do not insert a 5-in-6, or a 6-in-7 guide sheath 
into a 6F or 7F guiding catheter, respectively, as doing 
so will result in an inner diameter that is too small for 
use with the Absorb BVS. 
o If a guide sheath is necessary, the inner diameter must 
meet or exceed the above minimum guiding catheter 
requirements for Absorb BVS (i.e., only the 7-in-8 
GuideLiner provides an adequate inner diameter (0.071” 
ID), 8F guiding catheter would be required). 
o For XIENCE, please follow IFU for guiding catheter 
size. 
Baseline angiogram and identification of the potential target lesion: 
• Assessment of the potential target lesion(s) to be treated must 
be done to ensure angiographic criteria are met; this must occur 
prior to pre-dilatation and vessel sizing. Refer to the Imaging 
Guidance Document.  
• To exclude enrollment of excessively small vessels, if  the 
operator believes that  based on visual angiographic 
assessments, the distal reference vessel diameter is ≤ 2.75 mm 
such that the plan is to implant a 2.5 mm device (stent or 
scaffold) in a target lesion, it is strongly recommended that 
either on-line QCA or intravascular imaging (ultrasound or 
optical coherence tomography) is used and demonstrates that 
the measured distal RVD for this target lesion is ≥ 2.50 mm (by 
at least one of these imaging modalities). This measurement 
may be performed before or after pre-dilatation, but before 
randomization. If the distal RVD measures <2.5 mm, that lesion 
IS NOT ELIGIBLE for randomization. Such a lesion may be 
treated as a non-target lesion.  
Pre-dilatation of potential target lesion(s) 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 169 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• Pre-dilatation of at least one of the planned target lesions(s) 
must be performed and be successful before calling IVRS. 
However, each target lesion must be pre-dilated before device 
implantation in that lesion.  
• Pre-dilatation must be performed with an angioplasty balloon; 
cutting or scoring balloons may be used per physician 
discretion.  
• The pre-dilatation balloon should be sized 1:1 to the visually 
estimated RVD and should be no more than 0.25 mm smaller 
than RVD. If the pre-dilatation balloon is sized 1:1 a non-
compliant balloon is strongly recommended.  
The pre-dilatation balloon must be equal in length or shorter than 
the planned scaffold/stent length. 
Important: Full balloon expansion with the pre-dilatation balloon 
must be achieved before the patient is randomized into the study. If 
there is any question that the target lesion was not fully dilated or 
that any significant resistance to expansion from the lesion remains, 
the lesion should be re-dilated with a non-compliant balloon (sized 
1:1 to the RVD) at higher pressure. Absorb BVS or XIENCE must 
not be implanted in a lesion in which full balloon expansion has not 
been achieved. 
• The potential target lesion(s) must continue to meet 
angiographic criteria following adequate pre-dilatation, to be 
regarded as “successful pre-dilatation”. 
o RVD remains ≥ 2.50 mm - ≤ 3.75 mm, and length of the 
lesion that will be covered by the device (including any 
edge dissections) is still ≤ 24 mm. 
o Residual %DS is a maximum of < 40% (per visual 
estimation); ≤ 20% is strongly recommended.  
o TIMI Grade 3 flow (per visual estimation).  
o No angiographic complications (e.g. distal embolization, 
side branch closure). 
o No dissections NHLBI grade D-F.  
o No chest pain lasting > 5 minutes.   
o No ST-segment depression or elevation lasting > 5 
minutes. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 170 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• For two or three potential target lesions, the lesion with the 
highest possibility of failing eligibility criteria after pre-
dilatation (per investigator’s assessment) should be identified as 
the 1st target lesion and pre-dilated first before randomization.  
o If the 1st target lesion was successfully pre-dilated and 
eligibility criteria are still met, the operator may at this 
point choose to randomize the patient, or pre-dilate other 
lesions. If other lesions are pre-dilated, all such pre-
dilatations must be considered successful according to 
the above criteria prior to randomization. If there are 
two target lesions in a single epicardial coronary artery, 
it is strongly recommended that both be successful pre-
dilated before the patient is randomized. The IVRS is 
called to randomize the subject. All target lesions must 
be treated with the assigned device.  
o If the 1st target lesion was successfully pre-dilated but 
did not meet vessel sizing criteria, treat as a non-target 
lesion. Once the first lesion is successfully treated as a 
non-target lesion, the second lesion or third lesion must 
meet successful predilatation and vessel sizing criteria. 
Afterwards IVRS must be called and the target lesion(s) 
will be treated per assignment. 
o If pre-dilatation of the 1st target lesion fails (or if pre-
dilatation of any lesion fails if multiple lesions are pre-
dilated prior to randomization), the patient may not be 
randomized, and the interactive voice response system 
(IVRS) must not be called. The lesion will be treated 
with XIENCE or standard of care. 
o If the 1st target lesion was successfully pre-dilated but no 
longer met eligibility criteria (or if any lesion after pre-
dilatation no longer met eligibility criteria if multiple 
lesions are pre-dilated prior to randomization), the 
patient may not be randomized, and the interactive voice 
response system (IVRS) must not be called. 
o If after successful pre-dilatation, randomization and 
treatment of the 1st target lesion with the assigned 
device, and pre-dilatation of the 2nd or 3rd target lesion 
failed, the patient is to be treated with XIENCE. For any 
lesion in which pre-dilatation did not meet the success 
definition, the default device is XIENCE. 
• Each target vessel and lesion should also be such that the 
operator believes either the Absorb BVS or XIENCE devices 
could be delivered to and cross the target lesion after pre-

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 171 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
dilatation (e.g. absence of excessive vessel or lesion tortuosity 
or calcification).  
Vessel Sizing 
• Following the use of nitroglycerine (at least 100 µg 
intracoronary nitroglycerine, >150 µg preferred)46 and 
successful pre-dilatation of the potential target lesion(s), vessel 
sizing must be conducted by visual estimation. If nitroglycerine 
is not available, intravenous nitroprusside or intravenous 
calcium channel blocker may be used per physician discretion. 
• Quantitative methods such as on-line QCA, IVUS or OCT may 
be used if the site is experienced with these techniques, taking 
into account that QCA tends to under-estimate RVD compared 
to visual estimation and OCT, whereas IVUS tends to over-
estimate lumen RVD compared to visual estimation and OCT. 
Specifically, use of pre-PCI and post-PCI IVUS or OCT is 
strongly recommended to optimize device sizing and results. 
Follow core laboratory guidelines for the use of each modality. 
• Prior to randomization, IVUS or OCT can be used to evaluate 
the vessel if there is question regarding the eligibility of the 
vessel either before or after pre-dilatation. Specifically, to 
exclude enrollment of excessively small vessels, if  the operator 
believes that  based on visual angiographic assessments, the 
distal reference vessel diameter is ≤ 2.75 mm such that the plan 
is to implant a 2.5 mm device (stent or scaffold) in a target 
lesion, it is strongly recommended that either on-line QCA or 
intravascular imaging (ultrasound or optical coherence 
tomography) is used and demonstrates that the measured distal 
RVD for this target lesion is ≥ 2.50 mm (by at least one of these 
imaging modalities). This measurement may be performed 
before or after pre-dilatation, but before randomization. If the 
distal RVD measures <2.5 mm, that lesion IS NOT ELIGIBLE 
for randomization. Such a lesion may be treated as a non-target 
lesion. A subject must not be randomized in ABSORB IV if: 
o Vessel size or lesion length before or after pre-dilatation 
does not satisfy eligibility criteria. 
o Moderate or heavy calcification, tortuosity or other 
conditions are present proximal or within the target 
 
46 If the patient’s blood pressure is so low that ≥ 100 ug of nitroglycerine cannot be administered, the patient should 
not be randomized. It is suggested that ≥200 µg of nitroglycerine be administered if the systolic blood pressure is 
>140 mmHg. Timing of nitroglycerine administration and pre-dilatation is per physician discretion, but must be 
before randomization and assessment of scaffold or stent size. 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 172 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
segment, reducing the likelihood that the Absorb BVS or 
XIENCE can be either delivered to or expanded at the 
lesion. 
o Complications and/or adverse events were identified 
during IVUS or OCT usage (e.g. vessel dissection 
NHLBI grade D-F).47   
• Table 2.0 provides the guidance of vessel and device sizing 
during the procedure, which are detailed as the following: 
o First, assess RVD based on visual estimation 
o Then, select a pre-dilatation balloon sized 1:1 to RVD or 
0.25 mm smaller than RVD. For example, for RVD of 
2.5 mm, a pre-dilatation balloon of 2.25 or 2.5 mm 
should be used. 
o Use the size of the inflated pre-dilatation balloon, as 
well as the results after pre-dilatation, to reassess the 
RVD for appropriate vessel sizing for the scaffold or 
stent. If the reassessed RVD after pre-dilatation exceeds 
the specified range for a specific BVS size, the next 
available size Absorb BVS can be used. For example, if 
the RVD is reassessed as 2.8 mm after pre-dilatation of a 
vessel that was believed to be 2.5 mm before pre-
dilatation, then implant a 3.0 mm BVS. 
o Post-dilatation of the scaffold is strongly recommended 
for all Absorb treated lesions, especially for any 
implanted 2.5 mm ABSORB scaffolds.  
o For patients randomized to XIENCE, the decision to 
post-dilate should be made according to standard 
practice. 
o Post-dilatation must always be performed with a non-
compliant balloon, sized 1:1 to the vessel, using at least 
16 atm of pressure.. Always make sure the non-
compliant post-dilatation balloon has a length short 
enough so it is inflated within the scaffold margins to 
avoid edge dissection. The delivery balloon should not 
be used for post-dilatation. 
Table 2.0 
Vessel and Device Sizing 
 
47 Examples of complications associated with IVUS or OCT: side-branch occlusion, persistent S-T abnormalities, 
prolonged chest pain, flow limiting dissections etc. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 173 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Closest RVD 
by Visual 
Estimation 
Pre-dilatation 
Balloon Diameter 
Reassessed 
Closest RVD 
after Pre-
dilatation 
Absorb BVS 
Diameter 
2.5 mm 
2.25 or 2.5 mm 
2.5 mm 
2.5 mm 
2.75 mm 
2.5 – 2.75 mm 
2.75 mm 
3.0 mm 
3.0 mm 
2.75 – 3.0 mm 
3.0 mm 
3.0 mm 
3.25 mm 
3.0 – 3.25 mm 
3.25 mm 
3.5 mm 
3.5 mm 
3.25 – 3.5 mm 
3.5 mm 
3.5 mm 
3.75 mm 
3.5 – 3.75 mm 
3.75 mm 
3.5 mm 
 
Randomization 
• Upon completion of successful pre-dilatation and vessel sizing 
of the first target lesion (or of multiple target lesions, at operator 
discretion as described above), the interactive voice response 
system (IVRS) can be called. 
• A subject is considered registered and in the ITT population at 
the time of randomization.  
Lesion Treatment 
• It is highly recommended that the length of the Absorb BVS 
and XIENCE stent be selected to allow at least 2 mm of normal 
or nearly normal reference vessel at each edge. 
• If the Absorb BVS cannot reach or cross the lesion or additional 
lesion preparation is required, the Absorb BVS must be 
removed and a new Absorb BVS must be introduced after 
subsequent pre-dilatation(s) with the same sized or larger non-
compliant balloon at higher pressure. Note: the Absorb BVS 
should not be “Dottered” across the lesion if it does not cross 
easily. 
• If the Absorb BVS is unable to reach or cross the target lesion 
after multiple attempts (maximum of two Absorb BVS; 
including additional lesion preparation), a XIENCE stent must 
be used.  
• If XIENCE is unable to reach or cross the target lesion after 
multiple attempts (including additional lesion preparation), the 
investigator should treat the lesion per standard of care. 
• In the case of two or three target lesions assigned to the Absorb 
BVS, if any of the target lesions is unsuccessfully treated with 
Absorb BVS, XIENCE must be used for that lesion. If the target 
lesion that failed treatment of Absorb BVS is treated 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 174 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
successfully with XIENCE, the remaining target lesion(s) must 
be treated with Absorb BVS.  
• In the case of two or three target lesions assigned to XIENCE, if 
any of the target lesions is unsuccessfully treated with XIENCE, 
the investigator should treat the lesion per standard of care. If 
the target lesion that failed treatment with XIENCE is treated 
successfully with standard of care, the remaining target lesion(s) 
must be treated with XIENCE. 
• For patients in whom 2 or 3 target lesions will be treated, a 
maximum of one staged procedure is allowed. The decision to 
stage may be made prior to the first intervention, or 
immediately after the first intervention (depending on the 
complexity, contrast and radiation use of the first procedure). If 
a staged procedure becomes necessary, it is strongly 
recommended that the staged procedure occurs within 2 weeks 
of the index procedure, but in all cases no more than 35 days 
from the index procedure. The assigned device must be used for 
staged procedures. To avoid having to cross a previously 
implanted study device, it is strongly recommended that the 
staged lesion(s) be located in a separate epicardial vessel from 
the lesion(s) previously treated during the first intervention. 
• Successful lesion treatment is defined as final diameter stenosis 
≤ 30% with final TIMI-3 flow, with no residual dissection 
NHLBI grade ≥ type B, and no transient or sustained 
angiographic complications (e.g. distal embolization, side 
branch closure), no chest pain lasting > 5 minutes, and no ST 
segment elevation or depression lasting > 5 minutes.   
• For Absorb BVS, the scaffold should be deployed slowly, by 
pressurizing the delivery system in 2 atm increments each over 
5 seconds, until the scaffold is completely expanded. Pressure 
should be maintained for 30 seconds if tolerated by the patient. 
• For the Absorb BVS and XIENCE delivery balloon, do not 
exceed the rated burst pressure (RBP) per the IFU for the 
individual device. 
• Post-dilatation of target lesion treated with XIENCE should be 
per standard of care. 
• Post-dilatation of the scaffold is strongly recommended for all 
Absorb treated lesions, especially for any implanted 2.5 mm 
ABSORB scaffolds.  If post-dilatation of the target lesion 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 175 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
treated with Absorb BVS is performed the following guidance 
is given: 
o If a stent or scaffold cannot be re-crossed easily, 
excessive force with the balloon dilatation catheter or 
imaging catheter should be avoided. If it is necessary to 
re-cross the device, options to consider include changing 
the guide catheter orientation to reduce wire bias; 
consider use of a different wire or a wiggle wire or a 
buddy wire; attempt to cross the device with a balloon at 
0 atm (rather than negative pressure); or inflate and 
deflate the balloon to wing it to help centralize the tip. 
o A low profile, high pressure, non-compliant, balloon 
dilatation catheter that has not been previously inflated 
must be used. 
o Post-dilatation must always be performed with a non-
compliant balloon, sized 1:1 to the vessel, using at least 
16 atm of pressure. 
o The post-dilatation balloon length should be selected 
such that the balloon stays within the margins of the 
scaffold so as to avoid an edge dissection. 
o The expanded diameter of the post dilatation balloon 
must be within the allowable expansion limits of the 
scaffold. Do not dilate the Absorb BVS beyond the 
dilatation limit which is 0.5 mm above the nominal 
diameter. Doing so may result in scaffold damage. Thus, 
it is highly recommended that the compliance chart of 
the non-compliant balloon selected be carefully 
reviewed prior to dilatation and an appropriate 
maximum pressure used to ensure that the scaffold is not 
over-dilated. 
Table 3.0 
Scaffold Diameter and Maximum Diameter Limit  
Nominal Scaffold 
Diameter 
Post Dilatation Maximum 
Diameter Limit 
2.5 mm 
3.0 mm 
3.0 mm 
3.5 mm 
3.5 mm 
4.0 mm 
o The delivery balloon cannot be removed from the body 
and reinserted and used for post-dilatation. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 176 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• During randomization, if a bailout device is required for a target 
lesion (e.g., for edge dissection), the same device as the 
implanted device must be used. 
o Absorb BVS if target lesion is treated with Absorb BVS. 
o XIENCE if target lesion is treated with XIENCE.  
o If a bailout with an Absorb BVS device cannot be 
delivered to the site of the lesion, the device should be 
carefully withdrawn and a XIENCE used. 
o If an appropriate size Absorb BVS is not available 
XIENCE can be used. 
• Overlap of the bailout stent/scaffold with the implanted 
stent/scaffold should be 1-2 mm; gaps should be avoided.  
• IVUS or OCT guidance may be used as per standard of care in 
all patients.  
• Please refer to the physician training deck for user guidance in 
handling procedural issues (e.g., difficulty in re-crossing an 
implanted scaffold for purposes such as intravascular imaging 
or post-dilatation if needed). 
• Unplanned Lesions 
o In cases where treatment of a target lesion reveals 
unexpected additional lesion(s), the investigator may 
treat the lesion(s). This is considered an unplanned 
lesion. 
o If the lesion meets enrollment criteria both before and 
after pre-dilatation, the lesion must be treated with the 
assigned device. This lesion will be considered to be an 
unplanned target lesion. 
o If the lesion does not meet the enrollment criteria (either 
before or after pre-dilatation), the lesion must be treated 
with XIENCE. This lesion will be considered to be an 
unplanned non-target lesion. 
o Planned treatment of more than two lesions per 
epicardial vessel or planned treatment of more than three 
lesions per subject is not allowed. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 177 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Antiplatelet48 
Therapy 
Antiplatelet Medication Loading Dose: 
• Aspirin: Subjects must receive a loading dose of ≥ 300 mg of 
aspirin within 24 hours before the procedure, regardless of whether 
the patient was previously taking aspirin. For patients undergoing 
staged procedure who have not been discharged and have been 
prescribed daily aspirin while in hospital, no aspirin reloading is 
required.  
• P2Y12 receptor inhibitors: either clopidogrel, prasugrel or 
ticagrelor may be used as per standard of care and per label 
indications.  
o Clopidogrel: a peri-procedural loading dose 600 mg is 
required 
o Prasugrel: a peri-procedural loading dose of 60 mg is 
required 
o Ticagrelor: a peri-procedural loading dose of 180 mg is 
required.  
• For patients with stable coronary symptoms, silent ischemia, or 
acute coronary syndromes in whom all measured troponin and CK-
MB values were within normal limits, pre-loading with clopidogrel 
between 3 and 24 hours prior to the procedure or prasugrel or 
ticagrelor between 1-24 hours prior to the index procedure is 
strongly recommended.  If the above loading time periods are not 
possible, a P2Y12 inhibitor  must be administered in all patients no 
later than 1 hour after the procedure. If the subject receives less 
than the required amount of the loading dose for a P2Y12 receptor 
inhibitor, the investigator is to give the remaining amount of the 
same agent in the next 24 hours and within the protocol required 
timeframe. 
Note: The biomarker measurements in patients with stable coronary 
symptoms and silent ischemia may be pending at the time of the 
procedure, or may be drawn from the arterial sheath prior to first 
balloon inflation; such patients may still be randomized, and a 
P2Y12 receptor inhibitor must be administered no later than 1 hour 
after the procedure.  
For patients with acute coronary syndromes in whom any troponin 
or CK-MB value at any time prior to the index hospitalization was 
elevated, one of two options must be given a) a loading dose of  
 
48  ABSORB IV will allow the use of FDA approved P2Y12 inhibitors. Loading and maintenance dosages of all 
P2Y12 inhibitors should follow respective prescribing information. If outside the US, country specific approvals are 
allowed. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 178 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
clopidogrel between 3 and 24 hours prior to the index procedure or 
prasugrel or ticagrelor between 1-24 hours prior to the index 
procedure OR b) an intravenous GP IIb/IIIa inhibitor or cangrelor 
(see below) prior to and/or during PCI but prior to first balloon 
inflation, per institution standard of care.. If an intravenous GP 
IIb/IIIa inhibitor is given, a P2Y12 receptor inhibitor must be given 
within 1 hour following the index procedure. If intravenous 
cangrelor is used, the timing of the first administration of the 
P2Y12 receptor inhibitor should be as follows: clopidogrel or 
prasugrel are administered at the time of discontinuation of the 
cangrelor infusion; ticagrelor may be administered before, during, 
or immediately upon discontinuation of the cangrelor infusion. 
Ticagrelor is the preferred P2Y12 receptor inhibitor in cangrelor-
treated patients. Cangrelor should be maintained 2-4 hours post 
procedure according to product labeling. Note: If the subject 
receives less than the required amount of the loading dose for a 
P2Y12 receptor inhibitor, the investigator is to give the remaining 
amount of the same agent in the next 24 hours and within the 
protocol required timeframe.  
• The protocol required loading dose may be omitted in a) stable 
CAD or ACS patients maintained on chronic P2Y12 receptor 
inhibitor for ≥ 7 days, and b) patients who received a P2Y12 
receptor inhibitor loading dose 1-7 days prior to the procedure and 
who have been maintained on a daily dose since. However, it is 
strongly recommended that stable patients on chronic clopidogrel 
are reloaded with a P2Y12 receptor inhibitor. For ACS patients on 
chronic clopidogrel, they must be reloaded with a P2Y12 receptor 
inhibitor if they did not already receive a loading dose of 
clopidogrel, prasugrel, or ticagrelor in the 24 hours prior to the 
procedure 
• Ticlopidine may be used as a substitute at a dose in accordance with 
standard hospital practice only if the subject develops 
hypersensitivity or intolerance to clopidogrel, prasugrel, or 
ticagrelor during the trial.  
• Refer to respective prescribing information for P2Y12 receptor 
inhibitor for further details regarding loading practice.  
• Cangrelor may be used pre-PCI at operator discretion as per local 
practice in any patient (but should be used similarly in patients 
randomized to ABSORB and XIENCE): a pre-PCI loading dose of 
30 μg/kg IV followed by an IV infusion of 4 μg/kg for at least 2 
hours and for a maximum of 4 hours may be used, in conjunction 
with an oral P2Y12 inhibitor. If ticagrelor is selected, the ticagrelor 
loading dose may be given before, during or immediately upon 
discontinuation of the cangrelor infusion. If clopidogrel or prasugrel 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 179 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
are selected, a clopidogrel or prasugrel loading dose should be 
given immediately upon discontinuation of the cangrelor infusion, 
even if a loading dose was given earlier. 
Antiplatelet Medication Post-Procedure Daily Dose: 
• All subjects must be maintained at a minimum of 75 mg of 
clopidogrel daily or 5 or 10  mg of prasugrel daily (10 mg preferred 
in most patients*) or 90 mg twice daily of ticagrelor for a minimum 
of 12 months following the procedure. 
• All subjects must receive ≥75 to ≤100 mg of aspirin daily through 5 
years follow-up during the study and should continue to take aspirin 
indefinitely.  
*For prasugrel subjects < 60 kg in weight or ≥ 75 years of age a 
maintenance dose of 5 mg per day for 12 months is recommended. 
Patients with prior stroke or TIA should receive clopidogrel or 
ticagrelor, and cannot be administered prasugrel. 
Refer to respective prescribing information for P2Y12 receptor 
inhibitor for further details regarding maintenance dose. 
For subjects having staged procedures, the protocol-required pre-
procedure and post-procedure antiplatelet regimens must be 
repeated for the staged procedure in the same manner as done for 
the original index procedure. 
Cardiac 
Biomarker 
Collection 
Between Baseline and Discharge 
• All patients admitted with the diagnosis of possible acute coronary 
syndrome (including unstable angina, NSTEMI or STEMI) must 
have at least one and preferably 2 or more complete sets of cardiac 
biomarkers (a set consisting of troponin (I or T), CK and CK-MB)  
measured within 24 hours before the index procedure. 
Measurements should be at least 6 hours apart if multiple 
measurements are taken. Patients with stable coronary artery 
disease or silent ischemia must have a single set of cardiac 
biomarkers drawn. 
o If the patient has stable coronary artery disease or silent 
ischemia, the pre-procedure CK and CK-MB may be obtained 
during the procedure from the arterial sheath but prior to any 
angioplasty. The angioplasty may then proceed before the 
results are known. 
o To assist in determination of peri-procedural MI, all patients 
with an acute coronary syndrome (including unstable angina, 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 180 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
NSTEMI or STEMI) must have troponin and CK and CK-MB 
drawn from the arterial sheath prior to first balloon inflation.  
o First post-procedure CK and CK-MB draw at 6 to 12 hours 
post-procedure.  
o Second post-procedure CK and CK-MB draw at 18-24 hours 
post-procedure, or at the time of discharge as long as discharge 
is at or after 16 hours post-procedure.* 
o If either of the post-procedure CK-MB levels are ≥ 5x ULN, 
serial CK and CK-MB levels must be drawn until they are 
falling. 
o A 12 lead ECG must be obtained at baseline and within 24 
hours post procedure 
* For patients discharged prior to 16 hours, the subject will have to 
return to the enrolling institution for their second biomarker draw (or a 
visiting nurse may be sent to the patient’s home to collect the blood 
sample).  
CK and CK-MB levels are required at each time point. Troponins are 
required pre-procedure and from the arterial sheath prior to first balloon 
inflation during the procedure in patients with acute coronary 
syndromes. All troponin, CK and CK-MB levels collected at any time 
points pre-procedure, during the procedure and post-procedure, should 
be documented in the electronic case report forms.   
For subjects having staged procedures, the protocol required pre-
procedure and post-procedure cardiac enzyme and 12-lead ECG 
assessments must be repeated for the staged procedure in the same 
manner as done for the original index procedure. 
Primary 
Analytical 
Population 
The primary analysis population will be the ITT population. 
 
Note: Protocol 10-392 Part 1 (ABSORB III) compliance statement also applies to Part 2 
(ABSORB IV). 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 181 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
1. 
INTRODUCTION 
The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the 
safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular 
Absorb™ Bioresorbable Vascular Scaffold (BVS) System49 , and the Absorb GT1™ BVS 
System, as compared to the commercially approved, control stent XIENCE. In the subsequent 
sections of this protocol, the term “Absorb BVS” will be used to represent both Absorb™ BVS 
and Absorb GT1™ BVS. 
ABSORB IV is a prospective, randomized (1:1 Absorb BVS to XIENCE), single-blind, multi-
center trial, registering approximately 2600 subjects from approximately 140 sites50 in the 
United States and outside the United States. The primary objective of ABSORB IV is to evaluate 
30-day and long-term clinical outcomes of the Absorb BVS compared to XIENCE in the 
treatment of subjects with ischemic heart disease caused by up to three de novo native coronary 
artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per 
epicardial vessel. The primary endpoint data of TLF through 30-day, tested for non-inferiority of 
Absorb BVS to XIENCE, will be tested on the ~2600 ABSORB IV subjects. The secondary 
objectives of ABSORB IV will be to evaluate TLF at 1-year and the incidence of angina 
occurring within 1 year, with treatment of Absorb BVS compared to XIENCE.  The ABSORB 
IV protocol trial will compare patient reported outcomes, resource utilizations and costs between 
the Absorb BVS and XIENCE arms. These analyses will be based on all ~2600 subjects of 
ABSORB IV. The original design of the ABSORB IV trial also included an imaging ischemia 
sub-study aimed at providing the physiological and mechanistic evaluation of whether PCI 
treatment with Absorb BVS compared to XIENCE results in differences in myocardial ischemia 
in the early post-procedural period, and at 14 months and 62 months. However, this sub-study 
had to be stopped due to very slow enrollment (see Section 12 for more details). 
The enrollment/registration of ~2600 subjects in ABSORB IV will start after the completion of 
the enrollment/registration of 2000 primary analysis subjects in ABSORB III. All subjects in 
ABSORB IV will receive treatment of up to three de novo native coronary artery lesions in a 
maximum of two epicardial vessels, with a maximum two lesions in the same epicardial vessels 
with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm. All subjects will be screened per 
the protocol inclusion and exclusion criteria and all registered subjects will have clinical follow-
up at 30, 90, 180, 270 days and 1, 2, 3, 4, and 5 years. In addition, all ~2600 subjects in 
ABSORB IV will complete patient-reported outcome self-administered questionnaires at 
baseline, 30, 180 days, and at 1 year. Additional PRO assessments may be conducted at 1, 3 and 
5 years.  
 
49 The Absorb™ Bioresorbable Vascular Scaffold (BVS) System is the trade name for this product. During the 
course of development, multiple product names were used to describe this product including, Bioresorbable 
Vascular Scaffold (BVS) System, Bioabsorbable Vascular Stent, BVS Everolimus Eluting Coronary Stent System 
(EECSS), Abbott Vascular Bioabsorbable Device (AVBD) EECSS, BVS Cohort A (used in the ABSORB Cohort A 
trial) and BVS Cohort B (used in the ABSORB Cohort B trial). 
50 Majority sites in ABSORB IV also are participating sites in ABSORB III.  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 182 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
2. 
BACKGROUND INFORMATION 
2.1.1 Name of the Investigational Device 
The investigational device to be used in this trial is the Absorb BVS System51 and the Absorb 
GT1™ BVS System once it is commercially available. In this protocol, the investigational 
scaffold or test device is referred to as “the Absorb BVS”. The Absorb BVS System is 
manufactured by Abbott Cardiovascular Systems, Inc., California, an affiliate of Abbott 
Vascular, Inc. 
2.1.2 Intended Indication 
The Absorb Bioresorbable Vascular Scaffold (BVS) is a temporary scaffold that will fully resorb 
over time and is indicated for improving coronary luminal diameter in patients, including those 
with diabetes mellitus and acute coronary syndromes, with ischemic heart disease due to de novo 
native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm 
and ≤ 3.75 mm. 
2.1.3 Background Information 
Please refer to section 2.1.3 to 2.1.8 of ABSORB III Protocol (
 
, August 16, 2018) 
for the detailed background information of the investigational device Absorb BVS, the control 
device XIENCE V, as well as the summary of pre-clinical and clinical studies.   
2.1.4 Absorb GT1 
 
Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB 
IV trial. The Absorb GT1 BVS System is composed of the following components: 
• A bioresorbable poly(L-lactide) (PLLA) scaffold backbone 
• A coating comprised of the active pharmaceutical ingredient everolimus and 
bioresorbable poly(D,L-lactide) (PDLLA) 
• Four platinum marker beads, two each embedded at the proximal and distal ends of the 
scaffold for radiopacity 
• An optimized delivery system (ODS) that leverages technology advancements of the 
XIENCE family of products, and incorporates design features from the Absorb BVS, 
XIENCE Xpedition®, and XIENCE Alpine delivery systems 
   
The Absorb GT1 sizes are detailed in the table below. 
 
 
51 The commercially approved CE marked device will be used in geographies where it is commercially available. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 183 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Table 2.1: Absorb GT1 BVS System Size Matrix 
 
Scaffold 
Design 
Product 
Diameter 
(mm) 
Product Length (mm) 
8 
12 
18 
23* 
28 
Small 
2.5 
X 
X 
X 
X 
X 
3.0 
X 
X 
X 
X 
X 
Medium 
3.5 
N/A 
X 
X 
X 
X 
* The commercially approved 23mm Absorb BVS GT1 device will not be used in ABSORB IV. 
 
2.2 
Trial Rationale  
The Absorb BVS has been evaluated and continues to be evaluated in the ABSORB Family of 
Trials which includes ABSORB Cohort A and Cohort B, ABSORB EXTEND, ABSORB II and 
the ABSORB III Pivotal US trial. Retrospective comparison of Absorb BVS to XIENCE has 
demonstrated comparable TLF rates through 2 and 3 years (EXTEND 2-year TLF52: 6.2% vs. 
8.2%; Cohort B 3-year TLF53: 9.9% vs. 11.4%).  The potential long-term clinical benefit of 
Absorb BVS compared to metallic drug eluting stents has not been prospectively evaluated in 
randomized subject population.  
Recurring angina has been associated with lifestyle limitations and worse self-reported quality of 
life, making the relief of symptoms one of the primary reasons for performing PCI54. However, 
despite symptom relief with stenting, post-PCI angina recurrence is a clinically relevant burden 
that impacts patient’s quality of life. Recent retrospective descriptive comparison of Absorb BVS 
to XIENCE has shown preliminary evidence that Absorb BVS may be associated with lower rate 
of angina compared to XIENCE at 1 year (16% vs. 27.9%)55.  As Absorb BVS is a novel 
technology it will be important to evaluate the potential to reduce the recurrence of angina post 
PCI compared to existing DES technologies. The ABSORB IV trial will further evaluate the 
differences between Absorb BVS and XIENCE in the percentage of patients with angina after 
the stenting procedure, as determined by physician and/or research coordinator after interview of  
the patient, and as adjudicated by a clinical events committee (CEC). 
3. 
TRIAL OBJECTIVE 
ABSORB IV Primary Objective:  
 
52 Whitbourn RJ. ABSORB EXTEND: An interim report on the 24-month clinical outcomes from the first 240 
patients enrolled. TCT 2013. 
53 Serruys PW, Onuma Y, Garcia-Garcia H. First report of the three year clinical and multi-modality imaging results 
of the ABSORB trial evaluating the Absorb everolimus eluting bioresorbable vascular scaffold in the treatment of 
patients with De Novo native coronary artery lesions. ACC 2013. 
54 Holubkov R, Laskey WK, Haviland A, et al. Angina 1 year after percutaneous coronary intervention: a report 
from the NHLBI Dynamic Registry. Am Heart J. Nov 2002;144(5):826-833 
55 Stone GW. Demonstration of Clinical Superiority with a Bioresorbable Vascular Scaffold: The ABSORB IV 
Clinical Trial. http://www.tctmd.com/show.aspx?id=120552 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 184 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the 
treatment of subjects with ischemic heart disease caused by up to three de novo native 
coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two  
lesions per epicardial 
• To evaluate long-term clinical outcomes of the Absorb BVS compared to XIENCE in the 
treatment of subjects with ischemic heart disease caused by up to three de novo native 
coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two 
lesions per epicardial vessel.  
ABSORB IV Secondary Objectives:  
• To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the 
treatment of subjects with ischemic heart disease caused by up to three de novo native 
coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two  
lesions per epicardial 
• To evaluate the incidence of angina occurring within 1 year with treatment of Absorb BVS 
compared to XIENCE. 
4. 
CLINICAL TRIAL/INVESTIGATION FLOW AND 
FOLLOW-UP SCHEDULE 
4.1 
Number of Subjects to be Registered 
Approximately 2600 subjects will be registered in ABSORB IV from approximately 140 sites in 
the United States and outside the United States. The enrollment/registration of ABSORB IV will 
start after the completion of enrollment/registration of the 2000 primary analysis subjects of 
ABSORB III.  
4.2 
ABSORB Physician Training 
Investigators that have not participated in previous ABSORB trials or are not commercial users 
of the Absorb BVS device will participate in the ABSORB IV physician training program. 
Please refer to section 4.2 of ABSORB III Protocol (
 
, August 09, 2018) for the 
detailed information on the didactic training.  
4.3 
ABSORB IV Treatment Flow and Lesion Selection 
A maximum of three de novo native coronary artery lesions will be treated in a maximum of two 
epicardial vessels, with a maximum of two lesions per epicardial vessel. If there are two target 
lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart. 
One planned non-target lesion is allowed in ABSORB IV treated with a XIENCE per the IFU. 
However, in situations where treatment of a target lesion reveals additional lesion(s), the 
investigator may treat the lesion(s). This is considered an unplanned lesion. If the lesion meets 
enrollment criteria both before and after pre-dilatation, the lesion must be treated with the 
assigned device and will be considered to be an unplanned target lesion. If the lesion does not 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 186 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
recommended to optimize device sizing results. Details on the vessel sizing methods can be 
found in Imaging Guidance Document.  
To exclude enrollment of excessively small vessels, if  the operator believes that  based on visual 
angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is 
to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that 
either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is 
used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at 
least one of these imaging modalities). This measurement may be performed before or after pre-
dilatation, but before randomization. If the distal RVD measures <2.5 mm, that lesion IS NOT 
ELIGIBLE for randomization. Such a lesion may be treated as a non-target lesion.  Table 4.1 
provides the device sizes, RVD and lesion length for ABSORB IV. 
Table 4.1 
 Absorb BVS and XIENCE Sizes  
Device 
Lesion and Device Sizes 
RVD 1 
Lesion Length1 
Absorb BVS 
(Target lesion) 
RVD ≥ 2.50 mm - ≤ 3.75 mm 
Scaffold diameter: 2.5, 3.0 and 3.5 mm 
Lesion length ≤ 24 mm 
Scaffold Length2: 8, 12, 18 and 28 mm 3    
XIENCE4  
(Target lesion) 
 
RVD ≥ 2.50 mm - ≤ 3.75 mm 
Stent diameter: 2.5, 2.75, 3.0, 3.25 3.5, 
4.0 mm 
Lesion length ≤ 24 mm 
Stent Length: 8, 12, 15, 18, 23 and 28 mm 3  
 
1 Reference vessel diameter (RVD) and lesion length based on visual estimation  
2 Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 diameter Absorb BVS. Only the 12 mm length 
will be available for the 3.5 mm diameter.  
3 For target lesion, planned overlapping is not allowed (i.e., the lesion must be eligible for treatment with a single 
stent). However, bailout overlapping is allowed if required. 
4 XIENCE V, XIENCE Prime, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro, and XIENCE ProX will be used 
in this study. 
The commercially approved CE marked 23mm Absorb BVS device will not be used in this 
study. 
It is highly recommended a minimum of 2 mm (by visual estimation) of minimally diseased 
tissue be covered by the device at both the proximal and distal edges.  
Planned overlap of the target lesion is not allowed. Overlap in the case of bailout is allowed. 
Please refer to Section 7.3.5 for details regarding bailout. 
4.4 
Measures Taken to Avoid and Minimize Bias 
In ABSORB IV there will be several measures taken to avoid and minimize bias such as 
randomization and blinding. This process is detailed in the following sections. 
4.4.1 Randomization 
Stratified Randomization: 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 187 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
Timing of Randomization: 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 f 
   
 
  
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
  
 
 
 
 
  
 
 
 
 
   
 
 
 
 
 
 
 
 
 
  
  
 
  
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
  
 
  
 
  
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
  
 
 
 
 
  
 
 
  
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
  
 
 
  
 
 
 
  
 
 
  
 
 
 
 
  
 
  
  
 
 
  
 
 
 
 
 
 
 
 
 
 
4.4.2 Blinding 
   
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
  
 
  
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 188 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
  
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
4.5 
Early Termination of the Clinical Trial 
Please refer to section 4.6 of ABSORB III Protocol (
 
, August 09, 2018) for the 
relevant information about trial early termination. 
5. 
ENDPOINTS 
5.1 
Primary Endpoints 
TLF through 30-day, tested for non-inferiority against the control  
• This analysis will consist of ~2600 subjects in ABSORB IV. 
• TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-
defined MI definition, Appendix II) attributable to Target Vessel (TV-MI), or 
Ischemia-Driven Target Lesion Revascularization (ID-TLR). 
5.2 
ABSORB IV Major Secondary Endpoint 
• TLF through 1-year, tested for non-inferiority against the control  
• ABSORB IV Angina Powered Secondary Endpoint: The percentage of patients who 
experienced angina within 1 year, tested first for non-inferiority with reflex to superiority 
against the control. 
• Angina is defined as any angina or angina equivalent symptoms determined by the 
physician and/or research coordinator after interview of the patient, and as 
adjudicated by a clinical events committee (CEC). 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 189 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• This analysis will exclude angina or angina equivalent symptoms that occurred 
following the index procedure through hospital discharge or 7 days, whichever occurs 
first. 
• This analysis will consist of ~2600 subjects in ABSORB IV. 
 
5.3 
Additional Secondary Endpoint(s) 
In ABSORB IV the following clinical secondary endpoints will be analyzed for all the ~2600 
subjects.  
• Acute Success: (Combined Clinical/Angiographic Endpoint)  
o Device success (Lesion level analysis) 
o Procedural success (Subject level analysis) 
• Clinical Endpoint in hospital and at each follow-up point (30, 90, 180, 270 days; 1, 2, 3, 
4, 5 years). 
o Component 
 Death (Cardiac, Vascular, Non-cardiovascular) 
 Myocardial Infarction 
- Attributable to target vessel (TV-MI) 
- Not attributable to target vessel (NTV-MI) 
 Target Lesion Revascularization (TLR) 
- Ischemia driven TLR (ID-TLR)  
- Non ID TLR (NID-TLR) 
 Target Vessel Revascularization (TVR,) 
- ID TVR 
- Non ID TVR 
 All coronary revascularization 
o Composite Endpoints 
 Death/All MI 
 Cardiac Death/All MI 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 190 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 Cardiac Death/TV-MI/ID-TLR (TLF) 
 Cardiac Death/All MI/ID-TLR (MACE) 
 Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) 
 Death/All MI/All revascularization  
o Scaffold-Thrombosis / Stent Thrombosis (per ARC definition) 
 Timing (acute, sub-acute, late and very late) 
 Evidence (Definite and Probable) 
o Rehospitalization 
 Coronary artery disease related 
 Cardiovascular, non-CAD related 
 Non-cardiovascular related 
o Repeat coronary arteriography 
o TLF through 5 years based on 4600 subjects (2000 primary analysis subjects of 
ABSORB III and 2600 subjects of ABSORB IV) 
5.4 
Informational Endpoints  
5.4.1 Patient Reported Outcomes 
Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life 
at baseline, 1, 6, 12 months and will be assessed at 3 and 5 years throughout the remaining 
duration of the trial. These PRO endpoints will be evaluated in the ~2600 subjects of ABSORB 
IV. The following questionnaires will be used in this study:  
• Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life 
• EuroQoL 5D (EQ-5D) survey to assess overall health status 
The PROs will be analyzed to evaluate the relationship between quality of life and 
cardiovascular events that occurs post-PCI and to substantiate the clinical impact of the angina 
events identified in the trial. 
5.4.2 Health Economics 
During the course of the trial, the Sponsor (or the health economic core laboratory) will collect 
health economic data.  The data may include billing information and claims data for the index 
hospitalization and for subsequent hospitalizations during the follow-up period, for sites located 
in the United States only.  Patients will be asked to provide consent to access billing information 
for the purposes of conducting economic analysis of the trial.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 191 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Additional information regarding medical resource utilization may also be collected throughout 
the trial, including but not limited to: laboratory services, diagnostic procedures, or pharmacy 
records. 
6. 
SUBJECT SELECTION AND WITHDRAWAL  
6.1 
Subject Population 
Subjects registered into this Clinical Investigation will be male and female subjects derived from 
the general interventional cardiology population. The Clinical Investigation will register 
approximately 2600 subjects, with up to three de novo native coronary artery lesions in a 
maximum of two epicardial vessels and a maximum of two lesions per epicardial vessel, who 
meet all eligibility criteria, have provided written Informed Consent and have been registered in 
the trial.   
6.2 
Subject Screening and Informed Consent  
6.2.1 Subject Screening and Informed Consent 
Please refer to section 6.2.1 and 6.2.2 of ABSORB III Protocol (
 
, August 16, 2018) 
for the relevant information about subject screening and informed consent.  
6.3 
Eligibility Criteria  
Assessment for general eligibility criteria is based on the medical records of the site and 
interview with a candidate subject. Clinical and laboratory test of the eligibility assessment shall 
be per site standard of care. If some of the protocol required tests are not included in the site’s 
standard tests, they must be done, but after written Informed Consent has been obtained. Subjects 
must meet ALL of the inclusion criteria to be considered for the clinical evaluation. If ANY of 
the exclusion criteria are met, the subject is excluded from the clinical evaluation and cannot be 
registered. Please see Protocol Summary, Inclusion Criteria and Exclusion Criteria, for details 
of the eligibility criteria of ABSORB IV. 
6.4 
Point of Registration 
During the randomization phase, the subject is considered randomized after IVRS has been 
called and a device has been assigned (Absorb BVS or XIENCE). The subject is considered 
registered and in the ITT population at the point of randomization. Once randomization is 
completed and a treatment arm is assigned, crossover is not permitted. 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
Refer to Appendix IV and Figures 1 and 2 for further registration details.  
6.5 
Subject Discontinuation 
Please refer to section 6.5 of ABSORB III Protocol (
 
, August 16, 2018) for the 
relevant information about subject discontinuation.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 192 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
7. 
TREATMENT AND EVALUATION OF SAFETY AND 
EFFECTIVENESS 
7.1 
Baseline  
7.1.1 Baseline Laboratory Assessments to Confirm Subject Eligibility 
Subject preparation will be in accordance with standard hospital policy for the care of 
interventional cardiology subjects.  
7.1.2 Subject History 
Subject history will include demographics (e.g., age, gender)56, cardiac history including but not 
limited to Canadian Cardiovascular Society (CCS) and Braunwald classification of angina, 
history of myocardial infarction, diabetes mellitus, hypertension, hypercholesterolemia, previous 
CABG and PCI, and concomitant cardiovascular medications (Refer to Appendix II for 
Definitions).  In addition, measurements of weight, height, and resting blood pressure will be 
collected. 
7.1.3 Patient-Reported Outcomes Assessment 
All ~2600 subjects in ABSORB IV will complete the following Patient Reported Outcome 
questionnaires prior to the index procedure*. 
• EuroQoL 5D (EQ-5D) survey to assess overall health status. 
• Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life. 
Please refer to section 7.1.3 of ABSORB III protocol (
 
, August 16, 2018) for the 
details regarding each questionnaire. 
*Every effort should be made to have subjects complete all three patient reported outcomes 
questionnaires prior to the procedure.  However, in situations where this is absolutely not 
possible, subjects may complete them post-procedure, prior to discharge. Subjects who complete 
their questionnaires post-procedure should base their responses on their condition prior to the 
procedure.  
7.2 
Pre-Procedure  
7.2.1 Pre-Procedure Laboratory Assessment 
The following laboratory assessments need to be obtained prior to the index procedure or at the 
time of the index procedure depending on the assessment and condition of the subject. 
Table 7.1  
Baseline Laboratory Assessment 
 
56 Demographics include age, gender, post-menopausal status, date of birth, race/ethnicity, highest level of 
education, employment status and household income.  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 193 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Within 21 days prior to 
procedure† 
Within 7 days prior to 
procedure 
Within 48 hours prior to procedure 
Platelet and White Blood 
Count 
Hemoglobin 
Serum Creatinine 
HbA1c‡ 
Estimated GFR* 
Pregnancy test (if 
applicable) 
12-lead ECG (within 24 hours 
preferred) 
Creatine kinase (CK) 
Creatine kinase myocardial-band 
isoenzyme (CK-MB) 
Troponin (if suspected acute coronary 
syndrome, within 24 hours) 
†The 21-day lab results must be known prior to index procedure.  
‡ HbA1c is to be collected in diabetic subjects only, and its result is not needed prior to the index procedure. 
* Glomerular Filtration Rate 
 
The following applies to cardiac enzyme measurement pre-procedure and during the procedure. 
• All patients admitted with the diagnosis of possible acute coronary syndrome (including 
unstable angina, NSTEMI or STEMI) must have at least one and preferably 2 or more 
complete sets of cardiac biomarkers ( a set consisting of troponin (I or T), CK and CK-MB) 
measured within 24 hours of procedure. Measurements should be at least 6 hours apart if 
multiple measurements were taken.    
•  If the patient has stable coronary artery disease or silent ischemia, a pre-procedure CK and 
CK-MB must be drawn, but may be obtained during the procedure from the arterial sheath 
but prior to any angioplasty. The angioplasty procedure may then be performed before the 
results are known. 
• To assist in the determination of peri-procedural MI, during the procedure, all patients with an 
acute coronary syndrome (including unstable angina, NSTEMI or STEMI) must have troponin, 
CK and CK-MB drawn from the arterial sheath prior to first balloon inflation.  
For subjects having staged procedures, the protocol-required pre-procedure and post-procedure 
cardiac enzyme and 12-lead ECG assessments must be repeated for the staged procedure in the 
same manner as done for the original index procedure. 
7.2.2 Dual Anti-Platelet Medications 
Subjects selected for treatment with Absorb BVS or XIENCE must receive a loading dose of ≥ 
300 mg of aspirin within 24 hours, regardless of whether the patient was previously taking 
aspirin. For patients undergoing staged procedure who have not been discharged and have been 
prescribed daily aspirin while in hospital, no aspirin reloading is required.  
For patients with stable coronary symptoms, silent ischemia, or acute coronary syndromes in 
whom all measured troponin and CK-MB values were within normal limits, pre-loading with 
clopidogrel between 3 and 24 hours prior to the index procedure or prasugrel or ticagrelor 
between 1-24 hours prior to the index procedure is strongly recommended.  If the above loading 
time periods are not possible, the P2Y12 inhibitor must be administered in all patients no later 
than 1 hour after the procedure. If the subject receives less than the required amount of the 
loading dose for a P2Y12 receptor inhibitor, the investigator is to give the remaining amount of 
the same agent in the next 24 hours and within the protocol required timeframe. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 194 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Note: The biomarker measurements in patients with stable coronary symptoms and silent 
ischemia may be pending at the time of the procedure, or may be drawn from the arterial sheath 
prior to first balloon inflation; such patients may still be randomized, and a P2Y12 receptor 
inhibitor must be administered no later than 1 hour after the procedure.  
For patients with acute coronary syndromes in whom any troponin or CK-MB value at any time 
prior to the index hospitalization was elevated, one of two treatment options must be used a) a 
loading dose of  clopidogrel between 3 and 24 hours prior to the procedure or prasugrel or 
ticagrelor between 1-24 hours prior to the index procedure must be given, OR b) an intravenous 
GP IIb/IIIa inhibitor or cangrelor (see below) must be administered prior to and/or during PCI 
but prior to first balloon inflation, per institution standard of care. If an intravenous GP IIb/IIIa 
inhibitor is given, a P2Y12 receptor inhibitor must be given within 1 hour following the index 
procedure. If intravenous cangrelor is used, the timing of the first administration of the P2Y12 
receptor inhibitor should be as follows: clopidogrel or prasugrel are administered at the time of 
discontinuation of the cangrelor infusion; ticagrelor may be administered before, during, or 
immediately upon discontinuation of the cangrelor infusion. Ticagrelor is the preferred P2Y12 
receptor inhibitor in cangrelor-treated patients. Cangrelor should be maintained 2-4 hours post 
procedure according to label. 
Note: If the subject receives less than the required amount of the loading dose for a P2Y12 
receptor inhibitor, the investigator is to give the remaining amount of the same agent in the next 
24 hours and within the protocol required timeframe.  
The protocol required loading dose may be omitted in a) stable CAD or ACS patients maintained 
on chronic P2Y12 receptor inhibitor for ≥ 7 days,  and b) patients who received aP2Y12 receptor 
inhibitor loading dose 1-7 days prior to the procedure and who have been maintained on a daily 
dose since. However, it is strongly recommended that stable patients on chronic clopidogrel are 
reloaded with a P2Y12 receptor inhibitor. For ACS patients on chronic clopidogrel, they must be 
reloaded with a P2Y12 receptor inhibitor if they did not already receive a loading dose of 
clopidogrel, prasugrel, or ticagrelor in the 24 hours prior to the procedure. 
Ticlopidine may be used as a substitute at a dose in accordance with standard hospital practice 
only if the subject develops hypersensitivity or intolerance to clopidogrel, prasugrel, or ticagrelor 
during the trial. 
Refer to respective prescribing information for P2Y12 receptor inhibitor for further details 
regarding loading practice. 
Cangrelor may be used pre-PCI at operator discretion as per local practice in any patient (but 
should be used similarly in patients randomized to ABSORB and XIENCE): a pre-PCI loading 
dose of 30 μg/kg IV followed by an IV infusion of 4 μg/kg for at least 2 hours and for a 
maximum of 4 hours may be used, in conjunction with an oral P2Y12 inhibitor. If ticagrelor is 
selected, the ticagrelor loading dose may be given before, during or immediately upon 
discontinuation of the cangrelor infusion. If clopidogrel or prasugrel are selected, a clopidogrel 
or prasugrel loading dose should be given immediately upon discontinuation of the cangrelor 
infusion, even if a loading dose was given earlier. 
For subjects having staged procedures, the pre-procedure administration regimen of aspirin and 
P2Y12 receptor inhibitor (dosage requirements and timing) must be repeated prior to the staged 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 195 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
procedure in the same manner as done for the original index procedure. If the subject has not 
been discharged between the index and staged procedures, and has received daily aspirin while 
in hospital, no aspirin reloading is required (see above). 
7.2.3 Anticoagulation Medications 
Subjects must receive appropriate anticoagulation and other therapy according to standard 
hospital practice. Either unfractionated heparin or bivalirudin may be used for procedural 
anticoagulation, as per the discretion of the investigator. Subjects having been treated with low 
molecular weight heparin (LMWH) prior to the procedure should receive their last dose more 
than 8 hours prior to the index procedure, and then be anticoagulated during the procedure with 
either unfractionated heparin or bivalirudin. LMWH and fondaparinux are not permitted as 
procedural anticoagulants in this protocol.  
Use of glycoprotein IIb/IIIa inhibitors will be at the discretion of the investigator for stable 
patients. Patients with biomarker positive acute coronary syndromes in whom procedural 
anticoagulation is achieved with unfractionated heparin should receive a procedural glycoprotein 
IIb/IIIa inhibitor dosed per standard of care. Glycoprotein IIb/IIIa inhibitors should not routinely 
be used in bivalirudin anticoagulated patients unless 1) the patient had an acute coronary 
syndrome and did not receive recommended pre-loading with a P2Y12 receptor inhibitor (and in 
whom cangrelor is not used during the PCI); and/or 2) refractory ischemic and/or thrombotic 
complications develop during the procedure.  
7.2.4 Statin Therapy 
In the absence of absolute contraindications to statin use (e.g. severe allergy with prior use), it is 
strongly recommended to preload with statins 12 hours prior to the procedure regardless of LDL 
level and history of prior or current statin use. Recommended statin loading dose regimens 
include atorvastatin 80 mg or rosuvastatin 40 mg.  
7.3 
Index Procedure 
7.3.1 Baseline (Pre-Procedure) Angiography 
Baseline angiography of the target vessel(s) will be completed as per the Angiographic Core 
Laboratory Protocol. 
7.3.2 Imaging Guidance Document 
The Imaging Guidance Document will provide specific details and instructions from the 
angiographic core laboratory regarding vessel sizing. This document will be separate from the 
protocol.  
7.3.3 Treatment Rules of the Target Lesion(s) 
Please see Protocol Summary, Treatment Strategy, for details of the treatment rules of target 
lesion(s).  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 196 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
7.3.4 Treatment Rules of Unplanned Non-Target Lesion(s) 
In situations where treatment of a planned target lesion revealed additional lesion(s), the 
additional lesion(s) may be treated. These lesions are considered unplanned lesions. If the lesion 
meets enrollment criteria both before and after pre-dilatation, the lesion must be treated with the 
assigned device and will be considered as an unplanned target lesion. If the lesion does not meet 
the enrollment criteria (either before or after pre-dilatation), the lesion must be treated with 
XIENCE and will be considered as an unplanned non-target lesion. 
7.3.5 Bailout Stenting or Alternative Procedures 
Bailout procedures may be performed if the subject experiences: 
• Dissection requiring intervention 
• Occlusive complication as evidenced by a decrease in target vessel flow 
• Chest pain or ischemic changes measured by ECG that do not respond to repeat balloon 
inflations, medical therapy or lytic agents 
• Unplanned additional device is required to cover the target lesion 
During randomization, if a bailout device is required for a target lesion (e.g., for edge dissection), 
the same device as the implanted device must be used. Overlap of the bailout stent/scaffold with 
the implanted stent/scaffold should be 1-2 mm. Gaps should be avoided. 
ο Use Absorb BVS if target lesion is treated with Absorb BVS. 
ο Use XIENCE if target lesion is treated with XIENCE.  
ο If a bailout with an Absorb BVS device cannot be delivered to the site of the lesion, the 
device should be carefully withdrawn and a XIENCE used. 
ο If an appropriate size Absorb BVS is not available XIENCE can be used.  
IMPORTANT:  It is required that the bailout device be placed so that there is no visible gap 
between the Absorb BVS and the bailout device.  In such a case, at least 1 mm (minimum) to 2 
mm (maximum) overlap is required. 
IMPORTANT: In the rare event of acute occlusion following Absorb BVS placement and an 
additional drug-eluting stent is required for treatment, the bailout device should be XIENCE and 
deployed within the Absorb BVS such that the Absorb BVS is completely covered by the bailout 
device if this is believed to be in the best interest of the patient.  
Although a bailout procedure is not considered a major adverse cardiac event (MACE) unless the 
subject sustains death, emergent CABG, PCI or MI, such procedures should be avoided unless 
required for safe subject management.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 197 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
7.3.6 Final (Post-procedure) Angiography 
Angiographic imaging will also be performed after the Absorb BVS or XIENCE stent 
deployment.  Physicians should follow accepted hospital imaging practice to ensure good 
apposition of the Absorb BVS or XIENCE to the vessel wall.  For angiographic imaging, post-
implantation images should be captured the same orthogonal views that were used for the pre-
procedure images (after the guidewire has been withdrawn). Intracoronary nitroglycerine should 
be re-administered before final angiography. If nitroglycerine is not available, intravenous 
nitroprusside or intravenous calcium channel blocker may be used per physician discretion. 
7.3.7 Final (Post-procedure) IVUS and OCT 
IVUS and OCT may be performed post-procedure per site standard of care. If stent or scaffold 
under-expansion or substantial malapposition is seen and post-dilatation required, a non-
compliant balloon should be used. Do not dilate the Absorb BVS beyond the dilatation limit 
which is 0.5 mm above the nominal diameter. Repeat angiography in orthogonal views must be 
performed after any additional inflations. 
7.4 
Post–procedure  
7.4.1 Post-procedure Information to be Recorded 
The following information needs to be obtained between 12 hours following the index procedure 
and hospital discharge (in-hospital stay is considered to be a maximum of 7 days following the 
index procedure).  
Between 12 hours post-procedure and discharge 
• Date of discharge 
• Antiplatelet medications  
• Chronic concomitant medications  
• Adverse Events, if any  
7.4.2 Post-procedure Laboratory and Clinical Tests 
The following laboratory assessments need to be obtained between post-index procedure and 
hospital discharge. Hospital discharge cannot occur prior to 16 hours to ensure complete post-
procedure cardiac enzyme collection.  
IMPORTANT:  These tests must be performed whether or not they are considered part of the 
Investigator’s standard of clinical practice. 
Post-procedure and discharge 
• A 12-lead ECG must be obtained within 24 hours post procedure.  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 198 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• Both Creatine kinase (CK) and Creatine kinase myocardial-band isoenzyme (CK-MB) must 
be obtained for ALL subjects as it will be used for cardiac assessment of subjects post-index 
procedure 
o First post-procedure CK and CK-MB draw at 6 to 12 hours post-procedure.  
o Second post-procedure CK and CK-MB draw at 18-24 hours post-procedure, or at the 
time of discharge as long as discharge is at or after 16 hours post-procedure**. 
o If either of the post-procedure CK-MB levels are ≥ 5x ULN, serial CK and CK-MB 
levels must be drawn until they are falling. 
** For subjects discharged prior to 16 hours, the subject will have to return to the enrolling 
institution for their second biomarker draw. 
Alternatively, a visiting nurse may be sent to the patient’s home to collect the blood sample. CK 
and CK-MB levels are required at all time points. Troponins are required pre-procedure and from 
the arterial sheath prior to first balloon inflation during the procedure in patients with acute 
coronary syndromes. All troponin, CK and CK-MB levels collected at any time points pre-
procedure, during the procedure and post-procedure, should also be documented in the electronic 
case report forms.  
For subjects having staged procedures, the post-procedure cardiac enzyme and 12-lead ECG 
assessment for the original index procedure must be repeated following the staged procedure in 
the same manner as done for the original index procedure. 
7.4.3 Assessment of perception bias. 
Patients’ perception as to whether they received the control or test device may affect the rate of 
angina. As described in section 4.5.2, comprehensive efforts will be undertaken to maintain 
patient blinding. Nonetheless, for a variety of reasons patients may develop a belief as to which 
device they received, even if the blind is maintained. 
To assess any potential perception bias on the secondary endpoint of percentage of patients who 
experienced angina within 1 year, information will be collected in a brief patient perception 
assessment questionnaire administered by the research coordinator post-procedure in the hospital 
prior to discharge (≥ 4 hours to ≤ 7 days after the procedure) and at 1 year.  Subjects will be 
asked for their perception of what treatment they believe they might have received, and the basis 
of this perception. The following question(s) will be asked: 
1. Do you think you know which treatment you have received? 
a. Yes. 
b. No. 
If answered “Yes” to Question #1, then answer the following questions. If answered 
“No” to Question #1, do not answer the following questions. 
2. Which treatment do you think you have received? 
a. Standard metal stent. 
b. Temporary dissolving stent. 
3. Are you certain? 
a. Yes. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 199 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
b. No. 
4. Why do you think you know? 
a. I was told by /overheard the doctor who did the procedure. 
b. I was told by/overheard another person in the procedure room/cath lab. 
c. I was told by/overheard another person in the hospital before discharge. 
d. I was told by/overheard a family member or friend who was told. 
e. I believe so because I am feeling better. 
f. I believe so because I am not feeling better. 
g. Other (write in). 
7.4.4 Follow-up Antiplatelet Medications 
All subjects must be maintained at a minimum of 75 mg of clopidogrel daily or 5 or 10 mg of 
prasugrel daily (10 mg preferred in most patients)  or 90 mg twice daily of ticagrelor for a 
minimum of 12 months following the procedure. For prasugrel subjects < 60 kg in weight or ≥75 
years of age, a maintenance dose of 5 mg per day for 12 months is recommended. Patients with 
prior stroke or TIA should receive clopidogrel or ticagrelor, and cannot be administered 
prasugrel. All subjects must receive between ≥75 to ≤ 100 mg of aspirin daily through 5 years 
follow-up during the study and should continue to take aspirin indefinitely. 
Refer to respective prescribing information for P2Y12 receptor inhibitor for further details 
regarding maintenance dose. The start of anti-platelet medications, any changes or 
discontinuation of the medications, as well as the reasons for those change will be documented in 
the eCRF. 
For subjects having staged procedures, the follow-up regimen of aspirin and P2Y12 receptor 
inhibitor (dosage requirements and timing) must be maintained following both the original index 
procedure and the staged procedure. 
7.4.5 Other Chronic Concomitant Medications 
Please refer to section 7.4.4 of ABSORB III Protocol (
 
, August 16, 2018) for the 
relevant information about concomitant medications. 
7.5 
Clinical Follow-up for All Subjects 
Please see Protocol Summary for clinical follow-up schedule and PRO follow-up assessments.   
Registered subjects must be clinically followed even if no assigned device is implanted. Clinical 
follow-up visits must be conducted by a blinded physician, research coordinator, Nurse 
Practitioner or Physician Assistant who has been trained to the protocol.  
For subjects having staged procedures, the follow-up period is considered as having begun upon 
completion of the original index procedure. 
To assess any potential perception bias on the secondary endpoint of percentage of patients who 
experienced angina within 1 year, information will be collected in a brief patient perception 
assessment questionnaire administered by the research coordinator post-procedure in the hospital 
prior to discharge (≥ 4 hours to ≤ 7 days after the procedure) and at 1 year. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 200 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
The PRO questionnaires will be mailed to the subject for completion or can be completed during 
the phone or office visit. If questionnaires are mailed to the subjects, the subjects must mail the 
questionnaires back to the clinical site. 
The following information will be collected at each of the time points: 
• Any adverse events (including re-hospitalizations)*, repeat coronary angiography, details 
regarding angina, medications, laboratory tests and 12-lead ECGs, if performed; 
• Any angina events 
o If the subject experiences any symptoms of abnormal chest/arm/neck/jaw 
discomfort or pain, including angina-equivalent or atypical angina pain/sensation, 
data will be solicited and recorded regarding angina and angina-equivalent 
symptoms, including the quality, frequency and severity of discomfort/pain, to 
allow the CEC to adjudicate the symptoms as to angina/angina-equivalent vs. 
non-angina.  This information will be collected by the research coordinator using 
a standard script. A blinded cardiologist will review the information collected by 
the research coordinator, provide a diagnosis and sign-off on his/her diagnosis.  
• Any repeat coronary angiography and results of such, if applicable; 
• Details of any subsequent coronary interventions (e.g., repeat PCI or CABG); 
• Use and compliance of medications per clinical investigation plan; 
• Use and changes in concomitant cardiovascular medications. 
* All adverse events must be collected up to and including to the 1 year follow up for all ~2600 
subjects. Following the 1-year follow-up, it is mandatory to collect information on cardiac 
adverse events, device related adverse events and on serious adverse events. Please see section 
8.3.1 for details on adverse event reporting. 
7.6 
Additional Follow-up Visits for All Subjects  
Additional subject visits, such as unscheduled visits, may occur as clinically warranted. The 
following information will be collected:  
• Assessment of angina status 
• Adverse events (including re-hospitalizations) 
• Repeat coronary angiography 
• Details of any subsequent coronary interventions (e.g., repeat PCI or CABG)  
• Use and compliance to protocol medications (aspirin and prasugrel/clopidogrel/ 
ticagrelor/ticlopidine)  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 201 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• Use and changes in chronic concomitant medications (Refer to Appendix II for 
definition)  
For unscheduled visits for suspected ischemic cardiac events, sites should make reasonable 
efforts to obtain cardiac enzymes (Troponin I or T), CK and CK-MB, and/or ECG if the site is 
aware of the visit at the time of its occurrence. In all other scenarios (i.e., site does not become 
aware until after the fact), no protocol deviation will be issued if Troponin I or T, CK and CK-
MB, and/or ECG were not obtained at the time of the unscheduled visit. 
All efforts must be made to obtain follow-up information on subjects who have undergone 
procedures or have been treated for adverse events in a non-trial-related hospital(s). 
All coronary revascularizations must be classified prospectively by the investigator as ischemia-
driven or not ischemia-driven (Refer to Appendix II for definition). If a subject has a coronary 
revascularization, all clinical information such as symptoms or lack of symptoms of ischemia, 
and possible relations with the target lesion/vessel should be fully recorded in the source 
documents prior to angiogram. 
8. 
ADVERSE EVENTS 
8.1 
Definitions 
To comply with worldwide standards and guidelines on clinical trial adverse event reporting, AV 
has developed the below definitions to be used and adhered to by the investigators. The exact 
definitions as referenced in these standards and guidelines are included in appendix II.  
8.1.1 Adverse Event 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device. 
NOTE 1: This definition includes events related to the investigational medical device or the 
comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a medicinal (investigational) 
product, whether or not related to the medicinal (investigational) product. 
8.1.2 Serious Adverse Event 
If the AE meets any of the criteria below, it is regarded as serious adverse event (SAE).  
a) Led to a death, 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 202 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
b) Led to a serious deterioration in health that either: 
1) Resulted in a life-threatening illness or injury, or 
2) Resulted in a permanent impairment of a body structure or a body function, or 
3) Required in-patient hospitalization or prolongation of existing hospitalization, or 
4) Resulted in medical or surgical intervention to prevent life threatening illness or injury 
or permanent impairment to a body structure or a body function. 
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
d) An important medical event that may not result in death, be life-threatening, or require 
hospitalization but may be considered serious when, based upon appropriate medical judgment, 
may jeopardize the subject and/or may require intervention to prevent one of the outcomes listed 
in this definition. 
NOTE 1: This includes device deficiencies that might have led to a serious adverse event if a) 
suitable action had not been taken or b) intervention had not been made or c) if circumstances 
had been less fortunate. These are handled under the SAE reporting system. 
NOTE 2: A planned hospitalization for pre-existing condition, or a procedure required by the 
Clinical Investigation Plan, without a serious deterioration in health, is not considered to be a 
serious adverse event. 
8.1.3 Device Deficiency/Product Experience 
Device deficiency (DD) is defined as an inadequacy of a medical device related to its identity, 
quality, durability, reliability, safety or performance, such as malfunction, misuse or use error 
and inadequate labeling. This includes the failure of the device to meet its performance 
specifications or otherwise perform as intended.  Note: performance specifications include all 
claims made in the labeling of the device. 
Product Experience (PE) is defined as any expression of customer concern or dissatisfaction, 
including adverse events and patient issues that occurred during or after the use of a 
commercially available medical device. 
8.2 
Device Relationship 
Determination of whether there is a reasonable possibility that an investigational product or 
device caused or contributed to an AE is to be determined by the Investigator and recorded on 
the appropriate eCRF form. Determination should be based on assessment of temporal 
relationships, biologic plausibility, association (or lack of association) with underlying disease 
and presence (or absence) of a more-likely cause. 
8.2.1 Unanticipated Serious Adverse Device Effect (USADE) 
Unanticipated serious adverse device effect (USADE) refers to any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, a device, 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 203 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects. 
8.3 
Adverse Event/ Device Deficiency/ Product Experience Reporting 
8.3.1 Adverse Event and Serious Adverse Event Reporting 
All adverse events will be collected on each subject through the 1-year follow-up visit. After one 
year, only the following will be collected: 
• All serious adverse events. 
• All cardiac events regardless of seriousness or device relationship. 
• All trial device-related events and events for which the relationship to the trial device is 
unknown. 
• All unanticipated adverse device effects. 
• All Cerebral Vascular Accidents (CVAs). 
The Investigator will monitor the occurrence of adverse events for each registered subject during 
the course of the clinical trial/investigation and report as required by this protocol in section 8 
per AE and SAE definitions.  Adverse Events reported by the subject, observed by the 
Investigator, or documented in medical records should be recorded on the adverse event eCRF, 
whether believed by the Investigator to be related or unrelated to the investigational device 
implant as required by this protocol. 
A fax form will be made available to allow the investigator to report SAEs and device 
deficiencies in the event the entry cannot be made in the EDC (FRM2073001 SAE Notification 
Form). This does not replace the EDC reporting system, however, all information must still be 
entered in the EDC system as soon as feasible.  
For all registered patients, AEs (any new event/experience that was not present at baseline or 
worsening of an event present at baseline) will be collected as required by this protocol.  The 
reporting of AEs will start when the guiding catheter enters the subject’s vasculature.  Reported 
AEs will be monitored through the course of the trial.  Additional information with regards to an 
AE should be updated within the appropriate case report form. 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be 
recorded on the AE eCRF page.  
The investigator should report all SAEs to the Sponsor as soon as possible but no later than 
outlined below. 
Study site 
Reporting timelines 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 204 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
All Study Sites 
SAEs must be reported no later than 3 calendar days from the day the study 
personnel becoming aware of the event or as per the investigative site’s local 
requirements if the requirement is more stringent than those outlined. 
The date the site staff became aware that the event met the criteria of a serious adverse event 
must be recorded in the source document.  The investigator will further report the event to the 
IRB/EC according to the institution’s IRB/EC reporting requirements. 
Serious adverse events that occurred in the user or persons other than the study subject should 
not be entered in the EDC system. However they need to be reported on the SAE Notification 
Form (FRM2073001).   
Serious adverse events should be reported on the SAE Notification Form in the occurrence that 
the EDC System is not available.  This does not replace the EDC reporting system.  All 
information must still be entered in the EDC system once the system is back to normal function. 
8.3.2. Unanticipated Serious Adverse Device Effect Reporting to Sponsor and IRB 
Abbott Vascular requires the Investigator to report any USADE to the sponsor within 3 calendar 
days of the investigator’s knowledge of the event, unless local requirements are more stringent, 
and to the IRB/EC per IRB/EC requirements  
8.3.3 Device Deficiency/Product Experience Reporting 
All device deficiencies/product experiences should be reported within the EDC System on the 
appropriate eCRF. A fax form will be made available to allow the investigator to report device 
deficiencies in the event that the entry cannot be made in the EDC (Device Deficiency Report 
Form). This does not replace the EDC reporting system. However, all information must still be 
entered in the EDC system as soon as feasible. In case a device deficiency occurred before the 
patient ID and randomization number has been assigned, the device deficiency should be 
reported to the sponsor via a Device Deficiency Report Form. 
The investigator should report all DDs/PEs to the Sponsor as soon as possible but no later than 
outlined below.  
Study sites 
Reporting timelines 
All Study Sites 
DDs/PEs must be reported no later than 3 calendar days from the day the 
study personnel becoming aware of the event or as per the investigative 
site’s local requirements if the requirement is more stringent than those 
outlined. 
The device, if not implanted or not remained in the subject, should be returned to Abbott 
Vascular.   
Device deficiencies should be reported to the IRB/EC per the investigative site’s local 
requirements. 
8.3.4 Adverse Event Reporting to Country Regulatory Authorities by the Sponsor  
The Sponsor will report the SAEs and DDs/PEs to the country regulatory authority, per local 
requirements. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 205 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
8.4 
Safety Monitoring by Data Safety Monitoring Board 
The Data Safety Monitoring Board (DSMB) will serve in an advisory role to Abbott Vascular to 
ensure safety by reviewing cumulative data from the clinical trial at pre-scribed intervals for the 
purpose of safeguarding the interests of trial participants. The composition, guiding policies, and 
operating procedures governing the DSMB are described in a separate DSMB charter.  Based on 
safety data, the DSMB may consider a recommendation for modifications or termination of the 
trial based on any perceived safety concerns regardless of statistical significance. The 
recommendations of the DSMB are not binding, and all final decisions related to trial 
modifications rest with Abbott Vascular. 
9. 
ADJUDICATION OF EVENTS 
9.1 
The Clinical Events Committee (CEC) 
Please refer to section 9.1 of ABSORB III Protocol (
 
, August 16, 2018) for relevant 
information on CEC. In addition to the events adjudicated in ABSORB III, in ABSORB IV the 
CEC will also adjudicate any patient reported symptoms of abnormal chest/arm/neck/jaw 
discomfort or pain to angina/angina-equivalent vs. non-anginal symptoms.   
9.2 
Angiographic Core Laboratory 
The angiographic core laboratory will be responsible for reviewing all available follow-up 
coronary angiograms for registered subjects, to determine if a revascularization was performed 
by PCI, and if so, whether or not the revascularization was related to the target lesion, target 
vessel or non-target vessel. The angiographic core laboratory will also assess the initial 
completeness of revascularization as previously described.57,58 The data from angiographic core 
laboratory will be provided to CEC for adjudicate stent thrombosis events with angiographic 
follow-up. 
10. STATISTICAL ANALYSIS  
10.1 Statistical Overview  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 TLF is defined as a per-subject hierarchical count of cardiac death, target 
vessel Q-wave or non-Q-wave MI (per protocol-defined MI definition, Appendix II), or 
ischemia-driven target lesion revascularization (ID-TLR).  
 
57 Rosner GF et al. Impact of the presence and extent of incomplete angiographic revascularization after 
percutaneous coronary intervention in acute coronary syndromes: the Acute Catheterization and Urgent Intervention 
Triage Strategy (ACUITY) Trial”. Circulation. 2012;125:2613-2620 
58 Genereux P et al. Quantification and impact of untreated coronary artery disease after percutaneous coronary 
intervention. The residual SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) score. J Am Coll 
Cardiol. 2012 Jun 12;59(24):2165-74 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 206 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Details on the design of this endpoint will be included when finalized.  
Study Success 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
10.2 Analysis Populations  
10.2.1 Intent-to-Treat (ITT) Population  
 
 
  
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
10.2.2 As-Treated (AT) Population 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
   
10.3.1 ABSORB IV Primary Endpoint 
Primary Endpoint: TLF at 30-day Primary Endpoint 
TLF at 30-day will be tested for non-inferiority. This analysis will consist of ~2600 subjects in 
ABSORB IV. 
The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the TLF 
at 30 days with a one-sided alpha of 0.025.  
 
 
 
 
 
 
 
 
  
   
   
 
  
   
   
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
   
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 207 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
10.3.2 Powered Secondary Endpoints 
Powered Secondary Endpoint 1: TLF through 1 year 
TLF at 1-year will be tested for non-inferiority. This analysis will consist of ~2600 subjects in 
ABSORB IV. 
The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the TLF 
at 1 year with a one-sided alpha of 0.025.  
 
 
 
 
 
 
 
 
  
   
   
 
  
   
   
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
  
 
 
 
 
 
 
 
  
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
   
 
 
 
 
  
   
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
Power Secondary Endpoint 2: Angina through 1 year 
The Angina Powered Secondary Endpoint of percentage of patients who had angina within 1 
year (excluding an angina blanking period of the index hospitalization or the first 7 days post 
PCI, whichever occurs first) will be tested for non-inferiority with reflex testing to superiority. 
This analysis will consist of ~2600 subjects in ABSORB IV. 
The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for angina 
within 1 year with a one-sided alpha of 0.025.  
 
 
 
 
 
 
 
 
  
   
   
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 208 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
  
   
   
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
   
 
 
 
 
  
   
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
  
  
 
 
  
  
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
   
    
  
   
    
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.4 Statistical Analyses  
For binary variables such as TLF, TLR, and clinical procedure success, counts, percentages, and 
95% confidence intervals will be calculated, and p-values may be presented for hypothesis 
generating purposes. Pearson’s Chi-squared test or Fisher’s exact test will be performed when 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 209 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
appropriate. In addition, logistic regression will be performed to determine whether the baseline 
characteristics exhibit any trends in predicting TLF.  
For continuous variables such as age, means, standard deviations, and 95% confidence intervals 
for the mean will be calculated and p-values may be presented for hypothesis generating 
purposes. For time-to-event variables, such as time to TLF, survival curves will be constructed 
using Kaplan-Meier estimates, and log rank test results may be displayed. Unless specified, 
analyses will be performed with pooled data across all study sites. 
For further details refer to the statistical analysis plan (SAP). 
10.4.1 Primary Endpoint Analyses  
The ABSORB IV Primary Endpoint of TLF at 30-day will be analyzed for the ITT (~2600 
subjects of ABSORB IV) and the AT populations. The primary analysis will be based on the ITT 
population. The non-inferiority hypothesis testing will be performed using non-inferiority test by 
Farrington and Manning. Non-inferiority of Absorb BVS to XIENCE will be established if the p-
value for the non-inferiority test is less than 0.025.  
Details of the analyses for the primary endpoints can be found in the statistical analysis plan 
(SAP).  
10.4.2 Powered Secondary Endpoint Analysis  
The ABSORB IV Secondary Endpoint of TLF at 1-year will be analyzed for the ITT (~2600 
subjects of ABSORB IV) and the AT populations. The primary analysis will be based on the ITT 
population. The non-inferiority hypothesis testing will be performed using non-inferiority test by 
Farrington and Manning. Non-inferiority of Absorb BVS to XIENCE will be established if the p-
value for the non-inferiority test is less than 0.025.  
Analysis of the Angina Powered Secondary Endpoint of the percentage of patients with angina 
within 1 year will be based on the ITT population (~2600 subjects of ABSORB IV) and the AT 
population. The primary analysis will be based on the ITT population. The non-inferiority 
hypothesis testing will be performed using non-inferiority test by Farrington and Manning. Non-
inferiority of Absorb BVS to XIENCE will be established if the p-value for the non-inferiority 
test is less than 0.025.  
If the non-inferiority of Absorb BVS to XIENCE is demonstrated and the percentage is lower in 
Absorb BVS compared to XIENCE, a superiority test will be performed at the two-sided alpha 
0.05 level. 
10.4.3 Secondary Endpoint Analyses  
Secondary endpoints other than the powered endpoints described above will be summarized 
descriptively for the ITT population (~2600 subjects of ABSORB IV). For further details refer to 
the statistical analysis plan (SAP).  

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 210 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
10.4.4 Additional Analyses  
Adverse Events related to stent/scaffold thrombosis, vascular complications or bleeding 
complications, and their relation with antiplatelet therapies used in the trial will be investigated 
between the two treatment groups, if applicable.  
For further details refer to the SAP. 
10.4.5 Informational Endpoint Analyses  
Details on informational endpoint analyses can be found in the SAP. 
10.4.6 Subgroup Analysis 
Pre-specified subgroups such as diabetes, sex, age will be examined. Further details can be found 
in the SAP. 
10.4.7 Criteria for Early Termination of the Trial for Effectiveness  
No formal statistical rule for early termination of the trial for effectiveness is defined.  
10.4.10 
Procedures for Accounting for Missing, Unused or Spurious Data 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
10.4.11 
Pooling Strategy  
 
 
 
 
 
 
  
 
  
10.4.12 
Deviations from the Original Statistical Plan 
Any major changes to the statistical plan (available upon request) will be documented in an 
amendment to the statistical plan.  Less significant changes to the planned analyses will be 
documented in the final report. 
11. 
ADDITIONAL PROTOCOL INFORMATION  
Please refer to section 11 - 17 of ABSORB III Protocol (
 
, March 14, 2017) for 
relevant information on data access and handling, quality control, ethical consideration, 
publication policy, risk analysis and special population.  
11.1 Direct Access to Source Data/Documents Addendum 
It is possible that during the duration of the trial, subjects may receive medical care from 
institutions other than the study site. In addition to collecting the informed consent from patients, 
the Sponsor strongly recommends that study sites obtain a medical release authorization from the 
subject to facilitate the collection of relevant medical information from non-study site 
institutions. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 211 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 212 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
12. ABSORB-RESOLVE: REDUCTION IN ISCHEMIA WITH 
BIORESORBALE VASCULAR SCAFFOLDS—AN 
IMAGING SUB-STUDY TO ABSORB IV 
12.1. Background 
To date, no randomized controlled trial (RCT) has demonstrated the superiority of percutaneous 
coronary intervention (PCI) over medical therapy for the reduction of death or myocardial 
infarction (MI) in patients with stable coronary artery disease (CAD) [1,2]. Limitations of prior 
studies, however, have included excessively high rates of revascularization failure and 
incomplete coronary revascularization after PCI, and use of older generation stent technology 
(for example, only 2.7% of the COURAGE trial PCI patients received drug-eluting stents) [1,3]. 
Despite its negative primary clinical events outcome, COURAGE and numerous other RCTs 
have demonstrated that angina frequency and quality of life are significantly improved with PCI 
over medical therapy alone [4]. In COURAGE, a longitudinal assessment at 24 months observed 
PCI to improve health status compared to medical therapy, with two-thirds of patients 
undergoing PCI free of angina. The most prominent effect of PCI was noted for patients with 
either severe or frequent angina. Importantly, approximately half of subjects enrolled into the 
COURAGE study were asymptomatic or experienced minimal angina for a generally short 
duration of ~5 months, and PCI would be expected to be more effective in a more symptomatic 
group.  
The symptomatic improvements with PCI in the COURAGE trial—despite the low utilization of 
drug-eluting stents—may be mechanistically explained by the COURAGE nuclear sub-study in 
which myocardial ischemia was evaluated by single photon emission computed tomography 
(SPECT) [5]. Abnormal single photon emission computed tomography (SPECT) findings have 
been strongly associated with adverse prognosis and worsened angina [6].  In the COURAGE 
nuclear sub-study, it was hypothesized that ischemia reduction would be greater for patients who 
were randomized to receive PCI over those receiving medical therapy alone [5].  Among 309 
patients who underwent baseline and follow-up stress testing by SPECT, follow-up ischemia was 
assessed at 6-18 months (median 12 months). In PCI-treated patients, the mean amount of 
ischemic myocardium was reduced from 8.2% at baseline to 5.5% at follow-up-- equating to a 
mean reduction of 2.7% -- which compared favorably to the mean 0.5% reduction that was 
observed in the medical therapy alone arm (p < 0.001). These findings are in direct accordance 
with several pivotal randomized trials including the Asymptomatic Cardiac Ischemia Pilot 
(ACIP) and SWISSI II studies, each of which demonstrated superior clinical outcomes with PCI 
compared to medical therapy alone in patients with documented ischemia [7-8].  
12.1.1. 
Ischemia Assessment by SPECT 
Numerous non-invasive imaging tests exist for physiologic assessment of CAD, including 
echocardiography, cardiac magnetic resonance and myocardial perfusion imaging by either 
SPECT or positron emission tomography (PET) [9,10]. These modalities identify stress-induced 
wall motion abnormalities or regional myocardial perfusion defects as a surrogate for ischemia, 
and serve to identify individuals who may have severe coronary stenoses.  Among the non-
invasive stress modalities, myocardial perfusion imaging (MPI) by SPECT is performed most 
commonly, comprising ~90% of the more than 10 million stress imaging test performed in the 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 213 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
US annually [11]. MPI by SPECT determines the extent, severity and reversibility of myocardial 
ischemia with high performance [12]. In pooled analyses, the sensitivity and specificity of MPI 
to diagnose coronary stenosis is 85-90% and 70-75%, respectively.  Further, the prognostic value 
of MPI is unsurpassed by other non-invasive tests, with risk of CAD events escalating 
exponentially with increasing magnitude of inducible hypoperfusion [6]. 
12.1.2. 
Coronary CT Angiography (CCTA) 
A major goal of imaging is to accurately evaluate the angiographic severity of luminal stenoses. 
Coronary CT angiography (CCTA) has recently emerged as an accurate non-invasive method for 
determination of obstructive CAD [13]. In three prospective multicenter studies, the diagnostic 
sensitivity of CCTA for patients with and without known CAD has ranged between 85-99%, 
with specificities ranging between 64-90% [14-16].  CCTA has been demonstrated to be 
particularly effective in excluding obstructive coronary stenosis and a normal CCTA is 
associated with a very low annual mortality rate of 0.13% [17].  
However, there are limitations of CCTA, particularly as it relates to intracoronary stents [18]. 
Owing to blooming artifacts caused by metal, visualization of the coronary lumen within stents 
by CCTA is more challenging than evaluation of the native coronary arteries. Clinical studies 
published so far show low sensitivity to identify in-stent restenosis. The limited spatial resolution 
of CCTA, the type of stent, and stent diameter all contribute to limited clinical results. 
Importantly, as blooming artifacts are absent in CCTA imaging of bioresorbable vascular 
scaffolds (Absorb BVS), the diagnostic performance of CCTA may be improved after Absorb 
BVS implantation [19]. The coupling of a non-invasive technique for evaluation of symptomatic 
or ischemic patients with suspected in-scaffold restenosis may be cost-effective compared to 
traditional evaluation of metallic stents [20]. 
12.1.3. 
CT Perfusion (CTP) 
Recent advances in technology now enable MPI by CT, a procedure termed CT perfusion (CTP) 
[21]. Multidetector CT systems can image in a dynamic mode, in which sequential images are 
obtained over a period of time to record the kinetics of iodinated contrast in the arterial blood 
pool and myocardium. George et al, using a 64-detector CT in a canine ischemia model, 
performed CTP during adenosine infusion [22]. They found strong correlations between the ratio 
of myocardial upslope and left ventricular upslope and microsphere-derived MBF. The authors 
replicated the study in humans with adenosine stress 64- and 256-row detector CCTA and CTP. 
In the human study, they calculated the transmural perfusion ratio (sub-endocardial attenuation / 
sub-epicardial attenuation), which had a significant inverse linear correlation with percent 
diameter stenosis on quantitative intracoronary angiography (ICA) [23]. Further, the combination 
of CTP and CCTA was 86% sensitive and 92% specific for identifying patients with 
atherosclerosis causing perfusion abnormalities when compared with the combination of ICA 
and SPECT-MPI as the gold standard.  
In a prospective multicenter study of chest pain patients entitled the Combined Coronary 
Atherosclerosis and Myocardial Perfusion Evaluation Using 320 Detector Row Computed 
Tomography (CORE320) [24], CCTA with concomitant CTP was as effective as sequential 
SPECT-MPI and invasive angiography in identifying flow-limiting atherosclerotic lesions. The 
clinical utility of CTP may be particularly important in patients with a high coronary risk profile, 
known coronary artery disease, those with a high calcium score (e.g. >400 Agatston Units), or 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 214 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
those with suspected in-stent restenosis in whom severe coronary calcification or artifacts 
prevent accurate quantification of coronary stenosis by CT angiography. In patients scheduled 
for percutaneous revascularization, information about both coronary lesion characteristics and 
myocardial segments with reversible ischemia or infarcts may be helpful to plan the procedure 
and provide prognostic information.  
12.1.4. 
FFRCT 
At present, the “gold” standard assessment of the hemodynamic significance of coronary 
stenoses is fractional flow reserve (FFR). Recent advances in computational fluid dynamics 
(CFD) allow for calculation of coronary flow and pressure fields from anatomic image data [25]. 
Applied to CT, these technologies enable calculation of FFR (which reflects the ratio of maximal 
myocardial blood flow through a diseased artery to the blood flow in the hypothetical case that 
the artery was normal) without additional imaging or administration of additional medications. 
Several studies have reported incremental value of FFRCT in the diagnosis of CAD [26-28]. In 
the most contemporary of these prospective multicenter trials, the HeartFlowNXT study of 254 
patients with suspected CAD, FFRCT was more accurate for identification of ischemia-related 
arterial blockages than standard CCTA or ICA. Perhaps more importantly, FFRCT data matched 
closely with invasively measured FFR. The area under the receiver operating characteristic curve 
(AUC) was 0.82 for FFRCT (≤ 0.80) vs. 0.63 for CCTA (lumen reduction > 50%) (p < 0.0001) 
with invasive FFR as the reference standard. Per-patient sensitivity and specificity were 86% and 
79% for FFRCT vs. 94% and 34% for CCTA, and 91% and 51% for ICA (lumen reduction 
>50%).  
FFRCT offers several practical advantages in that it does not require modification of CT 
angiography protocols, does not require administration of additional medications beyond what is 
typically administered for CCTA, and does not result in any additional radiation exposure.  
12.1.5. 
The Present Study 
In the present proposal, we propose to determine the effects of the Absorb BVS on reversible 
myocardial and coronary lesion-specific ischemia by SPECT, CTP, and FFRCT; and to quantify 
group-to-group differences in myocardial ischemia in individuals undergoing coronary 
intervention with bioabsorbable scaffolds versus latest generation drug-eluting stents. Further, 
we will evaluate the long-term vascular responses to Absorb BVS by traditional diagnostic 
coronary CT angiography. 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 f 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
12.2. Rationale and Design of ABSORB-RESOLVe 
Hypothesis-generating clinical observations have surfaced that Absorb BVS may result in less 
angina than XIENCE. Specifically, the site-reported recurrence rate of angina after PCI was 
compared at different time periods from the SPIRIT IV trial (n = 2,051) and the ABSORB 
EXTEND registry (n = 375) (data on file, Abbott Vascular). Of note, both studies evaluated 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 215 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
angina recurrence at similar intervals and with similarly designed case report forms. This 
comparison excluded complex patients and lesions from SPIRIT IV (3-vessel PCI; PCI of 2 
lesions in a single vessel; RCA aorto-ostial lesions; bifurcation lesions). Non-Japanese Asian 
patients from ABSORB EXTEND were excluded because of historically low reported event rates 
and for more appropriate comparison to patients in SPIRIT IV. At 30 days angina had recurred in 
12.5% of XIENCE patients vs. 5.8% of Absorb BVS patients. At 1 year angina had recurred in 
26.7% of XIENCE patients vs. 15.9% of Absorb BVS patients (393 day HR [95% CI] = 0.55 
[0.42, 0.72], p < 0.0001). To further correct for baseline differences, a propensity adjusted 
comparison was performed between 602 XIENCE patients and 287 Absorb BVS patients (data 
on file, Abbott Vascular). In this analysis angina at 30 days had recurred in 11.3% of XIENCE 
patients vs. 7.0% of Absorb BVS patients. At 1 year angina had recurred in 28.1% of XIENCE 
patients vs. 16.0% of Absorb BVS patients (393 day HR [95% CI] = 0.53 [0.93, 0.74], p = 
0.0001). It is unknown to which extent this reduction in angina recurrence is due to reduced 
ischemia with Absorb BVS compared to XIENCE. 
The ABSORB-RESOLVe sub-study of the parent ABSORB IV trial has been specifically 
designed to address each important stage and mechanism of the ischemic cascade wherein the 
Absorb BVS may exert salutary anti-anginal effects. The substudy will employ both SPECT and 
CT in patients undergoing a prospective, multicenter, randomized 1:1 comparison of Absorb 
BVS to XIENCE.  
SPECT will be performed for determination of changes in myocardial ischemia. SPECT is 
currently the most commonly performed and most well-validated stress imaging test available, 
and enables quantification of relative perfusion deficits within myocardial territories, findings 
that can arise from both epicardial coronary artery (re-)stenosis as well as microcirculatory 
dysfunction and/or disease.  Additionally, the evaluation of functional capacity through exercise 
testing in those who are capable of it will allow for a direct assessment of the potential beneficial 
effects of Absorb BVS on reducing exertional angina. Available SPECT images taken within 60 
days prior to the index procedure will be analyzed to obtain a baseline measurement of ischemia. 
SPECT will be performed at 14 months, a time period after which most restenosis events have 
occurred, and a time period in which non-randomized comparative data have suggested that 
Absorb BVS implantation is associated with substantially less angina than the XIENCE metallic 
DES, the hypothesis which is being formally tested in ABSORB III. Finally, ischemia will be 
provoked prior to SPECT with a Bruce exercise test. Ischemia provoked by exercise is inherently 
different than pharmacologic induced differences in blood flow, and the inherent differences in 
vascular responses after Absorb BVS compared to XIENCE V (including exercise induced 
vasodilation at the treatment site and restored cyclic pulsatility) may be optimally differentiated 
with exercise induced hemodynamic changes. Exercise testing also allows between-group 
comparisons of additional variables including exercise time/capacity and ECG changes, and 
exercise induced angina. 
CT—inclusive of coronary CT angiography, CT perfusion, and FFRCT—will be performed at 
baseline, after the device has been implanted, and at 5-year follow-up for determination of 
changes in myocardial and coronary ischemia after Absorb BVS absorption is complete. CT will 
allow for assessment of the presence, extent and severity of coronary luminal stenosis, which are 
directly associated with ischemia and adverse events. Further, CT also allows for performance of 
pharmacologic CTP and FFRCT.  Both of these tests are “disruptive” methods for CAD 
evaluation. Given the spatial resolution of CT, MPI by CTP offers a distinct advantage over 
SPECT for evaluation of sub-endocardial ischemia evaluation while FFRCT allows for 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 216 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
determination of epicardial coronary lesion-specific ischemia. The baseline CT will allow 
determination of residual ischemia present in each group immediately after the procedural 
implant, whether originating from the target vessel or non-target vessel territories. Such residual 
ischemia will be correlated with early onset angina in each treatment group. The 5-year follow-
up CT, a time period in which the Absorb BVS has completely resorbed, allowing vascular 
remodeling with late lumen enlargement as well as restoration of normal vasomotion, will 
provide the highest likelihood of determining whether Absorb BVS reduces ischemia compared 
to XIENCE during long-term follow-up, consistent with the hypothesis which is being formally 
tested in ABSORB IV. In addition, CT at 5-years will be able to characterize changes in plaque 
morphology and extent and vessel dimensions and remodeling after resorption of the Absorb 
BVS, and correlate such changes to long-term outcomes in the 2 groups. 
12.3. ABSORB-RESOLVe Study Objectives: 
12.3.1. 
Primary Objective (Myocardial Ischemia by SPECT).  
The primary powered objective is to compare the efficacy of between group differences in % 
ischemic myocardium after treatment with Absorb BVS versus XIENCE at 14 ± 1 month follow-
up, as evaluated by SPECT. Percent (%) ischemic myocardium will be based upon a summed 
stress score (SSS), which will be calculated for all myocardial segments using a 17-segment 
AHA model. Each segment will be classified as having normal myocardial perfusion (=0), mild 
perfusion defect (=1), moderate perfusion defect (=2), severe perfusion defect (=3), or absence of 
perfusion (=4). The SSS will be converted as a function of 100, resulting in per-subject % 
ischemic myocardium.  
Sample Size Calculation  
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
   
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
  
   
 
 
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
   
 
 
 
 
 
 
 
  
   
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
  
 
  
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
12.3.2. 
Powered Secondary Objective (Myocardial Ischemia by CT). 
The secondary powered objective is to compare the efficacy of between-group differences in % 
ischemic myocardium after treatment with Absorb BVS versus XIENCE at 62 ± 1 month follow-

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 217 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
up as evaluated by CT perfusion. Percent (%) ischemic myocardium will be based upon a 
summed stress score in a manner identical to that for SPECT. 
Sample Size Calculation. 
 
 
 
 
 
 
  
   
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
   
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
12.3.3. 
Tertiary Objectives: 
12.3.3.1. 
Myocardial Ischemia by SPECT. 
To compare the effect of revascularization by Absorb BVS versus XIENCE on additional 
measures of between-group reversible ischemia differences at 14 ± 1 month follow-up. For this 
tertiary objective, myocardial ischemia will be evaluated by SPECT. Myocardial ischemia 
measures will include: 
1) Per-vessel territory % ischemic myocardium. Vessel territories will include those from 
the left anterior descending artery, left circumflex artery and right coronary artery. 
2) Significant ischemia reduction, as defined by ≥ 5% ischemic myocardium 
3) Rates of myocardial perfusion normalization 
4) Rates of residual ≥10% ischemic myocardium 
5) Reduction in high-risk SPECT findings (e.g., transient ischemic dilatation, increased lung 
uptake, right ventricular dilatation) 
6) Exercise-induced angina 
7) Exercise duration 
8) ST-segment depression during exercise 
9) Improvement in Duke Treadmill Score 
12.3.3.2. 
Myocardial Ischemia by SPECT 
To assess the reduction in % ischemic myocardium in ABSORB RESOLVe sub-study subjects 
from pre-procedure to 14 ± 1 month follow-up, and to assess between-group differences in the 
reduction of % ischemic myocardium between the Absorb BVS and XIENCE arms. Baseline 
SPECT imaging is not mandated per protocol; this secondary analysis will be performed only on 
subjects who have an available non-study SPECT and will be used for determination of reduction 
in % ischemia myocardium from pre-procedure to 14 ± 1 month follow-up. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 218 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
12.3.3.3. 
Myocardial Ischemia by SPECT 
To assess the extent of myocardial ischemia in ABSORB RESOLVe sub-study subjects who 
have met the parent ABSORB IV angina secondary endpoint (angina group) in comparison to 
subjects who have not met the angina secondary endpoint (non-angina group), and to assess 
between-group differences in the Absorb BVS and XIENCE arms. ABSORB IV angina 
secondary endpoint is defined in Section 5.2 of the ABSORB IV portion of the protocol. 
12.3.3.4. 
Myocardial Ischemia by CT. 
To compare the effect of revascularization by Absorb BVS versus XIENCE on additional 
measures of reversible ischemia reduction in a) the immediate post PCI period (within 7 days 
after the index PCI procedure) and b) at 62 ± 1 month follow-up. For this tertiary objective, 
myocardial ischemia (for both the target vessel territory and global ischemia) will be evaluated 
by CT perfusion. Myocardial ischemia measures will include: 
1) Between group reversible myocardial ischemia at 7 days. 
2) Within-patient reversible myocardial ischemia change from 7 days to 62 ± 1 month 
follow-up. 
3) Rates of myocardial perfusion normalization. 
4) Reduction in reversible myocardial ischemia by severity class [as classified by none 
(0%), mild (1-4%), moderate (5-9%) and severe (≥ 10%) ischemic myocardium. 
5) Rates of residual ≥ 10% ischemic myocardium. 
12.3.3.5. 
Lesion-Specific Ischemia by CT. 
To compare the effect of revascularization by Absorb BVS versus XIENCE on measures of 
target vessel and lesion-specific ischemia reduction in a) the immediate post PCI period (within 7 
days after the PCI period) and b) at 62 ± 1 month follow-up. For this tertiary objective(s), target 
vessel and lesion-specific ischemia will be evaluated by FFRCT. Lesion-specific ischemia 
measures will include between group (at 7 days and at 62 ± 1 month follow-up) and within –
patient (change from 7 days to 62 ± 1 month follow-up): 
1) Differences in absolute FFRCT value. 
2) Rate of trans-lesion hyperemic pressure difference normalization (as defined by FFRCT ≥ 
0.80). 
12.4. ABSORB-RESOLVe Study Population and Clinical Site Participation 
The study populations will consist of 370 consecutive consenting adult patients registered in the 
parent ABSORB IV trial. Site participation will be voluntary. The ABSORB-RESOLVe and 
parent ABSORB IV study subject enrollment will be simultaneous; that is, the 370 subjects 
registered in this sub-study will be a part of the ~2600 subjects in the ABSORB IV trial. These 
subjects will undergo all ABSORB IV scheduled follow-up and assessments in addition to the 
tests associated with this sub-study. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 219 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
12.4.1. Selection of Subjects 
12.4.1.1. Inclusion Criteria (in addition to standard inclusion criteria from ABSORB IV 
parent trial): 
1) Subjects that received only Absorb BVS or XIENCE as per their assigned 
treatment group. 
2) Successful and uncomplicated PCI procedure, as defined in the main protocol. 
3) Provision of informed, written consent for the ischemia substudy. 
12.4.1.2. Exclusion Criteria. (The following exclusions are in addition to the general 
exclusion criteria for the ABSORB IV trial.) 
1) Atrial fibrillation. 
2) Contraindication to adenosine. Contraindications include including 2nd or 3rd 
degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, 
severe asthma, severe COPD or bronchodilator-dependent COPD. 
3) Any condition making it unlikely that the patient will be unable or unwilling to 
follow all the ischemia substudy procedures. 
12.4.2. Test Schedule and Subject Visits 
Patients enrolled in the RESOLVE study will not undergo the ABSORB-RESOLVe specific 
testing in the protocol. Clinical follow-up will continue as per protocol and these patients will 
remain in full cohort analysis. All related imaging analysis will not be conducted.  
12.4.2.1. Baseline CT 
• Baseline CT (CT#1) performed after registration/randomization and after PCI but 
no later than 7 days after implantation of Absorb BVS or XIENCE in all eligible 
subjects. This test may be performed as an in-patient prior to hospital discharge, 
or after hospital discharge in a study approved facility. 
• For subjects in who the randomized PCI procedure is staged, CT#1 should be 
performed after the last staged procedure. Other tests, however (SPECT and 
CT#2) should be performed at a time course based on completion of the first PCI 
procedure (a similar procedure to clinical follow-up in the main ABSORB IV 
randomized trial).  
12.4.2.2. 14 ± 1 months (i.e. 13-15 months) SPECT 
• A 14 ± 1 month SPECT study will be performed for all eligible subjects, except 
under the following conditions (Figures 12.4.2 a, b): 
o Subjects with stable angina occurring before the 14 ± 1 month SPECT should 
receive a SPECT exam at the unscheduled visit, if clinically indicated or 
feasible. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 220 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
o If SPECT performed at the unscheduled visit shows no evidence of suspected 
ischemia, the following conditions apply: 
 If the SPECT exam occurred within ≤ 7 months of the index PCI, the 14 ± 
1 month SPECT must still be performed. 
 If the SPECT exam occurred > 7 months after the index PCI, the 14 ± 1 
month SPECT does not have to be performed; the SPECT performed at 
unscheduled visit will be analyzed as having met the 14 ± 1 month SPECT 
requirement. 
o If SPECT shows evidence of suspected ischemia at the unscheduled visit, it is 
strongly recommended that intracoronary angiography (ICA) is performed. 
 If the ICA demonstrates no in-stent restenosis (ISR) and TLR is not 
performed on all target lesions, the following conditions apply: 
- 
If the unscheduled visit occurred within ≤ 7 months of the index PCI, 
the 14 ± 1 month SPECT must still be performed. 
- 
If the unscheduled visit occurred > 7 months after the index PCI, the 
14 ± 1 month SPECT does not have to be performed; the SPECT 
performed at the unscheduled visit will be analyzed as having met the 
14 ± 1 month SPECT requirement. 
 If the ICA demonstrates ISR (QCA diameter stenosis > 50% as 
determined by the angiographic core laboratory), the following conditions 
apply: 
- 
If TLR is not performed on all target lesions, the 14 ± 1 month SPECT 
must still be performed. 
- 
If TLR is performed on all target lesions, or if ISR (QCA diameter 
stenosis > 50% as determined by the angiographic core laboratory) in 
all target lesions is present, the 14 ± 1 month SPECT does not have to 
be performed; the SPECT performed at the unscheduled visit will be 
analyzed as having met the 14 ± 1 month SPECT requirement. 
• Subjects with severe unstable angina or MI and suspected ISR occurring before 
the 14 ± 1 month SPECT who can’t exercise are not required to undergo SPECT 
before the unscheduled ICA. 
o If TLR was not performed on all target lesions, a 14 ± 1 month SPECT must 
still be performed. 
o If TLR is performed on all target lesions, or if ISR (QCA diameter stenosis > 
50% as determined by the angiographic core laboratory) in all target lesions is 
present, the 14 ± 1 month SPECT does not need to be performed. 
• If subjects miss CT#1, they should still undergo the 14 ± 1 month SPECT study. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 221 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• All subjects are strongly recommended to discontinue their anti-angina 
medications (i.e., nitrates, calcium channel blockers, and beta-blockers) 24 hours 
prior to the SPECT if there are no contraindications to discontinuing. Patients 
with recurrent angina are not required to discontinue their anti-angina 
medications. 
12.4.2.3. 62 ± 1 month CT 
• A 62 ± 1 month CT study will be performed for all eligible subjects, except under 
the following conditions (Figures 12.4.2.a, c): 
o Subjects with stable angina occurring before the 62 ± 1 month CT study 
should receive a CT exam at the unscheduled visit, if clinically indicated or 
feasible. If this event has occurred before 15 months and if SPECT has not yet 
been performed, this CT may be done on the same day as or within a few days 
of the SPECT imaging (note: if only one study can be performed in this time 
period, the SPECT should be given preference). If this event has occurred 
after 15 months or if SPECT had already been performed, the CT#2 exam 
should be performed (without SPECT). 
o If the CT performed at the unscheduled visit shows no evidence of suspected 
ischemia, the following conditions apply: 
 If the CT exam occurred within ≤ 36 months of the index PCI, the 62 ± 1 
month CT exam must still be performed. 
 If the CT exam occurred > 36 months after the index PCI, the 62 ± 1 
month CT exam does not have to performed; the CT performed at 
unscheduled visit will be analyzed as having met the 62 ± 1 month CT 
requirement. 
o If the CT exam shows evidence of suspected ischemia at the unscheduled 
visit, it is strongly recommended that the subject undergo intracoronary 
angiography (ICA). 
 If the ICA demonstrates no in-stent restenosis (ISR) and TLR is not 
performed on all target lesions, the following conditions apply: 
- 
If the unscheduled visit occurred within ≤ 36 months of the index PCI, 
the 62 ± 1 month CT exam must still be performed. 
- 
If the unscheduled visit occurred > 36 months after the index PCI, the 
62 ± 1 month CT exam does not have to performed; the CT exam 
performed at the unscheduled visit will be analyzed as having met the 
62 ± 1 month CT requirement. 
 If the ICA demonstrates ISR (QCA diameter stenosis > 50% as 
determined by the angiographic core laboratory), the following conditions 
apply: 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 222 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
- 
If TLR is not performed on all target lesions, the 62 ± 1 month CT 
exam must still be performed. 
- 
If TLR is performed on all target lesions, or if ISR (QCA diameter 
stenosis > 50% as determined by the angiographic core laboratory) in 
all target lesions is present, the 62 ± 1 month CT exam does not have 
to performed; the CT exam performed at the unscheduled visit will be 
analyzed as having met the 62 ± 1 month CT exam requirement. 
• Subjects with severe unstable angina or MI and suspected ISR occurring before 
the 62 ± 1 month CT exam who can’t exercise are not required to undergo the CT 
exam before the unscheduled ICA. 
o If TLR was not performed on all target lesions, a 62 ± 1 month CT exam must 
still be performed. 
o If TLR is performed on all target lesions, or if ISR (QCA diameter stenosis > 
50% as determined by the angiographic core laboratory) in all target lesions is 
present, the 62 ± 1 month CT exam does not need to be performed. 
• If subjects miss CT#1, they should still undergo the 62 ± 1 month CT exam study. 
• All subjects are strongly recommended to discontinue their anti-angina 
medications (i.e., nitrates, calcium channel blockers, and beta-blockers) 24 hours 
prior to the CT exam if there are no contraindications to discontinuing. Patients 
with recurrent angina are not required to discontinue their anti-angina 
medications. 
Both CT and SPECT should be performed in accordance with standard guidelines and standard 
protocols. The baseline and 62 ± 1 month CT protocol will be performed under rest and 
pharmacologic stress conditions. The 14 ± 1 month SPECT will be performed under rest and 
exercise stress conditions. Complete details regarding the each imaging modality and protocol 
will be provided in the ABSORB-RESOLVe guidance document provided to all participating 
sites. All participating ABSORB-RESOLVe sites will be required to submit one non-study 
SPECT and CT study to the core laboratory for site qualification prior to beginning enrollment. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 223 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Figure 12.4.2 a. Sub-study design: Overall Trial Flow  
 
 
Randomization
ABSORB or XIENCE 
 within 7 days after index procedure
14 ± 1 mo
62 ± 1 mo
See Figure 
12.4.2b
See Figure 
12.4.2c
CT #1
Within 7 day post-PCI
SPECT
14 ± 1 mo
CT #2
62 ± 1 mo
ICA due to 
suspected 
ISR, recurrent 
angina, other 
cardiac symptoms 
ICA due to 
suspected 
ISR, recurrent 
angina, other 
cardiac symptoms 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 226 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
12.4.3. Procedural Assessments and Treatment Strategy 
In the ABSORB-RESOLVe sub-study, all pre-procedure and post-procedure assessments, 
coronary lesion selection, treatment strategy and antiplatelet regimens must be followed as 
described in the ABSORB IV parent trial section. 
Patients enrolled in the RESOLVE study will not undergo the ABSORB-RESOLVe specific 
testing in the protocol. Clinical follow-up will continue as per protocol and these patients will 
remain in full cohort analysis. All related imaging analysis will not be conducted.  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 227 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
12.5. References 
1) Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada 
M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, 
Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; 
COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable 
coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16.  
2) BARI 2D Study Group, Frye RL, August P, Brooks MM, Hardison RM, Kelsey SF, 
MacGregor JM, Orchard TJ, Chaitman BR, Genuth SM, Goldberg SH, Hlatky MA, Jones 
TL, Molitch ME, Nesto RW, Sako EY, Sobel BE. A randomized trial of therapies for type 2 
diabetes and coronary artery disease. N Engl J Med. 2009 Jun 11;362(24):2503-15.  
3) Kereiakes DJ, Teirstein PS, Sarembock IJ, Holmes DR Jr, Krucoff MW, O'Neill WW, 
Waksman R, Williams DO, Popma JJ, Buchbinder M, Mehran R, Meredith IT, Moses JW, 
Stone GW. The truth and consequences of the COURAGE trial. J Am Coll Cardiol. 2007 Oct 
16;50(16):1598-623.  
4) Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan 
PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree 
R, Barnett PG, Teo KK, Boden WE; COURAGE Trial Research Group, Mancini GB. Effect 
of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008 Aug 
14;359(7):677-87.  
5) Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, 
O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, 
Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates 
ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy 
with or without percutaneous coronary intervention to reduce ischemic burden: results from 
the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation 
(COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. 
6) Klocke FJ, Baird MG, Lorell BH, Bateman TM, Messer JV, Berman DS, et al. 
ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging--executive 
summary: a report of the American College of Cardiology/American Heart Association Task 
Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 1995 Guidelines 
for the Clinical Use of Cardiac Radionuclide Imaging). Journal of the American College of 
Cardiology. 2003;42(7):1318-33. 
7) Davies RF, Goldberg AD, Forman S, Pepine CJ, Knatterud GL, Geller N, Sopko G, Pratt C, 
Deanfield J, Conti CR. Asymptomatic Cardiac Ischemia Pilot (ACIP) study two-year follow-
up: outcomes of patients randomized to initial strategies of medical therapy versus 
revascularization.Circulation. 1997 Apr 15;95(8):2037-43. 
8) Erne P, Schoenenberger AW, Burckhardt D, Zuber M, Kiowski W, Buser PT, Dubach P, 
Resink TJ, Pfisterer M. Effects of percutaneous coronary interventions in silent ischemia 
after myocardial infarction: the SWISSI II randomized controlled trial.JAMA. 2007 May 
9;297(18):1985-91. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 228 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
9) Dowsley T, Al-Mallah M, Ananthasubramaniam K, Dwivedi G, McArdle B, Chow BJ. The 
role of noninvasive imaging in coronary artery disease detection, prognosis, and clinical 
decision making. Can J Cardiol. 2013 Mar;29(3):285-96.  
10) Gershlick AH, de Belder M, Chambers J, Hackett D, Keal R, Kelion A, et al. Role of non-
invasive imaging in the management of coronary artery disease: an assessment of likely 
change over the next 10 years. A report from the British Cardiovascular Society Working 
Group. Heart. 2007;93(4):423-31.  
11) Shaw LJ, Marwick TH, Zoghbi WA, Hundley WG, Kramer CM, Achenbach S, et al. Why all 
the focus on cardiac imaging? JACC Cardiovascular imaging. 2010;3(7):789-94. 
12) Fleischmann KE, Hunink MG, Kuntz KM, Douglas PS. Exercise echocardiography or 
exercise SPECT imaging? A meta-analysis of diagnostic test performance. Journal of nuclear 
cardiology : official publication of the American Society of Nuclear Cardiology. 
2002;9(1):133-4. 
13) Min JK, Shaw LJ, Berman DS. The present state of coronary computed tomography 
angiography a process in evolution. Journal of the American College of Cardiology. 
2010;55(10):957-65. 
14) Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, et al. Diagnostic 
performance of 64-multidetector row coronary computed tomographic angiography for 
evaluation of coronary artery stenosis in individuals without known coronary artery disease: 
results from the prospective multicenter ACCURACY (Assessment by Coronary Computed 
Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. 
Journal of the American College of Cardiology. 2008;52(21):1724-32. 
15) Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, et al. Diagnostic 
performance of coronary angiography by 64-row CT. The New England journal of medicine. 
2008;359(22):2324-36. 
16) Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, et al. 
Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, 
multicenter, multivendor study. Journal of the American College of Cardiology. 
2008;52(25):2135-44. 
17) Min JK, Dunning A, Lin FY, Achenbach S, Al-Mallah M, Budoff MJ, et al. Age- and sex-
related differences in all-cause mortality risk based on coronary computed tomography 
angiography findings results from the International Multicenter CONFIRM (Coronary CT 
Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry) of 
23,854 patients without known coronary artery disease. Journal of the American College of 
Cardiology. 2011;58(8):849-62. 
18) Kumbhani DJ, Ingelmo CP, Schoenhagen P, Curtin RJ, Flamm SD, Desai MY. Meta-analysis 
of diagnostic efficacy of 64-slice computed tomography in the evaluation of coronary in-stent 
restenosis. Am J Cardiol. 2009 Jun 15;103(12):1675-81. 
19) Onuma Y, Dudek D, Thuesen L, Webster M, Nieman K, Garcia-Garcia HM, Ormiston JA, 
Serruys PW. Five-year clinical and functional multislice computed tomography angiographic 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 229 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
results after coronary implantation of the fully resorbable polymeric everolimus-eluting 
scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial. JACC 
Cardiovasc Interv. 2013 Oct;6(10):999-1009. 
20) O’Day K and Min JK. Two-Year Diagnostic Costs Using a Coronary CT Angiographic-
Based Diagnostic Algorithm for Patients with Suspected In-stent Restenosis Previously 
Stented with Bioresorbable Vascular Scaffold versus Metallic Stents. CRT 2014 (Abstract 
accepted). 
21) Ko BS, Cameron JD, Defrance T, Seneviratne SK. CT stress myocardial perfusion imaging 
using multidetector CT--A review. J Cardiovasc Comput Tomogr. 2011Nov-Dec;5(6):345-
56.  
22) George RT, Jerosch-Herold M, Silva C, Kitagawa K, Bluemke DA, Lima JA, Lardo AC. 
Quantification of myocardial perfusion using dynamic 64-detector computed tomography. 
Invest Radiol. 2007 Dec;42(12):815-22. 
23) George RT, Arbab-Zadeh A, Miller JM, Kitagawa K, Chang HJ, Bluemke DA, Becker L, 
Yousuf O, Texter J, Lardo AC, Lima JA. Adenosine stress 64- and 256-row detector 
computed tomography angiography and perfusion imaging: a pilot study evaluating the 
transmural extent of perfusion abnormalities to predict atherosclerosis causing myocardial 
ischemia. Circ Cardiovasc Imaging. 2009 May;2(3):174-82. 
24) Rochitte CE, George RT, Chen MY, Arbab-Zadeh A, Dewey M, Miller JM, Niinuma H, 
Yoshioka K, Kitagawa K, Nakamori S, Laham R, Vavere AL, Cerci RJ, Mehra VC, Nomura 
C, Kofoed KF, Jinzaki M, Kuribayashi S, de Roos A, Laule M, Tan SY, Hoe J, Paul N, 
Rybicki FJ, Brinker JA, Arai AE, Cox C, Clouse ME, Di Carli MF, Lima JA. Computed 
tomography angiography and perfusion to assess coronary artery stenosis causing perfusion 
defects by single photon emission computed tomography: the CORE320 study. Eur Heart J. 
2013 Nov 19. [Epub ahead of print]  
25) Taylor CA, Fonte TA, Min JK. Computational fluid dynamics applied to cardiac computed 
tomography for noninvasive quantification of fractional flow reserve: scientific basis. J Am 
Coll Cardiol. 2013 Jun 4;61(22):2233-41.  
26) Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, 
Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini 
GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve 
from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45.  
27) Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky 
A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive 
fractional flow reserve computed from coronary computed tomographic angiograms. Results 
from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing 
Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 
2011 Nov 1;58(19):1989-97.  
28) Nørgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri  L, De 
Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, 
Kaltoft A, Lassen JF, Bøtker HE, Achenbach S; NXT Trial Study Group. Diagnostic 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 230 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
Performance of Noninvasive Fractional Flow Reserve Derived From Coronary Computed 
Tomography Angiography in Suspected Coronary Artery Disease: The NXT Trial (Analysis 
of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 
1;63(12):1145-55.  
29) Chevalier, B. ABSORB Cohort B Trial:  Evaluation of the Absorb Everolimus Eluting 
Bioresorbable Vascular Scaffold (Absorb) in the Treatment of Patients with de novo Native 
Coronary Artery Lesions – 4-Year Clinical Results of Cohort B1.  Chevalier, Bernard.  
Transcatheter Cardiovascular Therapeutics 2013. 
30) Onuma Y, Dudek D, Thuesen L, Webster M, Nieman K, Garcia-Garcia HM, Ormiston JA, 
Serruys PW.  Five-year clinical and functional multislice computed tomography 
angiographic results after coronary implantation of the fully resorbable polymeric 
everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB 
cohort A trial.  JACC Cardiovasc Interv. 2013 Oct;6(10):999-1009. 
31) Gada, Hemal; Kirtane, Ajay J; Newman, William; Sanz, Mark; Hermiller, James B; 
Mahaffey, Kenneth W; Cutlip, Donald E; Sudhir, Krishnankutty; Hou, Liming; Koo, Kai; 
Stone, Gregg W.  Five-Year Results of a Randomized Comparison of XIENCE V 
Everolimus-Eluting and TAXUS Paclitaxel-Eluting Stents: Final Results From the SPIRIT 
III Trial.  JACC. Cardiovascular interventions (Nov 7, 2013). 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 231 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX I: ABBREVIATIONS AND ACRONYMS 
Please refer to APPENDIX I of ABSORB III Protocol (
 
 March 14, 2017) for a 
complete list of abbreviations and acronyms. 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 232 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX II: DEFINITIONS 
Please refer to Appendix II of ABSORB III Protocol (
 
, March 14, 2017) for 
complete list of definitions. New or updated definitions are listed below: 
MYOCARDIAL INFARCTION (MI)  
Protocol MI Definition: Periprocedural MI definition is modified from Moussa ID, Klein LW, 
Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW. 
Consideration of a new definition of clinically relevant myocardial infarction after coronary 
revascularization: an expert consensus document from the Society for Cardiovascular 
Angiography and Interventions (SCAI). J Am Coll Cardiol. 2013 Oct 22;62(17):1563-70. 
This definition will be used for the primary analysis of ABSORB IV and secondary analysis of 
ABSORB III. 
Classification 
Biomarker Criteria 
Additional Criteria 
Periprocedural – patients 
with a) stable CAD, or b) 
silent ischemia, or c) 
acute coronary 
syndromes with at least 2 
baseline troponin values 
which remained <ULN, 
or d) acute coronary 
syndromes in whom the 
troponin and/or CK-MB 
levels were elevated but 
all returned to <ULN 
prior to the procedure 
Absolute CK-MB rises within 48 hours of 
the procedure to > 5 x ULN for post-PCI 
or CK-MB > 10 x ULN for post-CABG 
Baseline value* < ULN; see also 
** 
Periprocedural – patients 
with stable CAD and 
elevated baseline CK-
MB, or acute coronary 
syndromes in whom at 
least 2 baseline troponin 
and CK-MB values were 
drawn and the most 
recent troponin and CK-
MB values were less 
than the preceding 
measures by >25% 
Absolute incremental CK-MB rise within 
48 hours of the procedure from the most 
recent CK-MB level by > 5 x ULN for 
post-PCI or > 10 x ULN for post-CABG 
 
Periprocedural – patients 
with elevated baseline 
CK-MB in whom the 
biomarker levels have 
not been shown to be 
stable or falling as 
defined above (either 
because only one CK-
MB was measured, or 
the most recent CK-MB 
measure in a series was 
either still increasing or 
had not decreased by 
The CK-MB rises within 48 hours of the 
procedure by an absolute increment from 
the most recent CK-MB level of  > 5 x 
ULN for post-PCI or > 10 x ULN for post-
CABG plus new ST-segment elevation or 
depression plus signs consistent with a 
clinically relevant MI, such as new onset 
or worsening heart failure or sustained 
hypotension. 
The following must also be 
present: 
1. New ST-segment elevation or 
depression, 
2. Plus signs consistent with a 
clinically relevant MI, such as 
new onset or worsening heart 
failure or sustained 
hypotension. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 233 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
>25% from the most 
recent measure) 
Spontaneous (before or 
>48 hours after any 
coronary 
revascularization 
procedure) 
Troponin >ULN or CK-MB > ULN 
 
  
One or more of the following must 
also be present: 
- Symptoms of ischemia;   
- ECG changes  indicative of new 
ischemia -  (new ST-T changes or 
new LBBB),   
- Development of pathological Q 
waves;   
 - Imaging evidence of a new loss 
of  viable myocardium or a new 
regional wall  motion abnormality 
ULN=Upper limits of the local laboratory normal (will be collected from each hospital laboratory prior 
to study commencement);  
LBBB=Left Bundle-branch Block 
* Baseline CKMB value is required before study procedure and presumes a typical rise and fall post 
procedure to diagnose a peri procedure MI 
 
** Whenever at least one baseline and one post procedure CK-MB measure are available in a patient 
with stable CAD, adjudication of MI will be based solely on these biomarker values. If the patient has 
stable ischemic heart disease and the baseline CK-MB measure are not available, they will be assumed to 
be within normal limits and MI will be adjudicated by the CEC solely according to the post procedure 
CK-MB measures. TROPONINS WILL NOT BE USED TO DIAGNOSE PERI-PROCEDURAL MI.  
• Periprocedural MI After PCI:  
The periprocedural period includes the first 48 hours after PCI. 
• Periprocedural MI After CABG:  
The periprocedural period includes the first 48 hours after coronary artery bypass grafting 
(CABG). 
• Spontaneous MI:  
MI after the periprocedural period may be secondary to late stent complications or 
progression of native disease. Performance of ECG and angiography supports 
adjudication to either a target or non-target vessel in most cases.  
With the unique issues and pathophysiological mechanisms associated with these later 
events as well as the documented adverse impact on short and long-term prognosis, a 
more sensitive definition than for periprocedural MI of any elevation of troponin or 
CKMB above the 99th percentile of the upper range limit (or ULN if URL is not 
available) is used. All late events that are not associated with a revascularization 
procedure will be considered simply as spontaneous. 
Myocardial infarctions will also be adjudicated based on the following classification:  
• Q wave MI  
Development of new, pathological Q wave on the ECG (≥ 0.04 seconds in duration and ≥ 
1 mm in depth) in ≥ 2 contiguous precordial leads or ≥ 2 adjacent limb leads) 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 234 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
• Non-Q wave MI  
Those MIs which are not Q-wave MI. 
Myocardial infarctions will also be adjudicated as to their relation to the Target Vessel 
All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be 
considered related to the target vessel. 
For Universal and WHO MI definitions, please refer to ABSORB III protocol (
 
, 
August 16, 2018). These definitions will be used for secondary analysis for ABSORB IV and 
ABSORB III.   
ANGINA 
Angina is defined as any angina or angina equivalent symptoms determined by the physician 
and/or research coordinator after interview of the patient, and as adjudicated by a clinical events 
committee (CEC).  
ADVERSE EVENT [AE] 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device. 
NOTE 1: This definition includes events related to the investigational medical device or the 
comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a medicinal (investigational) 
product, whether or not related to the medicinal (investigational) product. 
UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT 
Unanticipated serious adverse device effect (USADE) refers to any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, a device, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects. 
SERIOUS ADVERSE EVENT [SAE] 
If the AE meets any of the criteria below, it is regarded as serious adverse event (SAE).  
a) Led to a death, 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 235 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
b) Led to a serious deterioration in health that either: 
1) Resulted in a life-threatening illness or injury, or 
2) Resulted in a permanent impairment of a body structure or a body function, or 
3) Required in-patient hospitalization or prolongation of existing hospitalization, or 
4) Resulted in medical or surgical intervention to prevent life threatening illness or injury 
or permanent impairment to a body structure or a body function. 
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
d) An important medical event that may not result in death, be life-threatening, or require 
hospitalization but may be considered serious when, based upon appropriate medical judgment, 
may jeopardize the subject and/or may require intervention to prevent one of the outcomes listed 
in this definition. 
NOTE 1: This includes device deficiencies that might have led to a serious adverse event if a) 
suitable action had not been taken or b) intervention had not been made or c) if circumstances 
had been less fortunate. These are handled under the SAE reporting system. 
NOTE 2: A planned hospitalization for pre-existing condition, or a procedure required by the 
Clinical Investigation Plan, without a serious deterioration in health, is not considered to be a 
serious adverse event. 
DEVICE DEFICIENCY (DD) 
Device deficiency (DD) is defined as an inadequacy of a medical device related to its identity, 
quality, durability, reliability, safety or performance, such as malfunction, misuse or use error 
and inadequate labeling. This includes the failure of the device to meet its performance 
specifications or otherwise perform as intended.  Note: performance specifications include all 
claims made in the labeling of the device.  
PRODUCT EXPERIENCE (PE) 
Product Experience (PE) is defined as any expression of customer concern or dissatisfaction, 
including adverse events and patient issues that occurred during or after the use of a 
commercially available medical device. 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 237 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
5. 
Pre-procedure ECG preferred to be done within 24 hours. Post-procedure ECG must be done within 24 hours post-
index procedure.  
6. 
Refer to body of the protocol for details regarding pre-procedure antiplatelet loading requirements. Post-procedure: 
prasugrel 5 or 10 mg daily, clopidogrel a minimum of 75 mg daily or ticagrelor 90 mg twice daily, must be given for a 
minimum of 12 months, and Aspirin ≥ 75 mg to ≤ 100 mg daily must be taken through 5 years follow up (potentially 
up to 10 years follow-up) during the study, and should continue to be taken indefinitely. If a subject develops 
hypersensitivity to clopidogrel, prasugrel or ticagrelor, subject may be switched to ticlopidine at a dose in accordance 
with standard hospital practice.   
7. 
For unscheduled visits for suspected ischemic cardiac events, sites should make reasonable efforts to obtain cardiac 
enzymes (Troponin I or T), CK and CK-MB, and/or ECG if the site is aware of the visit at the time of its occurrence. In 
all other scenarios (i.e., site does not become aware until after the fact), no protocol deviation will be issued if Troponin 
I or T, CK and CK-MB, and/or ECG were not obtained at the time of the unscheduled visit. 
8. 
Baseline (prior to pre-dilatation) and final (after stenting/post dilatation) angiogram must be obtained and sent to the 
core laboratory.  
9. 
Every effort should be made to have subjects complete all patient reported outcomes questionnaires (EQ-5D and SAQ-
7) prior to the procedure.  However, in situations where this is absolutely not possible, subjects may complete them 
post-procedure, prior to discharge.  Subjects who complete their questionnaires post-procedure should base their 
responses on their condition prior to the procedure.    
10. All registered subjects may complete PRO (EQ-5D and SAQ-7) at 30, 180 days, and at 1, 3 and 5 years. 
11. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD and for ACS patients it  
must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left 
ventriculography during the index procedure but prior to randomization in order to confirm the subject’s eligibility 
12. Administered ≥ 4 hours to ≤ 7 days after the procedure, preferably before hospital discharge, and at 1 year follow-up. 
13. Baseline CT Angiogram/Perfusion will be performed up to 7 days after the index procedure or staged procedure, 
whichever occurs last. 
14. Only for subjects in the ABSORB-RESOLVe Ischemia Sub-study. The first CT will be conducted between the day of 
the index or staged procedure, whichever occurs last, up to 7 days after that procedure. The SPECT will be completed 
at 14 ± 1 month and the second CT will be conducted at 62 ± 1 month. 
15. If a subject enrolled in the ABSORB-RESOLVe Ischemia Sub-study has a cardiovascular related unscheduled event, 
please follow the procedures outlined in section 12.4.2.2 and 12.4.2.3. 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 238 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX IV: 
ENROLLMENT AND REGISTRATION 
PROCESS 
 
   
 
 
 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 239 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
   
    
 
 
 
 
 
 
 
 
 
 
 
 
   
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
    
  
 
• 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
p
  
 
  
    
 
 
 
 
   
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 240 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX V: VESSEL TREATMENT & RANDOMIZATION 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 241 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
  
 
 
 
 
 
  
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 242 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
r
  
 
 
 
 
   
 
 
 
   
 
r
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
  
r
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
  
 
 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 243 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX VI: RISK STRATIFICATION OF CARDIAC 
CATHERIZATION, STENTING AND PERCUTANEOUS 
TRANSCATHETER CORONARY ANGIOPLASTY 
Potential risks associated with the study device and everolimus were described in the original 
protocol. Based on additional clinical and commercial experience, and more conservative 
grouping of MedDRA Preferred Terms, Abbott Vascular can now provide a consolidated list of 
anticipated adverse events and, in alignment with ISO14155:2011 requirements, the estimated 
frequencies of those risks. 
There is extensive clinical and commercial experience worldwide with cardiac catheterization 
and interventional procedures. It is expected that the risks will not be significantly different with 
the use of the Absorb BVS and XIENCE V stent in this trial. The incidence rates of the known 
complications that may arise from a stenting procedure were obtained from the pooled XIENCE 
V trials conducted by AV (Spirit First, Spirit II, Spirit III RCT, Spirit III JPN, Spirit III 4.0 mm, 
Spirit IV, Spirit V Diabetic, Spirit V Registry, Spirit Women, XV USA, XV DAPT, and XV 
India using MedDRA Preferred Terms of site-reported 1 year adverse events regardless of 
relationship to device or procedure ) and were classified using the frequency categories as below.  
Death and stent thrombosis within 1 year have been observed in < 2.0% of the patients enrolled 
in these trials. 
1. Very common: ≥ 10%: Unstable or stable angina pectoris  
2. Common: ≥ 1.0% to < 10%: Cardiac, pulmonary or renal failure; access site complications 
including pain, hematoma, or hemorrhage; vascular complication including at the entry site, 
which may require vessel repair; coronary artery dissection; arrhythmia including atrial and 
ventricular; myocardial infarction, including acute myocardial infarction; nausea and vomiting; 
hypotension; hypertension; restenosis 
3. Uncommon: ≥ 0.1% to < 1.0%: Cardiac arrest; emergent or non-emergent surgery; allergic or 
hypersensitivity reactions to contrast agent or platinum, polymer poly (L-lactide) (PLLA), 
polymer poly (D,L-lactide) (PDLLA), and drug reactions to everolimus, antiplatelet drugs or 
contrast agent; bleeding complications which may require transfusion; coronary artery spasm; 
distal emboli; fever; catheter site infection or pain; myocardial ischemia; palpitations; coronary 
artery perforation; pericarditis; peripheral ischemia (due to vascular injury); pseudoaneurysm; 
pulmonary edema; stroke/CVA/TIA; total occlusion of coronary artery; ventricular tachycardia; 
and ventricular fibrillation; vessel dissection 
4. Rare: ≥ 0.01% to < 0.1%: Arteriovenous fistula; cardiac tamponade; coronary artery 
embolism; arterial injury; procedural nausea; shock; peripheral artery dissection; peripheral 
nerve injury; renal insufficiency; pericardial effusion 
5. Very Rare: < 0.01% (including not reported AEs): Abrupt coronary artery closure; coronary 
artery aneurysm; arterial rupture; everolimus IFU risks. 
Some IFU risks, including everolimus risks have not been observed in AV clinical studies. These 
risks are listed in the very rare category. There may be risks related to the device that are 
unknown at present. Likewise the exact frequency of the risk might be unknown. 

Abbott Vascular 
 
 
ABSORB III Randomized Controlled Trial 10-392 
Page 244 of 244 
August 16, 2018  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ABSORB III Randomized Control Trial 
 
 August 16, 2018. 
APPENDIX VII: 
CONTACT INFORMATION 
A list of investigational site co-ordinates can be obtained upon request from the Clinical Project 
Manager for the study. The Clinical Project Manager can be reached at 
.