A Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in Comparison With the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China
Phase: NA
Conditions: Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
Sponsor: Medtronic Vascular

Signed By
Meaning of Signature
Date/Time (UTC)
APPROVALS
CONFIDENTIAL
  
DOCUMENT/RECORD 
 
 
This document/record is electronically controlled; printed copies are considered uncontrolled. 
System of Record: Regulatory Affairs Domain 
 
Document Name
RAD Version
Title
Document Approver
Therapy SME
Document Author
Bousquette, Lisa
02/14/2019 09:47:57
1.0
Clinical Quality/Compliance
02/13/2019 10:24:18
Ibrahim, Sherif, MD
Onyx RCT CIP ver 2.0
Clinical Study Manager (CSM)
Lei, Kevin
02/15/2019 15:02:00
Zhong, Christina
02/13/2019 17:13:13
02/15/2019 06:45:09
Liu, Minglei, PhD.
02/13/2019 10:24:13
Wang, Joanna
Lei, Kevin
Monitor
Safety
02/13/2019 10:24:17
Lei, Kevin
02/13/2019 15:38:07
Lei, Kevin
Lei, Kevin
02/13/2019 10:24:15
02/13/2019 10:24:16
Medical Writer
02/15/2019 01:58:36
Clinical Leadership
Yu, Fiona
Biostatistician
Resolute Onyx China RCT CIP v2.0 EN_final 20190213.docx
Program Lead

RESOLUTE ONYX CHINA RCT STUDY
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Clinical Investigation Plan
Clinical Investigation Plan
Title
RESOLUTE ONYX China RCT Study
A Randomized Controlled Trial to Evaluate the Safety and 
Efficacy of the Medtronic Resolute OnyxTM Zotarolimus-
Eluting Coronary Stent System in Comparison with the 
Medtronic Resolute IntegrityTM Zotarolimus-Eluting 
Coronary Stent System in the Treatment of Subjects 
Eligible for Percutaneous Transluminal Coronary 
Angioplasty (PTCA) in China
Study Device Name
Study Arm:
Resolute OnyxTM Zotarolimus-Eluting
Coronary Stent System
Control Arm:
Resolute IntegrityTM Zotarolimus-Eluting
Coronary Stent System
Model/Specification
Refer to Table 7-1 and Table 7-2
Classification of Study Device
Class III
Class III Medical Device Fulfil 
Clinical Trial Approval
No
Similar Device Marketed in 
China
Yes
Document Version No. and 
Date
2.0, 13-Feb-2019
Lead Site
Fuwai Hospital, Chinese Academy of Medical Sciences
No.167 North Lishi Road, Xicheng District, Beijing, China
Coordinating Investigator
Dr. Yongjian Wu
Sponsor
Medtronic, Inc.
710 Medtronic Parkway, Minneapolis, MN 55432, USA
Local Sponsor/Agent
Medtronic (Shanghai) Management Co., Ltd
Room 2106A, 2106F, 2106G, 2106H, Floor 21, Donghua 
Financial Building, No. 28 Maji Road, China (Shanghai) 
Pilot Free Trade Zone, 200120, Shanghai, P.R. China
Confidentiality Statement
The information contained in this document is confidential and the proprietary property of Medtronic.
Any distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly
prohibited. Persons to whom the information is disclosed must know that it is confidential and that it
may not be further disclosed by them.

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Investigator Statement
1.1.
Read and Approved by Investigator
Clinical Investigation Plan Title:
RESOLUTE ONYX China RCT Study
A Randomized Controlled Trial to Evaluate the Safety and 
Efficacy of the Medtronic Resolute OnyxTM Zotarolimus-
Eluting Coronary Stent System in Comparison with the 
Medtronic Resolute IntegrityTM Zotarolimus-Eluting 
Coronary Stent System in the Treatment of Subjects 
Eligible for Percutaneous Transluminal Coronary 
Angioplasty (PTCA) in China
Sponsor:
Medtronic, Inc.
Local Sponsor/Agent:
Medtronic (Shanghai) Management Co., Ltd
Version Number/Date:
2.0, 13-Feb-2019
I hereby confirm below:
-
I will conduct this study in strict compliance with the Declaration of Helsinki, current 
laws and regulations of China, and the Clinical Investigation Plan (CIP). 
-
I will ensure accuracy, completeness and timeliness of the data reported in the Case 
Report Forms and in all other study required reports, and complete the final study report 
on time.
-
The study devices will be used only for this study and the receipt and use of the study 
devices will be recorded completely and accurately and the records will be retained 
during the process of the clinical study.
-
The Medtronic authorized monitor, auditor and the regulatory authorities have the right 
to conduct monitoring, audit and inspection for this study.
-
The clinical study should be conducted in strict compliance with the clinical study 
agreement signed by all parties.
I have read this version of the Clinical Investigation Plan of RESOLUTE ONYX China RCT 
Study, including all appendices and the above statements.  I fully agree all the above 
requirements and will ensure that the study is conducted as described herein.
Investigator Comment:
Investigator’s Name (Print):
Institution:
Investigator’s Signature:
Date (dd/mmm/yyyy):

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1.2.
Read and Approved by Clinical Research Institution 
Clinical Investigation Plan Title: 
RESOLUTE ONYX China RCT Study
A Randomized Controlled Trial to Evaluate the Safety 
and Efficacy of the Medtronic Resolute OnyxTM
Zotarolimus-Eluting Coronary Stent System in 
Comparison with the Medtronic Resolute IntegrityTM
Zotarolimus-Eluting Coronary Stent System in the 
Treatment of Subjects Eligible for Percutaneous 
Transluminal Coronary Angioplasty (PTCA) in China
Sponsor:
Medtronic, Inc.
Local Sponsor/Agent:
Medtronic (Shanghai) Management Co., Ltd
Version Number/Date: 
2.0, 13-Feb-2019
Institution Name/Site Name
Comments of Clinical Research 
Institution
Signature / Stamp
Date (dd/mmm/yyyy):

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Table of Contents 
Investigator Statement........................................................................................................................2
1.1. Read and Approved by Investigator..................................................................................................2
1.2. Read and Approved by Clinical Research Institution .......................................................................3
Table of Contents ........................................................................................................................................4
List of Figures..............................................................................................................................................8
List of Tables................................................................................................................................................8
Glossary................................................................................................................................................9
Synopsis..............................................................................................................................................11
Introduction.......................................................................................................................................14
4.1. Background .....................................................................................................................................14
4.2. Purpose............................................................................................................................................15
Objectives and Endpoints.................................................................................................................16
5.1. Objectives........................................................................................................................................16
Primary Objective..................................................................................................................16
5.2. Endpoints.........................................................................................................................................16
Primary Endpoint...................................................................................................................16
Secondary Endpoints.............................................................................................................16
Study Design ......................................................................................................................................17
6.1. Duration...........................................................................................................................................17
6.2. Rationale..........................................................................................................................................17
Product Description ..........................................................................................................................19
7.1. Study Device Name and Description ..............................................................................................19
Study Arm - Resolute OnyxTM Zotarolimus-Eluting Coronary Stent System.....................19
Control Arm - Resolute IntegrityTM Zotarolimus-Eluting Coronary Stent System.............21
7.2. Device Model and Labelling...........................................................................................................22
7.3. Intended Use....................................................................................................................................25
7.4. Probability analysis of success........................................................................................................25
7.5. Probability analysis of failure..........................................................................................................25
Selection of Subjects..........................................................................................................................26
8.1. Study Population .............................................................................................................................26
8.2. Subject Enrollment..........................................................................................................................26
8.3. Inclusion Criteria.............................................................................................................................26

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General Inclusion Criteria: ....................................................................................................26
Angiographic Inclusion Criteria (visual estimate):................................................................26
8.4. Exclusion Criteria............................................................................................................................27
General Exclusion Criteria ....................................................................................................27
Angiographic Exclusion Criteria...........................................................................................28
Criteria for Additional Procedures.........................................................................................29
Study Procedures...............................................................................................................................30
9.1. Schedule of Events..........................................................................................................................30
9.2. Subject Screening............................................................................................................................32
9.3. Subject Consent...............................................................................................................................32
Consent..................................................................................................................................32
Revision for Informed Consent Form....................................................................................33
9.4. Randomization and Treatment Assignment ....................................................................................33
9.5. Procedures .......................................................................................................................................33
Preparation and Angiography................................................................................................34
Target Lesion Pre-treatment ..................................................................................................34
Point of Enrollment ...............................................................................................................34
Stenting Procedure.................................................................................................................35
End of Procedure ...................................................................................................................36
Post-procedure to Hospital Discharge ...................................................................................36
9.6. Medication Compliance ..................................................................................................................36
9.7. Assessment of Efficacy ...................................................................................................................37
9.8. Assessment of Safety.......................................................................................................................37
9.9. Recording Data................................................................................................................................37
Follow-up ..............................................................................................................................37
9.10.
Deviation Handling...................................................................................................................39
9.11.
Subject Withdrawal or Discontinuation....................................................................................40
Risks and Benefits...........................................................................................................................42
10.1.
Potential Risks...........................................................................................................................42
10.2.
Potential Benefits ......................................................................................................................44
10.3.
Risk-Benefit Rationale..............................................................................................................44
10.4.
Liability.....................................................................................................................................45
10.5.
Alternatives ...............................................................................................................................45

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Adverse Events and Device Deficiencies.......................................................................................46
11.1.
Definitions/Classifications ........................................................................................................46
11.2.
Evaluation and Documentation of Adverse Events...................................................................48
11.3.
Anticipated Adverse Events......................................................................................................48
11.4.
Reporting of Adverse Events ....................................................................................................49
11.5.
Documentation and Reporting of Device Deficiencies.............................................................49
11.6.
Emergency Contact Details.......................................................................................................51
Data Review Committees...............................................................................................................52
12.1.
Clinical Events Committee (CEC)............................................................................................52
Statistical Design and Methods .....................................................................................................53
13.1.
Statistical Design, Methods and Analytical Procedures............................................................53
13.1.1   Statistical Analysis Method....................................................................................................53
13.2.
Sample Size Calculation Consideration....................................................................................53
Total Sample Size..................................................................................................................53
Minimum and Maximum Enrollment Number per Site and Rationale .................................54
13.3.
Significant Level and Statistical Power ....................................................................................55
13.4.
Expected Drop-out Rate............................................................................................................55
13.5.
Trial Result Pass/Fail Criteria ...................................................................................................55
13.6.
Early Termination of the Trial Based on Statistical Rationales ................................................55
13.7.
Analysis Data Set, Handling of Missing Data, Unused or Erroneous Data (including withdrawals) 
and Spurious Data ..................................................................................................................................55
13.8.
Deviation from Pre-specified Analysis Plan .............................................................................56
13.9.
Criteria and Rationale for Selection of Subjects for Analysis...................................................56
Ethics ...............................................................................................................................................57
14.1.
Statement(s) of Compliance......................................................................................................57
14.2.
Role of Medtronic .....................................................................................................................57
14.3.
General Duties...........................................................................................................................57
14.4.
Ethics Committee (EC) .............................................................................................................57
General Study Requirements.................................................................................................58
Informed Consent and Ethics Committees ............................................................................58
Regulatory Consideration..............................................................................................................59
15.1.
Regulatory Submission .............................................................................................................59
Study Administration.....................................................................................................................60
16.1.
Investigator and Investigational Site Selection .........................................................................60

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Investigator Responsibility / Performance.............................................................................61
Training of Investigational Sites............................................................................................61
Clinical Investigation Agreement..........................................................................................61
Curriculum Vitae...................................................................................................................62
16.2.
Monitoring.................................................................................................................................62
16.3.
Audits and Inspections ..............................................................................................................62
16.4.
Data Management .....................................................................................................................63
Case Report Forms ................................................................................................................63
Source Documentation ..........................................................................................................63
Transmission of Data.............................................................................................................64
Data Queries ..........................................................................................................................64
Time Windows for Completing Case Report Forms and Reports.........................................64
Electronic Clinical Data Systems ..........................................................................................65
16.5.
Study Materials and Study Specific Equipment........................................................................65
16.6.
Device Accountability...............................................................................................................65
16.7.
Confidentiality...........................................................................................................................66
16.8.
CIP Amendments ......................................................................................................................66
16.9.
Record Retention.......................................................................................................................66
16.10.
Publication and Use of Information ..........................................................................................67
16.11.
Suspension or Early Termination..............................................................................................67
16.12.
Study Close-Out........................................................................................................................68
16.13.
Clinical Study Registration .......................................................................................................68
16.14.
Investigator Reports ..................................................................................................................68
Insurance.........................................................................................................................................70
Study Reimbursement....................................................................................................................70
Reference.........................................................................................................................................70
Appendixes......................................................................................................................................71
Appendix 1 Study Contacts.....................................................................................................................71
Appendix 2 List of Definitions................................................................................................................72
Appendix 3 Angiographic Core Lab Procedures.....................................................................................88
Appendix 4 Sample Informed Consent Form..........................................................................................89
Appendix 5 Sample Case Report Forms .................................................................................................90
Appendix 6 Instructions for Use (Resolute Integrity) .............................................................................91

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Appendix 7 Resolute Onyx stent Investigator’s Brochure (IB) ..............................................................92
Appendix 8 Device Label........................................................................................................................93
Appendix 9 Investigators and Institutions List........................................................................................94
Version History...............................................................................................................................95
List of Figures
Figure 6-1 Study Flow Chart...............................................................................................................18
Figure 7-1 Resolute Integrity and Resolute Onyx Stent Materials......................................................20
Figure 7-2 Resolute Integrity and Resolute Onyx Stent Design .........................................................20
Figure 7-3 Onyx RX Delivery System with Stent...............................................................................21
Figure 7-4 MicroTrac RX (Delivery System and Resolute Integrity Stent)........................................22
List of Tables
Table 3-1 Study Arm (Resolute Onyx™ Stent Size Matrix)...............................................................12
Table 3-2 Control Arm (Resolute Integrity™ Stent Size Matrix).......................................................13
Table 7-1 Stent Model Number and Size of Resolute Onyx ...............................................................22
Table 7-2 Stent Model Number and Size of Resolute Integrity ..........................................................24
Table 8-1 Study Arm (Resolute Onyx™ Stent Size Matrix)...............................................................27
Table 8-2 Control Arm (Resolute Integrity™ Stent Size Matrix).......................................................27
Table 8-3 Previous and Additional Procedure Criteria .......................................................................29
Table 9-1 Schedule of Treatments and Assessments...........................................................................30
Table 9-2 Schedule of Treatments and Assessments...........................................................................37
Table 9-3 Repeat Angiographic Follow-up.........................................................................................38
Table 11-1 Adverse event definitions for reporting requirements ......................................................46
Table 11-2 Expected, non-reportable events related to a surgical procedure......................................48
Table 11-3 AE Reporting Requirements.............................................................................................50
Table 16-1 Investigator Reporting Guidance for Submitting Data .....................................................64
Table 16-2 Investigator Reporting Responsibilities............................................................................68

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Glossary
Acronym/Abbreviation
Term
% DS
Percent diameter stenosis
ACC
American College of Cardiology
AE
Adverse event
AHA
American Heart Association
CABG
Coronary artery bypass graft
CASS
Coronary Artery Surgery Study
CCSC
Canadian Cardiovascular Society Classification
CE
Conformité Européenne
CEC
Clinical Events Committee
CFDA
China Food and Drug Administration
CK
Creatine kinase
CK-MB
Creatine kinase myocardial-band isoenzyme
CRF
Case report form
CRO
Contract Research Organization
CSR
Clinical Study Report
CTO
Chronic Total Occlusion
DES
Drug eluting stent
DS
Diameter stenosis 
DAPT
Dual Anti-Platelet Therapy 
EC
Ethics Committee
ECG
Electrocardiogram
EDC
Electronic data capture
EU
European Union
GCP
Good Clinical Practices
GI
Gastrointestinal
ICH
International Conference on Harmonization 
ICF
Informed Consent Form
IFU
Instructions for Use
FAS
Full Analysis Set
LAD
Left anterior descending coronary artery
LCX
Left circumflex coronary artery
LIMA
Left internal mammary artery
ISO
International Organization for Standardization

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LVEF
Left ventricular ejection fraction
MACE
Major adverse cardiac event
mg
Milligram
MI
Myocardial infarction
MLD
Minimum luminal/lumen diameter
µg
Microgram
mm
Millimeter
NHLBI
National Heart, Lung, and Blood Institute
PCI
Percutaneous coronary intervention
PP set
Per protocol set
PTCA
Percutaneous transluminal coronary angioplasty
QCA
Quantitative coronary angiography
QWMI
Q wave myocardial infarction
RCA
Right coronary artery
RIMA
Right internal mammary artery
RVD
Reference vessel diameter
RX
Rapid exchange
SAE
Serious adverse event
SAP
Statistical Analysis Plan
SCAI
Society for Cardiovascular Angiography and Interventions
SD
Standard deviation
STEMI
ST-elevation myocardial infarction
TIA
Transient ischemic attack
TIMI
Thrombolysis in myocardial infarction
TLF
Target lesion failure
TLR
Target lesion revascularization
™
Trademark
TVF
Target vessel failure
TVR
Target vessel revascularization
UADE
Unanticipated adverse device effect
US
United States
WHO
World Health Organization

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Synopsis
Study Title: RESOLUTE ONYX China RCT Study
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic Resolute 
OnyxTM Zotarolimus-Eluting Coronary Stent System in Comparison with the Medtronic 
Resolute IntegrityTM Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects 
Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China
Purpose
This pre-market study is initiated for Resolute Onyx CFDA product 
registration. The purpose of this study is to evaluate the clinical 
safety and efficacy of the Resolute Onyx Stent System, compared to 
the Resolute Integrity Stent System in subjects who are eligible for 
percutaneous transluminal coronary angioplasty (PTCA) in de novo
lesions amenable to treatment with either of the two stent systems in 
China
Study Design
Pre-Market, Prospective, Multi-center, Open-label, Randomized 
Controlled Trial
Study Device
Study Arm: Resolute OnyxTM Zotarolimus-Eluting Coronary Stent 
System
Control Arm: Resolute IntegrityTM Zotarolimus-Eluting Coronary 
Stent System
Objective
To evaluate the safety and efficacy of the Resolute OnyxTM
Zotarolimus-Eluting Coronary Stent System as compared to the 
Resolute IntegrityTM Zotarolimus-Eluting Coronary Stent System in 
subjects requiring stent implantation
Primary Endpoint
In-stent Late Lumen Loss (LLL) at 9 months post procedure as 
measured by QCA
Secondary Endpoints
Secondary Clinical Endpoints:

Acute Success (device, lesion, procedure) 

The following secondary endpoints will be assessed at 30 days, 
6 months, 9 months and annually thereafter through 5 years:
-
Major Adverse Cardiac Events (MACE) 
-
Death (Cardiac and Non-cardiac)
-
Myocardial infarction (all MI and Target Vessel Myocardial 
Infarction (TVMI))
-
All revascularizations (Target Lesion Revascularization 
(TLR), Target Vessel Revascularization (TVR) and Non-
TVR) 
-
Target Vessel Failure (TVF) 
-
Target Lesion Failure (TLF) 
-
Stent Thrombosis (ST)
Secondary Angiographic Endpoints (at 9 months post 
procedure): 

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
In-stent and in-segment percent diameter stenosis (%DS)

In-stent and in-segment binary angiographic restenosis (BAR)
rate

In-stent and in-segment minimal luminal diameter (MLD)

In-segment Late Luminal Loss
Number of Sites
Approximately 20 study sites in China
Sample Size
Approximately 550 subjects 
Randomization
1:1 randomization
Study Sites and
Investigators
Refer to Appendix 9-Investigator and Institutions List
Inclusion / Exclusion 
Criteria
Only key criteria will be listed in the synopsis, see all criteria in 
section 8.3 and 8.4
Key Inclusion Criteria:

The subject is an acceptable candidate for treatment with a drug-
eluting stent in accordance with the applicable guidelines on 
percutaneous coronary interventions, and the Investigator 
Brochure (IB) of Resolute Onyx, and, the Instructions for Use 
(IFU) of Resolute Integrity

Intention to follow randomization for implanting at least one 
Resolute Onyx stent or one Resolute Integrity stent

The subject requires treatment of up to 3 target lesions in up to 2 
separate target vessels [2 target lesions in 1 vessel (including its 
side branches) and 1 target lesion in a separate vessel (including 
its side branches)] amenable to treatment with stents with 
diameter from 2.25 mm to 4.0 mm

Target lesion must be de novo lesion located in a native 
coronary artery, with the visually estimated target reference 
vessel diameter (RVD) and lesion length eligible for treatment 
by the stent size ranges shown in below stent Size Matrix
Table 3-1 Study Arm (Resolute Onyx™ Stent Size Matrix)
Diameter
(mm)
Length (mm)
8
12
15
18
22
26
30
2.25
●
●
●
●
●
●
●
2.5
●
●
●
●
●
●
●
2.75
●
●
●
●
●
●
●
3.0
●
●
●
●
●
●
●
3.5
●
●
●
●
●
●
●
4.0
●
●
●
●
●
●
●

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Table 3-2 Control Arm (Resolute Integrity™ Stent Size Matrix)
Diameter
(mm)
Length (mm)
8
9
12
14
15
18
22
26
30
2.25
●
-
●
●
-
●
●
●
●
2.5
●
-
●
●
-
●
●
●
●
2.75
●
-
●
●
-
●
●
●
●
3.0
-
●
●
-
●
●
●
●
●
3.5
-
●
●
-
●
●
●
●
●
4.0
-
●
●
-
●
●
●
●
●
Key Exclusion Criteria:

Serum creatinine level > 2.5 mg/dl within 7 days prior to index 
procedure

Evidence of an acute STEMI within 24 hours prior to index 
procedure

Any previous treatment of the target lesion, including but not 
limited to previous PTCA, or an in-stent restenosis (ISR) lesion

Target lesion is in a bypass graft, including but not limited to 
saphenous vein graft (SVG) or a left/right internal mammary 
artery (LIMA/RIMA)

Unprotected left main coronary artery disease

TIMI flow is 0 (including but not limited to CTO lesion)

Planned two stent treatment for bifurcated lesions (bifurcated 
lesions treated with provisional stenting is allowed)
Study Assessments
Screening and implant procedure, heath status assessments at 30 
days, 6 months, 9 months, and annual assessments from 1-5 years
Study Duration
The study will be conducted to allow data collection and analysis 
through the 5-year follow-up assessment or until the study has been 
formally terminated
The enrollment period is estimated to be approximately 11 months. 
Subjects will remain in the study with baseline, procedure, 1 month, 
6 months, 9 months and annual follow-up assessments until the final 
study assessment (i.e. 5 Year Assessment), study exit, or death, 
whichever comes first
Statistical Methods
The primary endpoint of in-stent late lumen loss (LLL) at 9 months 
post procedure of the study arm will be compared to LLL of the 
control arm with a non-inferiority margin of 0.16 mm. A total of 550 
subjects yields 98% power, assuming a two-sided type I error at 0.05 
level of significance and 25% loss to follow-up rate

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Introduction 
4.1.
Background 
Coronary artery stents have shown to improve the safety and the efficacy of percutaneous 
coronary interventions (PCI) over balloon angioplasty alone 1, 2, 3, 4. Notwithstanding, restenosis is 
still encountered in 20-40% of coronary lesions after implantation of a bare metal stent5 , 
incurring frequent repeat revascularization procedures. This negatively impacts patients “quality 
of life and society” health care expenditures. The introduction of drug-eluting stents (DES), with 
localized and controlled release of anti-restenotic agents, have successfully addressed the 
problem of stent restenosis by demonstrating significantly less restenosis and need for repeat 
revascularization6.
The Resolute Onyx Zotarolimus-Eluting Coronary Stent System (Resolute Onyx) represents 
Medtronic’s new generation of DES which incorporates thinner stent struts and increases 
radiopacity over predicate stents, while retaining the essential characteristics of the Resolute 
Zotarolimus-Eluting Coronary Stent System (Resolute) and Resolute Integrity Zotarolimus-
Eluting Coronary Stent System (Resolute Integrity). The thinner stent struts improve acute 
deliverability performance by way of crossing profile and flexibility. The increased radiopacity 
improves the acute performance by ensuring accurate and complete lesion coverage. The 
iterative design improvements of contemporary stents have empowered physicians with a greater 
ability to deliver and deploy stents in more challenging locations safely.
The RESOLUTE clinical data provide assurance to the safe and effective use of the zotarolimus 
drug and BioLinx polymer in over 1 million coronary stenting procedures. The Global 
RESOLUTE Clinical Trial Program has enrolled over 7,500 subjects in whom there is high 
quality, long-term outcomes data. No Resolute Onyx clinical study data are available on Chinese 
population so far. The RESOLUTE ONYX China RCT Study is intended to demonstrate that the 
efficacy observed in the Global RESOLUTE Clinical Trial Program is maintained with the 
iterative modifications made to the Resolute Onyx stent.
Data collected from the RESOLUTE ONYX Clinical program studies will augment the existing 
data generated to date in the RESOLUTE Clinical Trial Program.
The RESOLUTE ONYX Clinical Program currently includes the RESOLUTE ONYX Core 
                                                          
1 Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal 
angioplasty. N Engl J Med. Mar 19 1987;316(12):701-706.
2 Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. for the 
Benestent Study Group. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery 
disease. Benestent Study Group. N Engl J Med. 1994;331(8):489-495
3 Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison 
of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl 
J Med. 1994;331(8):496-501.
4 Kimura T, Yokoi H, Nakagawa Y, Tamura T, Kaburagi S, Sawada Y, Sato Y, Hamasaki N, Nosaka H, et al. Three-year follow-up after 
implantation of metallic coronary-artery stents. N Engl J Med. 1996;334(9):561-566.
5 Kastrati A, Mehilli J, Dirschinger J, Pache J, Ulm K, Schuhlen H, Seyfarth M, Schmitt C, Blasini R, Neumann FJ, Schomig A. Restenosis after 
coronary placement of various stent types. Am J Cardiol. 2001; 87(1):34-39. 
6 Lemos PA, Serruys PW, Sousa JE. Drug-eluting stents: cost versus clinical benefit. Circulation. Jun 24 2003; 107(24):3003-3007. 

R E S O L U T E O N Y X C H I N A R C T S T U D Y
Cli ni c al I n v e sti g ati o n Pl a n 
M D T 1 6 0 6 1 R E S 0 0 5
V ersi o n
2 . 0
P a g e 1 5 of 9 5
M e dtr o ni c C o nfi d e nti al
T his d o c u m e nt is el e ctr o ni c all y c o ntr oll e d
0 5 6 -F 2 7 5, v 3. 0 Cli ni c al I n v esti g ati o n Pl a n T e m pl at e
( 2. 2 5 m m – 4. 0 m m) Cli nical St u d y , c o n d ucte d i n t he U nite d States ( U S) a n d t he R E S O L U T E 
O N Y X 2. 0 m m Cli nical St u d y c o n d ucte d i n t he U S a n d Ja pa n, i n a d diti o n t o t he R E S O L U T E 
O N Y X C hi na Si n gle Ar m a n d R C T st u dies: 

T he R E S O L U T E O N Y X C ore ( 2. 2 5 m m – 4. 0 m m) Cli nical St u d y  s uccessf ull y met b ot h 
t he pri mar y e n d p oi nt a n d pre-s pecifie d p o were d sec o n dar y e n d p oi nts. T he pri ma r y 
e n d p oi nt of i n-ste nt late l u me n l oss at 8 m o nt hs was c o m pare d t o hist orical c o ntr ol of t he 
R E S O L U T E U S A n gi o/I V U S S u b -St u d y  wit h pr o pe nsit y sc ore a dj ust me nt. T he 
pr o pe nsit y  sc ore a dj uste d o ne-si de d 9 5 % c o nfi de nce i nter val is -0. 0 2 m m, w hic h is less 
t ha n t he pre-s pecifie d n o n-i nferi ority mar gi n ( 0. 2 0 m m) t heref ore n o n -i nferi orit y has 
bee n de m o nstrate d ( p < 0. 0 0 1). After n o n -i nferi orit y is de m o nstrate d, pre-s pecifie d 
s u peri orit y is f urt her e val uate d, si nce t he pr o pe nsit y sc ore a dj uste d o ne-si de d 9 5 % CI is 
less t ha n 0 m m, s u peri orit y is als o met ( p = 0. 0 2 9) .

T he R E S O L U T E O N Y X 2. 0 m m Cli nical St u d y c o m plete d s u bject e nr oll me nt o n 
Fe br uar y  2 3, 2 0 1 6 a n d c urre ntly is i n t he pr ocess of c o n d ucti n g t he re q uisite s u bject 
f oll o w-u p assess me nts.
F or Res ol ute O n y x , the z otar oli m us dr u g a n d dr u g c o nce ntrati o n of 1. 6 g/ m m 2 of ste nt s urface 
area re mai n t he sa me as t he pre dicate Res ol ute pr o d ucts . T he Bi oli n x™p ol y mer a n d dr u g c oati n g 
f or m ulati o n als o re mai n t he sa me. T heref ore, Res ol ute O n yx is e x pecte d t o ha ve t he sa me l on g -
ter m safety a n d effecti ve ness as pre dicate Res ol ute ste nts, wit h i m pr o ve d ac ute perf or ma nce.
T he Res ol ute O n y x  ste nt recei ve d C E ( C o nf or mité E ur o pée n ne) certificate i nitiall y i n Se pte m ber 
2 0 1 4 a n d has bee n c o m mercialize d i n 8 9 c o u ntries /re gi o ns w orl d wi de. T o date, i n ter nati o nal 
c o m mercial e x perie nce wit h Res ol ute O n y x has de m o nstrate d a l o w c o m plai nt rate q ua ntitati vel y 
a n d q ualitati vel y c o m para ble t he pre dicate Res ol ute Inte grit y pr o d uct. T he c ore sizes of Res ol ute 
I nte grit y ste nt ha ve bee n a p pr o ve d f or c o m mercial use b y C hi na F o o d a n d Dr u g A d mi nistrati o n 
( C F D A) i n Fe b 2 0 1 6.
4. 2.
P ur p ose
T his st u d y  is i nitiate d f or Res ol ute O n yx pr o d uct re gistrati o n wit h C F D A. T he p ur p ose of t his 
st u d y is t o c o n d uct a pr os pecti ve, m ulti-ce nter, o pe n -la bel, ra n d o mize d c o ntr olle d e val uati o n of 
t he cli nical safety a n d efficac y of t he Res ol ute O n yx Ste nt S y ste m, c o m pare d t o t he Res ol ute 
I nte grit y Ste nt Sys te m i n s u bjects w h o are eli gi ble f or perc uta ne o us t ra nsl u mi nal c or o nar y 
a n gi o plast y ( P T C A) i n de n ov o lesi o ns a me na ble t o treat me nt wit h eit her of t he t w o ste nt 
s yste ms i n C hi na.

R E S O L U T E O N Y X C H I N A R C T S T U D Y
Cli ni c al I n v e sti g ati o n Pl a n 
M D T 1 6 0 6 1 R E S 0 0 5
V ersi o n
2 . 0
P a g e 1 6 of 9 5
M e dtr o ni c C o nfi d e nti al
T his d o c u m e nt is el e ctr o ni c all y c o ntr oll e d
0 5 6 -F 2 7 5, v 3. 0 Cli ni c al I n v esti g ati o n Pl a n T e m pl at e
O bjecti ves a n d E n d p oi nts
5. 1.
O bjecti ves
Pri m ar y O bjecti ve
T o e val uate t he safet y a n d efficac y of t he Res ol ute O n y x T M Z otar oli m us -El uti n g C or o nar y  Ste nt 
S y ste m as c o m pare d t o t he Res ol ute I nte grit yT M Z otar oli m us -El uti n g C or o nar y  Ste nt S yste m i n 
s u bjects re q uiri n g ste nt i m pla ntati o n.
5. 2.
E n d p oi nts
Pri m ar y E n d p oi nt
I n-ste nt Late L u me n L oss ( L L L) at 9 m o nt hs p os t pr oce d ure as meas ure d b y Q ua ntitati ve 
C or o nar y  A n gi o gra p hy ( Q C A).
Sec o n d ar y E n d p oi nts
Sec o n d ar y Cli nic al E n d p oi nts:

Ac ute S uccess ( de vice, lesi o n, pr oce d ure)

T he f oll o wi n g sec o n dar y cli nical e n d p oi nts will be assesse d at 3 0 da y s, 6 m o nt hs, 9 m o nt hs 
a n d a n n uall y t hereafter t hr o u g h 5 ye ars:
o
Maj or A d verse Car diac E ve nts ( M A C E), defi ne d as t he c o m p osite of deat h, m y ocar dial 
i nfarcti o n ( Q-wa ve a n d n o n - Q-wa ve), or cli nicall y- dri ve n re peat tar get lesi o n 
re vasc ularizati o n b y perc uta ne o us or s ur gical met h o ds
o
Deat h ( Car diac a n d N o n- car diac)
o
M y ocar dial i nfarcti o n (all MI  a n d Tar get Vessel M yocar dial I nfarcti o n (T V MI ))
o
All re vasc ularizati o ns ( T ar get Lesi o n Re vasc ularizati o n (T L R ), T ar get Vessel 
Re vasc ularizati o n (T V R ) a n d N o n-T V R )
o
Tar get Vessel Fail ure ( T V F), defi ne d as c o m p osite of car diac deat h, tar get vessel 
m y ocar dial i nfarcti o n or cli nicall y -dri ve n tar get vessel re vasc ularizati o n ( T V R )
o
Tar get Lesi o n Fail ure ( T L F) defi ne d as t he c o m p osite of car diac deat h, tar get vessel 
m y ocar dial i nfarcti o n or cli nicall y -dri ve n t ar get lesi o n re vasc ularizati o n ( T L R)
o
Ste nt T hr o m b osis ( S T) (as deter mi ne d b y A R C defi niti o ns )
Sec o n d ar y A n gi o gr a p hic E n d p oi nts (at 9 m o nt hs p ost pr oce d ure):

I n-ste nt a n d i n-se g me nt perce nt dia meter ste n osis ( % D S)

I n-ste nt a n d i n-se g me nt bi nar y a n gi o gra p hic reste n osis ( B A R) rate ( defi ne d as ＞5 0 % 
dia meter ste n osis ( D S))

I n-ste nt a n d i n-se g me nt mi ni mal l u mi nal dia meter ( M L D)

I n-se g me nt late l u mi nal l oss ( L L L)

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Study Design 
The Medtronic RESOLUTE ONYX China RCT Study is a pre-market, prospective, multi-
center, open-label, randomized controlled study aiming to enroll approximately 550 subjects 
from approximately 20 study sites in China who are eligible for percutaneous treatment with 
both Resolute Onyx stent and Resolute Integrity stent.
All subjects presenting to the cardiac catheterization laboratory for possible interventional
treatment are potential candidates. Those subjects who sign the Ethics Committee (EC) 
approved informed consent and subsequently fulfill all inclusion criteria and no exclusion 
criteria will be enrolled in the trial and will be randomized using an interactive web response 
system (IWRS) at a 1:1 ratio to:
•
Study arm: subjects will be treated by Resolute Onyx stent
OR
•
Control arm: subjects will be treated by Resolute Integrity stent
The investigators will be required to verify that all inclusion and none of the exclusion criteria 
are met. To keep in line with the intent and spirit of the study, each lesion as stented will need 
to be given a single CASS site that best reflects its anatomical position. Medtronic will not 
consider this inconsistence to be a noncompliance.
Every effort will be tried to avoid potential bias. A randomized design has been chosen as the 
soundest method to compare two treatment options. Due to the similar design characteristics 
of the devices, the study investigators and operators cannot be blinded, the subjects will also 
not be blinded. However to ensure the integrity of the study outcomes, angiograms will be 
reviewed by an independent angiographic core lab and the event adjudication will be 
conducted by an independent clinical event committee (CEC), consisting of cardiologists who 
are not participating in the study.
The study flowchart is shown in Figure 6-1.
6.1.
Duration
The enrollment period is anticipated to be approximately 11 months. Subjects will remain in 
the study and continue with baseline, 1 month, 6 months, 9 months and annual follow-up 
assessments until the final study assessment (i.e. 5-year assessment), study exit, or death, 
whichever comes first. Consequently, the entire study duration from enrollment to 5-year 
follow-up completion is anticipated to be approximately 71 months.
6.2.
Rationale 
The purpose of this study is to evaluate the clinical safety and efficacy of the Resolute Onyx
stent(s), compared to the Resolute Integrity stent(s) implanted in subjects in China. This study 
is conducted to provide evidence in Chinese subjects confirming the clinical safety and 
efficacy of Resolute Onyx stent which has already been demonstrated in other populations 
outside of China. The study design is based on the CFDA DES clinical study guideline (draft 

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version for public comments).  The data will be submitted to CFDA for Resolute Onyx 
product registration approval.
Obtain informed consent
Diagnostic Angio available?
Lesion criteria met?
Perform Angio
Screening
Investigator reviews all 
eligibility criteria and subject 
is suitable   
Discharge
Follow ups 
(30 Days, 6 Months, 9 Months (+ 
Angio Follow Up), 12 Months, 2 
Years, 3 Years, 4 Years & 5 Years)
YES
Randomization
Resolute Onyx : 
Resolute Integrity
1:1
YES
YES
NO
NO
YES
NO
Procedure – Resolute Onyx
Procedure – Resolute Integrity
Figure 6-1 Study Flow Chart

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Product Description
7.1.
Study Device Name and Description
Study Arm - Resolute OnyxTM Zotarolimus-Eluting Coronary Stent System
The Medtronic Resolute OnyxTM Zotarolimus-Eluting Coronary Stent System (Resolute Onyx 
Stent System) consists of four components:
1.
Resolute OnyxTM Bare Metal Stent– a premounted cobalt alloy and platinum-iridium 
alloy based stent
2.
Delivery System – Resolute Onyx™ Rapid Exchange (RX) Delivery System
3.
Polymer System - BioLinx™ Polymer System
4.
Zotarolimus – Anti-proliferative drug component/active pharmaceutical ingredient
Resolute Onyx is the next iteration of the Resolute family of products and utilizes the 
identical Resolute coating system (zotarolimus drug substance, BioLinx polymer, and drug 
dose density) as all predicate products within the Resolute portfolio. The product consists of 
the Onyx stent platform, Resolute coating system and next generation Onyx stent delivery 
system.
The Resolute Onyx stent is an iterative design update to the commercially available Resolute 
Integrity stent and utilizes the same continuous sinusoid manufacturing technology, with 
slight modifications to stent geometry incorporated to provide a lower crossing profile and 
thus improved deliverability over predicate products. The stent is manufactured from a 
composite wire which has an outer shell and an inner core. The following sections describe 
the constituent components of the Resolute Onyx product.
7.1.1.1.
Resolute Onyx Stent Platform
Resolute Onyx utilizes the Onyx bare metal stent which is manufactured from a composite 
wire which has an outer shell and an inner core. The outer shell is of the identical cobalt 
chromium alloy used for the Resolute Integrity stent. The inner core material is a 
Platinum/Iridium alloy intended to enhance radiopacity. A pictorial representation of the 
Resolute Onyx stent materials compared to the predicate, Resolute Integrity, is provided in 
Figure 7-1. The stent design has been modified slightly to provide a lower crossing profile 
and thus, improved deliverability over predicate products. A pictorial representation of the 
Resolute Onyx stent compared to the predicate, previous generation of Resolute Integrity is 
provided in Figure 7-2.

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Figure 7-1 Resolute Integrity and Resolute Onyx Stent Materials
Resolute Integrity Stent
Resolute Onyx Stent
Figure 7-2 Resolute Integrity and Resolute Onyx Stent Design
7.1.1.2.
Resolute Onyx Delivery System
The delivery system consists of a balloon-expandable intracoronary stent premounted on the 
Resolute Onyx™ Rapid Exchange (RX) delivery system with a catheter effective working 
length of 140 cm. The delivery system is compatible with 0.36 mm (0.014 in) maximum outer 
diameter guidewires and 1.42 mm (5 Fr/0.056 in) minimum inner diameter guide catheters. A 
graphic representation of the Onyx Rapid Exchange (RX) delivery system is presented in 
Figure 7-3.

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Components Not Shown:
Hypotube stiffening wire
Inner Shaft (Inner Member)
Figure 7-3 Onyx RX Delivery System with Stent
7.1.1.3.
Polymer System
Resolute Onyx stent employs the identical BioLinx polymer coating as its predicate Resolute 
products. The BioLinx polymer is the carrier for the drug substance, zotarolimus, and 
provides an extended elution profile for the finished product.
7.1.1.4.
Drug-Zotarolimus
The drug zotarolimus is a proprietary chemical entity licensed from Abbott Laboratories. 
Zotarolimus is a tetrazole-containing macrocyclic drug. This component remains unchanged 
from the approved predicate Resolute products. The suggested mechanism of action of 
zotarolimus is to bind to FKBP-12, leading to the formation of a trimeric complex with the 
protein kinase mTOR (mammalian target of rapamycin) inhibiting its activity. Inhibition of 
mTOR results in the inhibition of protein phosphorylation events associated with translation 
of mRNA and cell cycle control. Resolute Onyx utilizes a drug dose density of approximately 
1.6 g/mm2 of stent surface area, which is identical to the drug dose density used for the 
approved predicate Resolute products. The total drug content (per stent) is determined by both 
drug dose density and stent surface area. The active drug Zotarolimus is intended to reduce 
the incidence of restenosis in coronary interventions.
Control Arm - Resolute IntegrityTM Zotarolimus-Eluting Coronary Stent 
System
The Medtronic Resolute Integrity Stent System consists of four components:
1.
Integrity Bare Metal Stent – a pre-mounted cobalt alloy based stent
2.
Delivery System – MicroTrac Rapid Exchange (RX) Delivery system
3.
Polymer system - BioLinx™ Polymer System
4.
Zotarolimus –Anti-proliferative drug component/active pharmaceutical ingredient
The Integrity stent is a result of manufacturing process modifications and optimizations to the 
approved Driver and Micro-Driver coronary stent platform. The primary modification is a 
change to the method of forming the stent sinusoidal architecture. The Integrity stent is 
manufactured from a cobalt alloy as the Driver stent. To create the Integrity stent, a single 
cobalt alloy wire is formed into a continuous sinusoidal pattern of crowns and struts which are 
then wound around a mandrel (see Figure 7-2).

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7.1.2.1.
MicroTrac Delivery System
The Resolute Integrity stent utilizes the MicroTrac delivery system design which has been
approved by CFDA in the core sizes of Resolute Integrity™ Zotarolimus-Eluting Coronary 
stent system. 
The Resolute Integrity stent is pre-mounted on a custom MicroTrac Stent Delivery System on 
a rapid exchange (RX) catheter with a balloon (See Figure 7-3). The balloon delivery system 
has two radiopaque markers to aid in the placement of the stent during fluoroscopy. The 
delivery system is compatible with 0.014” (0.36 mm) guidewires and has an effective length 
of 140 cm.
Figure 7-4 MicroTrac RX (Delivery System and Resolute Integrity Stent)
The distal end of the catheter shaft, proximal to the balloon, contains a guidewire entry port, 
providing the RX feature of this device. The proximal end of the catheter contains a luer 
adapter for balloon inflation and deflation.
7.1.2.2.
Polymer System and Drug-Zotarolimus
The same as those in the Resolute Onyx stent system. 
More detailed information of the products, including indications for use, contraindications, 
warnings and precautions, preclinical testing and materials in contact with tissues or body 
fluids, how supplied including storage and other information can be found in the 
Investigators’ Brochure (IB) and/or ‘Instructions for Use’ (IFU).
7.2.
Device Model and Labelling
Both stent systems will be labeled according to local labelling requirements in Chinese and 
indicated for clinical trial use only.
Table 7-1 Stent Model Number and Size of Resolute Onyx
Stent Name
Stent Diameter (mm)
Stent Length (mm)
Stent Model Number (CFN)
Resolute Onyx
2.25
8
RONYX22508X
Resolute Onyx
2.25
12
RONYX22512X
Resolute Onyx
2.25
15
RONYX22515X
Resolute Onyx
2.25
18
RONYX22518X

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Stent Name
Stent Diameter (mm)
Stent Length (mm)
Stent Model Number (CFN)
Resolute Onyx
2.25
22
RONYX22522X
Resolute Onyx
2.25
26
RONYX22526X
Resolute Onyx
2.25
30
RONYX22530X
Resolute Onyx
2.5
8
RONYX25008X
Resolute Onyx
2.5
12
RONYX25012X
Resolute Onyx
2.5
15
RONYX25015X
Resolute Onyx
2.5
18
RONYX25018X
Resolute Onyx
2.5
22
RONYX25022X
Resolute Onyx
2.5
26
RONYX25026X
Resolute Onyx
2.5
30
RONYX25030X
Resolute Onyx
2.75
8
RONYX27508X
Resolute Onyx
2.75
12
RONYX27512X
Resolute Onyx
2.75
15
RONYX27515X
Resolute Onyx
2.75
18
RONYX27518X
Resolute Onyx
2.75
22
RONYX27522X
Resolute Onyx
2.75
26
RONYX27526X
Resolute Onyx
2.75
30
RONYX27530X
Resolute Onyx
3
8
RONYX30008X
Resolute Onyx
3
12
RONYX30012X
Resolute Onyx
3
15
RONYX30015X
Resolute Onyx
3
18
RONYX30018X
Resolute Onyx
3
22
RONYX30022X
Resolute Onyx
3
26
RONYX30026X
Resolute Onyx
3
30
RONYX30030X
Resolute Onyx
3.5
8
RONYX35008X
Resolute Onyx
3.5
12
RONYX35012X
Resolute Onyx
3.5
15
RONYX35015X
Resolute Onyx
3.5
18
RONYX35018X
Resolute Onyx
3.5
22
RONYX35022X
Resolute Onyx
3.5
26
RONYX35026X
Resolute Onyx
3.5
30
RONYX35030X
Resolute Onyx
4
8
RONYX40008X
Resolute Onyx
4
12
RONYX40012X
Resolute Onyx
4
15
RONYX40015X
Resolute Onyx
4
18
RONYX40018X
Resolute Onyx
4
22
RONYX40022X
Resolute Onyx
4
26
RONYX40026X

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Stent Name
Stent Diameter (mm)
Stent Length (mm)
Stent Model Number (CFN)
Resolute Onyx
4
30
RONYX40030X
Table 7-2 Stent Model Number and Size of Resolute Integrity
Stent Name
Stent Diameter (mm)
Stent Length (mm)
Stent Model Number (CFN)
Resolute Integrity
2.25
8
RSINT22508X
Resolute Integrity
2.25
12
RSINT22512X
Resolute Integrity
2.25
14
RSINT22514X
Resolute Integrity
2.25
18
RSINT22518X
Resolute Integrity
2.25
22
RSINT22522X
Resolute Integrity
2.25
26
RSINT22526X
Resolute Integrity
2.25
30
RSINT22530X
Resolute Integrity
2.5
8
RSINT25008X
Resolute Integrity
2.5
12
RSINT25012X
Resolute Integrity
2.5
14
RSINT25014X
Resolute Integrity
2.5
18
RSINT25018X
Resolute Integrity
2.5
22
RSINT25022X
Resolute Integrity
2.5
26
RSINT25026X
Resolute Integrity
2.5
30
RSINT25030X
Resolute Integrity
2.75
8
RSINT27508X
Resolute Integrity
2.75
12
RSINT27512X
Resolute Integrity
2.75
14
RSINT27514X
Resolute Integrity
2.75
18
RSINT27518X
Resolute Integrity
2.75
22
RSINT27522X
Resolute Integrity
2.75
26
RSINT27526X
Resolute Integrity
2.75
30
RSINT27530X
Resolute Integrity
3
9
RSINT30009X
Resolute Integrity
3
12
RSINT30012X
Resolute Integrity
3
15
RSINT30015X
Resolute Integrity
3
18
RSINT30018X
Resolute Integrity
3
22
RSINT30022X
Resolute Integrity
3
26
RSINT30026X
Resolute Integrity
3
30
RSINT30030X
Resolute Integrity
3.5
9
RSINT35009X
Resolute Integrity
3.5
12
RSINT35012X
Resolute Integrity
3.5
15
RSINT35015X
Resolute Integrity
3.5
18
RSINT35018X

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Stent Name
Stent Diameter (mm)
Stent Length (mm)
Stent Model Number (CFN)
Resolute Integrity
3.5
22
RSINT35022X
Resolute Integrity
3.5
26
RSINT35026X
Resolute Integrity
3.5
30
RSINT35030X
Resolute Integrity
4
9
RSINT40009X
Resolute Integrity
4
12
RSINT40012X
Resolute Integrity
4
15
RSINT40015X
Resolute Integrity
4
18
RSINT40018X
Resolute Integrity
4
22
RSINT40022X
Resolute Integrity
4
26
RSINT40026X
Resolute Integrity
4
30
RSINT40030X
7.3.
Intended Use
The Resolute Onyx Stent System (investigational) and Resolute Integrity Stent System 
(control) are intended to improve coronary luminal diameters in subjects with symptomatic 
ischemic heart disease due to stenotic lesion(s) amenable to treatment with stents’ diameter 
from 2.25 mm to 4.0 mm and stents’ length from 8 mm to 30 mm. The stents are intended as
permanently implanted devices.
7.4.
Probability analysis of success
The manufacturing system of Medtronic has been tested and proven for many years. The 
quality of the investigational device has been carefully examined and verified before delivery. 
The investigational device has been commercially available globally, including the Europe 
and many other countries, with a certain number of clinical application or post-marketing 
follow-up. The basic principles, structure composition and materials etc. comply with the 
international and domestic standards, or has been carefully examined and verified by 
Medtronic, as well as tested, qualified by CFDA certificated medical device testing 
organization. The study design of this study complies with related CFDA instructions and 
requirements of ethical review, and all potential subjects will be strictly selected according to 
indications of the investigational device.
7.5.
Probability analysis of failure
Although regulatory/ethical/scientific and medical requirements have been fully taken into 
consideration, the unanticipated risk in the clinical application of investigational device could 
lead to failure of this study. Potential risks could be reduced with well-trained study staff and 
strict protocol compliance.

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Selection of Subjects
8.1.
Study Population
Those who are eligible for PTCA in de novo lesions amenable to treatment with either 
Resolute Onyx or Resolute Integrity stent systems will be the target study population in 
China. Approximately 550 subjects from approximately 20 sites who meet the eligibility 
criteria and sign the informed consent form will participate in this study.  
8.2.
Subject Enrollment
All subjects presenting to the cardiac catheterization laboratory for possible interventional 
treatment are potential candidates. Subjects who do not meet all inclusion criteria or meet any 
one of the exclusion criteria will not be enrolled to participate in the clinical study. For details 
of the point of enrollment, refer to section 9.5.3.
8.3.
Inclusion Criteria
Subject must meet all of the following criteria to be eligible for treatment in the study:
General Inclusion Criteria:
1. Subject is 18 years old
2. The subject is an acceptable candidate for treatment with a drug-eluting stent in 
accordance with the applicable guidelines on percutaneous coronary interventions, the 
Investigator Brochure (IB) of Resolute Onyx™stent, and the Instructions for Use (IFU) of
Resolute Integrity™ stent
3. The subject has been informed of the nature of the study and has consented for the subject 
to participate and authorized the collection and release of his/her medical information by 
signing an Informed Consent Form
4. Intention to follow randomization for implanting at least one Resolute Onyx stent or one 
Resolute Integrity stent
5. Subject agrees to have all study procedures performed, and is willing to comply with all 
protocol-required evaluations and to return to the same investigational site where the 
procedure was performed for follow up angiography
Angiographic Inclusion Criteria (visual estimate):
The subject and each target lesion/vessel must meet all of the following angiographic criteria
to be considered for inclusion in the trial:
6. The subject requires treatment of up to 3 target lesions in up to 2 separate target vessels [2 
target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate 
vessel (including its side branches)] amenable to treatment with stents with diameter from 
2.25 mm to 4.0 mm
7. Target lesion must be de novo lesion located in a native coronary artery, with the visually 
estimated target reference vessel diameter (RVD) and lesion length eligible for treatment 
by the stent size ranges shown in Table 8-1 Resolute OnyxTM Stent Size Matrix or Table 
8-2 Resolute IntegrityTM Stent Size Matrix

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Table 8-1 Study Arm (Resolute Onyx™ Stent Size Matrix)
Stent Diameter
(mm)
Stent Length (mm)
8
12
15
18
22
26
30
2.25
●
●
●
●
●
●
●
2.5
●
●
●
●
●
●
●
2.75
●
●
●
●
●
●
●
3.0
●
●
●
●
●
●
●
3.5
●
●
●
●
●
●
●
4.0
●
●
●
●
●
●
●
Table 8-2 Control Arm (Resolute Integrity™ Stent Size Matrix)
Stent Diameter
(mm)
Stent Length (mm)
8
9
12
14
15
18
22
26
30
2.25
●
-
●
●
-
●
●
●
●
2.5
●
-
●
●
-
●
●
●
●
2.75
●
-
●
●
-
●
●
●
●
3.0
-
●
●
-
●
●
●
●
●
3.5
-
●
●
-
●
●
●
●
●
4.0
-
●
●
-
●
●
●
●
●
8. Target lesion must have visually estimated stenosis 50%
9. Target vessel must have a thrombolysis in myocardial infarction (TIMI) flow 2
8.4.
Exclusion Criteria
General Exclusion Criteria
Subjects will be excluded from the study if any of the following criteria are met:
1. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, P2Y12 
inhibitors, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings 
(e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-
medicated
2. History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, 
rapamycin, tacrolimus, everolimus, or any other analogue or derivative
3. Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) 
count < 3,000 cells/mm³ within 7 days prior to index procedure
4. Serum creatinine level > 2.5 mg/dl within 7 days prior to index procedure
5. Evidence of an acute STEMI within 24 hours prior to index procedure
a.
Q wave myocardial infarction (QWMI);
OR

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b.
Elevated cardiac biomarker values [preferably cardiac troponin (cTn)] with at least 
one value above the upper reference limit (URL) and with at least one of the 
following:
•
Symptoms of ischemia
•
New or presumed new significant ST-segment–T wave (ST–T) elevation of 
2mm from baseline or new left bundle branch block (LBBB)
•
Development of pathological Q waves in the ECG
•
Imaging evidence of new loss of viable myocardium or new regional wall
motion abnormality
Note: Subjects with evidence or suspicion of an acute MI (per Investigator or Sub-
Investigator determination) must have cardiac biomarker values reviewed prior to enrollment
6. Any previous treatment of the target lesion, including but not limited to previous PTCA, 
or an in-stent restenosis (ISR) lesion
7. Any staged PCI of any vessel at any time post index procedure
8. Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation
prior to index procedure
9. Previous percutaneous coronary intervention (PCI) of the target vessel within 9 months 
prior to the procedure
Note: Refer to Table 8-3 in Section 8.4.3 for criteria of previous PCI of the target and other 
(non- target) vessel(s)
10. During the index procedure, the target lesion requires treatment with a device other than 
percutaneous transluminal coronary angiography (PTCA) prior to stent placement 
(including, but not limited to, cutting/scoring balloon, atherectomy, laser, thrombectomy, 
etc.)
11. History of a stroke or transient ischemic attack (TIA) within the prior 6 months
12. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
13. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
14. Concurrent medical condition with a life expectancy of less than 12 months
15. Currently participating in an investigational drug or another device trial that has not 
completed the primary endpoint or that clinically interferes with the current trial endpoints
16. Inability to comply with the required trial antiplatelet regimen
17. A woman who is pregnant, lactating or planning to be pregnant within 12 months after 
index procedure
Angiographic Exclusion Criteria
Subjects will be excluded from the trial if any of the following criteria are met (for subjects 
with two or three target lesions, all target lesions/vessels must not meet any of the criteria 
below):
18. Target lesion is in a bypass graft, including but not limited to saphenous vein graft (SVG) 
or a left/right internal mammary artery (LIMA/RIMA)

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19. Unprotected left main coronary artery disease (no patent bypass graft(s) to one or more 
branches of the left coronary artery; the left anterior descending or circumflex artery, with 
an obstruction greater than 50% in the left main coronary artery)
20. TIMI flow is 0 (including but not limited to CTO lesions)
21. Planned two stent treatment for bifurcated lesions (bifurcated lesions treated with 
provisional stenting is allowed)
22. Previous stenting in the target vessel that: within 9 months prior to procedure; or previous 
stenting in the target vessel ≤15 mm from the target lesion
23. The target vessel has evidence of thrombus
Criteria for Additional Procedures
Table 8-3 Previous and Additional Procedure Criteria
Prior to Index Procedure
Time Point
Target Vessel(s)
Non-Target Vessel(s)
> 9 months pre-index
Any approved treatment, 
provided:
-Target lesion must be at least 
15 mm away from a previously 
placed stent or treatment 
Any approved treatment
9 months to > 30 days pre- index
No PCI
Any approved treatment
30 days to index
No PCI
No PCI
Post Index Procedure
- No planned/staged PCI at any time post index procedure. 
- If deemed medically necessary by investigator, the subjects should receive any necessary 
treatment, but any interventional or surgical treatment to coronary artery lesions post index 
procedure (including but not limited to PCI and/or CABG) should be reported as 
revascularization events

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Study Procedures 
9.1.
Schedule of Events
Table 9-1 Schedule of Treatments and Assessments
Event
Index Hospitalization
Follow up Assessments
Screen/Pre-procedure
Procedure
Post-Procedure1
30-day
6-month
9-month
1-5 years 
annually
Screen
Prior to procedure within
Subject
Contact2
Angio
Follow up
Subject
Contact2
7 days
72 hrs.
Informed Consent
●
Demographics
●
Medical and cardiac history
●
Cardiac risk factors
●
Current cardiac status
●
Angina Status
●
●
●
●
●
White Blood Cell
●
Platelet Count
●
Serum creatinine
●
Pregnancy Test3
●
Cardiac biomarkers4
●
●1st: ≥3hrs;2nd: >4 hrs.
after 1st and < 24 hrs.
12-lead ECG5
●
●
LVEF6
●
Eligibility
●
●
●
●
Procedure data
●
Angiogram7
●
●
AE and SAE8
●
●
●
●
●
●
●
●
ConcomitantMedication9
●
●
●
●
●
●
●
●

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1.
End of procedure is defined as removal of the guide catheter
2.
Subject contact includes phone call, mail, email or clinical visit
3.
Only required for no-menopause women subjects
4.
Cardiac biomarkers will be collected pre-procedure within 72 hours and post-procedure at two time points: the first collection should occur 3 
or more hours post-procedure and the second collection should occur 4 hours after the first collection but prior to 24 hours. It is preferred to 
collect CK and another biomarker e.g. CK-MB and/ or Troponin:

Preferred: “CK and CK-MB” or “CK and Troponin” or “CK, CK-MB and Troponin”

Unacceptable: “CK” values alone (will treat CK value alone as protocol deviation)

If a Myocardial Infarction has occurred after procedure or during study period, CK and CK-MB or CK and Troponin values will be 
collected. If any CK elevation (CK above upper limit of normal) is noted post-procedure, CK and CK-MB or CK and Troponin 
measurements will continue to be performed per local hospital practice starting from when the first elevation is noted until return of levels 
towards normal or discharge and recorded on the appropriate CRF
5.
A 12 lead ECG will be performed within 7 days prior to the procedure and within 24 hours post-procedure or at discharge whichever comes 
first. Relevant copies of ECGs will be collected for death or any (suspected) myocardial infarction or (suspected) stent thrombosis that occurs 
after the index procedure for adjudication purposes by a Clinical Events Committee (CEC). This includes copies of the baseline ECG (pre- and 
post-index procedure and discharge) and event ECG (most abnormal ECG and last ECG recorded) if available
6.
A LVEF value within the last 6 months pre-procedure is acceptable
7.
For subjects for death or any (suspected) myocardial infarction or (suspected) stent thrombosis that occurs after the index procedure, all 
baseline, procedural, 9 months follow-up (if applicable) and event angiograms will be collected. The angiograms will be reviewed by an 
independent angiographic core lab
8.
All AE information (e.g. AEs and SAEs) will be documented from the date the informed Consent From (ICF) signed until the 5-year follow-up 
assessment
9.
Only anti-platelet and anti-coagulation medication will be collected as concomitant medication from the date the ICF signed until the 5-year
follow-up assessment

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9.2.
Subject Screening 
All subjects admitted for potential PCI of the coronary arteries are the targeted study 
population. Subjects who signed the Informed Consent Form (ICF) and meet all eligibility 
criteria will continue the next study processes
9.3.
Subject Consent
Consent
Written informed consent must be obtained prior to subject participation in any study related 
activity.  Subjects should receive the EC approved ICF well in advance of the consent 
discussion.  During the consent discussion, the investigator or his/her designee must fully 
inform the subject of all pertinent aspects of the study that are relevant to a subject’s decision 
to participate in the clinical study.  If a subject is illiterate, an impartial witness must be 
present during the entire informed consent discussion. All items discussed in the ICF must be 
explained.  The language used shall be in the subject’s native language, as non-technical as 
possible and must be understandable to the subject and the impartial witness, where 
applicable.
The subject must have ample time and opportunity to read and understand the ICF to inquire 
about details of the study, and to decide whether or not to participate in the clinical study. All 
questions about the study should be answered to the satisfaction of the subject. The informed 
consent process shall be documented before any procedure specific to the clinical study is 
applied.
Neither the investigator, nor the investigation site staff shall coerce or unduly influence a 
subject to participate or to continue to participate in the clinical study.  The informed consent 
process shall not appear to waive the subject’s rights.
It is anticipated that some patients may sign a consent form and later be found to be ineligible 
due to angiographic criteria. Such patients are not considered part of the study endpoint 
analysis population.
When the subject decides to participate in the clinical study, the ICF must be signed and 
personally dated by the subject and investigator or authorized designee.  If applicable, the 
witness shall also sign and personally date the consent form to attest that the information in 
the ICF was accurately explained and clearly understood by the subject, and that informed 
consent was freely given. Signing the ICF serves to document the written and verbal 
information that the investigator or authorized delegate provides to the subject, the subject’s 
understanding of the information, and their agreement to participate.  After all persons have 
signed and dated the ICF, the investigator must provide the subject with a copy of the signed 
and dated ICF.  The original signed consent form will be retained in the subject’s study 
records.  
No patients from a vulnerable population will be included into the study. In addition, due to 
the nature of the eligibility criteria of the study, waiver of prior informed consent process due 
to emergency treatments is not applicable in this study.

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Revision for Informed Consent Form
As directed by the regulatory authorities, EC or Medtronic, subjects may have to be re-
consented to new revisions of the informed consent throughout the duration of the study.
Medtronic will inform the investigators whenever information becomes available that may be 
relevant to the subject’s confirmed participation in the study. The investigator or his/her 
designee should inform the subject in a timely manner.
Medtronic will revise the written ICF whenever new information becomes available that may 
be relevant to the subject’s confirmed participation in the study. The revised information will 
be sent to the investigator for EC approval. After approval by the EC, a copy of this 
information must be provided to the participating subjects, and the informed consent process 
as described above needs to be repeated.
9.4.
Randomization and Treatment Assignment
After written informed consent has been obtained, all of the inclusion and none of the 
exclusion criteria have been met, and prior to percutaneous coronary intervention, subjects 
will be randomized using an interactive web response system (IWRS). Randomization will be 
performed at 1:1 ratio to the study arm or control arm. As described in section 6, 
investigators, operators and subjects will not be blinded.
Subjects will be randomized to one of the following two groups:
•
Study group - Treatment with Medtronic Resolute Onyx Stent System (Table 8-1)
•
Control group - Treatment with Medtronic Resolute Integrity Stent System (Table 8-2)
If by mistake a subject is randomized twice or more, the first assigned treatment arm will be 
used for the intention-to-treat analysis, and investigators should treat subjects accordingly. 
The subjects who are assigned to Resolute Onyx Stent System treatment group should only be 
treated with the Resolute Onyx Stent System. The subjects who are assigned to Resolute 
Integrity Stent System treatment group should only be treated with the Resolute Integrity 
Stent System. If the assigned stents were not used, this will be reported as protocol deviation.
Randomization will be documented on electronic CRFs. Due to the “open” nature of this 
study, it is important to prevent selection bias. Since knowledge of the randomization 
procedure may lead to selection bias, the randomization procedure therefore will be described 
in a separate document.
9.5.
Procedures
Subject preparation and treatment of the target lesion(s) will be performed in accordance with 
the hospital’s standard policies and procedures for care of the interventional cardiology 
patients unless otherwise specified in this Investigation Plan.
The stenting procedure should be performed according to the IB for the Resolute Onyx stent,
IFU for the Resolute Integrity stent and the Angiographic Core Lab procedures in Appendix 
3.

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All standard ancillary devices (e.g., guidewires, sheaths/guiding catheters, pre-dilatation 
balloons, etc.) used during the preparation and procedure should be used in accordance with 
the Resolute Onyx stent IB or Resolute Integrity Stent IFU as applicable.
Preparation and Angiography
The procedures below will be followed for subject preparation and baseline angiography:
1.
Using standard procedures for balloon angioplasty, an introducer sheath of at least 6 
French will be introduced using the standard approach.
The guiding catheter used during the stent procedure must be 6 French or larger and the 
guide wire diameter must not be larger than 0.014 in (0.36 mm).
2.
Heparin or bivalirudin, with or without a GP IIb/IIIa receptor blocker, will be 
administered and supplemented as needed to maintain anticoagulation throughout the 
procedure.
3.
Following an intracoronary injection of nitroglycerin, baseline angiography of the 
vessel(s) will be performed in at least 2 near-orthogonal views that show the target 
lesion(s) free of foreshortening or vessel overlap, using a 6 French or larger guide 
catheter (see Appendix 3).
Target Lesion Pre-treatment
The target lesion(s) will be pre-treated in accordance with IB for Resolute Onyx stent and the 
IFU of Resolute Integrity. The use of other pre-treatment (e.g., cutting balloons, atherectomy, 
laser, thrombectomy, etc.) is not allowed.
Point of Enrollment
Based on the review of available information, all patients who are deemed to be a potential 
candidate for the study will be asked to participate. The point of enrollment is the moment of 
randomization.
Per full analysis set (FAS) principles, subjects who did not have a study stent implanted but a 
study stent was introduced into the guide catheter will be followed through 12 months for 
clinical assessments. Since analysis will be performed according to the FAS principle, 
subjects, who went through the randomization but did not have study stent implanted due to 
reasons such as delivery failure of one of more study stents, should be included and followed 
up until 12 months clinical follow up finished. In cases where the procedure was stopped prior 
to the study stent being delivered into the guide catheter (e.g. subject became unstable, power 
outage, equipment issues, etc.), the subject will not participate or be followed in the clinical 
study. No replacement will be done for randomization.
All reportable events occurring after the randomization, irrespective of whether the stent 
implantation procedure has actually started, must be documented in the electronic Case 
Report Form (eCRF).

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Subject enrollment and stent use information will be submitted to Medtronic on the eCRF 
within 10 business days or as soon as source documents are available. Subject screening and 
enrolment will be documented in subject identification log and screening log as appropriate.
Stenting Procedure
The stenting procedure should be performed according to the IB for Resolute Onyx and IFU 
for Resolute Integrity.
Stent length(s) should be selected so that the lesion can be fully covered.  Careful stent sizing 
is important to successful stenting. In general, the stent size should be chosen to match the 
diameter of the reference vessel and to correspond with the length of the lesion and the stent 
length (single stent or after overlapping if multiple stents) must be 3 mm longer than the 
lesion length.
For subjects with multiple target lesions, the first lesion must be treated successfully and the 
subject must be clinically stable before treatment of the following lesion(s) is attempted.
Post-dilatation may be performed at the Investigator’s discretion with appropriately sized 
(length and diameter) balloons to assure that the stent is in full contact with the vessel wall. 
Do not use the stent delivery balloon for post-dilatation.   
Successful treatment of the lesion is defined as:
1.
<10% residual diameter stenosis result is achieved (visual assessment)
2.
TIMI 3 flow is present post treatment
3.
No evidence of dissection (NHLBI Type C, D, E or F), thrombus or distal 
embolization at the first study lesion site post-treatment
Prior to attempted treatment of the second study lesion, subjects must be clinically stable 
without angina or ECG changes consistent with coronary ischemia.  If the subject is not 
clinically stable, or shows signs or symptoms of possible coronary ischemia following 
treatment of the first study lesion, treatment of the second lesion should be deferred, if 
possible.  Subsequent treatment of the second lesion should be with a study stent if performed 
during the trial index procedure.  If the second lesion requires treatment after the index 
procedure, a non-study stent must be used.
For subjects with planned treatment of only one lesion but during the procedure a second 
lesion meeting trial criteria is identified, a study stent should be used if stenting is needed and 
treatment cannot be deferred.  If the lesion does not meet trial criteria, a non-study stent 
should be used if stenting is needed and the lesion will be considered a non-target lesion for 
purposes of analysis and will be considered a protocol deviation.
9.5.4.1.
Bailout
Bailout procedures should be avoided unless required for subject safety. If bailout procedures 
are performed, justification should be documented on the CRF.

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If a subject in the trial experiences a major dissection or an occlusive complication (as 
evidenced by decreased target vessel flow, chest pain, or ischemic electrocardiogram (ECG) 
changes which do not respond to standard rescue techniques), bailout procedures may be 
performed.  For these events occurring during the study procedure, additional stenting with 
study stents may be employed as a bailout treatment.
In this trial, it is recommended that each target lesion to be covered with a single stent.  If 
overlapping is necessary, it is recommended to overlap the study stents for 3 mm to avoid the 
potential for gap restenosis.  If incomplete coverage occurs during the procedure, additional 
stenting with study stents may be employed to provide complete coverage.
9.5.4.2.
Treatment Failure
A study stent that enters the guide catheter but fails to be implanted at the intended location 
will be recorded in the eCRF. In the event of a failure to implant at least one study device, the 
Investigator may choose to treat the target lesion(s) with any approved device.
Note: There are no clinical data available regarding the interaction of the Resolute Onyx stent 
or Resolute Integrity stent implanted in the vicinity of other types of drug-eluting stents.
Damaged or failed Resolute Onyx or Resolute Integrity stent(s) (including ancillary devices) 
must be returned to Medtronic per related instructions in Medtronic SOP.
End of Procedure
Upon procedure completion, an intracoronary injection of nitroglycerin must be administered 
and final angiography of the vessel(s) performed in the same two near-orthogonal views that 
were taken at baseline, showing the target lesion(s) free of foreshortening or vessel overlap, 
using a 6 French or larger guiding catheter (see Appendix 3).
The end of the procedure is defined as the time the last guide catheter is removed from the 
subject. If the subject is returned to the procedure room and a guiding catheter is reinserted 
and a dilatation is performed, this should be considered a repeat intervention.
Adverse events that occur during the procedure must be recorded on the CRF.
Post-procedure to Hospital Discharge
For post-procedure subject management, immediately after the procedure the following will 
be performed:
1. Heparin or bivalirudin (as market approved by geography) should be discontinued.
2. Vascular sheaths should be removed according to standard hospital practice.
3. Approved vascular closure devices may be used at the discretion of the Investigator in 
accordance with the manufacturer’s instructions.
Qualified study staff at the investigational site will assess the subject’s clinical status 
(including angina) prior to discharge and record any adverse events.
9.6.
Medication Compliance
The following anti-platelet therapy is strongly recommended for index procedure:

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Aspirin: 75 mg daily for 3 days prior to the procedure, or a peri-procedural loading dose 
between 250-500 mg.
Approved P2Y12 inhibitor medications: (i.e. Clopidogrel: 75 mg for 3 days prior to the 
procedure or a pre-procedural loading dose between 300-600 mg).
Following the procedure, Aspirin (at least 75 mg daily) should be continued indefinitely. 
Approved P2Y12 inhibitors (i.e. Clopidogrel) should be prescribed for at least 6 months in
stable ischemic heart disease subjects and for at least 12 months in subjects with acute 
coronary syndrome (ACS)as per ACC/AHA/SCAI guidelines
All other co-medication usage is at the Investigators discretion and should be done according 
to hospital routine.
It is important that the subject is compliant with the post-procedural antiplatelet 
recommendations. Premature discontinuation of prescribed antiplatelet medication could 
result in a higher risk of thrombosis, myocardial infarction or death. Prior to enrollment in this 
trial, if a surgical or dental procedure is anticipated that would require early discontinuation of 
antiplatelet therapy, the Investigator and subject should carefully consider whether 
participation in the trial and the associated recommended antiplatelet therapy is the 
appropriate choice. Following enrollment, should a surgical or dental procedure be 
recommended, the risks and benefits of the procedure should be weighed against the possible 
risk associated with interruption or premature discontinuation of antiplatelet therapy.
Subjects who require interruption or premature discontinuation of antiplatelet therapy 
secondary to significant active bleeding, should be monitored carefully for cardiac events and, 
once stabilized, have their antiplatelet therapy resumed as soon as possible, per the discretion 
of their treating physicians.
9.7.
Assessment of Efficacy
Efficacy will be evaluated by the status of primary endpoint and secondary endpoints related 
with efficacy.
9.8.
Assessment of Safety
Safety will be evaluated by the safety related endpoints, and reported AE and SAE data.
9.9.
Recording Data
Follow-up 
Follow-up assessments will be done at the intervals listed in Table 9-2:
Table 9-2 Schedule of Treatments and Assessments
Follow-up Interval
Window
Method
30 Days
± 5 days
Contact*
6 Months
±14 days
Contact

R E S O L U T E O N Y X C H I N A R C T S T U D Y
Cli ni c al I n v e sti g ati o n Pl a n 
M D T 1 6 0 6 1 R E S 0 0 5
V ersi o n
2 . 0
P a g e 3 8 of 9 5
M e dtr o ni c C o nfi d e nti al
T his d o c u m e nt is el e ctr o ni c all y c o ntr oll e d
0 5 6 -F 2 7 5, v 3. 0 Cli ni c al I n v esti g ati o n Pl a n T e m pl at e
9 M o nt h s
± 3 0 da y s
Cli nic Visit
1 2 M o nt h s
± 3 0 da y s
C o ntact
2 Year s
± 3 0 da y s
C o ntact
3 Year s
± 3 0 da y s
C o ntact
4 Year s
± 3 0 da y s
C o ntact
5 Year s
± 3 0 da y s
C o ntact
* S u bject c o ntact i ncl u des p h o ne call, e mail or cli nic visit
E xce pt f or s u bjects w h o are re q uire d t o u n der g o t he 9-m o nt h f oll o w- u p a n gi o gra p h y , t he 
f oll o w- u ps at ot her ti me p oi nts ca n be d o ne by p h o ne or prefera bl y b y o ut patie nt cli nic visit.
T he 9 -m o nt h f oll o w -u p i ncl u des cli nical assess me nt a n d a n a n gi o gra p h y. Cli nical assess me nts 
(e. g. a n gina stat us, verif yi n g a d verse e ve nts) m ust be perf or me d pri or t o t he a n gi o gra p h y. If a 
patie nt has a re peat a n gi o gra m pri or t o t he 9 m o nt hs visit a n d t he tar get lesi o n is n ot 
vis ualize d, a n gi o gra p h y m ust be perf or me d at t he 9- m o nt h visit. If a patie nt has a re peat 
a n gi o gra m pri or t o t he 9- m o nt h f oll o w-u p visit a n d t he tar get lesi o n is vis ualize d, t he 
re q uire me nts f or 9- m o nt h a n gi o gra m are pr o vi de d i n Ta ble 9 - 3.
T a ble 9- 3 Re pe at A n gi o gr a p hic F oll o w -u p
P ost -Pr oce d ure A n gi o gr a p hic 
Ti me P oi nt
T ar get Lesi o n 
Re v asc ul ariz ati o n 
Perf or me d ?
A n gi o gr a p h y 
Re q uire d at 9 
m o nt hs ?
< 3 0 da y s p ost-pr oce d ure
Yes
Yes
N o
Yes
≥
3 0 da y s p ost- pr oce d ure
Yes
N o
3 0 da y s t o 5 m o nt hs p ost-pr oce d ure
N o
Yes
> 5 m o nt hs p ost pr oce d ure
N o
N o
N ote : c o m plia nce t o t he f oll o w-u p sc he d ule is esse ntial t o e na ble a n a nal y sis of t he res ults i n 
a scie ntificall y s o u n d a n d mea ni n gf ul wa y. If, f or w hate ver reas o n, t he s u bject f oll o w - u p 
ca n n ot be sc he d ule d wit hi n t he ti me wi n d o w or occ urre d o utsi de t he ti me wi n d o w, it is still 
esse ntial t o d oc u me nt t he s u bject data at a date as cl ose as p ossi ble t o t he calc ulate d f oll o w - u p 
date. S u bject l ost-t o-f oll o w- u p ( L T F U) s h o ul d be a v oi de d as m uc h as p ossi ble a n d 
I n vesti gat ors are ur ge d t o d o t heir utm ost best t o mai ntai n s u bject’s f oll o w - u p c o m plia nce. At 
e ver y f oll o w-u p assess me nt t he st u d y site researc h pers o n nel s h o ul d tr y  t o c o ntact t he s u bject.
Ta ble 9 - 1 i n secti o n 9. 1 s u m marizes w hat data will be c ollecte d pr os pecti vel y wit hi n t his 
st u d y.  
9. 9. 1. 1.
E C G
A 1 2 -lea d electr ocar di o gra m ( E C G) will be perf or me d wit hi n 7 da ys pri or t o t he pr oce d ure 
a n d wit hi n 2 4 h o urs p ost- pr oce d ure or pri or t o disc har ge w hic he ver c o mes first. F or e ve nts 
t hat occ ur after t he i n de x pr oce d ure a n d are relate d t o a st u d y e n d p oi nt i ncl u di n g b ut n ot 
li mite d t o deat h, (s us pecte d) m yocar dial i nfarcti o n or ste nt t hr o m b osis e ve nts, e ve nt E C G 

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printouts will be collected for adjudication purposes by an independent Clinical Events 
Committee (CEC).
9.9.1.2.
Angiography
There is a mandatory angiographic follow-up at 9 months post procedure for all subjects per 
study design. Visual estimation of lesion characteristics in relation to the index procedure will 
be done by the operator and core lab separately.
Baseline, procedural, 9-month angiographic follow-up and event angiograms will be collected 
that are related to a study primary or secondary endpoint, including but not limited to death, 
(suspected) myocardial infarction or stent thrombosis.
Furthermore, angiograms will be collected in cases of a delivery failure. All angiograms will 
be reviewed by an independent angiographic core lab.
9.9.1.3.
Cardiac Biomarkers
Cardiac biomarkers will be collected pre-procedure within 72 hours and post-procedure at two
time points: the first collection should occur 3 or more hours post-procedure and the 
second collection should occur 4 hours after the first collection but prior to 24 hours. It is 
preferred to collect CK and another biomarker e.g. CK-MB and/ or Troponin:

Preferred: “CK and CK-MB” or “CK and Troponin” or “CK, CK-MB and Troponin”

Unacceptable: “CK” values alone (will treat CK value alone as protocol deviation)
If a Myocardial Infarction has occurred after procedure or during study period, CK and CK-
MB or CK and Troponin values will be collected. If any CK elevation (CK above upper limit 
of normal) is noted post-procedure, CK and CK-MB or CK and Troponin measurements will 
continue to be performed per local hospital practice starting from when the first elevation is 
noted until return of levels towards normal or discharge and recorded on the appropriate CRF.
9.9.1.4.
Other Clinical Laboratory Procedures & Test
Please refer to Table 9-1.
9.9.1.5.
Medication
The electronic CRF will have separate pages to capture data on concomitant medication 
information. The concomitant medication page will be limited to capture data on anti-
platelet/anticoagulant medication.
9.9.1.6.
Source document collection in case of events to be adjudicated by the CEC
For the purpose of adjudication of events by the Clinical Events Committee, relevant event 
related source documents will be collected for events that need to be adjudicated by the CEC. 
Refer to the CRF instructions for further details.
9.10. Deviation Handling
A protocol deviation is defined as an event where the clinical investigator or site personnel 
did not conduct the study according to the protocol or the Investigator agreement.  The 

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investigator is not allowed to deviate from these documents except with prior approval and 
under emergency circumstances. All deviations shall be documented and explained, 
regardless the reason for the deviation.  Examples of protocol deviations include but are not 
limited to the following:

Failure to obtain informed consent prior to participation

Incorrect version of the informed consent form used

Failure to obtain EC approval before the start of the study

Implanted subject did not meet inclusion/exclusion criteria

Fail to treat subjects according to the randomization result

Required testing and/or measurements not done or incorrectly done

Unauthorized use of investigational devices

Adverse events not reported in the required time frame as required by regulation or as 
specified in the CIP

Control of study devices not maintained

Source data permanently lost

Enrollment of subjects during lapse of EC approval

Enrollment limits exceeded
Investigators should obtain prior approval from Medtronic before initiating any change or 
deviation from the CIP, except where necessary to protect the life or physical wellbeing of a 
subject in an emergency situation.  Such approval shall be documented in writing and 
maintained in the investigator site files.  Prior approval is generally not expected in situations 
where unforeseen circumstances are beyond the investigator’s control (e.g. subject did not 
attend scheduled check-up).
Deviations will be reported to Medtronic regardless of whether medically justifiable, pre-
approved by Medtronic, or taken to protect the subject in an emergency.  Study deviations 
should be reported to Medtronic via the Study Deviation eCRF (1 eCRF for each protocol 
deviation per each subject).  Relevant information for each deviation will be documented on a 
deviation form completed by site personnel and reviewed by the Investigator.
Investigators should report deviations to Medtronic and their reviewing EC in accordance 
with reporting requirements of local EC.
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying 
any corrective and/or preventive actions that may be warranted such as amending the CIP, in
accordance with Medtronic SOPs.  Repetitive or serious investigator compliance issues may 
represent a need to initiate a corrective action plan, which may include suspension of 
enrollment or termination of the investigator’s or site’s participation in the study.
9.11. Subject Withdrawal or Discontinuation 
All subjects will be encouraged to remain in the study through the 5-year follow-up.  
However, it is acknowledged that subjects have the right to discontinue participation at any 
time without penalty or loss of benefits to which the subject is otherwise entitled or the 

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Investigator may deem study withdrawal an appropriate action for a given subject due to 
documented medical reasons.
Subjects will be included in the analyses up to the time that consent was withdrawn but they 
will not be replaced in the enrollment of total study subjects. If discontinuation is because of 
problems related to the study device, the subject shall be asked to be followed for collecting 
safety data outside the clinical investigation. In all other cases, no additional data will be 
captured after the subject withdraws or is removed from the study, unless the information is 
publicly available.
If a subject decides to withdraw from the study or is withdrawn / removed from the study, the 
investigator will document the reason for withdrawal and indicate any rationale for the 
withdrawal from the study in the subject’s file. Examples of situations in which an 
investigator may withdraw a subject from the study include but are not limited to:
1. Subject routinely fails to complete required procedures
2. Medical necessity
Subject Lost-To-Follow-Up (LTFU) should be avoided as much as possible and investigators 
are urged to do their utmost best to maintain subject follow-up compliance. Continuous 
attempts throughout the five-year follow-up period should be made to contact the subject, the 
subject’s family or referring physician before documenting a subject LTFU. It is highly 
recommended to document each attempt to contact the subject and the method used (e.g. 
telephone contacts, registered letters) in the subject’s records.
A study exit form is required for all subjects upon his or her completion of the study, 
regardless of the reason for study exit.
Subjects exiting the study will not receive any additional continued care as part of the study. 
Subjects will be treated according to standard of medical care (including the standard care 
specified for post PCI procedure) following exit from the study.

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Risks and Benefits
The results of risk analysis, balancing benefits against risks associated with both the device 
system itself and procedures involved in its use, is included in the Resolute Onyx IB and 
Resolute Integrity IFU.
10.1. Potential Risks
For the detailed information on the risks of implantation of the Resolute Onyx stent or the
Resolute Integrity stent, including a complete list of warnings, precautions and potential 
adverse events, refer to the Resolute Integrity IFU and the Resolute Onyx IB.
With the use of coronary stenting devices, IVUS (intravascular ultrasound), or PCI 
(percutaneous coronary intervention) here lists the potential adverse events in order of 
severity:
•
Death
•
Aneurysm, pseudoaneurysm, or arteriovenous fistula (AVF) 
•
Stent deformation, collapse, or fracture 
•
Emergency surgery: peripheral vascular or coronary bypass 
•
Stroke / transient ischemic attack (TIA) 
•
Cardiac tamponade 
•
Coronary artery occlusion, perforation, rupture, or dissection  
•
Pericarditis
•
Embolism (air, tissue, device, or thrombus)
•
Thrombosis (acute, subacute, late, or very late)
•
Incomplete stent apposition
•
Myocardial infarction (MI) 
•
Restenosis of the stented artery
•
Arrhythmias 
•
Hemorrhage requiring transfusion
•
Shock / pulmonary edema
•
Coronary artery spasm
•
Abrupt vessel closure
•
Hypotension / hypertension
•
Allergic reaction (to contrast, antiplatelet therapy, stent system - material, drug or 
polymer coating)
•
Peripheral ischemia / peripheral nerve injury
•
Infection or fever
•
Unstable angina
•
Access site pain, hematoma or hemorrhage

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•
Balloon rupture
•
Stent migration
•
Failure to deliver the stent
•
Stent misplacement
The occurrence of the above listed complications may lead to the need for a repeat 
catheterization and/or percutaneous coronary intervention, myocardial infarction, emergency 
bypass surgery, or death. The following additional side effects/complications may be 
associated with, but not limited to, the use of zotarolimus:
•
Anemia
•
Circumoral paresthesia
•
Diarrhea
•
Dry skin
•
Headache
•
Hematuria
•
Infection
•
Pain (abdominal or arthralgia)
•
Rash
The side effects/complications of the BioLinx polymer are no different than those of other 
stent coatings and may include, but are not limited to, the following:
•
Focal inflammation at the site of stent implantation
•
Restenosis of the stented artery
•
Allergic reaction
Participation in this study also makes subjects be exposed to radiation from x-ray procedures. 
Whether or not participate the study, subjects will undergo a diagnostic angiography and/or 
index PCI procedure, during which they will be exposed to x-ray. What is extra requirement 
for subjects is the 9-month angiographic follow-up (if applicable). These tests or treatments 
involve a small amount of radiation, but it is necessary to guide the procedure or examination. 
The amount of radiation subjects is exposed to during this study will depend on the 
complexity of the procedure.
There may be other discomforts and risks related to the device and/or this study that are not 
foreseen at this time.
Standard risks associated with the medical device used in this study, an analysis of Adverse 
Device Effects and a history of modification or recall of device under investigation or 
equivalent devices are listed in the IB.  
The evaluation of risk associated with the Resolute Onyx Stent System and the Resolute 
Integrity Stent System was performed in accordance with ISO14971: 2012 and Medtronic 
internal requirements. Based on the analysis performed, the residual risks associated with 
each hazard/failure mode were deemed acceptable to allow for clinical evaluation.

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The risks associated with using this device are those associated with standard percutaneous 
coronary diagnostic and treatment procedures.  The additional risk of using this device is 
associated with the zotarolimus drug and BioLinx polymer coating.
The risks of the Resolute Onyx System and Resolute Integrity System are not entirely known, 
but are believed to be similar to those that are associated with the standard, customary 
stenting of a stenosed coronary artery.
10.2. Potential Benefits
Participation will provide subjects and treating physicians an additional treatment option with 
Medtronic’s new generation DES (The Resolute Onyx stent), which has been approved in 89 
other countries and regions around the world. Participation also contributes to expanding the 
knowledge base with respect to procedural and clinical outcomes of new coronary stents.
Moreover, investigator will provide up to 5 years’ clinical follow up to subjects post 
procedure according to the CIP procedure, which means subjects will receive more regular 
health care and follow up than the standard care in China for those who do not participate in 
this study.
10.3. Risk-Benefit Rationale
For study arm Resolute Onyx, the pre-clinical data (including animal studies and other 
technical testing) suggest Resolute Onyx Stent System can be used safely and reliably for its 
intended purposes. Resolute Onyx stent had already been approved and widely used in 89 
countries or regions around the world already, including EU.
Risks associated with using the Resolute Onyx stent are similar to those associated with any 
other approved drug-eluting coronary stent (DES) used during percutaneous coronary 
interventional procedures.  
For control arm Resolute Integrity, it is a CFDA approved product. So the risks are also 
similar to using any other approved DES.
Compared with eligible patients who receive routine hospital care (any approved DES) and do 
not participate in this study, subjects will have very limited extra risks than using any 
approved DES.
All efforts will be made to minimize the risks in the study by selecting Investigators who are 
experienced and skilled in interventional procedures including stenting, by training 
implanting physicians on the IB and IFU prior to the study start at each site, by clearly 
defining inclusion/exclusion criteria to ensure only appropriate subjects are enrolled, by 
ensuring that treatment and check-up of the subject are consistent with current medical 
practices, and by an independent CEC which will review endpoint-related adverse events in 
order to advise Medtronic regarding study conduct should safety concerns be identified.

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10.4. Liability
Subjects do not need to pay for the investigational devices (including study arm device and 
control arm device). Moreover, the 9 months angiographic follow up procedure cost does not 
require subjects to pay.
The free device, free angiographic examine at 9 months post procedure and a more regular 
clinical health care post procedure provided in this study are reasonable and can overweigh 
the risks.
10.5. Alternatives
Presently, therapeutic alternatives for subjects with the clinical indication targeted for the 
Resolute Onyx stent system and Resolute Integrity stent system range through the following:

Other commercially available stent system with a drug or without drug

Balloon angioplasty

CABG

Medical treatment

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Adverse Events and Device Deficiencies
11.1. Definitions/Classifications
The definitions to be applied for the purposes of reporting adverse events are provided in 
Table 11-1.
Table 11-1 Adverse event definitions for reporting requirements
Event Type
Definition
Adverse Event 
(AE)
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.
(ISO 14155:20115 section 3.2)
The medical events with disadvantages occurred during the clinical study, 
no matter whether they are related to investigational medical devices or 
not.
(Good Clinical Practice for Medical Devices (CFDA Order No.25) -Article 
93)
Serious Adverse 
Event (SAE)
Adverse event that 
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.
                                                          
5 International Standard ISO 14155:2011(E). Clinical investigation of medical devices for human subjects –
Good Clinical Practice.

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Event Type
Definition
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.
(ISO 14155:2011 section 3.37)
Any untoward medical occurrence during the clinical study: results in 
death or serious deterioration in health; life-threatening diseases or injuries; 
causing permanent damage to the body structure or function; requires 
hospitalization or prolongation of hospitalization; requires medical 
operations or intervention for preventing from persistent or significant 
disability/incapacity; results in fetal distress, fetal death, or congenital 
anomaly/birth defect.
(Good Clinical Practice for Medical Devices -Article 93)
Adverse Device 
Effect (ADE)
Adverse event related to the use of an investigational medical device.
NOTE 1: This definition includes adverse events resulting from insufficient 
or inadequate instructions for use, deployment, implantation, installation, 
or operation, or any malfunction of the investigational medical device.
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuse of the investigational medical device.
(ISO 14155:2011 section 3.1)
Serious Adverse 
Device Effect 
(SADE)
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event.
(ISO 14155:2011 section 3.36)
Unanticipated 
Serious Adverse 
Device Effect 
(USADE)
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.
NOTE: Anticipated serious adverse device effect (ASADE) is an effect, 
which by its nature, incidence, severity or outcome has been identified in 
the risk analysis report.
(ISO 14155:2011 section 3.42)
Device Deficiency 
(DD)
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance.
NOTE: Device deficiencies include malfunctions, use errors, and 
inadequate labeling.
(ISO 14155:2011 section 3.15)
Any unreasonable risk caused by a medical device in normal use during 
clinical study that may endanger human health or life safety, such as label 
error, quality issues, malfunction and etc.
(Good Clinical Practice for Medical Devices -Article 93)

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Medical occurrences that are inherent to a surgical procedure and expected to occur in the
majority of subjects for a projected duration may be considered unavoidable. Such events 
include, but are not limited to, those listed in Table 11-2. These medical occurrences should 
not be reported as adverse events during this study.
Table 11-2 Expected, non-reportable events related to a surgical procedure
Event Description
Timeframe (hours) 
from the procedure
Anesthesia related nausea / vomiting (with or without treatment)
24
Low-grade fever (<37.8°C)
48
Pain at access site (with or without standard treatment and 
patient not returning to clinic to have additional treatment)
72
Mild to moderate bruising / ecchymosis at access site(s) as 
determined by physician
168
Sleep problems (insomnia) (with or without treatment)
72
Back pain related to laying on table (with or without treatment)
72
Bleeding at access site (not requiring treatment)
24
MACE and Stent Thrombosis
MACE and/or stent thrombosis events should be reported through eCRF immediately after the 
Investigator and/or other study designated staff becomes aware of the event.
11.2. Evaluation and Documentation of Adverse Events
Investigators are required to evaluate and document all AE (including SAE) and Device 
Deficiencies (per the definitions in Table 11-1) from the time subjects are consented until they 
are no longer participating in the study.  
For all observed AEs, investigators should assess and document the information on the 
Adverse Event and/or non-subject AE eCRF.
In addition, for all endpoint events, sites should submit relevant information to Medtronic for 
the Clinical Events Committee (CEC) members to use in their adjudication of the event.
11.3. Anticipated Adverse Events
Latest list of adverse events that are anticipated for subjects participating in this study is 
described in the Resolute Onyx IB (see appendix 7) and Resolute Integrity IFU (see appendix 
6).

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11.4. Reporting of Adverse Events
All AE information will be collected in this study. Investigators should provide continuous 
monitoring, assessment and documentation of the adverse events throughout the duration of 
the study. Therefore, all AE information will be collected from subjects are consented through 
the 5-year follow-up assessment.
A list of AEs that may be associated with the use of the study device and/or the interventional
procedure is provided in the IB and IFU. AE reporting requirements are provided in Table 11-
3.  Initial reporting may be done by phone, fax, e-mail, or on the eCRF completing as much 
information as is available. The original fully completed AE eCRF must be submitted to 
Medtronic as soon as possible.
In case the investigator requires information from Medtronic in an emergency situation, the 
investigator may contact Medtronic.  A list of contact information will be kept separately.
Adverse event (AE) reporting will be completed according to local regulatory requirements.
Note that ISO definitions are used for adverse event classifications. The AE review and 
reporting process will be specified in this section 11 and/or the clinical safety management 
and potential complaint plan.
How long to follow an AE (AEs should be followed until one of these criteria is met):

Until the AE resolves

Until no further action can be taken for an ongoing AE

Until the subject exits the study, or

Until study closure
NOTE: In the case of permanent impairment, continue to follow the event until it stabilizes 
and the overall clinical outcome has been ascertained
11.5. Documentation and Reporting of Device Deficiencies
Device Deficiency information will be collected throughout the study and reported to 
Medtronic.  
All Device Deficiencies, regardless if it led to an AE, must be reported.  Information reported 
on the Device Deficiency Form shall include a description of the deficiency, the date of onset, 
actions taken as a result of the deficiency, and the date the deficiency was first noticed by the
investigator.
Device deficiencies that did not lead to an adverse event but might have led to an SAE if a) a 
suitable action had not been taken, or b) an intervention had not been made, or c) 
circumstances had been less fortunate, should be reported to Medtronic as soon as possible. 
Initial reporting may be done by phone, fax, e-mail, or on the eCRF completing as much 
information as is available. The original fully completed Device Deficiency eCRF must be 
submitted to Medtronic as soon as possible.

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Table 11-3 AE Reporting Requirements
For the following events, reporting requirements are:
-
Serious Adverse Events (SAE)
Investigators shall immediately adopt appropriate therapeutic measures for subjects, and 
simultaneously report to the management department of medical device clinical study in 
clinical Research institutions in written form. Management department of medical device 
clinical study shall report to:
Medtronic
Immediately 
Local food and drug regulatory authority and health 
and family planning competent authority of the 
province, autonomous region and municipality 
directly under the central government where the 
clinical Research institution locates
Within 24 hours
Ethics Committee
Within 24 hours/per EC’s requirements
For the following events, reporting requirements are:
-
All other AEs
-
All other Device Deficiencies
Investigators shall record all the adverse events and device deficiencies occurred during the 
clinical study. Investigators shall analyze the reasons for the events with Medtronic and 
document the analysis result in written report, including the comments of continuing, 
suspending or terminating study, which shall be reported to the Ethics Committee through 
management department of medical device clinical study in clinical Research institutions 
for review. 
To Medtronic
Submit in a timely manner after the 
investigator first learns of the event.
To Ethics Committee
Per EC’s requirements 
For the following events, reporting requirements are:

Serious Adverse Events (SAE)

DD with SADE potential 
Medtronic submits to:
The food and drug regulatory authorities and health 
and family planning competent authorities at the 
same level 
Within 5 working days upon being
informed
Other clinical Research institutions and 
investigators participating in the study
As per local reporting requirement

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Ethics Committee
Timely report to EC of the clinical 
Research institution through 
management department of medical 
device clinical study
NOTE: In case there is/are additional AE reporting requirement(s) and/or process(es) (e.g. 
internal hospital policy or province regulatory authority instruction, etc.), these specific AE 
reporting requirement and process must be documented in a separate cover.
11.6. Emergency Contact Details
Investigators should contact their Medtronic clinical research specialist or site monitor if they 
have any questions regarding reportable AE.  Medtronic will provide and maintain a listing of 
current contact details for each site.  

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Data Review Committees 
12.1. Clinical Events Committee (CEC)
A Clinical Events Committee (CEC) will provide independent medical review and 
adjudication of clinical events and clinical endpoints in this study. The CEC is made up of 
clinicians (interventional and non-interventional) with pertinent expertise who are not 
participants in the study and who do not have any other real or potential conflicts of interest.  
The CEC is charged with the development of specific criteria used for the categorization of 
adverse events and clinical endpoints in the study. Criteria will be established for selected 
complications and clinical events.
At the onset of the study, the CEC will establish explicit rules outlining the minimum amount 
of data required and the algorithm followed in order to classify an event.
The Medtronic Clinical Safety Department or designee will categorize all clinical events and 
provide this information, along with all available source documentation to the CEC. The CEC 
will meet regularly to review and adjudicate all events in which the required minimum data 
are available.
Details will be documented in the Charter of the Clinical Events Committee.

R E S O L U T E O N Y X C H I N A R C T S T U D Y
Cli ni c al I n v e sti g ati o n Pl a n 
M D T 1 6 0 6 1 R E S 0 0 5
V ersi o n
2 . 0
P a g e 5 3 of 9 5
M e dtr o ni c C o nfi d e nti al
T his d o c u m e nt is el e ctr o ni c all y c o ntr oll e d
0 5 6 -F 2 7 5, v 3. 0 Cli ni c al I n v esti g ati o n Pl a n T e m pl at e
St atistic al Desi g n a n d Met h o ds
1 3. 1. St atistic al D esi g n, Met h o ds a n d A n al ytic al P r oce d ures
T his st u d y  is a pre -mar ket, p r os pecti ve, m ulti-ce nter, o pe n -la bel, ra n d o mize d c o ntr olle d st u d y 
ai me d t o e val uate t he cli nical safety a n d efficac y of t he Res ol ute O n yx Ste nt S y ste m, 
c o m pare d wit h t he Res ol ute Inte grit y Ste nt S yste m i n s u bjects t hat are eli gi ble f or 
perc uta ne o us tra nsl u mi nal c or o nar y  a n gi o plasty ( P T C A) i n d e n ov o lesi o ns a me na ble t o 
treat me nt wit h eit her of t he t w o ste nt s yste ms i n C hi na. T he pri mar y  e n d p oi nt is i n-ste nt Late 
L u me n L oss ( L L L) at 9 m o nt hs p ost pr oce d ure as meas ure d b y Q ua ntitati ve C or o nar y 
A n gi o gra p h y ( Q C A) .
Statistical A nal y sis Met h o d
Descri pti ve A nal y sis：Cate g orical data will be descri be d usi n g c o u nts a n d perce nta ges . 
C o nti n u o us data will be descri be d usi n g mea ns , sta n dar d de viati o ns , ma xi m u m, mi ni m u m, 
me dia ns, t he 2 5t h a n d t he 7 5t h perce ntiles.
Baseli ne De m o gra p hics A nal y sis: Base d o n t he descri pti ve a nal ysis, cate g orical data will be 
c o m pare d bet wee n t he t w o gr o u ps usi n g C hi -s q uare test wit h c o nti n uit y c orrecti o n, a n d w he n 
m ore t ha n 2 5 % of t he cells of t he c o nti n ge nc y  ta ble ha ve a fre q ue nc y less t ha n 5, t he n Fis her's 
e xact test will b e use d. C o nti n u o us varia bles wit h n or mal distri b uti o n will be teste d usi n g t w o 
sa m ple t-test, a n d n o n-n or mal c o nti n u o us data will be teste d wit h Wilc o x o n Ra n k S u m test.
Effecti ve ness A nal ys is: F or t he pri mar y  e n d p oi nt, 9 – m o nt h L L L, t he t w o ar ms will be 
c o m pare d usi n g a nal ys is of c o varia nce ( A N C O V A) wit h baseli ne ( p ost pr oce d ure M L D) a n d 
sites as c o variates. T he L L L of t he t w o ar ms will be pr o vi de d, a n d t he treat me nt differe nce as 
well as t he c orres p o n di n g 9 5 % c o nfi de nce i nter val will be esti mate d usi n g t he least s q uares 
esti mati o n. Ot her effecti ve ness e n d p oi nts will be a nal yz e d usi n g si milar met h o d as baseli ne 
a nal ys is.
Safet y A nal ys is: A d verse e ve nt will be re p orte d wit h e ve nt c o u nts a n d perce nta ges, a n d will 
be c o m pare d usi n g c hi -s q uare test or Fis her exact test. Mea n w hile, t he s y m pt o m, se verit y  a n d 
t he relati o n t o i n vesti gati o nal de vices of all a d verse e ve nts will be descri be d i n a detaile d 
ma n ner.
All statistical a nal y ses will be perf or me d wit h t w o-si de d 0. 0 5 si g nifica nt le vel. Statistical 
s oft ware S A S9. 4 or hi g her will be use d .
1 3. 2. S a m ple Size C alc ul ati o n C o nsi der ati o n
T ot al S a m ple Size
Acc or di n g t o t he C F D A D E S cli nical st u d y  g ui deli ne ( draft versi o n f or p u blic c o m me nts), at 
least 4 0 0 e val ua ble s u bjects will be 1: 1 ra n d o mize d.

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The primary endpoint to be evaluated in this trial is in-stent late lumen loss (LLL) at 9 months 
post-procedure. In the historical Resolute China RCT trial, the observed in-stent late lumen 
loss at 9 months was 0.16 ± 0.38 mm for the Resolute arm.6
The null hypothesis for this study is that the Resolute Onyx study arm will have a primary 
endpoint of in-stent late lumen loss at 9 months equal to or exceeding that of the Resolute 
Integrity control arm by 0.16 mm or more. The alternative hypothesis is that the Resolute 
Onyx study arm will have 9 months in-stent late lumen loss less than that of the control arm 
plus 0.16 mm. Rejection of the null hypothesis will signify that the Resolute Onyx stent is 
non-inferior to the Resolute Integrity stent with regard to 9 months in-stent late lumen loss.
Specifically, the null (H0) and alternative (H1) hypotheses are:
H0: A ≥C + 
H1: A < C + 
Where μA is the true in-stent late lumen loss for the Resolute stent and μC is the true in-stent 
late lumen loss for the control stent.
The parameter assumptions are:
A =  C
Common standard deviation of 0.4 mm
= 0.16 mm
Two sided α = 0.05
1:1 randomization
25% lost to angiographic follow up
With these assumptions, a total of 534 subjects (400 evaluable, 200 in each group) will yield 
98% power to reject the null hypothesis of inferiority in favor of the alternative hypothesis of 
non-inferiority. To be more conservative, it is planned to enroll approximately 550 subjects.
Power Analysis and Sample Size (PASS) was used to compute sample size.
Minimum and Maximum Enrollment Number per Site and Rationale
This trial will be conducted simultaneously at multiple sites. In principle, every effort will be 
tried to make the enrollment distributed evenly to each site, to ensure adequate representation 
of each site. However, in consideration of the feasibility and the enrollment progress, the 
enrollment will be adjusted according to the real situation, to ensure the enrollment numbers 
                                                          
6 Xu B, Yang Y, Yuan Z, et al. Zotarolimus-and paclitaxel-eluting stents in an all-comer population in China: the RESOLUTE China 
randomized controlled trial[J]. JACC: Cardiovascular Interventions, 2013, 6(7): 664-670.

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among different sites are relatively balanced. For any specific site, the maximum enrollment 
number should not exceed 20% of the total sample size.
13.3. Significant Level and Statistical Power
Refer to section 13.2.1 for the level of significance (two-sided 0.05), and the power (98%).
13.4. Expected Drop-out Rate
In this RCT trial, because the subjects need to receive invasive assessment during primary 
endpoint angiographic follow-up, so based on the historical experience, the expected drop-out 
rate of this trial is up to 25% (only for the angiographic follow-up).
13.5. Trial Result Pass/Fail Criteria
For Primary Endpoint Analysis 
The study pass/fail criteria is based on statistical hypothesis and the final analysis results.
The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 
months, defined as the difference between the post-procedure minimal lumen diameter 
(MLD) and the follow-up angiography MLD, of the Resolute Onyx Stent System compared to 
Resolute Integrity Stent System in the de novo population requiring stent implantation in 
China. If the upper limit of the two sided 95% confidence interval of the difference of the 
primary endpoint is less than , then Resolute Onyx stent is considered non-inferior to 
Resolute Integrity stent.
13.6. Early Termination of the Trial Based on Statistical Rationales
Interim analysis and corresponding early termination criteria are not planned for this trial. So 
this section is not applicable. 
13.7. Analysis Data Set, Handling of Missing Data, Unused or Erroneous
Data (including withdrawals) and Spurious Data 
For the possible missing data during the trial, in general missing data will only be imputed for 
the primary endpoint analysis. The imputation method will be specified in the Statistical 
Analysis Plan (SAP). However, for this coronary stent trial which uses Late Lumen Loss as 
the primary endpoint, the expected lost to 9 months angiographic follow up rate can be up to 
25%, so missing data imputation may cause bias. So this trial will use all observed available 
data for primary analysis, and if necessary, will also use multiple or single imputation as 
secondary analysis or supplementary analysis. For missing data related to other measures, 
imputation will not be performed. More details will be provided in SAP.
Erroneous or spurious data will be cleaned before performing statistical analysis. The data of 
withdrawal subjects will also be included in the final statistical analysis. Reasons for 
withdrawal will be specified in the statistical report. The missing of primary endpoint data 
caused by early withdrawal will be handled with the methods for missing data as mentioned 
above.

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13.8. Deviation from Pre-specified Analysis Plan
The statistical analysis plan (SAP) will be confirmed by the sponsor and the coordinating
investigator/leading site, and finalized before the database is locked for analysis. The SAP 
may be modified according to the actual scenarios observed during the study phase before 
final approval. In principle, major analysis principle, methods or analysis sets will not be 
changed. All revisions will be recorded.
13.9. Criteria and Rationale for Selection of Subjects for Analysis
Statistical analysis sets should be clearly defined prior to the time when analysis is carried 
out. The analysis sets for this study are defined as follows:
Full Analysis Set (FAS):  According to the Intention to treat (ITT) principle, all subjects who 
have participated in the trial and used the investigational devices, will be included in the FAS.
Per-Protocol (PP):  Subjects who finished the trial, excluding those who had major protocol 
deviations (subjects did not meet all of the inclusion criteria or none of the exclusion criteria).
The primary endpoint analysis will be performed in both FAS set and PP set. Besides, all 
baseline demographics and secondary efficacy analysis will be performed in FAS set. Safety 
assessment will also be performed in FAS set (so will not define SS set separately).

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Ethics
14.1. Statement(s) of Compliance 
The study shall be conducted in accordance with the Declaration of Helsinki 2013 and 
applicable local regulations, Good Clinical Practice for Medical Devices (CFDA Order 
No.25), CIP, the clinical study agreement, and the ethical principles that have their origin in 
the Declaration of Helsinki 2013.
The principles of the Declaration of Helsinki have all been implemented by means of the 
patient informed consent process, EC approval, study training, clinical study registration, 
preclinical testing, risk benefit assessment, and publication policy.  Pediatric, legally 
incompetent, or other vulnerable subjects are not eligible for the study.
The study will not begin until EC and regulatory authority approvals/notification, as 
appropriate, are received.  
14.2. Role of Medtronic
As the Sponsor of this clinical study, Medtronic has the overall responsibility for the conduct 
of the study.  In this study, Medtronic will have certain direct responsibilities and may 
delegate other responsibilities to consultants and/or contract research organizations.
The sponsor will avoid improper influence on, or inducement of the subject, monitor, and 
investigator(s) or other parties participating in, or contributing to, the clinical study by 
implementing the informed consent process, Clinical Investigation Agreements, EC approval.
No medical care will be provided for subjects after the study has been completed and subject 
will be treated according to the standard routine practice after the study period. In addition, 
there is no post-study access of the investigational device for participants as initial treatment 
and the need for additional devices is not anticipated.
14.3. General Duties
Medtronic’s general duties consist of submitting applications and information to appropriate 
regulatory authorities, obtaining regulatory and EC approvals, selecting qualified 
Investigators, ensuring proper clinical site monitoring, ensuring subject informed consent is 
obtained and ensuring that the EC and relevant regulatory authorities are promptly notified of 
significant new information about the investigation.
Medtronic is responsible for providing quality data that satisfies regulations and informing 
Investigators, EC and relevant regulatory authorities of safety events and deviations from the 
investigation plan as appropriate. The Medtronic Clinical Study Team will make sure the 
written progress reports and a final report were submitted to regulatory authorities and site 
ECs.  
14.4. Ethics Committee (EC)
The study will be conducted in accordance with the requirements of local Ethics Committees.  
The responsible Ethics Committee (EC) at each investigational site must approve the study 

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protocol and consent.  Study activities will not commence prior to receipt of documentation of 
EC approval by the site and Medtronic.  The Investigator and study site staff must comply 
with the requirements of their EC.
Prior to enrolling subjects, each investigational site’s EC will be required to approve all 
necessary study documents including the CIP, the Informed Consent Form (ICF) and any 
other written information to be provided to the subjects.  EC approval of the clinical study 
must be received in the form of a letter and provided to Medtronic before commencement of 
the study at an investigational site.  The approval letter must contain enough information to 
identify the version or date of the documents approved.  If this information is not contained in 
the approval letter, it must be retrievable from the corresponding submission letter. If the EC 
approval letter is not in English, the Medtronic clinical study team must ensure documented 
review of the letter in English, or a translation to English must be obtained. In addition the 
approval letter needs to be accompanied by an EC roster or letter of compliance, to allow 
verification that the investigator, other site study staff, and/or Medtronic personnel are not 
members of the EC. If they are members of the EC, written documentation is required stating 
that he/she did not participate in the approval process.  Medtronic will prepare the required 
documents and send them to the investigator for reporting to the EC.  Investigators must 
inform Medtronic of any change in status of EC approval once the investigational site has 
started enrollment.  If any action is taken by an EC with respect to the investigation, that 
information will be forwarded to Medtronic by the respective investigator.
General Study Requirements
Prior to enrolling any subjects in the study, all requirements need to be fulfilled. Each site 
must have written documentation of site/Investigator readiness, including but not limited to 
EC approval, a signed investigator agreement, and site research personnel training 
documentation. The Investigators shall agree to this protocol and any amendments by signing 
and dating the investigator agreement.
The participating Investigator is responsible for adhering to this CIP, the Declaration of 
Helsinki 2013, the agreement and the applicable local regulatory requirements.
Informed Consent and Ethics Committees
All subjects must provide written informed consent in accordance with approved by the site’s 
EC and Medtronic. A copy of the informed consent form from each site must be forwarded to 
Medtronic for review and approval prior to submitting it to the EC. A sample copy of the 
informed consent form is provided in Appendix 4. Each site must provide Medtronic with a 
copy of the investigational site’s EC approval letter and the EC approved informed consent 
form. Approvals for the continuation of the study at each investigational site must be kept 
current and notifications forwarded to Medtronic.

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Regulatory Consideration
15.1. Regulatory Submission
Study documents will be submitted to Regulatory Authority according to CFDA 
Announcement 2015 No.87, prior to commencement of study. If the regulatory authority 
imposes any additional requirements (e.g. safety reports, progress reports etc.), Medtronic will 
prepare the required documents and send them to the respective authority. 
Additionally, this study will comply with an administrative permission filing requirement 
from the Human Genetic Resources Management Office (HGRM). This filing requirement is 
named as ‘Sampling, Collection, Transaction, Export and Outbound Transfer of Human 
Genetic Resources’ administrative permission filing.
During the study, safety information (SAE, etc.) will be submitted to Regulatory Authority 
according to CFDA Order No. 25 within the required time.
Primary endpoint CSR and subsequent CSRs, along with the CIP, will be submitted to CFDA 
as part of the product registration application.

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Study Administration
16.1. Investigator and Investigational Site Selection
Investigators selected will be responsible for fulfilling the clinical study requirements 
specified in this investigation plan.  The investigational site must have the necessary 
experience and resources to comply with the requirements.  The following criteria will be 
used to select investigators and investigational sites for participation in the clinical study:
•
Site should appoint a medical person responsible for clinical study who has related 
specialty, qualification or title as at least assistant senior in the clinical research
institutions, such as associate chief physician, associate professor, or associate researcher
or equivalent.
•
Investigation sites must be the institutions qualified for conducting clinical study by the 
regulatory department of CFDA and the Administrative Department of Health under the 
State Council.
•
Investigator is qualified by training and expertise in the diagnosis and treatment of 
subjects requiring a percutaneous coronary intervention (PCI) procedure with a drug-
eluting stent.
•
Investigator and clinical research staff have experience with conducting clinical device 
study that comply with applicable regulatory standards studies and have the time to 
conduct the study in accordance with the investigation plan.
•
Agreement to comply with the investigation plan and applicable regulatory requirements.
•
Adequate volume of potential subjects who meet the eligibility criteria
•
Number of simultaneous competing clinical studies that might interfere with subject 
enrollment or study conduct.
•
Appropriate facilities, resources, and equipment.
•
An expressed desire to participate in the study.
•
Willing to undergo monitoring and auditing by Medtronic or relevant regulatory 
authorities.
•
Willing to undergo required study training.
•
Willing and able to complete study initiation activities in a timely manner (i.e., within 2 
to 3 months)
•
Site must have a high-speed Internet connection to ensure an acceptable speed of data 
transfer.
•
All investigational sites and investigators will sign the appropriate Clinical Investigation
Agreement before they are accepted for the clinical study.
•
Throughout the conduct of the study, Medtronic and/or its designees will closely monitor 
compliance with the investigation plan, the applicable local laws and regulations, the 
requirements of the EC, and the terms of the Clinical Study Agreement.  Medtronic may 
suspend or terminate the study prematurely at any site with repeated occurrences of 
significant non-compliance.

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Investigator Responsibility / Performance
The Investigator is responsible to ensure that all work and services related to this study 
described herein, or incidental to those described herein, are conducted in accordance with the 
medical practice and Good Clinical Practice for Medical Devices (CFDA Order No. 25), the 
requirements of the EC, the investigation plan, and the terms of the Clinical Study Agreement 
and all applicable local laws.
The Investigator will provide copies of the current study Investigation Plan to all authorized 
Sub-Investigators or other staff members responsible for the conduct of the study.
The Investigator must maintain a Delegation of Authority Form listing appropriately qualified 
persons to whom the Investigator has delegated significant study related duties.
Training of Investigational Sites
Medtronic and/or its designees are responsible for ensuring the training of appropriate clinical 
site personnel, including the Investigator, Sub-Investigator(s), Research Coordinator(s), and 
as necessary other site personnel as appropriate (e.g. cath lab personnel).  Initial training will 
be conducted by Medtronic or its designees before study site activation to ensure proper 
reporting of adverse events, device usage, uniform data collection and compliance with the 
Investigation Plan (i.e., protocol and consent processes). The site Principal Investigator has to 
be trained by Medtronic or its designees. Training will consist of, at a minimum, a review of 
the device IB, IFU, protocol, techniques for the identification of eligible subjects, instructions 
on data collection, the electronic data capture system, study schedules, and applicable China 
regulations. Medtronic and/or its designees are responsible for training of key site personnel 
appropriate to the tasks they have been delegated by the site Principal Investigator. Medtronic 
and/or its designees and/or the site Principal Investigator can conduct full study training for 
site personnel who were not trained prior to study site activation. Ongoing assistance 
regarding completion and submission of eCRFs as well as retraining (if necessary) will be 
provided by Medtronic and/or its designee.
An individual Training Record must be signed and dated by appropriate person (Medtronic 
and/or its designee or the site Principal Investigator) conducting the training, and each 
member of the research team that attended the training session. Site personnel assigned to the 
study after the initial training visit will undergo full training, which must be documented via 
submission to Medtronic of a signed Training Record, before any study activity is performed.
Signed training records must be submitted to Medtronic and a copy of each training record 
retained in the Investigator Site File (ISF).
Clinical Investigation Agreement
A Clinical Investigation Agreement shall be entered into effect by the participating site and/or 
the principal clinical investigator at each site as per the local legal requirements, and returned 
to Medtronic prior to the commencement of any study activities. The investigator is indicating 
approval of the Protocol and subsequent amendments, by signing and dating the agreement. 
Amendments to this protocol shall be agreed upon between Medtronic and clinical 
investigator(s) and be recorded with a justification for the amendments.

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Curriculum Vitae
Recent signed and dated curriculum vitae from each investigator participating in this study, 
evidencing the required qualifications, including the year and where obtained, and shall 
include their current position at the site. 
16.2. Monitoring
Monitoring visits and/or remote reviews will be conducted at the start, during and at the 
closure of the clinical study in accordance with Medtronic SOPs and the Monitoring Plan.  
Investigational sites will be monitored to ensure compliance with the study protocol 
(including the informed consent process), adherence to applicable regulations, accuracy of 
study data, and to ensure the safety and wellbeing of the subjects is preserved.  Prior to 
subject enrollment, an initiation visit will be completed with each site. Monitoring visits will 
also be used to verify that study data submitted on case report forms are complete and 
accurate with respect to the subject records and to verify device accountability.
Site personnel will complete electronic case report forms (eCRFs) following each subject 
study schedule.  Study data submitted will be reviewed against subject charts and other 
sources containing original records of subject data.  
Upon study completion, Site Closeout Visits will be conducted, as outlined in the Monitoring 
Plan.
Medtronic will provide monitoring and monitoring oversight.  Representatives of Medtronic 
(i.e. contractors and designees) may also act as the study monitors to the site.  
Prior to the first site activation a monitoring plan will be established outlining the activities, as 
well as study materials to be supplied to sites, the process for corrective and preventive 
actions and Investigator disqualification procedures. 100% of source data verification (SDV) 
will be performed and extent of SDV will be described in the monitoring plan.
The principal investigator(s), his/her delegate(s) and the study coordinator(s) are expected to 
be present and available during the monitoring visit to discuss monitoring outcomes. This 
accessibility is of particular importance for reviewing data in the eCRF. Direct access to 
subject medical files for source data verification will need to be granted and prepared prior to 
any monitoring visits.
16.3. Audits and Inspections
Medtronic may conduct audits at participating clinical sites.  The purpose of an audit is to 
assess clinical study activities independently of the personnel directly involved in the study.  
Regulatory authorities and ECs may also perform inspections at participating sites.  The 
investigator and/or institution shall permit Medtronic and Regulatory Authority direct access 
to source data and documents.  Any Regulatory Authority inspection announcements shall be 
forwarded immediately to the Medtronic Clinical Study Manager of this study.  A list of 
contact information will be kept separately.

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16.4. Data Management
Medtronic will oversee all data management functions and provide support if necessary. 
Leading site will be accountable for data management and analysis about the study data in a 
centralized manner according to local regulations.
Case Report Forms
Study sites will assign a unique study ID number to each subject, as applicable. Records of 
the subject/ID relationship(s) will be maintained by the study site. Individual subject medical 
information obtained as a result of this study will be considered confidential.
The investigator must ensure accuracy, completeness and timeliness of the data reported in 
the CRFs and in all other required reports. Data reported on the CRFs which are derived from 
source documents must be consistent with the source documents and discrepancies need to be 
justified in a documented rationale, signed and dated by the (principal) investigator, and filed 
in the subject medical file.
Only authorized persons can complete CRFs. CRFs shall be signed by investigators 
(physicians only) as specified on the Delegated Tasks List included in the Investigator Site 
File.
The Electronic Data Capture (EDC) system maintains an audit trail on entries, changes or 
corrections in eCRFs. If a person is only authorized to complete eCRFs or to make changes to 
an already signed eCRF, the investigator shall re-sign this eCRF. All required data for this 
study will be collected on standardized electronic Case Report Forms (eCRFs).
Source Documentation
Regulations require that an investigator maintain information in the study subject’s medical 
records to corroborate data collected on the CRF.  To comply with these regulatory 
requirements, the following information will be maintained and made available as required by 
Medtronic and/or its designees and/or regulatory inspectors.  Shadow charts are not 
appropriate or adequate for source documentation.  Complete medical (clinical and hospital) 
records may include the following documentation:
1.
Medical history/physical condition of the study subject before involvement in the study 
sufficient to verify investigation plan entry criteria and evaluations of prior signs and 
symptoms 
2.
Medical record documenting that informed consent was obtained for the subject’s 
participation in the study
2.
Description of device implantation procedure (material used, drugs administered during 
the procedure, date, time, angiographic and clinical findings, etc.)
3.
Dated and signed notes for each study subject visit including results of examinations
4.
Notations on abnormal lab results and their clinical significance/resolution
5.
Dated printouts or reports of special assessments, (e.g., ECG reports, blood tests)

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6.
Description of adverse events and follow-up of the AEs (at a minimum: event 
description, onset date, date investigator became aware of the event, duration, relation to 
study device, treatment, and outcome)
7.
Notes regarding concomitant medications taken during the study (including start and 
stop dates)
8.
Study subject’s condition upon completion of or withdrawal from the study
Where printouts of electronic medical records, are provided as source documents, or where 
copies of source documents are retained as source documents, they should be signed and 
dated by a member of the investigation site team indicating they are a true reproduction of the 
original source document.
The eCRFs will not serve as source documents.  Source documentation for data elements not 
routinely captured in medical records may vary from site to site: the site may use worksheets 
if identified as source documents.
Transmission of Data
Required data will be recorded on the appropriate electronic Case Report Forms at the time of 
or as soon as possible after the subject visit.  The eCRF and any requested supporting source 
documents must be sent to Medtronic and/or retrieved from the investigator during 
monitoring visits.  Questions about completion of the eCRF may be directed to the Medtronic 
study team.
Data Queries
During the review of source documents and eCRF at the monitoring visits, any discrepancies 
will be queried by Medtronic or its designee and must be resolved by the investigational site 
staff and investigator in a timely manner.
Time Windows for Completing Case Report Forms and Reports
Table 16-1 Investigator Reporting Guidance for Submitting Data
Type of CRF/Report/Data
Expected Completion 
by Site within
Process
Investigational device usage
2 business days or as 
soon as available
Submit within 2 business days
CRFs (e.g., Inclusion/ Exclusion, 
Baseline, Report of 
Noncompliance, Study Exit 
Form)
10 business days or as 
soon as source 
documents available 
Submit via EDC 
Angiograms (Baseline and 
clinical events)
10 business days or as 
soon as available
Site to send media to Core 
Laboratory within 10 business 
days of data collection

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Electronic Clinical Data Systems
Data will be captured in an electronic data capture system.
16.5. Study Materials and Study Specific Equipment
Medtronic will control the supply of investigational devices and study materials (e.g. 
Investigator Site File, eCRF access).  Investigational devices will not be sent to the site until 
the site is activated.  Medtronic will not provide any study-specific equipment to the sites.
16.6. Device Accountability
In this study, both Resolute Onyx Stent System and Resolute Integrity Stent System are 
considered as study devices.  As such, they should be stored in a secure location.  The method 
of storage should prevent the use of these investigational devices for other applications than 
mentioned in this CIP.  Sites are required to maintain investigational device records that 
contain the following information:

Investigational device name

Serial number / Lot number 

Date of receipt of device

Name of person receiving the device

Name of person using the device

Date of implant or use

ID number of subjects receiving or using the device

Disposition (implanted, disposed of, or returned to Medtronic)
For devices that are returned to Medtronic or disposed of, sites are required to document the 
following information:

The device serial numbers / Lot numbers 

The quantity and reason for the device being returned to Medtronic or disposed of

Name of the person who returned or disposed of each device

Date of shipment back to Medtronic
Device accountability records must be maintained at the study site. The quantity of devices 
received by the study site, those returned, and those devices used at the study site will be 
recorded in device accountability records. The Investigator or an authorized designee must 
explain in writing the reasons for any discrepancy noted in device accountability. When the 
study enrollment is complete, the Investigator shall return any unused devices, opened or 
unopened, to Medtronic.
Medtronic and/or its designee will train the Investigator and appropriate site personnel on 
device-tracking instructions and requirements, which will include the site’s record keeping 
responsibilities of receipt and disposition of all investigational devices shipped to and 
returned by the site.

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Note:  for additional information on shipment, receipt, and return of study devices refer to the 
device tracking instructions.
16.7. Confidentiality
Subject confidentiality will be maintained throughout the clinical study in a way that ensures 
the information can always be tracked back to the source data.  For this purpose, a unique 
subject identification code [e.g. site number, subject number and randomization number] will 
be assigned and used to allow identification of all data reported for each subject.  
Study data may be made available to third parties, e.g., in the case of an audit performed by 
regulatory authorities, provided the data are treated confidentially and that the subject’s 
privacy is guaranteed.  The identity of a subject will never be disclosed in the event that study 
data are published.
16.8. CIP Amendments
As appropriate, Medtronic will submit changes in the clinical investigation plan to the 
appropriate regulatory authorities and to Investigators to obtain EC re-approval as required. 
Furthermore investigators shall sign any approved amendment.
16.9. Record Retention
Records must be maintained by the investigator in compliance with national regulations.  
Investigator records including the Investigator Site File, subject medical files and CRFs are 
subject to regulatory inspection (and Medtronic) and copying, and must be retained for a 
period of 10 years after the investigation is completed or terminated, or longer if required by 
applicable local regulations.
The investigator is responsible for the preparation and retention of the records cited below.

All correspondence with another investigator, EC, Medtronic, a monitor, or regulatory 
agencies, including required reports and study documents which pertain to the 
investigation.

Records of receipt, use, and final disposition of a device.  

Records of each subject's case history and exposure to the device.  Case histories include 
the case report forms and supporting source data (signed and dated informed consent 
forms, medical records, e.g., progress notes of the physician, subject’s hospital chart, 
nursing notes).  

The clinical investigation plan, with documents showing the dates of and reasons for each 
deviation from the protocol.

Any other records that relevant regulatory authorities require to be maintained by 
regulation or by specific requirement for a category of investigations or a particular 
investigation.
In addition, the Medtronic Clinical Research Department should be contacted if the Principal 
Investigator plans to leave the investigational site.

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Investigator may withdraw responsibility to maintain records for the time required by the 
study protocol by transferring custody to another qualified person willing to accept 
responsibility for them. Medtronic will report this change within 10 days to the relevant 
regulatory authorities as necessary.
Medtronic will maintain study records under its responsibility until no Resolute Onyx and
Resolute Integrity are used, or at least 15 years, whichever is longer.
16.10.Publication and Use of Information
Publications based on the results of the study will follow the process outlined in the Clinical 
Study Agreement.  A publication committee may be formed to oversee the preparation of 
manuscripts and identify authors and writers for primary and ancillary publications of the 
study results.
During the course of or at the conclusion of the study, a multi-center manuscript may be 
prepared for publication in a reputable peer-reviewed scientific journal. The publication of the 
results from any single site experience within the study is not allowed until the preparation 
and publication of the multi-center results has occurred. Exceptions to this rule require the 
prior approval of Medtronic.  
Additional secondary manuscripts with principal authorship drawn from members of this 
study’s investigators or other study related individuals or groups are probable. The analysis of 
other pre-specified and non-pre-specified endpoints as well as other proposed investigations 
by Investigators or other study related individuals or groups will require prior approval by 
Medtronic.  For the purpose of timely abstract presentation and publication, such secondary 
publications will be delegated to the appropriate principal authors, and final analyses and 
manuscript review for all multi-center data will require the approval of Medtronic.
16.11.Suspension or Early Termination
Medtronic, Investigator, EC and/or the relevant regulatory authorities have the right to 
suspend or terminate this study or a participating site at any time and remove study materials 
from the site as appropriate.  A study/site may be suspended or terminated for any of the 
following reasons:

Unsatisfactory rate of subject enrollment or compliance to eligibility criteria.

Repeated noncompliance with the investigation plan.

Inaccurate, incomplete, and/or untimely submission of data.

The rate of adverse events in the study or other similar studies indicates a potential 
health hazard to the subjects caused by the device.

Interim analysis indicates that the results significantly differ from the clinical study
objectives or statistical endpoints
In case of study suspension and termination, the investigator shall timely notify the subjects 
and assure they will obtain with proper treatment and follow-ups.

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If decision is made to suspend or terminate a clinical study, within 5 days, Medtronic shall 
notify, with a written explanation, all the management departments of medical device clinical 
study in the clinical research institutions, which will in turn notify investigator and EC. The 
suspended clinical study must not be recommenced without the approval from EC. After the 
clinical study closure, Medtronic shall notify in written its local Food and Drug 
Administration (province, autonomous region or municipality as appropriate) where it locates.
Investigator must inform the subjects, Medtronic, the Ethic Committees and relevant 
regulatory authorities respectively of such a discontinuity case with rationale if the decision of 
suspension or early termination of the study is made by the investigator.
Medtronic shall ensure that all investigators who conduct the clinical study comply with the 
clinical investigation plan. In case a clinical research institution and an investigator are found 
failed to comply with relevant laws and regulations, Good Clinical Practice for Medical 
Devices (CFDA Order No. 25) and this clinical investigation plan, Medtronic shall identify it 
and implement a course of corrective actions. For serious case or continued case without 
rectification, Medtronic should terminate the study at this clinical research institution and 
notify the local Food and Drug Administration (province, autonomous region or municipality 
as appropriate) where this clinical research institution locates and CFDA.
16.12.Study Close-Out
Upon completion of the clinical study (when all subjects enrolled have completed the follow-
up assessments and the CRFs and queries have been completed), Medtronic and/or its 
designees will notify the site of closeout and that notification to EC and regulatory authority 
will be done, if required. A study closeout visit may be performed if defined in the monitoring 
plan. All unused study materials and equipment will be collected and returned to Medtronic 
and/or its designees or appropriately discarded as per instruction by Medtronic and/or its 
designee.
16.13.Clinical Study Registration
The registration process in a public registry clinicaltrials.gov will be followed.
16.14.Investigator Reports
The investigator is responsible for the preparation and submission of the reports cited in the 
Table 16-2. Reports must be prepared in complete, accurate and timely manner. These reports 
may be subject to regulatory inspection (and Medtronic) and copying, and the retention 
requirements described above for Investigator Records. In addition to the reports listed in the 
following table, relevant regulatory authorities or the reviewing EC may request reports 
pertaining to any aspect of the clinical study.
Table 16-2 Investigator Reporting Responsibilities
REPORT
SUBMIT TO
DESCRIPTION/CONSTRAINTS
Withdrawal of EC 
Approval
Medtronic
The investigator must report a withdrawal of the 
reviewing EC’s approval of the investigator’s part of 
the investigation within 5 working days. 

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REPORT
SUBMIT TO
DESCRIPTION/CONSTRAINTS
Progress Report
Medtronic, EC
The investigator must submit this report at least 
annually or more often if required by EC for the 
duration of the study. Copy of submitted report to be 
provided to Medtronic
Deviation from 
Investigation Plan 
(Emergency)
Medtronic & EC
Notification must be made as soon as possible if the 
deviation was made to protect the life or physical 
wellbeing of a subject.
Deviation from 
Investigation Plan 
(Other – Non 
Emergent)
Medtronic & EC
If the deviation may affect the scientific soundness of 
the plan or the rights, safety and welfare of the 
subjects (and is not an emergency), then the deviation 
must be approved by Medtronic and the reviewing 
authority prior to its implementation.  If the deviation 
does not affect these issues (study soundness, rights, 
safety, etc.) then only Medtronic must approve it, 
(except in cases which are beyond the control of the 
investigator—see Section 9.10 Deviation Handling).
Failure to Obtain 
Informed Consent
Medtronic & EC
The Investigator must notify Medtronic and the 
reviewing EC within 5 business days after device 
use.  The report must include a brief description of 
the circumstances justifying the failure to obtain 
informed consent.
Final Report
Medtronic, 
Regulatory 
Authorities & EC
This report must be submitted within 3 months after 
termination or completion of the investigation. Copy 
of EC submitted report to be provided to Medtronic.
NOTE:
1.  The investigator will report to the EC and Medtronic in a timely manner through the management 
department of medical device clinical study in clinical research institution.
2.  In case there is/are additional reporting requirement(s) and/or process(es) (e.g. internal hospital 
policy or province regulatory authority instruction, etc.), these specific reporting requirement and 
process must be documented in a separate cover.

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Insurance
If subjects are physically injured as a result of participation in this study, reasonable and 
appropriate medical treatment will be provided by Medtronic, if such treatment is not already 
covered by subject’s medical insurance according to the local requirements.  The local 
sponsor Medtronic (Shanghai) Management Co, Ltd. is a wholly owned subsidiary of 
Medtronic, Inc., which as the parent company of such entity maintains appropriate clinical 
study liability insurance coverage as required under applicable laws and regulations and will 
comply with applicable laws and customs concerning specific insurance coverage.  If 
required, a Clinical Study Insurance statement/certificate will be provided to the EC.
Study Reimbursement
Funding for the study will be defined according to the local regulations and must be agreed 
upon in writing by the clinical research institution and Medtronic before the study 
commences. The payments for the study should be appropriate relative to the number of 
subjects enrolled.  The Resolute OnyxTM Stent System and Resolute IntegrityTM Stent System 
will be provided by Medtronic free of charge for use in this clinical study. A reasonable 
amount of the angiography procedure and travel expense for the 9-month angiographic 
follow-up will be reimbursed. No any other compensation for the participation in this study 
will be provided by Medtronic.
Reference
The related references have been inserted in the footnote where applicable.

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Appendixes
Appendix 1 Study Contacts
Sponsor:
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432, USA
Local Sponsor (Project & 
Site Management):
Medtronic (Shanghai) Management Co., Ltd
Room 2106A, 2106F, 2106G, 2106H, Floor 21, Donghua 
Financial Building, No. 28 Maji Road, China (Shanghai) Pilot 
Free Trade Zone, 200120, Shanghai, P.R. China
Clinical Operations:
Medtronic, Inc.
Medtronic Core Clinical Solutions
Strategy and Scientific Operations
710 Medtronic Parkway, LS330
Minneapolis, MN 55432
Monitoring & Site 
Management
R&G Pharma Studies Co., Ltd.
Floor11, North Tower, Building B, Huatong Plaza, No.19 
Chegongzhuangxilu, Haidian District
Beijing, 100048, China
Phone : (86) -10-88018650
Fax : (86) -10-88019978
Website : www.rg-pharma.com
Clinical Events 
Committee:
Cardiovascular Research Foundation
111 East 59th Street, 12th Floor
New York, NY 10022
Phone : (646) 434-4122
Fax : (646) 434-4508
Website : http://www.crf.org
Angiographic Core Lab:
Cardiovascular Research Foundation
111 East 59th Street, 12th Floor
New York, NY 10022
Phone : (646) 434-4122
Fax : (646) 434-4508
Website : http://www.crf.org
The detailed contact list will be kept separate from the CIP and provided to the investigators. 
Medtronic will maintain an updated list. For specific contact information of the core members 
(e.g. Medical expert) refer to the detailed list.
For the relevant qualification documents of Medtronic refer to the EC review document 
package.

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Appendix 2 List of Definitions
ACUTE CLOSURE
Acute Closure: The occurrence of new (during the procedure) severely reduced flow 
(TIMI grade 0-1) within the target vessel that persisted and required rescue by stenting or 
other treatment, or resulted in myocardial infarction or death.  Abrupt closure requires 
proven association with a mechanical dissection of the treatment site or instrumented 
vessel, coronary thrombus, or severe spasm.  Abrupt closure does not mean “no reflow” 
(due to microvascular flow limitation), in which the epicardial artery is patent but had 
reduced flow.  Abrupt closure also does not mean transient closure with reduced flow in 
which the index treatment application does reverse the closure.
Sub-acute Closure: Abrupt closure that occurred after the procedure is completed (and the 
left the catheterization laboratory) and before the 30-day follow-up evaluation.
Threatened Acute Closure: A grade B dissection and 50% diameter stenosis or any 
dissection of grade C or higher.
ACUTE GAIN
The immediate dimensional change in minimal luminal diameter (mm) that occurred after the 
final post-dilatation as compared to the minimal luminal diameter at baseline and measured by 
quantitative coronary angiography from the average of 2 orthogonal views. 
ACUTE SUCCESS
All acute success data will be reported per Medtronic historical protocol definitions listed 
below.
Device Success: 
Medtronic historical definition: The attainment of <50% residual stenosis of the target 
lesion using only the assigned device.
Current definition: The attainment of < 30% residual stenosis by QCA (or < 20% by 
visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device 
only. These measurements will be made by the independent angiographic core 
laboratory. If the core laboratory is unable to assess the % residual stenosis, the 
Investigator’s assessment as recorded in the CRF will be used for the statistical 
analysis.
Lesion Success: 
Medtronic historical definition: The attainment of <50% residual stenosis of the target 
lesion using any percutaneous method.
Current definition: The attainment of < 30% residual stenosis by QCA (or < 20% by
visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous 

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method. These measurements will be made by the independent angiographic core 
laboratory. If the core laboratory is unable to assess the % residual stenosis, the 
Investigator’s assessment as recorded in the CRF will be used for the statistical 
analysis.
Procedure Success: 
Medtronic historical definition: The attainment of <50% residual stenosis of the target 
lesion and no in-hospital MACE.
Current definition: The attainment of < 30% residual stenosis by QCA (or < 20% by 
visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous 
method without the occurrence of MACE during the hospital stay. These 
measurements will be made by the independent angiographic core laboratory. If the 
core laboratory is unable to assess the % residual stenosis, the Investigator’s 
assessment as recorded in the CRF will be used for the statistical analysis.
Device Specific Procedure Success:  
Device success and no in-hospital MACE.
ANGIOGRAPHIC BINARY RESTENOSIS (ABR) RATE
Percent of subjects with a follow-up percent diameter stenosis of 50%.
ANTICIPATED ADVERSE EVENT
Any undesirable experience (sign, symptom, illness, abnormal laboratory value, or other 
medical event) occurring to a subject, whether or not considered related to the investigational 
product(s) or drug regimen prescribed as part of the clinical protocol, predefined in the 
clinical protocol and/or IFU, that is identified or worsens during a clinical study.
BINARY ANGIOGRAPHIC RESTENOSIS
A ≥ 50% in-stent diameter stenosis at the follow-up angiogram. If an in-stent measurement is 
not available, the in-lesion diameter will be used.
BLEEDING COMPLICATION
A procedure related hemorrhagic event that requires a transfusion or surgical repair. These may 
include a hematoma requiring treatment of retroperitoneal bleed.
BRAUNWALD CLASSIFICATION OF UNSTABLE ANGINA
Severity:
Class 1:
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 

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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 months.
Class 2:
Angina at rest, sub-acute. Patients with one or more episodes of angina at rest 
during the preceding month but not within the preceding 48 hours.
Class 3: 
Angina at rest, acute. Patients with one or more episodes of angina at rest 
within the preceding 48 hours.
Clinical circumstances in which unstable angina occurs:
Class A:
Secondary unstable angina. Patients in whom unstable angina develops 
secondary to a clearly identified condition extrinsic to the coronary vascular 
bed that has intensified myocardial ischemia. Such conditions reduce 
myocardial oxygen supply or increase myocardial oxygen demand and include 
anemia, fever, infection, hypotension, uncontrolled hypertension, 
tachyarrhythmia, unusual emotional stress, thyrotoxicosis and hypoxemia 
secondary to respiratory failure.
Class B:
Primary unstable angina. Patients who develop unstable angina pectoris in the 
absence of an extra-cardiac condition that have intensified ischemia, as in 
Class A.
Class C:
Post-infarction unstable angina. Patient who develop unstable angina within 
the first two weeks after a documented acute myocardial infarction.
CALCIFICATION
Readily apparent radiopacities within the vascular wall at the site of the stenosis and is 
classified as none/mild, moderate (radiopacities noted only during the cardiac cycle before 
contrast injection), and severe (radiopacities noted without cardiac motion before contrast 
injection generally compromising both sides of the arterial lumen).
CANADIAN CARDIOVASCULAR SOCIETY CLASSIFICATION (CCSC) OF 
ANGINA7,8
Class I
Ordinary physical activity does not cause angina, such as walking and climbing 
stairs. Angina with strenuous or rapid or prolonged exertion at work or 
recreation.
Class II
Slight limitation of ordinary activity. Angina upon walking or climbing stairs 
rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in 
wind, or under emotional stress, or only during the first hours after awakening. 
                                                          
7
Campeau, L.. 2002. The Canadian Cardiovascular Society grading of angina pectoris revisited 30 years later. Can J Cardiol 18 (4): 371-
9.
8
Campeau L. Letter: Grading of angina pectoris. Circulation 54 (3): 522-3.

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Angina if walking more than two blocks on the level and climbing more than 
one flight of ordinary stairs at a normal pace and in normal conditions.
Class III
Marked limitations of ordinary physical activity. Walking one to two blocks on 
the level and climbing one flight of stairs in normal conditions and at a normal 
pace.
Class IV
Inability to carry on any physical activity without discomfort. Angina 
syndrome may be present at rest.
CEREBROVASCULAR ACCIDENT (CVA) (see Stroke)
The occurrence of cerebral infarction (ischemic stroke) or intracerebral hemorrhage or 
subarachnoid hemorrhage (hemorrhagic stroke).
CLINICALLY-DRIVEN TARGET LESION REVASCULARIZATION (TLR)
Revascularization at the target lesion associated with positive functional ischemia study or 
ischemic symptoms AND an angiographic minimal lumen diameter stenosis 50% by QCA, 
or revascularization of a target lesion with diameter stenosis 70% by QCA without either 
angina or a positive functional study.
CLINICALLY-DRIVEN TARGET VESSEL REVASCULARIZATION (TVR)
Revascularization in the target vessel associated with positive functional ischemia study or 
ischemic symptoms AND an angiographic minimal lumen diameter stenosis 50% by QCA, 
or revascularization of a target vessel with diameter stenosis 70% by QCA without either 
angina or a positive functional study.
De novo LESION
A lesion not previously treated.
DEATH
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
Any death due to immediate cardiac cause (e.g. MI, low-output 
failure, fatal arrhythmia). Unwitnessed death and death of 
unknown cause will be classified as cardiac death. This includes 
all procedure related deaths including those related to concomitant 
treatment.
Vascular death
Death due to cerebrovascular disease, pulmonary embolism, 
ruptured aortic aneurysm, dissecting aneurysm, or other vascular 
cause.

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Non-cardiovascular 
death
Any death not covered by the above definitions, including death 
due to infection, sepsis, pulmonary causes, accident, suicide or 
trauma.
DELIVERY SUCCESS: Complete passage of the stent across the target lesion with full 
expansion of the stent to the desired diameter at the desired location.
Note: Failed delivery: failure to pass the stent through the guiding catheter into the coronary 
artery, failure to pass it completely across the target lesion, or failure to expand the stent to its 
desired diameter. Failed delivery includes proximal deployment defined as those instances of 
failed delivery when the stent could be advanced only partially across the target lesion but 
was deployed nonetheless by full expansion.
DEVICE RELATED ADVERSE EVENT
Any adverse event for which a causal relationship between the device and the event is at least 
a reasonable possibility (i.e., the relationship cannot be excluded).
DIABETES MELLITUS9
A group of metabolic diseases characterized by hyperglycemia resulting from defects in 
insulin secretion, insulin action or both.
Three ways to diagnose diabetes are possible, and each must be confirmed, on a subsequent 
day, by any one of the three methods given:
1. Symptoms of diabetes plus casual plasma glucose concentration > 200 mg/dl (11.1 
mmol/l). Casual is defined as any time of day without regard to time since last meal. The 
classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss. 
2. Fasting plasma glucose (FPG) > 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric 
intake for at least 8 hours.
3. Two hour post-load glucose (PG) > 200 mg/dl (11.1 mmol/l) during an oral glucose 
tolerance test (OGTT). The test should be performed as described by the World Health
Organization (WHO)10, using a glucose load containing the equivalent of 75 gm 
anhydrous glucose dissolved in water.
In the absence of unequivocal hyperglycemia with acute metabolic decompensation, 
these criteria should be confirmed by repeat testing on a different day. The third measure, 
OGTT, is not recommended for routine clinical use.
Medtronic working definition of diabetes mellitus: For the purposes of this study a 
patient is considered to have a history of diabetes mellitus if he/she: is taking insulin, is 
taking oral antidiabetic agents, is on a modified diet to control diabetes mellitus, or has a 
diagnosis of diabetes mellitus documented in the medical record but is untreated, prior to 
the index procedure.  Patients who are taking insulin, or both insulin and oral agents, will 
be classified as insulin dependent.  Patients who are taking oral agents only, a modified 
                                                          
9 
Report of the expert committee on the diagnosis and classification of diabetes mellitus. 2003. Diabetes Care 26 Suppl 1S5-20.
10 Diabetes mellitus. Report of a WHO Study Group. 1985. World Health Organ Tech Rep Ser 7271-113.

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diet only, both oral agents and a modified diet, or are currently untreated, will be 
classified as non-insulin dependent.
DISSECTION, NHLBI (National Heart, Lung, and Blood Institute) CLASSIFICATION11
Grade A
Small radiolucent area within the lumen of the vessel disappearing with the 
passage of the contrast material.
Grade B
Appearance of contrast medium parallel to the lumen of the vessel 
disappearing within a few cardiac cycles.
Grade C
Dissection protruding outside the lumen of the vessel persisting after passage 
of the contrast material.
Grade D
Spiral shaped filling defect with or without delayed run-off of the contrast 
material in the antegrade flow.
Grade E
Persistent luminal filling defect with delayed run-off of the contrast material 
in the distal lumen.
Grade F
Filling defect accompanied by total coronary occlusion.
DISTAL EMBOLIZATION
A new abrupt cut off or filling defect distal to the treated lesion.
EMERGENT BYPASS SURGERY
Coronary bypass surgery performed on an urgent or emergent basis for severe vessel 
dissection or closure, or treatment failure resulting in new ischemia.
INCOMPLETE APPOSITION
Failure of the stent to completely appose to the vessel wall after placement. Defined as one or 
more stent struts separated from the vessel wall with evidence of blood speckles behind the 
strut in the ultrasound image.
IN-SEGMENT MEASUREMENT
The measurements either within the stented segment or within 5 mm proximal and distal to 
the stent edges. 
IN-STENT MEASUREMENT
The measurements within the boundaries of the stent.
                                                          
11 Detre, K., R. Holubkov, S. Kelsey, M. Bourassa, D. Williams, D. Holmes, Jr., G. Dorros, D. Faxon, R. Myler, K. Kent, et al. 1989. One-
year follow-up results of the 1985-1986 National Heart, Lung, and Blood Institute's Percutaneous Transluminal Coronary Angioplasty 
Registry. Circulation 80 (3): 421-8.

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LATE INCOMPLETE APPOSITION
Incomplete apposition of the stent at follow-up that was not present post-procedure. See also 
incomplete apposition.
LATE LOSS INDEX
The ratio of late loss to acute gain.
LATE LUMEN/LUMINAL LOSS (LLL)
The difference between the post-procedure minimal lumen diameter (MLD) and the follow-up 
angiography MLD.
LESION CLASS (American College of Cardiology/American Heart Association Class)12
Type A Lesions: Minimally complex, discrete (length < 10 mm), concentric, readily 
accessible, non-angulated segment (< 45°), smooth contour, little or no calcification, less 
than totally occlusive, not ostial in location, no major side branch involvement, and an 
absence of thrombus.
Type B Lesions: Moderately complex, tubular (length 10 to 20 mm), eccentric, moderate 
tortuosity of proximal segment, moderately angulated segment (> 45°, < 90°), irregular 
contour, moderate or heavy calcification, total occlusions < 3 months old, ostial in 
location, bifurcation lesions requiring double guidewires, and some thrombus present.
Type B1: One adverse characteristic.
Type B2: Two or more adverse characteristics.
Type C Lesions: Severely complex, diffuse (length > 20 mm), excessive tortuosity of 
proximal segment, extremely angulated segments > 90°, total occlusions > 3 months old 
and/or bridging collaterals, inability to protect major side branches, and degenerated vein 
grafts with friable lesions.
MAJOR ADVERSE CARDIAC EVENTS (MACE)
The composite of death, myocardial infarction (Q wave and non-Q wave), or clinically-driven 
repeat target lesion revascularization by percutaneous or surgical methods.
MINIMAL LUMINAL DIAMETER (MLD)
The average of two orthogonal views (when possible) of the narrowest point within the area 
of assessment – in lesion, in stent or in segment. MLD is visually estimated during 
                                                          
12 Smith, S. C., Jr., J. T. Dove, A. K. Jacobs, J. W. Kennedy, D. Kereiakes, M. J. Kern, R. E. Kuntz, J. J. Popma, H. V. Schaff, D. O. 
Williams, et al. 2001. ACC/AHA guidelines of percutaneous coronary interventions (revision of the 1993 PTCA guidelines)--executive 
summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (committee 
to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty). J Am Coll Cardiol 37 (8): 2215-39.

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angiography by the Investigator; it is measured during QCA by the Angiographic Core 
Laboratory.
MYOCARDIAL INFARCTION (MI)
Medtronic extended historical definitions of MI will be utilized for regulatory reporting.
Medtronic Historical Definition of Q wave MI (QWMI): will require one of the following 
criteria:

Chest pain or other acute symptoms consistent with myocardial ischemia and new 
pathological Q waves in two or more contiguous ECG leads as determined by an ECG 
core laboratory or independent review of the CEC, in the absence of timely cardiac 
enzyme data.

New pathologic Q waves in two or more contiguous ECG leads as determined by an 
ECG core laboratory or independent review of the CEC and elevation of cardiac 
enzymes. In the absence of ECG data the CEC may adjudicate Q wave MI based on the 
clinical scenario and appropriate cardiac enzyme data.
Medtronic Historical Definition of Non-Q Wave MI (NQWMI): elevated CK ≥ 2X the 
laboratory upper limit of normal with the presence of an elevated CK-MB (any amount 
above the laboratory upper limit of normal) in the absence of new pathological Q waves.
Extended Historical Definitions:
I. PCI (PERCUTANEOUS CORONARY INTERVENTION)
Ia. Baseline Biomarkers of Myocardial Damage (CK and CK-MB and Trop < 1*URL) 
and not acute MI in progress.
PERIPROCEDURAL <48 HOURS POST PCI
A. New pathologic q waves in 2 contiguous ECG leads AND:

any CK-MB > 1*URL or

in the absence of CK-MB: Troponin > 1*URL or

in the absence of CK-MB and Troponin: CK > 1*URL or

in the absence of CK-MB and Troponin and CK: CEC decision upon clinical 
scenario
B. Appropriate cardiac enzyme data (respecting top-down hierarchy, b1 to b3):
b1. CK 2* URL Confirmed by : 

CK-MB > 1*URL or 

in the absence of CK-MB:, Troponin > 1*URL or

in the absence of CK-MB and Troponin: CEC decision upon clinical scenario
OR
b2. In the absence of CK: CK-MB > 3*URL
OR

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b3. In the absence of CK and CK-MB: Troponin > 3*URL
Note
URL = upper reference limit, defined as 99th percentile of normal reference range
Ib. If Baseline Biomarkers of Myocardial Damage: CK and/or CK-MB > 1*URL or
acute MI in progress 
MYOCARDIAL INFARCTION, RE-INFARCTION (EXTENSION) <48 HOURS POST PCI
A. If CK (or CK-MB) from index MI has not yet reached its maximum level:

Recurrent thoracic chest pain or ischemia equivalent >20 minutes (or new ECG 
changes consistent with MI) 
AND

Appropriate cardiac enzyme data:
o
A rise in CK within 24 hours of the index event >2*URL (confirmed by 
either CK-MB or Troponin > 1*URL) and 50% above the previous level
or
o
In absence of CK: a (post PCI) rise in CK-MB within 24 hours of the index 
event >3*URL and 50% above the previous level. Or
o
In absence of CK and CK-MB: a (post PCI) rise of Troponin within 24 hours 
of the index event >3*URL and 50% above the previous level. 
B. If elevated CK (or CK-MB) following the index MI has peaked AND CK level has 
returned < URL then any new rise in:

CK >2*URL(confirmed by either CK-MB > URL or Troponin >URL) or

in the absence of CK: CK-MB > 3*URL or

in the absence of CK and CK-MB, Troponin > 3*URL
C. If CK (or CK-MB) following the index MI has peaked AND CK level has NOT returned 
to < URL:

A rise in CK 50% above the previous level and > 2 URL confirmed by either 
CK-MB > URL or Troponin > URL. or

In absence of CK, when CK-MB has NOT returned < URL, a rise in CK-MB 
50% above the previous level and > 3 URL. or

In absence of CK, when CK-MB and Troponin has not returned < URL a rise in 
Troponin 50% above the previous level and >3*URL
SPONTANEOUS MI >48 HOURS(PCI)

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A. Recurrent thoracic chest pain or ischemic equivalent AND

New pathologic q waves in 2 contiguous ECG leads AND any CK-MB > 
1*URL. Or

in the absence of CK-MB: Troponin > 1*URL or

in the absence of CK-MB and Troponin: CK > 1*URL or

in the absence of CK-MB and Troponin and CK: CEC decision upon clinical 
scenario
B. Appropriate cardiac enzyme data (respecting top-down hierarchy):
b1. CK 2* URL Confirmed by:

CK-MB > 1*URL or 

in the absence of CK-MB: Troponin > 1*URL or

in the absence of CK-MB and Troponin: CEC decision upon clinical scenario
OR
b2. In the absence of CK: CK-MB > 3*URL
OR
b3. In the absence of CK and CK-MB: Troponin > 3*URL
OR
b4. In the absence of CK, CK-MB and Troponin, clinical decision based upon clinical 
scenario.
II. CABG (CORONARY ARTERY BYPASS GRAFTING)
IIa. Baseline Biomarkers of Myocardial Damage (CK and CK-MB and Trop < 1*URL) 
and not acute MI in progress.
PERIPROCEDURAL <72 HOURS POST CABG
A. New pathologic q waves in 2 contiguous ECG leads or recurrent signs or symptoms 
consistent with myocardial ischemia AND

CK-MB >5x URL or

in the absence of CK-MB: Troponin > 5*URL or

in the absence of CK-MB and Troponin: CK > 5 URL or

in the absence of CK-MB and Troponin and CK: CEC decision upon clinical 
scenario
B. Appropriate cardiac enzyme data 
- CK-MB 10* URL or
- In the absence of CK-MB: Trop > 10*URL. or
- In the absence of CK-MB and Troponin: CK > 10*URL
IIb. If Baseline Biomarkers of Myocardial Damage: CK and/or CK-MB > 1*URL or
acute MI in progress

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MYOCARDIAL INFARCTION, RE-INFARCTION (EXTENSION) <72 HOURS POST CABG
A. If Peak CK (or CK-MB) from index MI has not yet reached its maximum level:

Clinical signs or symptoms consistent with recurrent myocardial ischemia
AND

Appropriate cardiac enzyme data:
o
A rise in CK-MB within 24 hours of the index event >10*URL  and 50% 
above the previous level.
o
In absence of CK-MB: a rise in Troponin within 24 hours of the index event 
>10*URL and 50% above the previous level.
o
In absence of CK-MB and Troponin: a rise in CK within 24 hours of the index 
event >10*URL and 50% above the previous level.
B. If elevated CK (or CK-MB) following the index MI has peaked AND CK-MB level has 
returned < URL, any new rise in:

CK-MB >10*URL or

in the absence of CK-MB: Troponin > 10*URL or

in the absence of CK-MB and Troponin: CK > 10*URL
C. If elevated CK (or CK-MB) following the index MI has peaked AND CK-MB level has 
NOT returned < URL:

A rise in CK-MB 50% above the previous level and > 10 URL or

In absence of CK-MB: a rise in Troponin 50% above the previous level and > 
10* URL. or

In absence of CK-MB and Troponin: a rise in CK 50% above the previous level 
and >10*URL
NO REFLOW
A sustained or transient reduction in antegrade flow that is not associated with an obstructive 
lesion at the treatment site. 
PERCENT DIAMETER STENOSIS
The value calculated as 100 x (RVD – MLD)/RVD using the mean values from two 
orthogonal views (when possible) by QCA.
PERCENT VOLUME OBSTRUCTION
Stent intimal hyperplasia and calculated as 100 x (Stent Volume (SV) – Lumen Volume 
(LV))/SV.
PERFORATION
Perforations will be classified as follows:

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Angiographic perforation: perforation detected by the clinical site or the core laboratory 
at any point during the procedure.
Clinical perforation: perforation requiring additional treatment (including efforts to seal 
the perforation or pericardial drainage), or resulting in significant pericardial effusion, 
acute closure, myocardial infarction, or death.
Pericardial hemorrhage/tamponade: perforation resulting in cardiac tamponade.
PERCUTANEOUS CORONARY INTERVENTION (PCI)
Refers to all interventional cardiology methods for treatment of coronary artery disease.
PERSISTING DISSECTION
Dissection at follow-up that was present post-procedure. See also “dissection”.
PERSISTING INCOMPLETE APPOSITION
Incomplete apposition at follow-up that was present post-procedure. See also “incomplete 
apposition.”
RESTENOTIC LESION
A lesion in a vessel segment that has undergone prior percutaneous treatment with or without 
a stent placement. 
REFERENCE VESSEL DIAMETER (RVD)
The average of normal segments within 10 mm proximal and distal to the target lesion from two 
orthogonal views using QCA. 
STENT THROMBOSIS
All stent thrombosis data will be reported according the Academic Research Consortium 
(ARC) definitions14.
Academic Research Consortium (ARC) Definition:
Stent thrombosis should be reported as a cumulative value over time and at the various 
individual time points as specified below. Time 0 is defined as the time point after the guiding 
catheter has been removed and the patient has left the catheterization lab.
Timing:
Acute stent thrombosis *
0 – 24 hours post stent implantation
                                                          
14 Cutlip, D. E., et al. (2007). "Clinical end points in coronary stent trials: a case for standardized definitions." Circulation 115(17): 2344-
2351.
* Acute or subacute stent thrombosis can also be replaced by the term early stent thrombosis. 

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Subacute stent thrombosis * 
> 24 hours – 30 days post stent implantation
Late stent thrombosis
Very late stent thrombosis
> 30 days – 1 year post stent implantation
> 1 year post stent implantation
* Acute or subacute stent thrombosis can also be replaced by the term early stent thrombosis.
Three categories of evidence define stent thrombosis: Definite, Probable, Possible 
1. Definite (either by angiographic or pathologic confirmation):
a.
Angiographic confirmation of stent thrombosis is considered to have occurred if:  
a.
Thrombolysis In Myocardial Infarction (TIMI) flow is:
1. TIMI flow grade 0 with occlusion originating in the stent or in the segment 
5mm proximal or distal to the stent region in the presence of a thrombus
2. TIMI flow grade 1, 2, or 3 originating in the stent or in the segment 5mm 
proximal or distal to the stent region in the presence of a thrombus 
b. AND at least one of the following criteria has been fulfilled within a 48 hour 
time window:
1.
New onset of ischemic symptoms at rest (typical chest pain with duration 
>20 minutes)
2.
New ischemic ECG changes suggestive of acute ischemia
3.
Typical rise and fall in cardiac biomarkers (refer to definition non-
procedural related MI).
NOTE:  The incidental angiographic documentation of stent occlusion in the absence of 
clinical signs or symptoms is not considered a confirmed stent thrombosis (silent 
occlusion). 
b. Pathologic confirmation of stent thrombosis:
Evidence of recent thrombus within the stent determined at autopsy or via examination 
of tissue retrieved following thrombectomy.
2. Probable: 
Clinical definition of probable stent thrombosis is considered to have occurred after 
intracoronary stenting in the following cases:
a.
Any unexplained death within the first 30 days.
b. Irrespective of the time after the index procedure any myocardial infarction (MI), 
which 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.
3. Possible:
Clinical definition of possible stent thrombosis is considered to have occurred with any 
unexplained death from 30 days following intracoronary stenting until end of study 
follow-up.

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STROKE
Sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or 
other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, 
embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.
STUDY DEVIATION
An event where the Investigator or site personnel did not conduct the study according to the 
investigation plan, applicable laws or regulations, or the Investigator Agreement.
TARGET LESION
Any lesion treated or attempted to be treated during the study procedure with the study 
device. The target lesion is the treated segment starting 5 mm proximal to the stent and ending 
5 mm distal to the stent.
TARGET LESION FAILURE (TLF)
Cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-
driven target lesion revascularization (TLR) by percutaneous or surgical methods
TARGET LESION REVASCULARIZATION (TLR)
Repeat PCI or CABG to the target lesion. See also clinically-driven target lesion 
revascularization.
TARGET VESSEL
The arterial segment and any branches and/or parent vessel that possess the target lesion. For 
this study, the target vessel can only be the left main (protected), LAD, LCx, RCA. Side 
branches less than 2.0 mm in diameter will not be considered ‘significant’ and therefore the 
disease in these vessels will not be considered significant.
TARGET VESSEL FAILURE (TVF)
The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or 
clinically-driven target vessel revascularization by percutaneous or surgical methods.
Target vessel failure will be reported when ANY of the following events occur:

Recurrent MI occurs in territory not clearly attributed to a vessel other than the target 
vessel.

Cardiac death not clearly due to a non-target vessel endpoint.

Target vessel revascularization is determined.

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TARGET VESSEL MYOCARDIAL INFARCTION (MI)
A MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target 
vessel. 
TARGET VESSEL REVASCULARIZATION (TVR)
Repeat PCI or CABG of the target vessel. See also clinically-driven target vessel 
revascularization.
THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) CLASSIFICATION13
TIMI 0
No perfusion.
TIMI 1
Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal 
to the stenosis for the duration of the cine run.
TIMI 2
Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. 
However, the rate of entry and/or clearance is slower in the coronary bed distal to 
the obstruction than in comparable areas not perfused by the dilated vessel.
TIMI 3
Complete perfusion. Filling and clearance of contrast equally rapid in the 
coronary bed distal to stenosis as in other coronary beds.
THROMBUS (INTRACORONARY)14
Non-occlusive thrombus: A (spheric, ovoid or irregular) non-calcified filling defect or 
lucency surrounded by contrast material (on three 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.
Occlusive thrombus: TIMI 0 or TIMI 1 intra-stent or proximal to a stent up to the most 
adjacent proximal side branch or main branch (if originating from the side branch).
TOTAL OCCLUSION
A lesion with no flow (TIMI 0). Total occlusions are usually classified as persisting less than 
or more than 3 months (chronic total occlusion).
TRANSIENT ISCHEMIC ATTACK (TIA)
A focal neurological abnormality of sudden onset and brief duration (lasting less than 24 
hours) that reflect dysfunction in the distribution of the effected artery. TIAs include transient 
monocular blindness (e.g., amaurosis fugax defined as a transient episode of monocular 
blindness, or partial blindness, lasting ten minutes or less) and transient hemispheric attacks.
                                                          
13 The Thrombolysis in Myocardial Infarction (TIMI) study. Phase I findings. TIMI Study Group. 1985. N Engl J Med 312 (14): 932-6.
14 Capone, G., N. M. Wolf, B. Meyer, and S. G. Meister. 1985. Frequency of intracoronary filling defects by angiography in angina 
pectoris at rest. Am J Cardiol 56 (7): 403-6.

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UNSTABLE ANGINA
Per the ACC/AHA 2002 Guideline Update for the Management of Patients with Unstable 
Angina and Non–ST-Segment Elevation Myocardial Infarction there are three (3) principal 
presentations of unstable angina (UA) 15:
1. Rest Angina. Angina occurring at rest and prolonged, usually >20 minutes. 
2. New-onset Angina. New-onset angina of at least CCS Class III Severity.
3. Increasing Angina. Previously diagnosed angina that has become distinctly more 
frequent, longer in duration, or lower in threshold (i.e., increased by greater than or 
equal to 1 CCS class to at least CCS Class III severity).
VASCULAR COMPLICATIONS
Vascular complications may include the following:
1. Pseudoaneurysm
2. Arteriovenous fistula (AVF)
3. Peripheral ischemia/nerve injury
4. Vascular event requiring transfusion or surgical repair
                                                          
15 Braunwald, E., E. M. Antman, J. W. Beasley, R. M. Califf, M. D. Cheitlin, J. S. Hochman, R. H. Jones, D. Kereiakes, J. Kupersmith, T. 
N. Levin, et al. 2002. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment 
elevation myocardial infarction--summary article: a report of the American College of Cardiology/American Heart Association task 
force on practice guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol 40 (7): 1366-74. 

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Appendix 3 Angiographic Core Lab Procedures
Note: A copy of the angiographic core laboratory procedure will be provided in the 
Investigator Site File, the study binder to the Investigator.

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Appendix 4 Sample Informed Consent Form
NOTE:  Refer to the most current version of the Sample Patient Informed Consent Form sent 
under separate cover.

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Appendix 5 Sample Case Report Forms
NOTE:Refer to the most current version of the case report forms sent under separate cover.

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056-F275, v3.0 Clinical Investigation Plan Template
Appendix 6 Instructions for Use (Resolute Integrity)
NOTE:Refer to the most current version of the instructions for use sent under separate cover 
or packaged with the device.

RESOLUTE ONYX CHINA RCT STUDY
Clinical Investigation Plan 
MDT16061RES005
Version 2.0
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056-F275, v3.0 Clinical Investigation Plan Template
Appendix 7 Resolute Onyx stent Investigator’s Brochure (IB)
NOTE:Refer to the most current version of the investigator’s brochure sent under separate 
cover.

RESOLUTE ONYX CHINA RCT STUDY
Clinical Investigation Plan 
MDT16061RES005
Version 2.0
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056-F275, v3.0 Clinical Investigation Plan Template
Appendix 8 Device Label
NOTE:Refer to the most current version of the device label sent under separate cover or 
packaged with the device.

RESOLUTE ONYX CHINA RCT STUDY
Clinical Investigation Plan 
MDT16061RES005
Version 2.0
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056-F275, v3.0 Clinical Investigation Plan Template
Appendix 9 Investigators and Institutions List
NOTE:Refer to the most current version of the investigator and institution list sent under 
separate cover.

RESOLUTE ONYX CHINA RCT STUDY
Clinical Investigation Plan 
MDT16061RES005
Version 2.0
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056-F275, v3.0 Clinical Investigation Plan Template
Version History
Version
Summary of Changes
Author(s)/Title
1.0
Initial release
Dong Li / CSM
2.0

Statistical Design and Methods: ITT is replaced by 
FAS.

Table of expected, non-reportable events related to 
a surgical procedure is added.

Appendix 2 List of Definitions: updated MACE 
definition
Kevin Lei / CSM