Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS)
Phase: NA
Conditions: Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion, Myocardial Ischemia
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: NCT03409731 
Absorb GT1 Japan PMS 
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS) 
Study Document No: 16-310 
Version 1.0 
Date: 08 November 2016 
 
 
Sponsor  
 
 
Abbott Vascular Japan Co., Ltd. 
        
 
 
 
3-5-27 Mita, Minato-ky, Tokyo 108-6304 
        
 
 
 
Japan 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Absorb GT1 Bioresorbable Vascular Scaffold System 
Post-marketing Surveillance Protocol 
 
16-310  
 
 
 
 
 
 
 
Principal Investigator: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbott Vascular Japan Co., Ltd. 
 
 
 
Result of this post-marketing surveillance shall be reported to the Ministry of Health, Labour and Welfare 
as a condition to marketing approval of the Absorb GT1 Bioresorbable Vascular Scaffold System. 
Your cooperation in this surveillance would be highly appreciated. 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Surveillance Device Approval Number 
 
 
 
Surveillance Device Approval Date 
 
Nov 2, 2016. 
 
Generic Name of the Surveillance 
Device 
 
Absorbable Coronary Stent 
 
Brand Name of the Surveillance Device 
 
Absorb GT1 Bioresorbable Vascular Scaffold System 
 
Surveillance Period (Registration Period) 
 
 
 
  
 
 
 
  
  
 
 
 
 
Post-marketing Surveillance Sponsor 
 
 
 
 
 
 
 
 
 
 
 
 
Post-marketing Surveillance Manager 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents 
 
LIST OF ACRONYMS AND ABBREVIATIONS ................................................................................................ 6 
1. 
PURPOSE ....................................................................................................................................................... 8 
2. 
SURVEILLANCE METHOD ...................................................................................................................... 8 
2.1 
SUBJECTS ................................................................................................................................................. 8 
2.2 
REGISTRATION METHOD .......................................................................................................................... 8 
2.3 
PLANNED SAMPLE SIZE .......................................................................................................................... 10 
2.4 
METHOD ................................................................................................................................................. 10 
3. 
SURVEILLANCE PERIOD ....................................................................................................................... 12 
4. 
TREATMENT OF PATIENTS .................................................................................................................. 13 
5. 
INFORMATION TO BE COLLECTED FOR THE SURVEILLANCE ............................................... 13 
5.1 
PATIENT BASELINE INFORMATION ......................................................................................................... 13 
1) 
Rave System Information ....................................................................................................................... 13 
2) 
Registration Information ....................................................................................................................... 13 
3) 
Demography .......................................................................................................................................... 13 
4) 
Ischemic Status and Other Cardiac Complications ............................................................................... 13 
5) 
Risk Factors and Comorbidities ............................................................................................................ 13 
6) 
Pre-procedural Laboratory Tests (If done, cardiac enzyme to be captured in cardiac enzyme form) .. 13 
7) 
Pre-procedural Antiplatelet Medications .............................................................................................. 13 
5.2 
PROCEDURAL INFORMATION .................................................................................................................. 13 
1) 
Basic Procedural Information ............................................................................................................... 14 
2) 
Treated Lesion Information (Per lesion, stenting procedure only. Bifurcation lesion should be 
regarded as two lesions if both stented) ......................................................................................................... 14 
3) 
Pre-dilatation/Preparation (to be generated per dilatation/preparation) ............................................. 14 
4) 
Stenting Information (Including attempted but not implanted, to be generated per stent) .................... 14 
5) 
Post-dilatation (to be generated per dilatation) .................................................................................... 14 
6) 
Final Results .......................................................................................................................................... 14 
5.3 
PRE- AND POST-PROCEDURAL CARDIAC ENZYMES ................................................................................ 14 
5.4 
PROCEDURAL COMPLICATIONS .............................................................................................................. 14 
5.5 
ANTIPLATELET MEDICATIONS AFTER THE PROCEDURE .......................................................................... 14 
5.6 
OTHER MEDICATIONS (PRE/POST-PROCEDURE) ..................................................................................... 14 
5.7 
CLINICAL FOLLOW-UP ............................................................................................................................ 14 
5.8 
IMAGING FOLLOW-UP (TARGET LESION ONLY) ....................................................................................... 14 
1) 
Primary imaging modality ..................................................................................................................... 14 
2) 
If MSCT/MRA, Restenosis assessment ................................................................................................... 14 
3) 
CAG ....................................................................................................................................................... 14 
4) 
Intravascular imaging ........................................................................................................................... 14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.9 
DEVICE MALFUNCTION/DEFICIENCY ..................................................................................................... 14 
5.10 
SCAFFOLD/STENT THROMBOSIS ............................................................................................................. 14 
5.11 
ADVERSE EVENT OTHER THAN ST (TO BE REPORTED) ........................................................................... 14 
5.12 
ADDITIONAL TREATMENT (IF DONE WITH ABSORB GT1) ....................................................................... 15 
1) 
Type ....................................................................................................................................................... 15 
2) 
Basic Procedural Information ............................................................................................................... 15 
3) 
Treated Lesion Information (Per lesion, stenting procedure only. Bifurcation lesion should be 
regarded as two lesions if both stented) ......................................................................................................... 15 
4) 
Pre-dilatation/Preparation (to be generated per dilatation/preparation) ............................................. 15 
5) 
Stenting Information (Including attempted but not implanted, to be generated per stent) .................... 15 
6) 
Post-dilatation (to be generated per dilatation) .................................................................................... 15 
7) 
Final Results .......................................................................................................................................... 15 
6. 
ENDPOINTS ................................................................................................................................................ 15 
6.1 
PRIMARY ENDPOINTS ............................................................................................................................. 15 
6.2 
OTHER ENDPOINTS ................................................................................................................................. 16 
6.2.1 
Clinical Endpoints ............................................................................................................................. 16 
6.2.2 
Angiographic Endpoints (core lab analysis) ..................................................................................... 16 
6.2.3 
IVUS/OCT Endpoints (core lab analysis) ......................................................................................... 17 
7. 
ANALYSIS AND REPORTING ................................................................................................................ 17 
7.1 
ADVERSE EVENT REPORTING ................................................................................................................. 17 
7.2 
ANGIOGRAPHIC CORE LABORATORY ..................................................................................................... 17 
7.3 
INTRAVASCULAR IMAGING ..................................................................................................................... 18 
7.4 
SCAFFOLD THROMBOSIS IMAGE-REVIEW COMMITTEE ........................................................................... 18 
7.5 
CLINICAL OBSERVATION - CLINICAL EVENTS COMMITTEE (CEC) ......................................................... 18 
7.6 
ANALYSIS OF SURVEILLANCE RESULTS ................................................................................................. 19 
8.  
PUBLICATION POLICY ........................................................................................................................... 19 
9.  
DEFINITIONS ............................................................................................................................................. 20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 6 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LIST OF ACRONYMS AND ABBREVIATIONS 
Acronym/ 
Abbreviation 
Description 
%DS 
Percent Diameter Stenosis 
ACC 
American College of Cardiology  
ACE 
Angiotensin-converting Enzyme 
ACS 
Acute Coronary Syndrome  
AHA 
American Heart Association  
ARB 
Angiotensin Receptor Blocker 
BVS 
Bioresorbable Vascular Scaffold 
CABG 
Coronary Artery Bypass Graft 
CAG 
Coronary Angiography 
CEC 
Clinical Event Committee  
CFR 
Coronary Flow Reserve  
CK 
Creatine Kinase 
CK-MB 
Creatine Kinase Myocardial Band Isoenzymes 
CRP 
C-reactive Protein 
CT 
Computer Tomography 
CTO 
Chronic Total Occlusion 
CVA 
Cerebrovascular Accident 
CVIT 
Japanese Association of Cardiovascular Intervention and Therapeutics 
DCA 
Directional Coronary Atherectomy 
ECG 
Electrocardiogram  
eGFR 
Estimated Glomerular Filtration Rate 
FFR 
Fractional Flow Reserve  
GPSP 
Good Post-marketing Study Practice 
HDL 
High Density Lipoprotein 
IFU 
Instruction for Use  
IVUS 
Intravascular Ultrasound 
LAD 
Left Anterior Descending Artery 
LCX 
Left Circumflex Artery 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 7 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Acronym/ 
Abbreviation 
Description 
LDL 
Low Density Lipoprotein 
LMCA 
Left Main Coronary Artery 
LMT 
Left Main Trunk 
LVEF 
Left Ventricular Ejection Fraction  
MACE 
Major Adverse Cardiac Event 
MI 
Myocardial Infarction  
MLA 
Minimal Lumen Area 
MLD 
Minimum Luminal Diameter  
MSCT 
Multiple Slice Computer Tomography 
MRA 
Magnetic Resonance Angiography 
NQMI 
Non Q-wave Myocardial Infarction 
NSTEMI 
Non-ST elevation Myocardial Infarction  
OCT 
Optical Coherence Tomography 
PCI 
Percutaneous Coronary Intervention 
PMS 
Post-marketing surveillance  
PRU 
P2Y12 Reaction Unit 
QCA 
Quantitative Coronary Angiography  
QMI 
Q-wave Myocardial Infarction 
RCA 
Right Coronary Artery 
RVD 
Reference Vessel Diameter  
ST 
Scaffold/Stent Thrombosis 
STEMI 
ST-elevation Myocardial Infarction 
SVG 
Great Saphenous Vein Graft 
TIA 
Transient Ischemia Attack  
TIMI 
Thrombolysis in Myocardial Infarction 
TLR 
Target Lesion Revascularization  
TVF 
Target Vessel Failure 
TVR 
Target Vessel Revascularization 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 8 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. 
PURPOSE 
 
This is a post-marketing use result surveillance (hereinafter referred to as “Surveillance”) conducted 
per the standards required by the Minster of Health, Labour and Welfare provided in the standards for 
post-marketing surveillances and studies [except for those defined in the Ministerial Ordinance on 
Good Clinical Practice for Medical Devices (MHLW Ordinance No. 36, 2005)] based on Paragraph 4, 
Article 23-2-9 (including application mutatis mutandis per Article 23-2-19 of Revised PAL) of the 
Law on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc. (Law No. 
145, 1960, hereinafter referred to as “Revised PAL”) by the Marketing Authorization Holder or 
accredited foreign manufacturer of a medical device defined in Paragraph 1, Article 23-2-5 of Revised 
PAL. The purpose of the Surveillance is to know the frequency and status of adverse device effects 
and adverse events in order to assure the safety of the new medical device, and to collect efficacy and 
safety information for evaluating clinical use results. 
 
2. 
SURVEILLANCE METHOD 
 
2.1 
Subjects 
 
Based on the Ministerial Ordinance on Good Post-marketing Study Practice for Medical Device, the 
Surveillance will continuously register patients with ischemic heart disease potentially indicated for 
treatment with the Absorb GT1 Bioresorbable Vascular Scaffold System (
 
 
 
 
  
 hereinafter referred to as “Absorb GT1”). 
 
Only on-label use of the Absorb GT1 will occur in this Surveillance until otherwise allowed by the 
Sponsor although this is a post-marketing use result surveillance. Detailed patient enrolment eligibility 
will be determined separately in guidelines. 
 
2.2 
Registration Method 
 
• 
The Surveillance may be conducted per site-specific requirements for patient registration to post-
marketing surveillance such as provision of information to patients and signed informed consent by 
patients, if applicable. 
• 
Patient registration will continuously occur when treatment with Absorb GT1 is attempted. 
• 
Lesions for which treatment with Absorb GT1 was attempted will be target lesions. 
o 
If an attempt of Absorb GT1 implantation was failed and the treatment was done with other 
stent/device instead, the background information and procedure information on the Absorb 
GT1 will be recorded. Follow-up is not required unless any adverse event occurred in relation 
to the attempted Absorb GT1 implantation. 
• 
Lesions treated with other stent during the index procedure will be non-target lesions. 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 9 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
If planning staged implantation (treatment is divided into several times in stages) is performed, the 
patient registration will occur at the time when treatment with Absorb GT1 is first attempted. 
o 
If treatment with Absorb GT1 is attempted for initial procedure, it will be the study procedure. 
 
If treatment with Absorb GT1 is attempted for additional procedure in addition to the 
initial procedure, only additional treatment form will be entered. 
 
Follow-up is also required for lesions treated with additional procedure. If any adverse 
events occur, the information will be recorded. 
o 
If treatment with Absorb GT1 is not attempted for initial procedure but attempted for 
additional procedure, the additional procedure will be the study procedure. The initial 
procedure is treated as history. 
• 
De novo lesions observed during follow-up can be treated with Absorb GT1. Such case will not be 
considered as a new registration. 
o 
Before starting commercial sale (if ST rate at 3 months is ≤ 0.9%, commercial sale will be 
started), if Absorb GT1 is attempted as the additional procedure during follow-up, only the 
additional treatment form will be entered. 
o 
Result of use of Absorb GT1 for treatment of in-scaffold restenosis of Absorb GT1 or stent 
restenosis of other stent is currently unknown. Do not use Absorb GT1 for restenosis treatment 
until the Sponsor provides updated information. 
o 
Follow-up is required for lesions treated with additional procedure. If any adverse events occur, 
the information will be recorded. 
• 
Quantitative measurement of RVD is strongly recommended for treatment with Absorb GT1 
• If IVUS/OCT is used for RVD measurement, RVD may be measured after pre-dilatation (if 
difficulty in lesion crossing is predicted) 
• 
Post-procedure IVUS/OCT is strongly recommended until operators became familiar with use of 
Absorb GT1. If incomplete scaffold expansion or apposition was observed, consider additional 
post-dilatation within the maximum balloon pressure of the device. 
• 
It is not recommended that patients registered in the Surveillance participate in any other therapeutic 
clinical study. Non-surveillance information/data obtained by the standard procedures of Surveillance 
Sites (eg, intravascular imaging) can separately be analyzed. 
• 
Scheduled imaging follow-up is not required in the Surveillance. However; 
• 
When a follow-up imaging is conducted as a scheduled or diagnostic test, the Sponsor may request 
Surveillance Sites for images and related materials. Surveillance sites will cooperate in providing 
to the Sponsor, if requested. 
• 
Absorb GT1 loses strength along with progression of bioresorption. Therefore, after proceeding of 
bioresorption, intravascular imaging is in principle limited for a diagnostic purpose. 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 10 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Absorb GT1 is not visible under X-RAY. Therefore, MSCT or MRA can be used as an initial 
stenotic diagnosis. 
 
2.3 
Planned Sample Size 
 
Target sample size of the Surveillance is approximately 2,000 patients. Commercial sale of Absorb GT1 
beyond the purpose of the Surveillance will be started if the scaffold thrombosis (ST) rate in the 2,000 
patients at 3 month is 0.9% or lower (ST rates for patients with Absorb GT1). 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
  
 
 
 
 
 
 
   
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
   
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.4 
Method 
 
The surveillance consists of two phases as detailed below. All- patients will be continuously registered in 
each phases. This means that Absorb GT1 must not be used outside of the Surveillance, except in the case 
of revascularization to the registered patients. 
 
Phase 1 (All- patients): 
• 
250 patients (approximately 45 sites) 
o 
Surveillance Sites: 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 11 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AVJ-301 investigational sites or medical institutions which have a physician with experience 
of implantation of Absorb GT1 (or previous types of the device) in or outside of Japan 
(considering possible move of AVJ-301 investigators to another site)  
• 
Main Purpose: To confirm the efficacy of physician training and to establish optimal training for 
increasing medical institutions participating in post-marketing evaluation. Procedural results will be 
evaluated sequentially for early feedback to the sites. Therefore, there will be no quantitative goal 
established to move to Phase 2. However, recommended procedure may be updated as required in order 
to achieve optimal acute result. 
• 
Lesions to be treated: Per product IFU 
• 
All cases will be treated by imaging-guided implantation technique using IVUS/OCT 
o 
At least first 150 cases will be analyzed by the core lab. 
• 
Primary Endpoint 1: Exclusion of very small vessels 
o 
In the ABSORB III trial, very small vessel with RVD < 2.25 mm per core lab QCA was a risk 
factor of scaffold thrombosis. 
o 
In the AVJ-301 and the ABSORB III trials, lesions with RVD < 2.25 mm consisted of 14.4% 
(59/411) and less than 20% of all the lesions registered respectively. Therefore, goal of the 
training is to exclude these very small vessels. 
o 
Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the 
core lab, which will analyze the images and give feedback to the site. Additional training or 
revision of registration criteria may occur as required in order to exclude almost all lesions 
with RVD < 2.5 mm from registration by the last half of Phase 1. 
• 
Primary Endpoint 2: Scaffold apposition and complete expansion evaluated by IVUS/OCT (analyzed 
by the core lab) 
o 
Descriptive analysis only 
Numerical goal will not be set because there is currently no imaging-guided BVS 
implantation technique established. 
However, implantation guidelines will be established upon agreement by Sponsor’s medical 
adviser and the core lab based on results of the clinical studies with this device and 
imaging-guided metallic stent implantation technique. 
IVUS/OCT images taken during procedure will be sent immediately to the core lab, which 
will analyze the images and give feedback to the site as required. Images of ST, if occurred, 
will also be sent to the core lab. 
o 
All core labs will be those located in Japan in order to fulfill the goals mentioned above. 
 
Phase 2 (All- patients): 
• 
Until 2000 patients are registered (up to 200 sites) 
o 
Surveillance sites: 
 
Phase 1 sites 
 
Sites which have a physician accredited by CVIT, and experience of ≥ 100 PCI cases 
per year. 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 12 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Main Purpose: To confirm safety 
• 
Lesions to be treated: Per product IFU unless otherwise instructed 
• 
To be treated by site standard procedure (imaging-guided implantation technique using IVUS/OCT 
recommended per product IFU) 
• 
Primary Endpoint: ST through 3 months 
o 
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase 2) 
 
≤ 18 patients (0.9%): To start commercial sale 
 
≥ 19 patients: To investigate the cause and take appropriate actions 
• 
All images of ST, if occurred, will be sent to the core lab. 
• 
At Phase 2, IVUS/OCT images post procedure may be analyzed in the core lab as well. Surveillance 
sites will cooperate to the Sponsor, if requested. 
 
3. 
SURVEILLANCE PERIOD 
 
Information will be collected for up to 5 years post procedure. 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Annual reports will be submitted to the regulatory authority after marketing approval. Data will be collected 
until all patients complete 5-year follow-up, and application for use result evaluation will then be submitted. 
 
Separately from the annual reports, frequency of ST will be reported as required. 
 
Data will be collected at the following time points: 
 
• 
Baseline (pre-procedure) 
• 
Procedure 
• 
Post-procedure to discharge 
• 
3 months (by visit preferred; by telephone is allowed) (Day 90 ± 14 days) 
• 
1 year (by visit preferred; by telephone is allowed) (Day 365 ± 28 days) 
• 
2 years (by visit or telephone) (Day 730 ± 28 days) 
• 
3 years (by visit or telephone) (Day 1095 ± 28 days) 
• 
4 years (by visit or telephone) (Day 1460 ± 28 days) 
• 
5 years (by visit or telephone) (Day 1825 ± 28 days) 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 13 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Scheduled imaging follow-up is not required for this surveillance. If any imaging is performed as site 
standard practice, the imaging modality and results should be recorded in case report forms. In addition, if 
any imaging is performed for diagnosis, these should also be recorded in case report forms. 
 
4. 
TREATMENT OF PATIENTS 
 
Absorb GT1 will be implanted per optimal technique recommended by Abbott Vascular Japan Co., Ltd. 
Physicians should refer to the warnings, contraindications, and precautions in the most current version of 
product IFU for optimal treatment of each patient. 
 
Physician will make final decision on antiplatelet therapy. However, product IFU of the Absorb GT1 BVS 
recommends dual antiplatelet therapy (DAPT) for at least 12 months. However, severe adverse device 
effect of very late stent thrombosis for more than one year after implantation was reported. Therefore, 
scheduled follow-up should be performed depending on the patient’s condition and necessity of extending 
antiplatelet therapy should be considered with paying attention to the risk of adverse reactions such as 
bleeding, patient’s background information, and anatomic features of the lesions. In addition to that, 
physician should also pay full attention to the increasing risk of bleeding due to the combination with 
anticoagulants. Physician should refer to the most current version of ADP antagonist IFU before treatment 
of each patient. Laboratory tests and clinical observation required for evaluating adverse reactions to ADP 
antagonists should be performed per the product IFU. 
 
5. 
INFORMATION TO BE COLLECTED FOR THE SURVEILLANCE 
 
 
5.1 
Patient Baseline Information 
 
1) 
Rave System Information 
2) 
Registration Information 
3) 
Demography 
4) 
Ischemic Status and Other Cardiac Complications  
5) 
Risk Factors and Comorbidities 
6) 
Pre-procedural Laboratory Tests (If done, cardiac enzyme to be captured in cardiac 
enzyme form) 
7) 
Pre-procedural Antiplatelet Medications 
 
5.2 
Procedural Information 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 14 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1) 
Basic Procedural Information 
2) 
Treated Lesion Information (Per lesion, stenting procedure only. Bifurcation lesion 
should be regarded as two lesions if both stented) 
3) 
Pre-dilatation/Preparation (to be generated per dilatation/preparation) 
4) 
Stenting Information (Including attempted but not implanted, to be generated per stent) 
5) 
Post-dilatation (to be generated per dilatation) 
6) 
Final Results 
 
5.3 
Pre- and Post-procedural Cardiac Enzymes 
 
5.4 
Procedural Complications 
 
5.5 
Antiplatelet Medications after the Procedure 
 
5.6 
Other Medications (Pre/Post-procedure) 
 
5.7 
Clinical Follow-up 
 
5.8 
Imaging Follow-up (target lesion only) 
 
1) 
Primary imaging modality 
2) 
If MSCT/MRA, Restenosis assessment 
3) 
CAG 
4) 
Intravascular imaging 
 
5.9 
Device Malfunction/Deficiency  
 
5.10 Scaffold/Stent Thrombosis 
 
5.11 Adverse Event Other Than ST (to be reported) 
 
 
Coronary Adverse events 
o 
Ischemia (Angina or ischemic test) 
o 
Diagnostic Catheter  
o 
Revascularization 
 
Bleeding 
 
Other serious adverse events (including adverse events related to antiplatelet medications)* 
 
Any adverse events related to Absorb GT1, or their causal relationship is "unknown" 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 15 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*a serious adverse event: led to death, resulted in a life-threatening illness or injury, requires inpatient 
hospitalization or prolongation of existing hospitalization for treatment, impairment (e.g. resulted in a 
permanent impairment of a body structure or a body function) or threatened to impairment, led to a 
congenital abnormality or birth defect, an important medical event that may not result above but may be 
considered serious based upon the investigator’s appropriate judgment. 
 
For the adverse events described above, the causal relationship with the device or the procedure, adverse 
events related to antiplatelet medications, and outcomes of every adverse event should be recorded. For 
serious adverse events, reasons for the judgment of seriousness should be recorded as well. 
 
5.12 Additional Treatment (If done with Absorb GT1) 
 
If Absorb GT1 is used for treatment in the registered patients before starting commercial use (i.e., before 
ST rate through 3 months is available for all the registered patients, as primary endpoint), the information 
should be recorded. 
 
1) 
Type 
2) 
Basic Procedural Information 
3) 
Treated Lesion Information (Per lesion, stenting procedure only. Bifurcation lesion should 
be regarded as two lesions if both stented) 
4) 
Pre-dilatation/Preparation (to be generated per dilatation/preparation) 
5) 
Stenting Information (Including attempted but not implanted, to be generated per stent)  
6) 
Post-dilatation (to be generated per dilatation)  
7) 
Final Results 
 
6. 
ENDPOINTS 
 
6.1 
Primary Endpoints 
 
• 
Scaffold thrombosis (Phase-1 + Phase 2 all patients with Absorb GT1): 
o 
If ST rate at 3 months is ≤ 0.9%, commercial sale will be started. 
o 
If ST rate at 2 years is ≥ 1.5%, investigation will be implemented to identify the cause. 
• 
Exclusion of very small vessels 
o 
For Phase-1 patients only 
• 
Scaffold apposition assessed by intravascular imaging: 
o 
For Phase-1 patients only 
• 
Device deficiency at procedure of implantation (all patients) 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 16 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2 
Other Endpoints 
 
To be evaluated per typical DES clinical studies. 
 
6.2.1 Clinical Endpoints 
 
 
• 
Component endpoints 
• 
Death (Cardiac/Vascular/Non-Cardiovascular) 
• 
Myocardial Infarction (TV-MI/NTV-MI) 
• 
Target Lesion Revascularization (ID-TLR/NID-TLR) 
• 
Target Vessel Revascularization (ID-TVR/NID-TVR) 
• 
All coronary revascularization 
 
• 
Composite endpoints 
• 
DMR (All death/All MI/All revascularization) 
• 
TVF (Cardiac death/All MI/ID-TVR) 
• 
MACE (Cardiac death/All MI/ID-TLR) 
• 
TLF (Cardiac death/TV-MI/ID-TLR) 
• 
Cardiac death/All MI 
 
6.2.2 Angiographic Endpoints (core lab analysis) 
 
Include the following: 
 
• 
Pre-procedure 
• 
Morphology 
• 
TIMI blood flow 
• 
Lesion length 
• 
Proximal RVD 
• 
Distal RVD 
• 
MLD 
• 
%DS 
 
• 
Post-procedure 
• 
TIMI blood flow 
• 
Proximal RVD 
• 
Distal RVD 
• 
MLD (in-stent/in-segment) 
• 
%DS (in-stent/in-segment) 
• 
Acute gain (in-stent/in-segment) 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 17 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2.3 IVUS/OCT Endpoints (core lab analysis) 
 
Include the following: 
 
• 
Pre-procedure (or after pre-dilatation) 
• 
Lumen diameter or Lumen area (proximal/distal) 
 
• 
Post-procedure 
• 
Lumen diameter or Lumen area (proximal/distal) 
• 
MLA 
• 
Incomplete apposition of the Absorb BVS strut 
• 
Fracture of the Absorb BVS strut 
 
 
7. 
ANALYSIS AND REPORTING 
 
7.1 
Adverse Event Reporting 
 
When the Surveillance Site obtains the information on occurrence of the following events, capture the 
information to the case recording form in principle within 48 hours. 
 
 
ST or events possibly considered as scaffold or stent thrombosis 
 
adverse events to be reported, described in Section 5.11  
 
device malfunction or deficiency 
 
Adjudication of deaths, MIs, and STs is performed by clinical events committee or scaffold thrombosis 
image-review committee. Surveillance sites will cooperate in providing images and relevant materials for 
adjudication to the Sponsor. 
 
7.2 
Angiographic Core Laboratory 
 
For Phase-1 patients, QCA assessments of baseline and post-procedure angiograms and lesion morphology 
will be performed also by the angiographic core lab as well as by Surveillance Sites. 
 
In case of ST, angiograms at baseline, procedure and the event will be analyzed by the angiographic core 
lab. 
 
The Sponsor may request Surveillance Sites for angiograms for any purpose other than the above. 
Surveillance sites will cooperate in providing the angiograms to the Sponsor, if requested. 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 18 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.3 
Intravascular Imaging 
 
For Phase-1 patients, intravascular (IVUS/OCT) assessments will be performed by the respective core lab. 
 
In case of ST, IVUS/OCT images at baseline, procedure and the event will be analyzed by the respective 
core lab. 
 
The Sponsor may request Surveillance Sites for IVUS/OCT images for any purpose other than the above. 
Surveillance sites will cooperate in providing the IVUS/OCT images to the Sponsor, if requested. 
 
7.4 
Scaffold Thrombosis Image-Review Committee 
 
Scaffold thrombosis events occurred during the Surveillance will be adjudicated by a scaffold thrombosis 
image-review committee. The committee will evaluate events reported by Surveillance Sites as scaffold 
thrombosis as outlined below:  
 
• 
Purpose 
 
To minimize risk of scaffold thrombosis by informing Surveillance Sites of result of investigation of 
scaffold thrombosis events occurred during the Surveillance based on all images, patient background 
information, and other relevant information concerning the events used to assess relationship to Absorb 
GT1 and complexity of lesions and to identify cause of scaffold thrombosis. Therefore, Surveillance sites 
will provide the information to the Sponsor as requested. 
 
• 
Member Selection 
 
In cooperation with CVIT, five (5) physicians who are well experienced with Absorb GT1 implantation or 
intravascular imaging will be selected in advance. Review committee meetings will require attendance of at 
least three (3) members. One (1) representative of Abbott Vascular may (not mandatory) attend the 
meetings or may present their opinion in advance. Physicians from relevant core labs may attend meetings 
or present their opinion depending on individual cases. 
 
• 
Review Method 
 
By teleconference or physical meeting. 
 
7.5 
Clinical Observation - Clinical Events Committee (CEC) 
 
Clinical events committee (CEC) will evaluate all deaths and suspicion of MIs for 3 years maximally. 
Surveillance sites will cooperate in providing materials needed to adjudication (e.g., death report, 
discharged summary) to the Sponsor, if a patient is dead or is suspected to MI. 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 19 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.6 
Analysis of Surveillance Results 
 
Analysis and reporting used for annual reports and application for use result evaluation will be performed 
per the Yakushokukisanhatsu Notification No. 1121-44 (November 21, 2014), “Handling of Use Result 
Evaluation Concerning Marketing Approval of Medical Devices and In-vitro Diagnostic Drugs”. Subgroup 
analysis may be performed as required for demonstrating the safety and efficacy, and the results will be 
included in the surveillance result overview of the application for use result evaluation. Adverse events 
other than death/MI/scaffold thrombosis will be adjudicated by Surveillance Sites. 
 
The following populations will be used for clinical evaluation: 
 
• 
Intent-to-Treat 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Full Analysis Set 
 
 
 
 
 
• 
Absorb Only Population 
 
 
 
 
 
 
 
 
Sub-group analysis includes the following but not limited to: 
• 
Sex 
• 
Diabetes 
• 
Stent diameter 
 
8.  
PUBLICATION POLICY 
 
The Sponsor shall have the right to access and use all data and results generated during the Surveillance.  
The publication and/or presentation of results from a single Surveillance Site are not allowed until 
publication and/or presentation of the multi-center results. The Sponsor acknowledges that the 
Surveillance’s Principal Investigator intends to publish a multi-center publication regarding the 
Surveillance results. 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. Prior approval from the Principal Investigator and the Sponsor is required for a live use 
or case reporting at Sites. 
 
Among the data obtained in the Surveillance, the data that are included in the JPCI Registry will 
periodically be transferred to the JPCI Registry Database. Therefore, use of these data only will be an 
exception to the policy above. 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 20 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9.  
DEFINITIONS 
 
Definitions in the Surveillance are shown in Attachment 2. 
 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 31 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 35 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ATTACHMENT 2: DEFINITION IN THE SURVEILLANCE 
 
Scaffold/Stent Thrombosis 
 
The definition of ARC will be used. The scaffold thrombosis image-review committee will adjudicate 
scaffold/stent thrombosis reported from the Surveillance Site based on this definition. 
 
Scaffold/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 scaffold/stent thrombosis*:  
0 - 24 hours post stent implantation  
 
Subacute scaffold/stent thrombosis*: 
>24 hours - 30 days post stent implantation 
 
Late scaffold/stent thrombosis†:  
30 days - 1 year post stent implantation 
 
Very late scaffold/stent thrombosis†: 
>1 year post stent implantation  
 
*Acute/subacute can also be replaced by early scaffold/stent thrombosis. Early scaffold/stent 
thrombosis (0 - 30 days) - this definition is currently used in the community. 
†Including “primary” as well as “secondary” late scaffold/stent thrombosis; “secondary” late 
scaffold/stent thrombosis is a scaffold/stent thrombosis after a target segment revascularization.  
 
 
Categories: 
 
Definite 
 
Probable 
 
Definitions of each category are as follows. 
 
 
Definite scaffold/stent thrombosis 
 
Definite scaffold/stent thrombosis is considered to have occurred by either angiographic or 
pathologic confirmation. 
 
 
Angiographic confirmation of scaffold/stent thrombosis* 
The presence of a thrombus† that originates in the scaffold/stent or in the segment 5 mm 
proximal or distal to the scaffold/stent and presence of at least one 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 elevation or depression in cardiac biomarkers (refer to definition of 
spontaneous MI)  

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 36 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
o 
Nonocclusive thrombosis 
o 
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 in- scaffold/stent or proximal to a scaffold/stent up to the most 
adjacent proximal side branch or main branch (if originates from the side 
branch).  
 
 *The incidental angiographic documentation of stent occlusion in the absence of clinical signs or 
symptoms is not considered a confirmed stent thrombosis. 
 †Intracoronary thrombus. 
  
Pathological confirmation   
Evidence of recent thrombus within the scaffold/stent determined at autopsy or via examination 
of tissue retrieved following thrombectomy.  
 
 
Probable scaffold/stent thrombosis 
 
Either of the following occurred after scaffold/stent implantation will be considered a probable 
scaffold/stent thrombosis: 
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. 
 
For the Surveillance, the principal definition of scaffold/stent thrombosis will be ARC definite or probable 
scaffold/stent thrombosis. 
 
Death (Per ARC Circulation 2007; 115: 2344-2351) 
 
CEC will adjudicate deaths based on ARC definition. 
 
The deaths in the Surveillance will be adjudicated per the ARC definition. All deaths are considered cardiac 
unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 37 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as 
cardiac.  
 
 
Cardiac death: 
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), 
unwitnessed death and death of unknown cause, all study 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. 
 
Myocardial Infarction 
 
CEC will adjudicate myocardial infarction. 
 
ECG assessment 
 
 
Q wave MI (Q-MI) 
Development of new, pathological Q wave on the ECG in ≥ 2 contiguous leads. 
 
 
Non-Q wave MI (NQ-MI) 
Not categorized as Q-MI but increasing biomarkers. 
 
Biomarker assessment 
 
If CK-MB is measured by Site-standards, the definition used in Absorb Japan clinical trial will be used. For 
other cases, use the Modified WHO definition. 
 
 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 38 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Definition used in the Absorb Japan clinical trial 
 
Classification and criteria of NQMI 
Classification 
Biomarker Criteria 
Additional Criteria 
Periprocedural PCI 
(≤48h post-PCI) 
CK-MB >5 x URL  
Baseline value* < URL 
Periprocedural CABG 
(≤48h post-CABG) 
CK-MB >10 x URL 
Baseline value < URL, and any of 
the following: 
New pathologic Q waves** or 
LBBB; new native or graft vessel 
occlusion; imaging evidence of 
loss of viable myocardium 
Spontaneous 
All late events that are not 
associated with a 
revascularization procedure 
will be considered simply as 
spontaneous. 
CK-MB > URL, or 
Troponin*** > URL 
One or more of the following must 
also be present:  
(a) symptoms of ischemia; 
(b) development of pathological Q 
waves** 
(c) ECG changes  indicative of 
new ischemia - (new ST-T changes 
or new LBBB), 
(d) or imaging evidence of a new 
loss of viable myocardium or a 
new regional wall  motion 
abnormality 
Reinfarction (not related to 
procedure) 
If the CK and CK-MB values are 
stable or decreasing on 2 samples, a 
25% 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.  
URL=Upper Reference Limit 
LBBB=Left Bundle-branch Block 
* Baseline biomarker value is required before study procedure and presumes a typical rise and fall post  
** If abnormal Q-wave is observed, then adjudicated as Q-MI 
*** If both values are obtained, then CK-MB must be used for adjudication 
 
 
Modified WHO definition 
 
Elevation of CK > 2 x URL and CK-MB > URL without abnormal Q-wave. 
 
Myocardial infarction - 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. 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 39 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Revascularization 
 
The revascularizations in the Surveillance will be adjudicated by Sites per the ARC definition. 
 
 
Location of Revascularization: 
 
 
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 clinically indicated or not clinically indicated 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 scaffold/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.  
 
 
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 Revascularization 
Revascularization of the vessel that is not treated at the time of the index procedure.  
 
Note: TLR and TVR will be adjudicated by the angiographic core laboratory. 
 
 
Ischemia-driven Revascularization (ID-TLR/TVR) 
 
 
A revascularization is considered ischemia-driven if associated with any of the following: 
o 
Positive functional ischemia study including positive FFR 
o 
Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA 
o 
Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive 
functional study 
 

 
Absorb BVS GT1 
Post-marketing Surveillance 
Protocol 
 
 
November 8, 2016 
Page 40 of 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other definitions 
 
Other definitions are based on the latest J-PCI definition.