Multi-center Study for Evaluating the Safety and Efficacy of the MedJ-01 Ridaforolimus Eluting Coronary Stent System (MedJ-01) In Coronary Stenosis Trial
Phase: NA
Conditions: de Novo or Restenosis Lesions
Sponsor: Medinol Ltd.

 
JNIR01 Protocol, Version 2.0, 18-Sep-2016 
  
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CLINICAL INVESTIGATION PLAN  
JNIR Trial 
Multi-center study for evaluating the safety and efficacy of  
the Ridaforolimus Eluting Coronary Stent System (MedJ-01)  
In Coronary Stenosis Trial 
CIP Number: JNIR01 
 
Cooperating Investigator (CI) 
Dr. Shigeru Saito 
Interventional Cardiologist  
Shonan Kamakura General Hospital 
Investigational Sites 
Approximately 10 sites in Japan will participate in 
the trial. An updated full site list is detailed in the 
trial’s Site Binder. 
Primary Investigators 
See Appendix 1 
Sponsor 
Medinol Ltd. 
PO Box 58165 
Tel Aviv, Kiryat Atidim, Israel 
Yoram Richter, PhD 
Chief Scientific Officer 
yrichter@medinol.com 
Michal Hershkovitz 
VP Clinical Development and Regulatory Affairs 
MichalH@medinol.com 
Medical Monitoring Oversight 
Ori Ben-Yehuda, MD 
Executive Director, Clinical Trials Center 
Cardiovascular Research Foundation 
111 East 59th Street 
New York NY, USA 
obenyehuda@crf.org 

 
 
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ICCC/ Regulatory / Safety / 
Data Management / Site 
Monitoring / Data Analysis 
Quintiles Transnational Japan K.K. 
4-10-18 Takanawa 
Minato-ku, Tokyo, Japan 
Representative: 
Noboru Shimizu 
Representative Director & President 
Supervisor: 
Jotaro Shinagawa  
Senior Vice President, Head of Product 
Development Services 
+81 3 6859 9500 
Core Laboratories  
(Angiographic, ECG) 
 
Clinical Events Committee 
Data Safety Monitoring Board 
Cardiovascular Research Foundation 
111 East 59th Street 
New York NY,USA 
Katharine Lymberis 
Administrative Director 
Clinical Trials Center 
klymberis@crf.org 
Clinical Investigation Plan Version 
and Date 
Version 2.0, 18-Sep-2016 
This Clinical Investigation Plan has been written in accordance with Annex A of ISO 14155 
(2011): Clinical investigations of medical devices for human subjects – Good Clinical Practice 
and ICH E6 Guidelines. In accordance with the ethical principles that have their origin in the 
Declaration of Helsinki, and that are consistent with the standard stated in Japanese Drug 
Medical Device Law Act 23.2.5 Part 3 and Act 80.2, and MHLW Ministerial Ordinance No. 36, 
Mar 23, 2005 (GCP of Medical Device), Article 273 and Article 274, Part 2, ISO 14155, where 
information is held within other trial documentation, e.g. in the Investigator Brochure, this is 
referenced where appropriate. 
 
 

 
 
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Compliance Statement 
The trial will be conducted in accordance with the design and specific provisions of this clinical 
investigation plan, in accordance with the ethical principles that have their origin in the Japanese 
Drug Medical Device Law Act 23.2.5 Part 3 and Act 80.2, and MHLW Ministerial Ordinance 
No. 36, Mar 23, 2005 (GCP of Medical Device), Article 273 and Article 274, Part 2, Declaration of 
Helsinki, and that are consistent with Good Clinical Practice (GCP), ISO 14155, ICH E6, and the 
applicable regulatory requirements. 
Clinical Investigation Plan Review 
We, the undersigned, have reviewed and approved the clinical investigation plan specified above 
and agree on its content. 
Coordinating Investigator’s Signature 
 
 
 
 
 
 
Coordinating Investigator 
 
Date 
 
 
 
Sponsor Representative’s Signature 
 
 
 
 
Sponsor Representative Name 
 
Date 

 
 
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CLINICAL INVESTIGATION PLAN REVISION SUMMARY 
 
Version 
Release Date 
Summary of Changes 
1.0  
Initial release  
03-Dec-2015 
N/A 
2.0 
Revision per 
PMDA's 
comments 
 
18-Sep-2016 
(In Bold –wording added) 
 Site Monitoring & Data Analysis CRO replaced - 
Quintiles Transnational Japan K.K. instead of NAC-RA 
KK  
 Subject Population, Inc. 2, Exc. 1 (in the Synopsis) and 
sections 3.1, 5.3, Table 3, 6.3.1.1, 6.3.2.1 – the word 
"subacute" is added before the word "STEMI" 
 Angiographic inclusion 7 (in the Synopsis and on sec. 
6.3.1.2) and 'Study Stent Use' sec. 6.4.6 – revised to 
reflect that "Overlapping stents are allowed with the 
investigational device" 
 Description of the investigational device, sec. 2.6  
Figures 1-4 are added 
o 2.6.1 –Stent: wording updated for better accuracy of 
stent description 
o Table 1: Available Stent Lengths and Nominal 
Diameters – updated 
o 2.6.2 – Delivery System: correction was made as 
follows: "The catheter has a distal port 
approximately 3025cm from the distal tip that 
accesses the guide wire lumen". 
o 2.6.3 – Polymer Coating: the word "matrix" is 
replaced with "blend", for better accuracy 
 BLAST Study –sec. 3.3.2 – wording updated to reflect 
study completion. 
 Pre-dilatation of target lesions, sec. 6.4.5 – revised to 
reflect that "pre-dilatation should be performed, per 
local clinical practice" 
 Pre-Procedure (Loading) Anti-Platelet Medication, sec. 
6.4.9.1 – Table 6 -  revised to adjust to the Japanese 
standard of care: 
A loading dose of clopidogrel ≤300 to 600 mg must be 
administered at least 6 hours prior to PCI, as per 
standard of care.  
 Definitions and Acronyms – Protocol Deviations-Major 
– the following change was made to the 4th bullet: "who 
did not receive at least 612 months of DAPT post 
baseline procedure".  
 Change number of study participants, per PMDA 
request– instead of "a total of 86 subjects" – "a total of 

 
 
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100 subjects" will be allocated in this study. 
    Accordingly, the following sections are revised:    
Synopsis, 6.1.1, 6.1.6, 6.3, 6.3,7. 
 Wording added on section: synopsis and 6.3.1.2- 
angiographic inclusion # 6, and section 6.3 'Subjects' - 
to clarify as to rotational atherectomy: "Complex 
lesions are allowed including calcified lesions (lesion 
preparation with scoring/cutting and rotational 
atherectomy (e.g.: Rotablator System and Directional 
Coronary Atherectomy, DCA) are allowed)…" 
 Sections 6.4.5 'Pre-Dilatation of Target Lesion', and 
6.4.7 'Treatment Failures and Device Malfunctions of 
the MEDJ-01' - wording added to clarify that Pre-
dilatation can include DCA. 
 Section 7 'Statistical Considerations' – revised to 
present the approach requested by PMDA. 
 Revisions per PMDA's comment as to de-registration, 
as follows: 
o Section 6.3.4 'Point of Enrollment', and section 21.1– 
'Definitions' – Analysis Data Sets (FAS):                
"If the study stent could not be implanted due to 
reasons that are not related to study device, is not 
advanced beyond the guiding catheter, the study 
subject will be de-registered from the trial and will 
not be analyzed as part of the full analysis set (FAS). 
Figure 5 – an asterisk added to refer to section 6.4.3 
o Section 6.4.3 – 'Enrollment' –"A subject will be de-
registered from the trial in case the study stent could 
not be implanted due to reasons that are not 
related to study device If the study stent is not 
advanced beyond the guiding catheter (for example, 
the lesion was not successfully properly pre-dilated 
prepared for stenting) the subject will be de-
registered from the trial. 
 Appendix 1 – Primary Investigators in the JNIR Study – 
deletion of Dr. Takeshi Serikawa, as he will not take 
part in this study. 
 
 Minor editorial revisions. 
 Protocol version name and date- updated 
 

 
 
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CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
MedJ-01 Ridaforolimus Eluting Stent System in Coronary Stenosis  
JNIR Trial 
CIP Number: JNIR01 
I have read this clinical investigation plan and appendices and agree to adhere to the 
requirements. I will provide copies of this clinical investigation plan and all pertinent 
information to the trial personnel under my supervision. I will discuss this material with them 
and ensure they are fully informed regarding the device and the conduct of the trial. 
I will conduct the trial in accordance with the Japanese Drug Medical Device Law Act 23.2.5 
Part 3 and Act 80.2, and MHLW Ministerial Ordinance No. 36, Mar 23, 2005 (GCP of Medical 
Device), Article 273 and Article 274, Part 2, clinical investigation plan, Good Clinical Practice 
guidelines, ISO 14155:2011 (Clinical Investigation of Medical Devices for Human Subjects - 
Good Clinical Practice), as well as local regulations. I also accept respective revisions to the 
clinical investigation plan approved by authorized personnel of the Sponsor and by regulatory 
authorities. 
This document contains proprietary and confidential information of Medinol Ltd. Do not 
copy, distribute, or share with others without prior written authorization from Medinol Ltd. 
 
 
Primary Investigator    (print) 
 
 
 
Primary Investigator    (signature) 
 
 
Date 
 
 
 
Institution Name/Location   (print) 
 
 

 
 
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TABLE OF CONTENTS 
 
1 
OVERALL SYNOPSIS OF THE CLINICAL INVESTIGATION ................................ 13 
2 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL 
DEVICE ................................................................................................................................ 17 
2.1 
Summary Description of the Investigational Device and Its Intended Purpose ............... 17 
2.1.1 
Summary Description of the Investigational Device .................................................... 17 
2.1.2 
Intended Purpose .......................................................................................................... 18 
2.2 
Details Concerning the Manufacturer of the Investigational Device ................................. 18 
2.3 
Traceability of the Investigational Device ............................................................................ 18 
2.4 
Intended Purpose of the Investigational Device in the Proposed Clinical Investigation .. 18 
2.5 
Populations and Indications for Which the Investigational Device Is Intended ............... 18 
2.6 
Description of the Investigational Device ............................................................................. 18 
2.6.1 
Stent .............................................................................................................................. 18 
2.6.2 
Delivery System ........................................................................................................... 19 
2.6.3 
Polymer Coating ........................................................................................................... 20 
2.6.4 
Ridaforolimus ............................................................................................................... 20 
2.7 
Summary of Necessary Training and Experience Needed to Use the Investigational 
Device ....................................................................................................................................... 20 
2.8 
Description of the Specific Medical or Surgical Procedures ............................................... 21 
3 
JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION ...... 21 
3.1 
Background ............................................................................................................................. 21 
3.2 
Evaluation of the Results of the Relevant Pre-Clinical Testing .......................................... 22 
3.3 
Evaluation of Clinical Data Relevant to the Proposed Clinical Investigation ................... 22 
3.3.1 
The PIONIR Study ....................................................................................................... 22 
3.3.2 
The BLAST Study ........................................................................................................ 23 
3.3.3 
The Iberian Study ......................................................................................................... 24 
3.3.4 
The Belgian Study ........................................................................................................ 24 
3.3.5 
The Vila Real Study ..................................................................................................... 25 
3.3.6 
The PREHAMI Registry .............................................................................................. 25 
3.3.7 
The BIONICS and NIREUS Trials .............................................................................. 26 
4 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND 
CLINICAL INVESTIGATION .......................................................................................... 26 
4.1 
Anticipated Clinical Benefits ................................................................................................. 26 
4.2 
Anticipated Adverse Device Effects ...................................................................................... 26 
4.3 
Residual Risks Associated with Investigational Device ....................................................... 27 
4.4 
Risks Associated with Participation in the Clinical Investigation ...................................... 27 

 
 
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4.5 
Possible Interactions with Concomitant Medical Treatments ............................................ 27 
4.6 
Steps to Control or Mitigate Risks ........................................................................................ 27 
4.7 
Risk-to-Benefit Rationale ....................................................................................................... 27 
5 
OBJECTIVES AND HYPOTHESES OF THE CLINICAL INVESTIGATION .......... 28 
5.1 
Objectives ................................................................................................................................ 28 
5.2 
Hypotheses to Be Accepted or Rejected by Statistical Data ............................................... 28 
5.3 
Claims and Intended Performance of the Investigational Device ...................................... 28 
5.4 
Risks and Anticipated Adverse Device Effects That Are to Be Assessed .......................... 28 
6 
DESIGN OF THE CLINICAL INVESTIGATION ......................................................... 28 
6.1 
General .................................................................................................................................... 28 
6.1.1 
Description of Trial ...................................................................................................... 28 
6.1.2 
Rationale for Trial ........................................................................................................ 28 
6.1.3 
Primary and Secondary Endpoints ............................................................................... 29 
6.1.3.1  Primary Endpoint ................................................................................................. 29 
6.1.3.2  Clinical Secondary Endpoints .............................................................................. 29 
6.1.4 
Methods and Timing for Assessing, Recording, and Analyzing Variables .................. 30 
6.1.4.1  Screening and Pre-Procedure .............................................................................. 31 
6.1.4.2  Pre-Procedure Laboratory Assessments .............................................................. 31 
6.1.4.3  Baseline Procedure .............................................................................................. 32 
6.1.4.4  Post-Procedure and Discharge ............................................................................ 33 
6.1.4.5  30 Days (± 7 days) and 6 Months (± 30 days) Follow-up (in clinic or telephone 
visit) ..................................................................................................................... 33 
6.1.4.6  1 year (- 30 Days / + 14 Days) Follow-up (in-clinic) .......................................... 34 
6.1.4.7  2, 3, 4, and 5 Year (± 60 days) Follow-up (in clinic or telephone visit) .............. 34 
6.1.4.8  Additional (Unscheduled) Follow-up Visits ......................................................... 34 
6.1.5 
Equipment to Be Used for Assessing the Clinical Variables ....................................... 35 
6.1.6 
Procedures for the Replacement of Subjects ................................................................ 35 
6.2 
Investigational Device ............................................................................................................. 35 
6.2.1 
Description of the Exposure to the Investigational Device .......................................... 35 
6.2.2 
List of Any Other Medical Devices or Medication to Be Used During the Clinical 
Investigation ................................................................................................................ 35 
6.2.3 
Number of Investigational Devices to Be Used ........................................................... 35 
6.3 
Subjects .................................................................................................................................... 36 
6.3.1 
Inclusion Criteria for Subject Selection ........................................................................ 36 
6.3.1.1  General Inclusion Criteria ................................................................................... 36 
6.3.1.2  Angiographic inclusion criteria (visual estimate) ................................................ 37 
6.3.2 
Exclusion Criteria for Subject Selection ...................................................................... 37 
6.3.2.1  General Exclusion Criteria .................................................................................. 37 
6.3.2.2  Angiographic Exclusion Criteria (visual estimate) .............................................. 39 
6.3.3 
Criteria and Procedures for Subject Withdrawal or Discontinuation ........................... 39 
6.3.3.1  When and How to Withdraw Subjects .................................................................. 39 
6.3.3.2  Data to Be Collected from Withdrawn Subjects ................................................... 40 
6.3.3.3  Follow-up for Withdrawn Subjects ...................................................................... 40 
6.3.4 
Point of Enrollment ...................................................................................................... 40 

 
 
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6.3.5 
Total Expected Duration of the Clinical Investigation ................................................. 42 
6.3.6 
Expected Duration of Each Subject’s Participation ...................................................... 42 
6.3.7 
Number of Subjects Required to Be Included in the Clinical Investigation ................. 42 
6.4 
Procedures ............................................................................................................................... 42 
6.4.1 
Baseline Angiography .................................................................................................. 42 
6.4.2 
Non-Target Vessel PCI and Non-Target Lesion PCI in Target Vessel ........................ 42 
6.4.3 
Enrollment .................................................................................................................... 43 
6.4.3.1  De-registered Subjects ......................................................................................... 43 
6.4.4 
Staged Procedures ........................................................................................................ 43 
6.4.5 
Pre-Dilation of Target Lesion(s) ................................................................................... 44 
6.4.6 
Study Stent Use ............................................................................................................ 44 
6.4.7 
Treatment Failures and Device Malfunctions of the MedJ-01 ..................................... 44 
6.4.8 
Bail-out Stenting Procedures ........................................................................................ 45 
6.4.9 
Concomitant Medications ............................................................................................. 45 
6.4.9.1  Pre-Procedure (Loading) Anti-Platelet Medication ............................................ 45 
6.4.9.2  Anticoagulation during Baseline Procedure ........................................................ 45 
6.4.9.3  Post-Procedure Anti-Platelet Medication ............................................................ 46 
6.4.10  Activities Performed by Sponsor Representatives ....................................................... 46 
6.4.11  Known or Foreseeable Factors That May Compromise the Outcome .......................... 46 
6.5 
Monitoring Plan ...................................................................................................................... 46 
6.5.1 
Monitoring .................................................................................................................... 46 
6.5.2 
Identification of Data Recorded on CRF and Considered Source Data ....................... 47 
6.5.3 
Direct Access to Source Data/Documents .................................................................... 47 
6.5.4 
Training ........................................................................................................................ 47 
6.5.4.1  Site Training ......................................................................................................... 47 
6.5.4.2  Training of Sponsor’s Monitors ........................................................................... 48 
6.5.5 
Quality Assurance Assessments ................................................................................... 48 
6.5.6 
Regulatory Agency Inspection ..................................................................................... 48 
7 
STATISTICAL CONSIDERATIONS ............................................................................... 48 
7.1 
Target groups of Analysis ...................................................................................................... 48 
7.2 
Analysis of Efficacy................................................................................................................. 49 
7.3 
Analysis of Safety .................................................................................................................... 51 
7.4 
Other subjects related to statistical analysis ........................................................................ 51 
7.5 
Sample Size Considerations ................................................................................................... 52 
8 
DATA MANAGEMENT ..................................................................................................... 52 
8.1 
Procedures Used for Data Review, Database Cleaning, and Issuing and Resolving 
Data Queries ............................................................................................................................ 52 
8.2 
Procedures for Verification, Validation, and Securing of Electronic Clinical Data 
Systems .................................................................................................................................... 52 
8.3 
Procedures for Data Retention and Specified Retention Period ........................................ 53 

 
 
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8.4 
Other Aspects of Clinical Quality Assurance ....................................................................... 53 
8.4.1 
Clinical Events Committee ........................................................................................... 53 
8.4.2 
Selection of Clinical Sites and Investigators ................................................................ 53 
8.4.3 
Clinical Investigational Plan and Informed Consent Approval at Investigative Sites .. 54 
8.4.4 
Source Documents ........................................................................................................ 54 
8.4.5 
Case Report Form (CRF) Completion .......................................................................... 54 
9 
AMENDMENTS TO CIP ................................................................................................... 54 
10  DEVIATIONS FROM CLINICAL INVESTIGATION PLAN ...................................... 55 
10.1  Statement Specifying That the Investigator Is Not Allowed to Deviate from the CIP ..... 55 
10.2  Procedures for Recording, Reporting, and Analyzing CIP Deviations ............................. 55 
10.3  Notification Requirements and Time Frames ...................................................................... 55 
10.4  Corrective and Preventative Actions and Principal Investigator Disqualification 
Criteria .................................................................................................................................... 55 
11  DEVICE ACCOUNTABILITY .......................................................................................... 56 
11.1  Investigational Product Accountability ................................................................................ 56 
11.2  Investigational Product Return ............................................................................................. 56 
12  STATEMENTS OF COMPLIANCE ................................................................................. 56 
13  INFORMED CONSENT PROCESS ................................................................................. 57 
13.1  General Process for Obtaining Informed Consent .............................................................. 57 
14  ADVERSE EVENTS, ADVERSE DEVICE/DRUG EFFECTS, AND DEVICE 
DEFICIENCIES .................................................................................................................. 58 
14.1  Definition of AE and ADE ..................................................................................................... 58 
14.1.1  Adverse Event (AE) ..................................................................................................... 58 
14.1.2  Adverse Device/Drug Effect (ADE) ............................................................................. 58 
14.2  Definition of Device Deficiencies ........................................................................................... 58 
14.3  Definition of SAE, SADE, and USADE................................................................................. 59 
14.3.1  Serious Adverse Event (SAE) ...................................................................................... 59 
14.3.2  Serious Adverse Device/Drug Effect (SADE) ............................................................. 59 
14.3.3  Anticipated Serious Adverse Device/Drug Effect (ASADE) ....................................... 59 
14.3.4  Unanticipated Serious Adverse Device/Drug Effect (USADE) ................................... 59 
14.4  Time Period in Which the Investigator Shall Report All AE and Device Deficiencies 
to the ICCC (Quintiles) .......................................................................................................... 60 
14.5  Details of Process for Reporting AE and Device Deficiencies ............................................. 60 
14.5.1  Reporting AE and Device Deficiencies ........................................................................ 60 
14.5.2  Reporting USADE ........................................................................................................ 60 
14.6  List of Foreseeable AE and ADE ........................................................................................... 61 
14.7  List of Foreseeable Device Deficiencies ................................................................................. 62 

 
 
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14.8  Emergency Contact Details for Reporting SAE and SADE................................................ 62 
14.9  Information Regarding the DSMB ........................................................................................ 62 
14.10 Adjudication of Clinical Endpoints ....................................................................................... 63 
14.10.1 Death ............................................................................................................................ 63 
14.10.2 Myocardial Infarction ................................................................................................... 63 
14.10.3 Revascularization ......................................................................................................... 63 
14.10.4 Stent Thrombosis .......................................................................................................... 63 
14.10.5 Vascular and Bleeding Complications ......................................................................... 63 
14.10.6 Other Adverse Events ................................................................................................... 64 
14.10.7 Follow-up of Subjects after Adverse Events ................................................................ 64 
15  VULNERABLE POPULATION ........................................................................................ 64 
16  SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL 
INVESTIGATION ............................................................................................................... 64 
16.1  Criteria and Arrangements for Suspension or Premature Termination of the Clinical 
Investigation or of the Clinical Investigation in One or More Sites ................................... 64 
16.2  Requirements for Subject Follow-Up ................................................................................... 64 
17  PUBLICATION POLICY ................................................................................................... 64 
17.1  Statement Indicating Whether the Results of the Clinical Investigation Will Be 
Submitted for Publication ...................................................................................................... 64 
17.2  Statement Indicating the Conditions under Which the Results of the Clinical 
Investigation Will Be Offered for Publication ..................................................................... 65 
18  COMPENSATION FOR HEALTH HAZARD ................................................................ 65 
19  PRIVACY POLICY ............................................................................................................ 65 
20  BIBLIOGRAPHY ................................................................................................................ 66 
21  DEFINITIONS AND ACRONYMS ................................................................................... 68 
21.1  Definitions ................................................................................................................................ 68 
21.1.1  Acronyms ..................................................................................................................... 80 
21.1.2  Abbreviations from Clinical Trials, Academic Bodies, or Regulations ....................... 82 
 
 
 
 

 
 
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LIST OF TABLES 
 
Table 1: Available Stent Lengths and Nominal Diameters ...........................................................19 
Table 2: List of Previous Clinical Experience ...............................................................................22 
Table 3: Schedule of Data Collection ............................................................................................30 
Table 4: Patient Status as Indicated by Biomarker Levels post-PCI .............................................33 
Table 5: Summary of Timing of Non-Target Vessel According to PCI Rules ..............................43 
Table 6: Pre-Procedure Anti-Platelet Medication Regimen ..........................................................45 
Table 7: Post-Procedure Anti-Platelet Medication Regimen .........................................................46 
Table 8: Categories of Adverse Events ..........................................................................................59 
Table 9: Foreseeable AE and ADE for DES Implantation ............................................................61 
Table 10: Foreseeable AE and ADE for Ridaforolimus ................................................................62 
Table 11: Foreseeable Device Deficiencies for DES Implantation ...............................................62 
 
LIST OF FIGURES 
 
Figure 1: Closed cell design ...........................................................................................................18 
Figure 2: Stent of the MedJ-01 mounted on balloon .....................................................................19 
Figure 3: Stent Delivery System ....................................................................................................19 
Figure 4: Molecular Structure of Ridaforolimus ...........................................................................20 
Figure 5: Screening and Enrollment Flow Chart ...........................................................................41 
 
 
 

 
 
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1 OVERALL SYNOPSIS OF THE CLINICAL INVESTIGATION 
JNIR Trial 
Device 
MedJ-01 Ridaforolimus Eluting Coronary Stent System (hereafter 
referred to as MedJ-01) 
Objectives 
Evaluating MedJ-01 safety and efficacy for de novo or  restenosis lesion with 
target vessel diameter of 2.5mm to 4.25, for subjects undergoing coronary 
artery stent implantation 
Trial Hypotheses 
JNIR01 is aimed at assessing TLF at one year with the MedJ-01 stent 
in a Japanese patient population, to show non-inferiority of JNIR01 
Target Lesion Failure at 12 months (TLF12) to the BIONICS TLF12.  
 
Subject Population 
Subjects undergoing PCI for angina (stable or unstable), silent 
ischemia (in absence of symptoms a visually estimated target lesion 
diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR 
≤0.80 must be present), NSTEMI, and recent subacute STEMI (>72 
hours from initial presentation and stable). Complex lesions are 
allowed. A maximum of two target vessels and two lesions  per vessel 
may be treated (two lesions separated by up to 10 mm that can be 
covered by a single stent are considered as one lesion); the total 
planned study stenting in the coronary tree cannot exceed 100 mm. 
Trial Design and 
Methods 
This is a prospective, multi-center single- arm, open label clinical trial.  
Lesions planned to be treated must be declared and recorded at time of 
enrollment.  
Clinical follow-up will be performed at 30 days, 6 months, and 1, 2, 3, 
4, and 5 years post enrollment.  
Primary Endpoint 
Target Lesion Failure (TLF) at 12 months defined as the composite of 
cardiac death, target vessel-related myocardial infarction, or ischemia-
driven target lesion revascularization. 
Secondary 
Endpoints 
Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 
2, 3, 4 and 5, except as noted:  
 Device, Lesion, and Procedure Success at time of baseline 
procedure 
 TLF at 30 days, 6 months, and 2, 3, 4 and 5 years defined as the 
composite of cardiac death, target vessel-related MI, or 
ischemia-driven TLR. 
 Major adverse cardiac events (MACE; the composite rate of 
cardiac death, any MI or ischemia-driven TLR)  
 Target vessel failure (TVF; the composite rate of death, target 
vessel related MI or ischemia-driven TVR)  
 All-cause mortality  
 Cardiac death  

 
 
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 Myocardial Infarction  
 Target Vessel Related MI  
 Ischemia-driven TLR  
 Ischemia-driven TVR  
 Stent Thrombosis (ARC definite and probable) 
Sample Size 
A total of 100 subjects will be allocated in this study. 
Inclusion Criteria 
General Inclusion Criteria: 
1. Age ≥ 20 years. 
2. Patient with an indication for PCI including angina (stable or 
unstable), silent ischemia (in absence of symptoms a visually 
estimated target lesion diameter stenosis of ≥70%, a positive 
non-invasive stress test, or FFR ≤0.80 must be present), 
NSTEMI, or recent subacute STEMI. For subacute STEMI the 
time of presentation to the first treating hospital, whether a 
transfer facility or the study hospital, must be >72 hours prior 
to enrollment and enzyme levels (CK-MB or Troponin) 
demonstrating that either or both enzyme levels have peaked. 
3. Non-target vessel PCI are allowed prior to enrollment 
depending on the time interval and conditions as follows: 
a. During Baseline Procedure:  
i. PCI of non-target vessels performed during the 
baseline procedure itself immediately prior to 
enrollment if successful and uncomplicated  defined as: 
<50% visually estimated residual diameter stenosis, 
TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no 
perforation, no persistent ST segment changes, no 
prolonged chest pain, no TIMI major or BARC type 3 
bleeding. 
b. Less than 24 hours prior to Baseline Procedure: 
i. Not allowed (see exclusion criteria #2). 
c. 24 hours-30 days prior to Baseline Procedure:  
i. PCI of non-target vessels 24 hours to 30 days prior to 
enrollment if successful and uncomplicated as defined 
above.  
ii. In addition, in cases where non-target vessel PCI has 
occurred 24-72 hours prior to the baseline procedure, at 
least 2 sets of cardiac biomarkers must be drawn at 
least 6 and 12 hours after the non-target vessel PCI.  
iii. If cardiac biomarkers are initially elevated above the 
local laboratory upper limit of normal, serial 
measurements must demonstrate that the biomarkers 
are falling. 

 
 
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d. Over 30 days prior to Baseline Procedure:  
i. PCI of non-target vessels performed greater than 30 
days prior to procedure whether or not successful and 
uncomplicated. 
4. Patient is willing and able to provide informed written consent 
and comply with follow-up visits and testing schedule. 
Angiographic inclusion criteria (visual estimate): 
5. Target lesion(s) must be located in a native coronary artery 
with visually estimated diameter of ≥2.5 mm to ≤4.25 mm. 
6. Complex lesions are allowed including calcified lesions (lesion 
preparation with scoring/cutting and rotational atherectomy 
(e.g.: Rotablator System) and Directional Coronary 
Atherectomy - DCA) are allowed), presence of thrombus that is 
non-occlusive and does not require thrombectomy, CTO, 
bifurcationlesions (except planned dual stent implantation), 
ostial RCA lesions, tortuous lesions, bare metal stent restenotic 
lesions, protected left main lesions. 
7. Overlapping stents are allowed with the investigational device 
(MedJ-01). 
Exclusion Criteria 
General Exclusion Criteria: 
1. STEMI within 72 hours (subacute) of initial time of 
presentation to the first treating hospital, whether at a transfer 
facility or the study hospital or in whom enzyme levels (either 
CK-MB or Troponin) have not peaked. 
2. PCI within the 24 hours preceding the baseline procedure. 
3. Non-target lesion PCI in the target vessel within 12 months of 
the baseline procedure. 
4. History of stent thrombosis. 
5. Cardiogenic shock (defined as persistent hypotension (systolic 
blood pressure <90 mm/Hg for more than 30 minutes) or 
requiring pressors or hemodynamic support, including IABP. 
6. Subject is intubated. 
7. Known LVEF <30%. 
8. Relative or absolute contraindication to DAPT for 12 months 
(including planned surgeries that cannot be delayed) 
9. Subject has an  indication for chronic oral anticoagulant 
treatment (with either vitamin K antagonists or novel 
anticoagulants – NOACs) 
10. Calculated creatinine clearance <30 mL/min using Cockcroft-
Gault equation. 
11. Hemoglobin <10 g/dL. 

 
 
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12. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3. 
13. White blood cell (WBC) count <3,000 cells/mm3. 
14. Clinically significant liver disease. 
15. Active peptic ulcer or active bleeding from any site. 
16. Bleeding from any site within the prior 8 weeks requiring active 
medical or surgical attention. 
17. If femoral access is planned, significant peripheral arterial 
disease which precludes safe insertion of a 6F sheath. 
18. History of bleeding diathesis or coagulopathy or will refuse 
blood transfusions. 
19. Cerebrovascular accident or transient ischemic attack within the 
past 6 months, or any permanent neurologic defect attributed to 
CVA. 
20. Known allergy to the study stent components e.g. cobalt, nickel, 
chromium, Carbosil®, PBMA, or limus drugs (ridaforolimus, 
zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs 
or any other analogue or derivative or similar compounds). 
21. Known allergy to protocol-required concomitant medications 
such as aspirin, or DAPT (Drugs that inhibit P2Y12 such as 
clopidogrel and prasugrel), or heparin, or iodinated contrast that 
cannot be adequately pre-medicated. 
22. Any co-morbid condition that may cause non-compliance with 
the protocol (e.g. dementia, substance abuse, etc.) or reduced 
life expectancy to <24 months (e.g. cancer, severe heart failure, 
severe lung disease).  
23. Patient is participating in any other investigational drug or 
device clinical trial that has not reached its primary endpoint, or 
plans to participate in any clinical trial. 
24. Women who are pregnant or breastfeeding (women of child-
bearing potential, defined as females of childbearing potential if 
they have not undergone a permanent contraceptive operation 
or they are not postmenopausal, must have a negative 
pregnancy test within one week before treatment. Permanent 
contraceptive operation is defined as: hysterectomy, 
hysterosalpingectomy, or bilateral oophorectomy. The status of 
a female should be considered as postmenopausal when she has 
not had a period for 12 consecutive months without an 
alternative medical cause). 
25. Women who intend to become pregnant within 12 months after 
the baseline procedure (women of child-bearing potential who 
are sexually active must agree to use a reliable method of 
contraception from the time of screening through 12 months 
after the baseline procedure). 

 
 
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26. Patient has received an organ transplant or is on a waiting list 
for an organ transplant. 
27. Patient is receiving or scheduled to receive chemotherapy 
within 30 days before or any time after the baseline procedure. 
28. Patient is receiving oral or intravenous immunosuppressive 
therapy or has known life-limiting immunosuppressive or 
autoimmune disease (e.g., HIV). Corticosteroids are allowed. 
Angiographic Exclusion Criteria (visual estimate): 
29. Target lesions in more than two (2) major coronary arteries 
(i.e., two of LAD, LCX, RCA) and their respective branches 
(the Ramus Intermedius is defined as a branch of the LCX). 
30. More than two target lesions per target vessel are planned (two 
lesions separated by less than 10 mm that can be covered by a 
single stent are considered as one lesion). 
31. More than 100 mm length of planned study stenting in the 
entire coronary tree. 
32. Occlusive thrombus and/or a thrombus requiring thrombectomy 
in a target vessel. 
33. Unprotected left main lesions ≥30%, or planned unprotected 
left main intervention. 
34. Ostial LAD or LCX lesions (stenting of any diseased segment 
within 5 mm of the unprotected left main coronary artery). 
35. Bifurcation lesions with planned dual stent implantation. 
36. Stenting of lesions due to DES restenosis. 
37. Another lesion in a target or non-target vessel (including all 
side branches) is present that requires or has a high probability 
of requiring PCI within 12 months after the baseline procedure. 
38. Target lesion exists in bypass graft vessels. 
 
2 IDENTIFICATION AND DESCRIPTION OF THE 
INVESTIGATIONAL DEVICE 
2.1 
Summary Description of the Investigational Device and Its Intended 
Purpose 
2.1.1 
Summary Description of the Investigational Device 
The MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug 
combination product comprising of: 
 Stent - a mounted Cobalt Chromium (CoCr) alloy based stent 
 Delivery System - Rapid Exchange (RX) Coronary System 
 Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® 
 Ridaforolimus drug - CAS Registry Number: 572924-54-0 

 
 
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2.1.2 
Intended Purpose 
The MedJ-01 Ridaforolimus Eluting Coronary Stent System is indicated for improving coronary 
luminal diameter in patients with symptomatic heart disease due to lesions in vessels with 
reference diameters of 2.5 mm to 4.25 mm, including complex lesions. 
2.2 
Details Concerning the Manufacturer of the Investigational Device 
Medinol Ltd. 
Beck Tech Building 
Har Hotzvim B, Hartom Street 8 
PO Box 45026 
Jerusalem, 9777508, Israel 
2.3 
Traceability of the Investigational Device 
Each device will be traced using the lot number that is affixed to the label of the device. Both the 
Sponsor (or designee) and the investigational site will maintain a log of the devices that have 
been shipped, received, implanted in subjects, and returned if unused at the end of the trial. 
2.4 
Intended Purpose of the Investigational Device in the Proposed Clinical 
Investigation 
See Section  2.1.2 
2.5 
Populations and Indications for Which the Investigational Device Is 
Intended 
See Section  2.1.2 
2.6 
Description of the Investigational Device 
2.6.1 
Stent 
The MedJ-01 is comprised of the CoCr Coronary Stent coated with a polymer matrix and 
ridaforolimus drug, mounted on RX System.  
The bare metal substrate CoCr stent is a continuous “closed cell” design with adaptive cells 
capable of differential lengthening, thereby enabling the stent to be flexible in the unexpanded 
state and to support the vessel, while conforming to its curvature, in the expanded state.  
 
Figure 1: Closed cell design 

 
 
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The bare metal stent (implant) component of the MedJ-01 is equivalent to the stent of the CE 
Marked and PMA approved (P#110004 /S001) ‘NIRxcell CoCr Coronary Stent on Rx System’ 
and to the stent of the PMA approved (P#110004) and Health Canada licensed (HC 86087) 
Presillion Plus Coronary Stent System, (also known as the PIONIR™ bare metal stent). 
 
Figure 2: Stent of the MedJ-01 mounted on balloon 
 
Table 1: Available Stent Lengths and Nominal Diameters 
 
Stent Nominal Diameter (mm) 
Stent Length 
2.5 
2.75 
3.0 
3.5 
4.0 
8 mm 
X 
X 
X 
X 
X 
12 mm 
X 
X 
X 
X 
X 
17 mm 
X 
X 
X 
X 
X 
20 mm 
X 
X 
X 
X 
X 
24 mm 
X 
X 
X 
X 
X 
28 mm 
X 
X 
X 
X 
X 
33 mm 
X 
X 
X 
X 
X 
 
2.6.2 
Delivery System 
The delivery catheter for the MedJ-01 is a rapid exchange balloon catheter with a hydrophilic 
coating. The usable length of the delivery system is 140cm, with shaft profiles of 2.1F (0.69mm) / 
2.6F (0.86mm), proximal and distal, respectively and for products up to 28 mm length, and 2.8F 
(0.94 mm) for products of 33mm.The catheter has a distal port approximately 30cm from the distal 
tip that accesses the guide wire lumen. The guide wire lumen begins at the distal port and terminates 
at the distal tip. The catheter has two (2) markers on the proximal catheter shaft that indicate, 
approximately, the exit of the balloon catheter tip from the guiding catheter (brachial: 93cm; femoral: 
103cm). The MedJ-01 delivery system design has a tapered tip to facilitate system deliverability and 
requires a 0.014" (0.36mm) diameter guide wire for navigation. 
 
Figure 3: Stent Delivery System  

 
 
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2.6.3 
Polymer Coating 
The stent is coated with a polymer blend coating consisting of poly n-butyl methacrylate 
(PBMA) and CarboSil® 20 55D polymer. 
2.6.4 
Ridaforolimus 
Ridaforolimus (CAS Registry Number: 572924-54-0; formerly deforolimus) is a member of the 
limus family of drugs. It is a unique, non-prodrug analog of rapamycin (sirolimus), a 
macrocyclic lactone produced by Streptomyces hygroscopicus. Ridaforolimus is manufactured 
by CARBOGEN AMCIS AG (Hauptstrasse 171, CH-4416 Bubendorf, Switzerland; FDA 
Registration Number: 3000998501). It is utilized on the stent system at a dose of 1.1 µg/mm2 
(with a drug load of 100 µg per 2.75/3.00 x 17 mm stent). 
The drug ridaforolimus, like rapamycin, is expected to permeate the cell membrane, bind to 
cytosolic FKBP12 and then to mTOR, a P13K-related protein kinase. Treatment of cultured 
tumor cell lines with Rapamycin in vitro has been shown to slow the rate of tumor proliferation. 
These effects are attributable to the inhibition of the multiple downstream effects of mTOR’s 
activity: synthesis of components required for macromolecular synthesis (such as ribosomes), 
cell size increase, and progression through the G1 phase of the cell cycle. In the in vitro studies, 
Ridaforolimus demonstrated anti-proliferative activity on a broad range of human tumor cell 
lines. The molecular structure of ridaforolimus is shown in Figure 4. 
 
Figure 4: Molecular Structure of Ridaforolimus 
Further detailed information on ridaforolimus can be found in the Investigator’s Brochure (IB)   
# 900186023. 
2.7 
Summary of Necessary Training and Experience Needed to Use the 
Investigational Device 
The MedJ-01 Ridaforolimus Eluting Coronary Stent System is similar to existing stent systems 
currently on the market so there will not be any additional training required for experienced 
interventionalists to implant the stents. Investigator training is described in Section  6.5.4.1. 

 
 
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2.8 
Description of the Specific Medical or Surgical Procedures 
Subjects in this trial will undergo coronary angiography and percutaneous coronary intervention 
(PCI) with stent implantation for narrowings (stenoses) in the coronary arteries using standard 
angiographic and stenting techniques. Both radial and femoral approaches are acceptable. 
Adherence to PCI guidelines issued by professional societies such as the ACCF/AHA/SCAI 
2011 Guideline for Percutaneous Intervention [1] is recommended. 
3 JUSTIFICATION FOR THE DESIGN OF THE CLINICAL 
INVESTIGATION 
3.1 
Background 
Percutaneous Intervention (PCI) is part of the standard treatment for coronary artery stenoses and 
has been shown to relieve ischemia and angina in stable coronary disease and improve outcomes 
in acute coronary syndromes particularly in patients with ST elevation myocardial infarction 
(STEMI). Stents, originally developed in the 1980s, have almost entirely replaced balloon 
angioplasty with the advantage of greater procedural success with reduced risk of abrupt closure 
as well as reduced rates of restenosis.[2] Bare metal stents, however, were still limited by up to 
30% restenosis rate due to neointimal proliferation. The advent of drug eluting stents (DES) 
which released anti-proliferative medications into the stented region markedly reduced the 
restenosis rate, thereby reducing the rate of repeat revascularization. Concern emerged, however, 
over late and very late stent thrombosis with the use of DES.[3] Stent thrombosis has been linked 
to delayed and incomplete endothelialization as well as stent mal-apposition and strut breakage. 
Additional issues with DES include a local inflammatory reaction, allergic reactions to the stent 
components, and impairment of endothelial function.[4] 
Different DES have been shown to have differing rates of angiographic late loss as well as 
different rates of clinical events such as target lesion failure (TLF) and stent thrombosis.[5] 
Different stent design, polymer features, and anti-proliferative drug used may impact these 
important clinical endpoints. The overall low event rate, however, has necessitated large scale 
clinical trials to evaluate new stents. Registration studies have also been limited by strict 
enrollment criteria which have excluded many patient and lesion types which are typically 
treated in clinical practice including complex lesions and patients with acute coronary 
syndromes.  
The MedJ-01 is a new DES which uses a closed-cell design and an improved delivery system 
and therefore may improve outcomes compared to other drug eluting stents. The present trial is 
aimed at assessing the safety and efficacy of the MedJ-01. 
The trial will enroll a broad population including patients with ACS (unstable angina, NSTEMI, 
and subacute STEMI) as well as complex lesions. The inclusion of patients with AMI and 
particularly subacute STEMI is justified given that the majority of PCIs are in patients with ACS 
with STEMI accounting for up to 30% of ACS cases. In order to reduce the potential for 

 
 
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confounding, patients with STEMI will be enrolled only after 72 hours (subacute) have elapsed 
from their initial hospital presentation. Typically such patients will have already undergone 
primary PCI of the culprit lesion. Stent thrombosis is increased in the setting of primary PCI 
mostly in the first 24 hours.[6] Therefore, confounding is unlikely and furthermore subjects will 
be stratified in the trial by ACS vs. non-ACS status. 
3.2 
Evaluation of the Results of the Relevant Pre-Clinical Testing 
A broad range of bench testing, stability, and shelf life studies as well as pre-clinical testing 
including biocompatibility, animal pharmacokinetic, and safety studies (single and overlapping 
configuration) in swine coronary arteries have been completed without any pertinent findings.  
The methods and results of the bench testing and the pre-clinical testing are contained in the IB 
which clearly demonstrates the justification for use of the investigational device in this trial. 
3.3 
Evaluation of Clinical Data Relevant to the Proposed Clinical 
Investigation 
Overall, clinical data for more than 900 patients are available to date for the use of the 
PIONIR™ stent (as part of the Presillion plus CoCr Coronary Stent on RX System device). See 
Error! Reference source not found.2 for a list of the clinical studies conducted, followed by a 
brief description of each study. These data have been presented to FDA in the PMA #P110004 
submission and its annual update reports. There has been no previous clinical experience 
specifically with the MedJ-01. 
Table 2: List of Previous Clinical Experience 
Study 
Number of Subjects 
Countries 
The PIONIR Study 
278 
Germany, Sweden, Belgium, Israel 
The BLAST Study 
57 (placebo group) 
Israel 
The Iberian Study 
318 
Spain, Portugal 
The Belgium Study 
101 
Belgium, Luxembourg 
The Vila Real Study 
20 
Portugal 
The PREHAMI Registry 
129 
Italy 
3.3.1 
The PIONIR Study 
This was the pivotal study conducted to demonstrate the safety and effectiveness of Presillion 
plus CoCr Coronary Stent on RX System (Presillion plus Stent System) in the treatment of 
de novo stenotic lesions in native coronary arteries. It was a post market study (for the EU, using 
an approved FDA protocol also supporting PMA submission) non-randomized, multi-center, 
prospective, single arm clinical study. Two hundred and seventy-eight (278) patients were 
enrolled to this study. Follow-up was performed at: discharge, 30 days, 180 days, 270 days, and 
1 year. 
The primary endpoint of the study was the incidence of target vessel failure (TVF) which was 
defined as the composite of cardiac death, target vessel myocardial infarction (Q-wave or 

 
 
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non Q-wave), or clinically-driven target vessel revascularization (TVR) by percutaneous or 
surgical methods, within 270 days of treatment with Presillion or Presillion plus Stent Systems.  
Study results: The 270-day TVF rate was 8.9% and the upper bound of the exact one-sided 95% 
confidence interval was 12.3%. Since this upper bound is less than 16.46% (a performance goal 
derived using a meta-analysis of the standard-of-care therapy for coronary stenting with bare 
metal stents), the study stent is considered to have met the performance goal. Lesion success was 
achieved in 100.0% (280/280) of cases. Device success was achieved in 98.2% (275/280) of 
cases. Procedural success was achieved in 97.8% (272/278) of cases.  
Conclusions: The 9-month results of the PIONIR study demonstrate Presillion Stent System and 
Presillion Plus Stent System to be safe and effective in the treatment of de novo stenotic lesions 
in native coronary arteries when compared to a performance goal derived using a meta-analysis 
of the standard-of-care therapy for coronary stenting with bare metal stents.[7] 
3.3.2 
The BLAST Study 
The BLAST Study was a phase II, dose-finding, randomized, multi-center, prospective, double 
blind clinical study of Presillion Stent System in combination with Liposomal Alendronate, 
compared to Presillion Stent System alone.  
The investigational product in this study was Liposomal Alendronate, a drug which was 
administered in a single dose, intravenously (IV) through a peripheral venous catheter. The study 
objective was to assess the safety and efficacy of the study drug in the treatment of de novo 
stenotic lesions in native coronary arteries in a population undergoing PCI, with implantation of 
a bare metal stent (Presillion stent).  
The information relevant to the investigator’s brochure focuses only on data from the placebo 
arm (57 out of 226 patients enrolled). Follow-up in this study includes: clinical follow-up at 
30 days, clinical and angiographic (stent) follow-up at baseline and 6 months, including QCA, 
IVUS at baseline and 6 months for pre-specified patients, and yearly contact through 5 years.  
The primary efficacy endpoint is the 6-month in-stent late lumen loss, as measured by QCA. 
Six-month results: The mean (±SD) of in-stent late lumen loss for the 57 per-protocol (PP) 
placebo arm patients was 0.86mm (± 0.60 mm). 
Conclusions: Despite the limited sample size, the outcomes of the placebo cohort (57 patients) 
analysis at 6 months post-procedure were presented to FDA in PMA #P110004. The Quantitative 
Angiographic Analysis provides complementary and supporting information on the safety and 
efficacy of the Presillion stent. 
Medinol has continued to collect safety information on this study, per protocol. The study has 
been completed on Jan. 2015. None of the SAEs reported were adjudicated as related to the study 
drug or device. 

 
 
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3.3.3 
The Iberian Study 
The Iberian Study was a multi-center, post-market surveillance registry evaluating the 
performance and long term safety of the Presillion™ stent in de novo native coronary artery 
lesions, in routine clinical practice. It was completed on 18 Apr 2011, with 318 patients enrolled. 
Follow-up was performed at 30 days and 1 year post implantation. The registry objective was to 
assess the incidence of Major Adverse Cardiac Events defined as a composite of cardiac death, 
myocardial infarction (Q-wave and non Q-wave) and clinically-driven target lesion 
revascularization at the 12-month follow-up period. It was limited to subjects who had received 
Presillion Stent System. While no inclusion or exclusion criteria were specified, uniform, 
complete and accurate data was collected peri-procedurally, during the baseline hospitalization, 
and during follow-up. All subjects were treated according to the Instruction for Use (IFU), 
including conduct of the stenting procedure.  
Study results: For the primary endpoint, a total of 9 subjects (2.9%) presented with MACE up to 
the 12-month FU, a figure significantly lower than the performance goal of 15% (p<0.001). For 
the secondary endpoint, device success was attained in 350 of the 354 lesions treated (98.9%); 
lesion success was present in 349 lesions (98.6%); and procedural success was reached for 
344 lesions (97.2%). 
Conclusions: The MACE rate at the 12 month follow-up (2.9%) was considerably lower than the 
performance goal (15.0%, p<0.001). Together with the good results for the secondary endpoints, 
this indicates adequate safety and performance of the Presillion stent. The possibility of 
underreporting of adverse events in this study cannot be ruled out. 
3.3.4 
The Belgian Study 
The Belgian Study was a non-randomized single arm registry, evaluating the safety of Presillion 
Stent System in the treatment of de novo stenotic lesions in native coronary arteries. This registry 
was initiated as a 30-day follow-up after the procedure. At a later stage, the follow-up period was 
prolonged to include an additional data point (as close as possible to, but after, the 6-month post-
procedure date). One hundred and one (101) patients were enrolled to the study. 
The primary safety measure is a composite of MACE defined as the composite of cardiac death, 
myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion 
revascularization at 30 days and 6 months post procedure. 
Study results: The MACE rate at the 30-day follow-up was 0. 
Conclusions: Clinical endpoints at 30 days and beyond, up to 6-12 months, demonstrated the 
safety and efficacy of the Presillion stent for the treatment of de novo coronary artery stenosis. 
Presillion Stent System proved to be safe in this cohort of 101 patients studied in Belgium and 
Luxembourg. 

 
 
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3.3.5 
The Vila Real Study 
The Vila Real Study was a prospective study of the first 20 patients undergoing implantation of 
at least one Presillion™ stent in Vila Real, Portugal. After discharge, patients were followed and 
assessed clinically at 3 and 6 months for the occurrence of MACE defined as cardiovascular 
death, myocardial infarction, stroke, or revascularization. 
Study results: The percentage of stenosis before and after angioplasty was 88.5+9.7% and 
10.6+4.3%, respectively. The minimal luminal diameter (MLD) before and after angioplasty was 
0.65+0.40 mm and MLD=2.58+0.36 mm, respectively. The success rate for Presillion 
implantation was 100%, with no significant drop in hemoglobin, no additional elevation of 
cardiac biomarkers or deterioration in renal function after the procedure. No MACE occurred 
before hospital discharge.  
Conclusions: The success rate for Presillion stent implantation was 100%, despite 73% of the 
lesions being classified as B2 or C and 27% presenting moderate or severe calcification, which 
confirmed the excellent profile and deliverability of these stents. Evidence of the good 
performance of the stents was also seen during hospitalization, with no occurrence of MACE or 
elevation of markers of myocardial necrosis compared to pre-PCI values. This initial experience 
with Presillion stents in consecutive patients referred for BMS implantation showed a high 
efficacy rate at six months and an excellent safety profile, despite dual antiplatelet therapy being 
maintained for only two months. 
3.3.6 
The PREHAMI Registry 
The prospective single-center PREHAMI (Presillion™ in High-risk Acute MI) Registry 
evaluated the in-hospital and 1-year outcomes of patients with high-risk acute myocardial 
infarction who underwent PCI with the bare-metal Presillion stent. One hundred and twenty-nine 
(129) patients were enrolled in the registry. The primary outcome of the registry was the 
occurrence of major adverse coronary events (MACE) defined as the composite of all-cause 
death, non-fatal acute myocardial re-infarction and target-vessel revascularization during initial 
hospitalization and at the 1-year follow-up. Stent thrombosis accounted in the MACE rate 
according to the clinical consequences of the thrombosis. 
Study results: The device success rate was 98.8% (there were only 2 cases in which the lesion 
could not be reached due to severe coronary tortuosity). The hierarchical MACE rates were 
7 (5.4%) during hospitalization, 17 (13.3%) at 6 months, and 22 (17.3%) at 1 year. 
Conclusions: The use of the Presillion stents in patients with high-risk acute MI treated 
invasively appeared to be safe and efficacious with optimal deliverability and good long-term 
outcomes. The in-hospital and long-term event rates were limited, with similar outcomes to those 
of previous real world registries enrolling unselected patients (both low and high risk) with 
STEMI and NSTEMI. 

 
 
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3.3.7 
The BIONICS and NIREUS Trials 
The BIONICS and NIREUS clinical studies assessing the BioNIR (the same stent system as 
MedJ-01) were initiated in March 2014 and aim to assess the safety and efficacy of the BioNIR 
in comparison to a second generation DES, the Resolute Zotarolimus-Eluting Coronary Stent 
System (Medtronic). 
BIONICS is a prospective, multi-center, single-blind, two-arm, 1:1 randomized clinical trial 
with a planned enrollment of approximately 1906 patients. The primary clinical endpoint is 
target lesion failure (TLF) at one year, with an additional angiographic endpoint of in-stent late 
lumen loss evaluated in approximately 200 patients at 13 months.  Among the patients of this 
subset, at least 100 are also planned for intravascular ultrasound (IVUS) at baseline and 13 
month follow up. The trial is conducted in the USA, Canada, Europe and Israel. 1919 patients 
have been enrolled to the BIONICS trial. Enrollment was completed on August 28, 2015. 
NIREUS is a prospective, multi-center, single-blind, two-arm, 2:1 randomized clinical trial  
(2 BioNIR : 1 Resolute) encompassing approximately 300 patients with a wide spectrum of 
Percutaneous coronary intervention (PCI) indications (stable angina as well as Acute coronary 
syndrome [ACS], including subacute ST segment elevation myocardial infarction [STEMI]).  
The primary endpoint is angiographic in-stent late loss at 6 months. Secondary clinical endpoints 
include target lesion failure (TLF) at 30 days, 6 months, 1 year and yearly thereafter until year 5. 
The trial is conducted in Europe and Israel. 302 patients have been enrolled to the NIREUS trial. 
Enrollment was completed on March, 24, 2015. 
Both studies are supervised by an independent Data Safety Monitoring Board (DSMB). The 
DSMB has convened 4 times since trials initiation to review the safety data of both studies 
and did not find any concerns. The DSMB voted to continue the trials without any changes. 
4 RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND 
CLINICAL INVESTIGATION 
The risks and benefits of the MedJ-01 are summarized in the Investigator’s Brochure. 
4.1 
Anticipated Clinical Benefits  
The study stent is expected to provide the same radial support as other coronary stents which 
maximize the lumen size of a stenosed artery as is commonly indicated for coronary stenting.  
Additionally, the potential benefit of the study stent is its effectiveness in inhibition of 
neointimal growth while enhancing endothelial coverage. The study stent has the potential to 
reduce rates of restenosis without increasing rates of late and very late stent thrombosis 
compared to other commercially available DES.  
4.2 
Anticipated Adverse Device Effects 
It is expected that the adverse device effects for MedJ-01 would not differ from the anticipated 
adverse device effects based on years of clinical experience with rapid exchange DES 
implantations. Please refer to the IB for details. 

 
 
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4.3 
Residual Risks Associated with Investigational Device 
Foreseeable adverse events and device deficiencies that may result from stent intervention can be 
found in Section 14.6 and 14.7 as well as in the IB. 
4.4 
Risks Associated with Participation in the Clinical Investigation 
There is extensive clinical and commercial experience worldwide with cardiac catheterization 
and interventional procedures and it is expected that the surgical and procedural risks will not be 
significantly different in this clinical trial. 
4.5 
Possible Interactions with Concomitant Medical Treatments 
While formal drug interaction studies were not conducted with MedJ-01 due to expected 
negligible systemic exposure, since Ridaforolimus is a rapamycin analog, the possible 
interactions for rapamycin analogs (e.g. zotarolimus, everolimus, biolimus, tacrolimus) may 
apply to MedJ-01 as well. 
4.6 
Steps to Control or Mitigate Risks 
Subjects with no aspirin resistance, allergy, or bleeding risk will continue on aspirin indefinitely 
and either clopidogrel (75 mg/day), or prasugrel (2.5-3.75 mg/day) for a minimum of 12 months 
following stent implantation according to national guidelines and standard of care unless an 
intervening medical necessity occurs such as severe bleeding, in accordance with the PCI 
recommendations from ACCF/AHA/SCAI [1] and the elective PCI guidelines from JCS [8]. If 
DAPT is discontinued before 12 months due to medical necessity (for example, severe bleeding) 
the reason should be documented.  
The investigational plan is specifically designed to manage and minimize risks through careful 
subject selection, thorough training of investigators, adherence to the pre-determined time points 
to assess subject clinical status and regular clinical monitoring visits by Sponsor appointed 
monitoring personnel.  
In addition, an independent Data Safety Monitoring Board (DSMB) will monitor safety of the 
subjects throughout the trial. 
4.7 
Risk-to-Benefit Rationale 
The MedJ-01 represents a potential advance in both stent and delivery system design and is 
expected to be noninferior to second generation DES such as the Resolute, Xience and Promus 
stents. Subjects enrolled in this trial have an indication for PCI due to significant coronary 
stenosis. The majority of risk associated with the trial is inherent to standard of care PCI and is 
not likely to be increased by participation in this trial. While there may be unknown risks 
associated with the novel MedJ-01 stent these are mitigated by the use of an approved stent 
platform and delivery system with a polymer coating (Carbosil) which is biocompatible and 
thrombo-resistant. Ridaforolimus is part of the rapamycin analog family of drugs for which there 

 
 
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is extensive experience on DES. Therefore the risk of the JNIR Trial is expected to be similar to 
other DES trials. The risk to benefit relationship is therefore similar to other DES studies and 
reasonable. 
5 OBJECTIVES AND HYPOTHESES OF THE CLINICAL 
INVESTIGATION 
5.1 
Objectives 
Evaluating MedJ-01 safety and efficacy for de novo or restenosis lesion with  target  vessel diameter of 
2.5 mm to 4.25 mm,  for subjects undergoing coronary artery stent implantation. 
5.2 
Hypotheses to Be Accepted or Rejected by Statistical Data 
JNIR01 is aimed at assessing TLF at one year with the MedJ-01 stent in a Japanese patient 
population to show non-inferiority of JNIR01 Target Lesion Failure at 12 months (TLF12) to the 
BIONICS TLF12. 
5.3 
Claims and Intended Performance of the Investigational Device 
The MedJ-01 Ridaforolimus Eluting Coronary Stent System is indicated for improving coronary 
luminal diameter in patients with heart disease including angina (stable or unstable), silent 
ischemia, NSTEMI, or recent subacute STEMI  due to lesions in vessels with reference 
diameters of 2.50 mm to 4.25 mm including complex lesions. 
5.4 
Risks and Anticipated Adverse Device Effects That Are to Be Assessed 
The risks and anticipated adverse device effects (ADE) are summarized in Section 14.6 as well 
as the IB. All ADEs will be assessed by collection of adverse events which will be determined by 
the investigator as either being related to the device or not. 
6 DESIGN OF THE CLINICAL INVESTIGATION 
6.1 
General 
6.1.1 
Description of Trial 
The JNIR Trial will enroll approximately 100 subjects with a wide spectrum of PCI indications 
(stable angina as well as ACS, including subacute STEMI (>72 hours since first hospital 
presentation).  
This is a prospective, multi-center, single-arm, open label clinical trial. Lesions planned to be 
treated must be declared and recorded at time of enrollment.  
6.1.2 
Rationale for Trial 
Drug eluting stents have significantly lowered the restenosis rate following PCI. Because of 
delayed re-endothelization, however, prolonged (current recommendations are for 12 months) 
dual anti-platelet therapy (DAPT) is indicated, but has not completely eliminated stent 
thrombosis, a serious complication with potential mortality. Rates for stent thrombosis with 

 
 
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second generation DES have been in the range of 1-3% at one year after stent implantation. 
Rates for restenosis as well as ST vary between stents and depend on a myriad of factors 
including stent design (for example, open- vs. closed-cell), strut thickness, stent material, 
flexibility of the stent, and degree of mal-apposition. It is therefore important to evaluate new 
stents. 
The present trial is therefore aimed at assessing TLF at one year with the MedJ-01 stent in a 
Japanese patient population to show non-inferiority of JNIR01 Target Lesion Failure at 12 
months (TLF12) to the BIONICS TLF12.  
The rationale for selection of TLF as the primary endpoint is based on recent US trials of best in 
class DES (Xience V, Promus Element and Resolute) including SPIRIT III, SPIRIT IV, 
PLATINUM, RESOLUTE US, RESOLUTE ALL-COMERS, TWENTE, COMPARE, and 
COMPARE II. 
6.1.3 
Primary and Secondary Endpoints 
6.1.3.1 
Primary Endpoint 
The primary endpoint is Target Lesion Failure (TLF) at 12 months defined as the composite of 
cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion 
revascularization (TLR). 
Definitions of terms and endpoints are located in Section  21.1. Acronyms and abbreviations are 
defined in Section Error! Reference source not found.. 
6.1.3.2 
Clinical Secondary Endpoints 
The secondary endpoints are to be evaluated at 30 days, 6 months, and 1, 2, 3, 4, and 5 years 
except as noted:  
 Device, Lesion, and Procedure Success at time of baseline procedure 
 TLF at 30 days, 6 months, and 2, 3, 4, and 5 years defined as the composite of cardiac 
death, target vessel-related MI, or ischemia-driven TLR. 
 Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or 
ischemia-driven TLR)  
 Target vessel failure (TVF; the composite rate of death, target vessel related MI or 
ischemia-driven TVR)  
 All-cause mortality  
 Cardiac death  
 Myocardial infarction  
 Target vessel related MI  
 Ischemia-driven TLR  
 Ischemia-driven TVR  
 Stent thrombosis (ARC definite and probable) 

 
 
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6.1.4 
Methods and Timing for Assessing, Recording, and Analyzing Variables 
Data collection commences after the subject has provided informed consent. Data collection 
including subject demographic information, laboratory tests, and procedural data as well as 
follow-up visits or telephone contacts will be conducted by an Investigator or site coordinator 
who has been trained on the CIP and Case Report Forms (CRF).  
Data required for analysis will be obtained as outlined in Table 3.  
After discharge from the hospital, each subject will be followed with in-clinic or phone follow-
up visits at 30 days, 6 months, and 1, 2, 3, 4, and 5 years. The 1-year follow-up will be 
conducted in-clinic unless the patient refuses to or cannot come to clinic.  
 
Table 3: Schedule of Data Collection 
TYPE OF DATA TO BE 
COLLECTED 
Screening 
(within 7 days1) 
Pre-Procedure 
(within 24 hours) 
Baseline Procedure 
Post-Procedure  
30 days ( 7 days) 
6 Months  
( 30 days)  
1 year (-30 days / 
+14 days)2 
2 years ( 60 days) 
3 year ( 60 days) 
4 year ( 60 days) 
5 year ( 60 days) 
Unscheduled visits 
Patient Informed Consent 
 
 
 
 
 
 
 
 
 
 
 
 
Patient Medical/Clinical History 
 
 
 
 
 
 
 
 
 
 
 
 
Angina Status 
 
 
 
 
 
 
 

 
 
 
 
General Eligibility Criteria 
 
 
 
 
 
 
 
 
 
 
 
 
Angiographic Eligibility Criteria 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Laboratory Tests: 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test (childbearing 
potential women only) 
 
 
 
 
 
 
 
 
 
 
 
 
CBC, Creatinine, BUN 
 
 
 
 
 
 
 
 
 
 
 
 
Lipid profile3 
 
 
 
 
 
 
 
 
 
 
 
 
CK, CK-MB or Troponin   
 
4 
 
5 
 
 
 
 
 
 
 
6 
12-Lead ECG 
 
 
 
 
 
 
2
 
 
 
 
6 
Coronary Angiogram & PCI 
 
 
 
 
 
 
 
 
 
 
 
 
Enrollment  and Study Stent 
Information 
 
 
 
 
 
 
 
 
 
 
 
 
Per Protocol DAPT Medications7 
 
 
 
 
 
 
 
 
 
 
 
 
DAPT Medications 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant Cardiac 
Medications 8 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse Events Monitoring 
 
9 
 
 
 
 
 
 
 
 
 
 
1. Subjects who undergo angiography following screening within 7 days but cannot proceed directly to enrollment (ie, undergo 
target PCI) can be enrolled within 30 days of the initial screening without reconsenting the patient and repeating screening 
procedures unless clinically indicated. 24 hr preprocedure angina status, cardiac enzymes, and ECG need to be repeated. In 
cases where target PCI is performed within 24-72 hrs. from non-target PCI, serial enzymes need to be obtained as detailed in 
inclusion criteria 3c. 
2. In-clinic visit at 1-year follow-up and ECG may be waived if subject refuses to return to clinic or is unable to return. A 
telephone visit should then be conducted in lieu of a clinic visit. 
3. Lipid profile is strongly recommended. 

 
 
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4. Within 24 hours pre-procedure. For subjects with ACS, enzyme levels need to be within 8 hours of the procedure or have 
already been shown to be decreasing. For subacute STEMI patients enzyme levels must have peaked for either CK-MB or 
Troponin (I or T) or both. High sensitivity troponin assays (hsTrop) are acceptable if non-hsTrop and CK-MB are not 
available at the local hospital. 
5. If Troponin is elevated or CK-MB is elevated  upper limit of normal, serial measurements  of CK and CK-MB (preferred) or 
Troponin (I or T) must be done until a decline is noted  
6. CK and CK-MB or Troponin (I or T) and ECG should be obtained for all suspected ischemic events. CK-MB is preferred but 
at sites where CK-MB is not available Troponin I or T may be used. 
7. Clopidogrel 75 mg daily or prasugrel 2.5 to 3.75 mg daily must be given for a minimum of 12 months according to national 
guidelines and standard of care as well as aspirin 81 to 100 mg daily to be taken indefinitely. 
8. Concomitant cardiac medications will be recorded by categories (e.g., statin, non-statin lipid lowering, ACE inhibitors, ARBs, 
beta-blockers, calcium channel blockers, other anti-anginals). 
9. Adverse events that occur after informed consent has been obtained will be recorded. 
6.1.4.1 
Screening and Pre-Procedure 
Subject preparation will occur in accordance with standard hospital policy for the care of 
interventional cardiology patients. Once screening has determined that a patient meets the 
general inclusion and exclusion criteria, written informed consent will be obtained according to 
Section  13. 
Subject information will include the following. Refer to Section  21.1 for definitions. 
 Demographics (e.g., age, gender, height, weight)  
 Risk factors (dyslipidemia, hypertension, family history of premature coronary disease, 
tobacco use, alcohol use and diabetes)  
 Cardiac history (previous MI, intervention history, and past angina status according to 
CCS and Braunwald classifications) 
 Current angina status 
 General eligibility criteria 
 Per-protocol DAPT medications 
 Concomitant cardiac medication by category 
 Adverse events that occur after informed consent has been obtained 
 Assurance that informed consent has been obtained correctly  
Subjects who undergo angiography following screening within 7 days but cannot proceed 
directly to enrollment (i.e., undergo target PCI) can be enrolled within 30 days of the initial 
screening without reconsenting the patient and per the following: 
 Repeating screening procedures is not required, unless clinically indicated.  
 24 hr. pre-procedure angina status, cardiac enzymes, and ECG need to be repeated.  
 In cases where target PCI is performed within 24-72 hrs. of non-target PCI, serial 
enzymes need to be obtained as detailed in inclusion criteria 3c. 
6.1.4.2 
Pre-Procedure Laboratory Assessments 
The following laboratory assessments are to be performed or must be available (having been 
done as part of routine clinical care) prior to the baseline procedure. 

 
 
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Required within 7 days prior to procedure: 
 Complete Blood Cell Count (CBC): RBC, WBC, hemoglobin, hematocrit, platelet 
 Creatinine, BUN  
Calculated creatinine clearance <30 mL/min using Cockcroft-Gault equation: 
o Male: Ccr = {(140 – age) x weight (kg)}/{72 x serum creatinine level (mg/dL)} 
o Female: Ccr = 0.85 x {(140 – age) x weight (kg)}/{72 x serum creatinine level (mg/dL)}  
 Pregnancy test (if applicable) 
If following angiography non-target PCI is performed but the subject cannot proceed 
directly to enrollment (ie, perform target PCI) the subject may be enrolled within 30 days 
of the initial screening without repeating the above tests. 
Strongly recommended within 7 days prior to procedure: 
 Lipid profile (total cholesterol, LDL, HDL, triglycerides) 
If following angiography non-target PCI is performed but the subject cannot proceed 
directly to enrollment (i.e., perform target PCI) the subject may be enrolled within 30 
days of the initial screening without repeating the above tests. 
Required within 24 hours pre-procedure: 
 Electrocardiogram (ECG) (See the trial’s Site Binder for ECG Core Lab Guidelines) 
 Current angina status 
 Creatine kinase (CK) and creatine kinase muscle-brain isoenzyme (CK-MB) (For 
subjects with ACS, enzyme levels need to be within 8 hours of the procedure or have 
already been shown to be decreasing.) 
 Troponin (T or I) where CK-MB is not available 
 If following angiography non-target PCI is performed but the subject cannot proceed 
directly to enrollment (i.e., perform target PCI) the subject may be enrolled within 30 
days of the initial screening BUT THE ABOVE WITHIN 24 HR PROCEDURES MUST 
BE REPEATED WITHIN 24 HRS. OF ENROLLMENT. 
6.1.4.3 
Baseline Procedure 
 Angiographic eligibility criteria 
 Enrollment and study stent information 
 Target lesion location 
 Non-target vessel treatment, if applicable 
 Anticoagulation administration 
 Procedural complications 

 
 
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 Per-protocol DAPT medications 
 Adverse events 
6.1.4.4 
Post-Procedure and Discharge 
 12 lead ECG  
 Angina status 
 All adverse events,  including related laboratory tests results and details of any 
subsequent repeat coronary angiography and results of such, if applicable 
 Per-protocol DAPT medications  
 Concomitant cardiac medication by category 
 CK and CK-MB or Troponin (I or T). Two post-PCI measures are recommended, but if 
early discharge is contemplated, at least one post procedure measurement 6-10 hours 
post-PCI is mandatory with the results known before discharge. The need for further 
cardiac biomarker measurement will be determined by the biomarker level as detailed in 
Table 4 below: 
Table 4: Patient Status as Indicated by Biomarker Levels post-PCI 
Biomarker Level  
Patient Status 
Action 
<ULN CK-MB 
or Troponin* 
<7X ULN  and 
Clinically stable 
The patient may be discharged without additional levels. 
1-3x ULN  CK-
MB or Troponin* 
7-20X  ULN  and 
Clinically stable 
The patient may be discharged but a second level is 
required at 12-18 hours. If the patient had an elevated 
troponin level immediately prior to study PCI and post-
PCI level is lower than the immediate pre-PCI level, a 
second level is not required. 
≥3x ULN CK-
MB or Troponin* 
>20 X ULN  
and/or  
Not clinically 
stable 
The patient may not be discharged until serial CK-MB or 
Troponin levels are decreasing  AND  the patient is 
stable. If the patient had an elevated troponin level 
immediately prior to study PCI and post-PCI level is 
lower than the immediate pre-PCI level, a second level is 
not required. 
*using conventional or hs-troponin assays with 99th percentile cutoff of 8.6 ng/L to 70 
ng/L 
6.1.4.5 
30 Days (± 7 days) and 6 Months (± 30 days) Follow-up (in clinic or telephone 
visit) 
 Angina status 
 All adverse events including related laboratory tests results, ECGs, details of any 
subsequent myocardial infarction, hospitalization, or repeat coronary angiography and 
results of such, if applicable 

 
 
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 Details of any subsequent coronary interventions (e.g., repeat PCI or CABG) 
 Compliance to protocol-required DAPT medications 
 Use and changes in chronic antiplatelet medication regimen. Data are collected for the 
duration of the trial 
 Concomitant cardiac medication by category 
6.1.4.6 
1 year (- 30 Days / + 14 Days) Follow-up (in-clinic) 
 Angina status 
 All adverse events including related laboratory tests results, ECGs, details of any 
subsequent myocardial infarction, hospitalization, or repeat coronary angiography and 
results of such, if applicable 
 Details of any subsequent coronary interventions (e.g., repeat PCI or CABG) 
 Compliance to protocol-required DAPT medications 
 Use and changes in chronic antiplatelet medications. Data are collected for the duration of 
the trial 
 Concomitant cardiac medication by category 
 12 Lead ECG 
Note: For subjects who refuse or cannot return to clinic for the 1 year visit, a telephone visit may 
be conducted in lieu of an in-clinic visit. 
6.1.4.7 
2, 3, 4, and 5 Year (± 60 days) Follow-up (in clinic or telephone visit) 
 Angina status 
 All adverse events including related laboratory tests results, ECGs, details of any 
subsequent myocardial infarction, hospitalization, or repeat coronary angiography and 
results of such, if applicable 
 Details of any subsequent coronary interventions (e.g. repeat PCI or CABG) 
 Use and changes in chronic antiplatelet medications. Data are collected for the duration of 
the trial 
 Concomitant cardiac medication by category 
6.1.4.8 
Additional (Unscheduled) Follow-up Visits 
Additional subject visits may occur as clinically warranted. The following information will be 
collected at such visits: 
 Data regarding all adverse events including related laboratory tests results, ECG, details of 
any subsequent myocardial infarction, hospitalization, or repeat coronary angiography and 
results of such, if applicable. For suspected ischemic events, CK and CK-MB or Troponin 
(I or T) must be measured and 12 lead ECG obtained. 
 Details of any subsequent coronary interventions (e.g., repeat PCI or CABG) 

 
 
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 Use and changes in chronic antiplatelet medication regimen. Data are collected for the 
duration of the trial 
 Concomitant cardiac medication by category 
6.1.5 
Equipment to Be Used for Assessing the Clinical Variables  
The Angiographic Core Lab will perform a qualitative and quantitative coronary analysis (QCA) 
(Pie Medical CAAS Workstation v. 5.11.2 Software) assessment of all target lesions pre-
procedure, post-procedure.  Morphological characteristics (calcification, tortuosity, bifurcation, 
presence of thrombus), TIMI flow and blush will be assessed at baseline. Complications (no 
reflow, slow reflow, abrupt closure, new or worsening thrombus, distal embolization, perforation 
and dissection by NHLBI criteria) will be assessed intra-procedurally and at the end of the 
baseline procedure.  
6.1.6 
Procedures for the Replacement of Subjects 
Discontinued subjects will not be replaced. De-registered subjects will not count towards the 
sample size of approximately 100 subjects and will not be included in the FAS but will be 
included in the safety analysis set and will be followed until resolution of any adverse events 
related to study procedures. 
6.2 
Investigational Device  
6.2.1 
Description of the Exposure to the Investigational Device  
All subjects will have a single treatment which is the study stent implantation at baseline 
procedure. The stent will remain implanted throughout the duration of the follow-up period. 
6.2.2 
List of Any Other Medical Devices or Medication to Be Used During the 
Clinical Investigation 
The stent implantation will be part of a standard cardiac intervention which includes accessory 
medical devices such as arterial sheaths, guidewires, guiding catheters, inflation devices, and 
other accessories. Standard medications such as heparin, contrast media, nitroglycerin, and 
relaxants are used. After the procedure, the subjects will receive DAPT for a minimum of 12 
months (see Section  6.4.9.3) according to national guidelines and standard of care as well as 
other medications as prescribed to control other co-morbidities such as hypertension, 
hypercholesterolemia, and heart failure. All of these accessory medical devices and medications 
are approved to be on the market. 
6.2.3 
Number of Investigational Devices to Be Used 
Each subject will receive at least one MedJ-01 stent. A subject can receive up to two stents per 
major coronary artery in a maximum of two major coronary arteries (A major coronary artery is 
defined as LAD, LCX, or RCA and their respective branches. The Ramus Intermedius is defined 
as a branch of the LCX). The total length of planned study stenting cannot exceed 100 mm.  

 
 
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6.3 
Subjects 
The Trial population will consist of approximately 100 male and female subjects undergoing PCI 
for angina (stable or unstable), silent ischemia, non ST elevation MI (NSTEMI), or recent ST 
elevation MI (STEMI >72 hours prior to enrollment and stable- subacute). 
Complex lesions are allowed including calcified lesions (lesion preparation with scoring/cutting 
and rotational atherectomy (e.g.: Rotablator System) and Directional Coronary Atherectomy, 
DCA) are allowed), presence of thrombus that is non-occlusive and does not require 
thrombectomy, CTO, bifurcation lesions (except planned dual stent implantation), ostial RCA 
lesions, tortuous lesions, bare metal stent restenotic lesions, protected left main lesions.  A 
maximum of two target vessels, with a maximum of two study stents per vessel or individual 
lesion length are allowed.; however, the total planned study stenting in the coronary tree cannot 
exceed 100 mm . 
Subjects must sign an IRB approved Subject Informed Consent Form, and meet all the general 
and angiographic eligibility criteria before being enrolled to the trial. 
6.3.1 
Inclusion Criteria for Subject Selection 
All inclusion criteria must be present for the patient to be eligible for enrollment. 
6.3.1.1 
General Inclusion Criteria 
1. Age ≥ 20 years. 
2. Patient with an indication for PCI including angina (stable or unstable), silent ischemia 
(in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a 
positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, or recent 
subacute STEMI. For subacute STEMI the time of presentation to the first treating 
hospital, whether a transfer facility or the study hospital, must be >72 hours prior to 
enrollment and enzyme levels (CK-MB or Troponin) demonstrating that either or both 
enzyme levels have peaked. 
3. Non-target vessel PCI are allowed prior to enrollment depending on the time interval as 
follows: 
a. During Baseline Procedure:  
i. PCI of non-target vessels performed during the baseline procedure itself 
immediately prior to enrollment if successful and uncomplicated defined 
as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 
flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST 
segment changes, no prolonged chest pain, no TIMI major or BARC type 
3 bleeding. 
b. Less than 24 hours prior to Baseline Procedure: 
i. Not allowed (see exclusion criteria #2). 
c. 24 hours-30 days prior to Baseline Procedure:  

 
 
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i. PCI of non-target vessels 24 hours to 30 days prior to enrollment if 
successful and uncomplicated as defined above.  
ii. In addition, in cases where non-target vessel PCI has occurred 24-72 hours 
prior to the baseline procedure, at least 2 sets of cardiac biomarkers must 
be drawn at least 6 and 12 hours after the non-target vessel PCI.  
iii. If cardiac biomarkers are initially elevated above the local laboratory 
upper limit of normal, serial measurements must demonstrate that the 
biomarkers are falling. 
d. Over 30 days prior to Baseline Procedure:  
i. PCI of non-target vessels performed greater than 30 days prior to 
procedure whether or not successful and uncomplicated. 
4. Patient or legal guardian is willing and able to provide informed written consent and 
comply with follow-up visits and testing schedule. 
6.3.1.2 
Angiographic inclusion criteria (visual estimate) 
5. Target lesion(s) must be located in a native coronary artery with visually estimated 
diameter of ≥2.5 mm to ≤4.25 mm. 
6. Complex lesions are allowed including calcified lesions (lesion preparation with 
scoring/cutting and rotational atherectomy (e.g.: Rotablator System) and Directional 
Coronary Atherectomy, DCA) are allowed), presence of thrombus that is non-occlusive 
and does not require thrombectomy, CTO, bifurcation lesions (except for planned dual 
stent implantation), ostial RCA lesions, tortuous lesions, bare metal stent restenotic 
lesions, protected left main lesions. 
7. Overlapping stents are allowed with the investigational device (MedJ-01). 
6.3.2 
Exclusion Criteria for Subject Selection 
All exclusion criteria must be absent for the patient to be eligible for enrollment. 
6.3.2.1 
General Exclusion Criteria 
1. STEMI within 72 hours (subacute) of initial time of presentation to the first treating 
hospital, whether at a transfer facility or the study hospital or patients in whom enzyme 
levels (either CK-MB or Troponin) have not peaked. 
2. PCI within the 24 hours preceding the baseline procedure. 
3. Non-target lesion PCI in the target vessel within 12 months of the baseline procedure. 
4. History of stent thrombosis. 
5. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure 
<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, 
including IABP. 
6. Subject is intubated. 
7. Known LVEF <30%. 

 
 
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8. Relative or absolute contraindication to DAPT for 12 months (including planned 
surgeries that cannot be delayed). 
9. Subject has an indication for chronic oral anticoagulant treatment (with either vitamin K 
antagonists or novel anticoagulants-NOACs 
10. Calculated creatinine clearance <30 mL/min using Cockcroft-Gault equation 
11. Hemoglobin <10 g/dL. 
12. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3. 
13. White blood cell (WBC) count <3,000 cells/mm3. 
14. Clinically significant liver disease. 
15. Active peptic ulcer or active bleeding from any site. 
16. Bleeding from any site within the prior 8 weeks requiring active medical or surgical 
attention. 
17. If femoral access is planned, significant peripheral arterial disease which precludes safe 
insertion of a 6F sheath. 
18. History of bleeding diathesis or coagulopathy or will refuse blood transfusions. 
19. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any 
permanent neurologic defect attributed to CVA. 
20. Known allergy to the study stent components, whether in the MedJ-01 e.g. cobalt, nickel, 
chromium, Carbosil®, PBMA, or limus drugs (ridaforolimus, zotarolimus, tacrolimus, 
sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar 
compounds). 
21. Known allergy to protocol-required concomitant medications such as aspirin, or DAPT 
(drugs that inhibit P2Y12 such as clopidogrel, prasugrel), or heparin, or iodinated 
contrast that cannot be adequately pre-medicated. 
22. Any co-morbid condition that may cause non-compliance with the protocol (e.g. 
dementia, substance abuse, etc.) or reduced life expectancy to <24 months (e.g. cancer, 
severe heart failure, severe lung disease).  
23. Patient is participating in any other investigational drug or device clinical trial that has 
not reached its primary endpoint or plans to participate in any clinical trial. 
24. Women who are pregnant or breastfeeding (women of child-bearing potential, defined as 
females of childbearing potential if they have not undergone a permanent contraceptive 
operation or they are not postmenopausal, must have a negative pregnancy test within one 
week before treatment. Permanent contraceptive operation is defined as: hysterectomy, 
hysterosalpingectomy, or bilateral oophorectomy. The status of a female should be 

 
 
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considered as postmenopausal when she has not had a period for 12 consecutive months 
without an alternative medical cause).  
25. Women who intend to procreate within 12 months after the baseline procedure (women 
of child-bearing potential who are sexually active must agree to use a reliable method of 
contraception from the time of screening through 12 months after the baseline 
procedure). 
26. Patient has received an organ transplant or is on a waiting list for an organ transplant. 
27. Patient is receiving or scheduled to receive chemotherapy within 30 days before or any 
time after the baseline procedure. 
28. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-
limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are 
allowed. 
6.3.2.2 
Angiographic Exclusion Criteria (visual estimate) 
29. Target lesions in more than two (2) major coronary arteries (ie, two of LAD, LCX, RCA) 
and their respective branches. (The Ramus Intermedius is defined as a branch of the 
LCX). 
30. More than two target lesions per target vessel are planned (two lesions separated by less 
than 10 mm that can be covered by a single stent are considered as one lesion). 
31. More than 100 mm length of planned study stenting in the entire coronary tree. 
32. Occlusive thrombus and/or a thrombus requiring thrombectomy in a target vessel. 
33. Unprotected left main lesions ≥30%, or planned unprotected left main intervention. 
34. Ostial LAD or LCX lesions (stenting of any diseased segment within 5 mm of the 
unprotected left main coronary artery). 
35. Bifurcation lesionswith planned dual stent implantation. 
36. Stenting of lesions due to DES restenosis. 
37. Another lesion in a target or non-target vessel (including all side branches) is present that 
requires or has a high probability of requiring PCI within 12 months after the baseline 
procedure. 
38. Target lesion exists in bypass graft vessels. 
6.3.3 
Criteria and Procedures for Subject Withdrawal or Discontinuation 
6.3.3.1 
When and How to Withdraw Subjects 
Each enrolled subject shall remain in the trial until completion of the required follow-up period. 
However, a subject’s participation in any clinical trial is voluntary and the patient has the right to 

 
 
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withdraw at any time without penalty or loss of benefit. Conceivable reasons for discontinuation 
may include, but not be limited to, the following: 
 Subject voluntary withdrawal 
 Subject withdrawal by physician as clinically indicated 
 Subject lost-to follow-up 
The reason for subject discontinuation must be documented on the CRF and source documents. 
The Primary Investigators must also report all subject discontinuations to their IRB as defined by 
their institution’s procedure. 
6.3.3.2 
Data to Be Collected from Withdrawn Subjects 
All data from evaluations and treatments performed prior to the withdrawal should be 
documented on the CRFs. Source documents and angiograms that pre-date the withdrawal 
should be submitted as required by the clinical investigation plan. No data that post-dates the 
withdrawal will be collected. 
6.3.3.3 
Follow-up for Withdrawn Subjects 
Once a subject has withdrawn from the trial, no further follow-up contact will be performed. 
However, vital status will be obtained from public records.  
6.3.4 
Point of Enrollment 
Patients will be screened and consented for enrollment prior to any sedation. Patients may be 
consented prior to diagnostic angiography with possible PCI intervention as well as prior to a 
planned PCI procedure. Once a patient has signed an informed consent, met all general and 
angiographic eligibility criteria, and a guidewire has successfully been passed beyond the 
target lesion, the patient will be considered enrolled in the trial (refer to instructions for de-
registration in the trial’s Site Binder). If the study stent could not be implanted due to reasons 
that are not related to study device,, the study subject will be de-registered from the trial and will 
not be analyzed as part of the full analysis set (FAS). 
 

 
 
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The screening and enrollment process is displayed in Figure 5 Error! Reference source not 
found.. 
 
Figure 5: Screening and Enrollment Flow Chart 
The trial will enroll patients for whom a decision to undergo PCI has already been made. In the 
case CABG-eligible conditions, it is recommended that a heart team be consulted in the decision 
of whether the patient should undergo CABG or PCI. 
 
 
*
*: refer to 6.4.3 Enrollment 

 
 
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6.3.5 
Total Expected Duration of the Clinical Investigation 
The clinical investigation will last from Q1 2016 until approximately Q3 2021.  
6.3.6 
Expected Duration of Each Subject’s Participation 
Each subject will remain in the clinical investigation for approximately 5 years from the time of 
the study stent implantation until the last follow-up office visit or telephone contact. 
The subjects will not be provided any follow-up contact or medical care related to the trial after 
the clinical investigation has been completed. 
6.3.7 
Number of Subjects Required to Be Included in the Clinical Investigation 
Based on the statistical assumptions described in section 7 enrollment of 100 subjects will 
provide 80% power expecting a 5% loss to follow up. 
6.4 
Procedures 
6.4.1 
Baseline Angiography 
Baseline angiography of the target vessel will be completed as per the Angiographic Core 
Laboratory Protocol contained in the trial’s Site Binder. Angiography of non-target vessels (if 
required) may be performed per site standard. 
Assessment of angiographic eligibility is based on a visual assessment of the immediate pre-
procedure angiogram obtained by the Investigator. A 6 French or larger guide catheter must be 
used for accurate QCA measurements. Following intra-coronary injection of nitroglycerin (50-
200 mcg IC nitroglycerin or per standard hospital practice), baseline angiography of the involved 
vessel will be performed for at least two orthogonal views showing the target lesion free of 
foreshortening or vessel overlap according to the Angiographic Core Laboratory Guidelines. 
Angiographic images of the target lesion must be sent to the Angiographic Core Laboratory per 
specified shipping method. 
6.4.2 
Non-Target Vessel PCI and Non-Target Lesion PCI in Target Vessel 
All non-target vessel PCI must be treated prior to enrollment.  
Non-target lesion PCI in the target vessel is allowed but must have occurred >12 months 
prior to the baseline procedure. 
The following are the criteria for non-target vessel PCI: 
During Baseline Procedure: The non-target vessel PCI must be successful and uncomplicated 
before enrollment of the subject into the trial and proceeding with enrollment. Successful and 
uncomplicated is defined as <50% visually estimated residual diameter stenosis, TIMI Grade 3 
flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no 
prolonged chest pain, no TIMI major or BARC type 3 bleeding. 
Within 24 hours prior to Baseline Procedure: PCI of non-target vessels are NOT allowed 
within the 24 hours immediately preceding the baseline procedure and enrollment. 

 
 
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24 hours to 72 hours prior to Baseline Procedure: Non-target vessel PCI can be performed 24 
to 72 hours prior to the baseline procedure. At least 2 sets of cardiac biomarkers must be drawn 
at least 6 and 12 hours after the non-target vessel PCI. If the biomarkers are initially elevated 
above the local laboratory upper limit of normal, the serial measurements must demonstrate that 
the biomarkers are falling. 
72 hours to 30 days prior to Baseline Procedure: PCI of non-target vessels can be performed 
72 hours to 30 days prior to enrollment if PCI was successful and uncomplicated.  
More than 30 days prior to Baseline Procedure: PCI of non-target vessels may be performed 
more than 30 days prior to enrollment whether successful and uncomplicated or not. 
Table 5: Summary of Timing of Non-Target Vessel According to PCI Rules 
Non-Target Vessel PCI 
Decision Matrix 
During 
Baseline 
Procedure 
Time prior to Baseline Procedure 
<24 hours 
24 hours 
to 72 hours 
72 hours to 
30 days 
>30 days 
Is PCI of a non-target 
vessel allowed? 
Yes 
No 
Yes 
Yes 
Yes 
Is procedural success 
required? 
Yes 
N/A 
Yes 
Yes 
No 
Must the procedure be 
uncomplicated? 
Yes 
N/A 
Yes 
Yes 
No 
Are serial biomarkers 
required? 
No 
N/A 
Biomarkers must be 
negative post 
procedure or falling
(at least 2 sets of 
measurements) 
No 
No 
N/A = not applicable 
6.4.3 
Enrollment 
Enrollment will occur after the angiographic eligibility criteria have been determined to be 
met and the lesion has been successfully crossed with the wire without complication.  
A subject will be de-registered from the trial in case the study stent could not be implanted due to 
reasons that are not related to study device (for example, the lesion was not properly prepared for 
stenting).  
6.4.3.1 
De-registered Subjects 
In case of de-registration, the de-registered subjects will be followed until resolution of any 
adverse event related to study procedures (refer to instructions for de-registration in the trial’s 
Site Binder). 
6.4.4 
Staged Procedures 
All target lesions must be planned to be treated during the baseline procedure. The 
investigator will declare which target lesions are intended for treatment at the time of enrollment. 
In the event all target lesions cannot be treated (for example, due to contrast load), planned 

 
 
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staged procedures of target lesions are allowed but must be declared immediately post baseline 
procedure. Staged procedures should be performed using the assigned stent. All staged 
procedures should be performed within six weeks of the baseline procedure. All follow-up visits 
are to be scheduled from the date of enrollment. 
6.4.5 
Pre-Dilation of Target Lesion(s) 
Pre-dilation is recommended but not required. It should be performed, per local clinical practice. 
An angioplasty balloon, cutting balloon, angiosculpt scoring balloon, or atherectomy (including 
DCA) can be utilized for pre-dilation. The pre-dilation balloon should be shorter than the 
planned stent(s) length to limit pre-dilation injury within the area to be stented. It is 
recommended that a pre-dilation catheter that is 0.5 mm smaller in diameter than the reference 
vessel is used. 
6.4.6 
Study Stent Use 
Prior to use, the study stent will be inspected and prepared according to the applicable 
Instructions for Use. Note: Refer to the MedJ-01 IFU in the trial’s Site Binder. 
 There is no limit to individual lesion length. However, the total planned stenting in the 
coronary tree cannot exceed 100 mm. A maximum of two target vessels may be treated 
with study stents with a maximum of two lesions per vessel. Two lesions separated by less 
than 10 mm that can be covered with a single stent are considered as one lesion 
 If more than one target lesion is treated, all lesions must receive the study stent.  
 If more than one lesion in the same epicardial vessel is treated, it is recommended that 
stenting be initiated distally and progress proximally. 
 Overlapping stents are allowed with the investigational device (MedJ-01). It is 
recommended that the distal stent should be deployed first, followed by deployment of the 
proximal stent, to reduce the risk of dislodging the proximal stent.  
 Stent sizing should follow a stent: artery ratio of 1.1:1 per operator’s visual estimate.  
 Brachytherapy must NOT be performed in conjunction with the baseline procedure. 
 Post-dilation is strongly recommended, and when performed should only be performed 
with balloon lengths that fit within the boundaries of the stent. Do not exceed the rated 
burst pressure as indicated in the product labeling of the study stents. The vessel size and 
lesion length should be assessed after post-dilation. An optimal stent result is final 
diameter stenosis of <20% by operator’s visual estimate. 
6.4.7 
Treatment Failures and Device Malfunctions of the MedJ-01 
In case of failure to deliver a study stent, typical measures should be undertaken to ensure the 
lesion has been adequately prepared, such as use of appropriately sized pre-dilatation balloons, 
cutting or scoring balloons, and/or rotational atherectomy (including DCA) as appropriate. Guide 

 
 
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catheter support should be optimized using standardized techniques, including use of buddy 
wires and/or guide extension devices as appropriate. If the study stent can still not be delivered, 
any commercially available stent may be used to successfully and safely complete the procedure. 
All failures and MedJ-01 malfunctions will be documented on the appropriate CRF. The MedJ-
01 should be returned to Medinol for analysis and be reported in the clinical results. Instructions 
for returning the MedJ-01 are included in the trial’s Site Binder. Treatment failures or device 
malfunctions should be reported in the CRF within 24 hours, per the instructions of EDC 
completion. 
6.4.8 
Bail-out Stenting Procedures 
Bailout stenting may be performed at the operator’s discretion. If a bailout stent is required, a 
MedJ-01 stent of an appropriate diameter and length must be used. If a MedJ-01 stent of 
appropriate length and diameter is not available, an approved coronary stent should be used, 
preferably a second generation DES. 
6.4.9 
Concomitant Medications 
6.4.9.1 
Pre-Procedure (Loading) Anti-Platelet Medication  
Loading doses of anti-platelet medications should be administered pre-procedure in all patients 
as shown in Error! Reference source not found.6. 
Table 6: Pre-Procedure Anti-Platelet Medication Regimen 
Agent 
Instructions 
Clopidogrel 
A loading dose of clopidogrel ≤300 mg must be administered at least 6 hours 
prior to PCI, as per standard of care.  
For subjects who are already on chronic clopidogrel therapy of 75 mg (≥4 
days), a loading dose should not be required at the investigator’s discretion. 
OR Prasugrel 
Prasugrel can be used in place of clopidogrel at the investigator’s discretion. A 
loading dose of prasugrel 20 mg must be administered on the day of PCI. 
For subjects already on chronic prasugrel therapy of 3.75 mg a day (or 2.5 mg 
if dose reduction is considered necessary for subjects) for ≥5 days  a loading 
dose of prasugrel 20 mg should not be required at the investigator’s discretion. 
Aspirin 
All subjects already taking daily chronic aspirin therapy should receive 81-
162 mg or dose per standard hospital practice before the procedure. 
Subjects not already taking daily chronic aspirin therapy should receive 81-
325 mg (or dose per standard hospital practice) preferably at least two hours 
before the procedure. 
6.4.9.2 
Anticoagulation during Baseline Procedure 
PCI should be performed with adequate anticoagulation. Unfractionated heparin (UFH) may be 
used according to local standards. 

 
 
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6.4.9.3 
Post-Procedure Anti-Platelet Medication 
Dual anti-platelet therapy should be instituted post procedure in all patients as shown in Error! 
Reference source not found.7. All subjects are required to have clopidogrel/prasugrel 
administration for a minimum of 12 months according to national guidelines (Guidelines 
for elective percutaneous coronary intervention in patients with stable coronary disease 
(JCS 2011) [8]) and standard of care as well as aspirin administration indefinitely unless an 
intervening medical necessity occurs such as severe bleeding. 
Table 7: Post-Procedure Anti-Platelet Medication Regimen 
Agent 
Instructions 
Clopidogrel 
All subjects who receive a study stent will be treated for a minimum of twelve 
months of clopidogrel (75 mg/day) according to national guidelines and 
standard of care. At least 12 months following stent implantation is 
recommended per  the JCS guidelines for elective percutaneous coronary 
intervention [8]. 
OR Prasugrel 
Prasugrel 3.75 mg/day can be used in place of clopidogrel at the investigator’s 
discretion. In subjects considered to require dose reduction by their conditions 
(body weight (<50 kg), age, renal function, and other risks), prasugrel should 
be given at a dose of 2.5 mg/day. 
Aspirin 
Subjects with no aspirin resistance, allergy, or bleeding risk should continue on 
aspirin (minimum of 81 mg/day and up to 162 mg/day or dose per standard 
hospital practice) indefinitely, in accordance with the JCS PCI 
recommendations and the JCS guidelines. Low-dose aspirin (≤100 mg/day) is 
preferred in all patients.  
6.4.10 
Activities Performed by Sponsor Representatives 
No activities other than monitoring will be performed by the Sponsor representatives. 
6.4.11 
Known or Foreseeable Factors That May Compromise the Outcome 
Factors that may compromise the outcome are lack of enrollment, poor data collection. 
6.5 
Monitoring Plan 
6.5.1 
Monitoring 
Sponsor and/or designee will monitor the trial over its duration according to the pre-specified 
monitoring plan. The trial monitor will visit each site at appropriate intervals to review 
investigational data for accuracy and completeness and ensure compliance with the clinical 
investigation plan. The trial monitor may inspect all documents and required records that are 
maintained by the Investigator/Site, including medical records (office, clinic, or hospital) for the 
subjects in this trial. Source documentation must be available to substantiate proper informed 
consent procedures, adherence to clinical investigation plan procedures, adequate reporting and 
follow-up of adverse events, accuracy of data collected on case report forms, and device 
information. A monitoring visit sign-in log will be maintained at the site. The Investigator and/or 
research coordinator will be available for monitoring visits. It is expected that the 

 
 
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Investigator/Site will provide the trial monitor with a suitable working environment for review of 
study-related documents. 
6.5.2 
Identification of Data Recorded on CRF and Considered Source Data 
The Investigator is responsible for maintaining complete and accurate documentation of the trial 
including but not limited to medical records, trial progress records, laboratory results, case report 
forms, signed informed consent forms, device accountability records, correspondence with the 
IRB as well as trial monitors and sponsor, adverse event reports, and information regarding 
subject discontinuations.  
The Investigator is required to maintain information in the subject’s medical records which 
documents and corroborates data entered in the case report forms. As a minimum the subject 
record should contain: 
 Medical history/physical exam documenting that subject meets inclusion/exclusion criteria 
 Documentation of subject’s consent and subject ID number in the trial 
 Dated and signed notes from each subject visit 
 Adverse events reported and their resolution or lack thereof including supporting 
documents such as hospital records, discharge summaries, catheterization reports, ECGs, 
etc. 
 Record of clinical investigation plan required medications during the trial 
 Record of the subject’s condition upon completion of or withdrawal from the trial 
6.5.3 
Direct Access to Source Data/Documents 
The Investigator and the associated institution will permit direct access to source data/documents 
for study-related monitoring, audits, IRB review and regulatory inspections. 
Subjects providing informed consent agree to allow the Sponsor or designee access and copying 
rights to pertinent information in their medical records concerning their participation in this trial. 
The Investigator will obtain, as part of the informed consent, permission for trial monitors or 
regulatory authorities to review, in confidence, any records identifying the subjects in this trial. 
This information may be shared with regulatory agencies; however, the Sponsor undertakes not 
to otherwise release the patient’s personal and private information.  
6.5.4 
Training 
6.5.4.1 
Site Training 
All Investigators and trial personnel are required to attend Sponsor training sessions, which may 
be conducted at an Investigator’s meeting, a site initiation visit, or other appropriate training 
sessions including training utilizing electronic media. Training of Investigators and trial 
personnel will include, but is not limited to, the investigational plan, investigational device 
usage, clinical investigation plan requirements, case report form completion and trial personnel 

 
 
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responsibilities. All Investigators and trial personnel who are trained must sign a training log (or 
an equivalent) upon completion of the training. Investigator and trial personnel must not perform 
any study-related procedures prior to being trained. All Investigators must be trained to the 
clinical investigation plan and trial procedures prior to enrolling subjects. 
6.5.4.2 
Training of Sponsor’s Monitors 
The Sponsor’s monitors or designee will be trained to the clinical investigational plan, case 
report forms, and investigational device usage. The Sponsor or designee is responsible for the 
training. Training will be conducted in accordance with the Sponsor’s and/or designee’s standard 
procedures. 
6.5.5 
Quality Assurance Assessments 
The Sponsor and/or designee may conduct periodic compliance assessments (on-site audits) at 
various study sites. A Sponsor representative or designee may request access to all trial records, 
including source documentation, for inspection and duplication during a compliance assessment. 
The Investigator and research coordinator must be available to respond to reasonable requests 
and queries made during the compliance assessment process.  
6.5.6 
Regulatory Agency Inspection 
In the event that an Investigator is contacted by a Regulatory Agency in relation to this trial, the 
Investigator will notify the Sponsor immediately. The Investigator and research coordinator must 
be available to respond to reasonable requests and inspection queries made during the inspection 
process. The Investigator must provide the Sponsor with copies of all correspondence that may 
affect the review of this trial. The Sponsor will provide any needed assistance in response to 
regulatory inspections. 
7 STATISTICAL CONSIDERATIONS 
Overview of Statistical Approach 
JNIR will be a single arm study enrolling Japanese patients with similar inclusion and exclusion 
criteria to the pivotal randomized BIONICS study. The primary endpoint of Target Lesion 
Failure will be the primary endpoint for the analysis. In order to ensure comparison of similar 
patients across these two populations a propensity-score matched analysis will be perfomed on 
both clinical and angiographic parameters. To maximize power and take advantage of the large 
BIONICS study, 4:1 matching will be done. 
7.1 Target groups of Analysis 
Target, ITT, and FAS population 
 
Investigators will treat 100 Japanese patients (JNIR) with BIONIR, and compare event rates to a 
previous study population (BIONICS) carried out in Europe, Israel, and North America. The 
primary end point will be Target Lesion Failure (TLF) in the Full Analysis Set (FAS) population 
contains all enrolled Japanese patients regardless of whether they were given the BIONIR stent, 

 
 
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while the as-treated (AS) population contains only those Japanese patients who received the 
study stent. By definition, the (AS) population cannot be larger than (FAS). 
7.2  Analysis of Efficacy 
7.2.1 Primary Endpoint 
Primary Endpoint hypothesis 
This trial measures the non-inferiority of JNIR Target Lesion Failure at 12 months (TLF12) to the 
BIONICS TLF12.  
 
The trial defines the statistical null hypothesis as 
  HNull:         TLF12 (JNIR) > TLF12 (BIONICS) +  
  HAlternative: TLF12 (JNIR)  ൑ TLF12 (BIONICS) +  
 
or in terms of absolute event-rate difference 
 
  HNull:         TLF12 (JNIR) - TLF12 (BIONICS) >   
  HAlternative: TLF12 (JNIR) - TLF12 (BIONICS) ൑  
 
where  is the margin of non-inferiority. 
 
Measured statistic 
Farrington-Manning methodology estimates the difference in TLF12 as  
߬ൌ 
TLF12 ሺJNIRሻെ TLF12 ሺBIONICSሻെ  
ටTLF12 ሺJNIRሻሾ1 െ TLF12 ሺJNIRሻሿ
ܰሺJNIRሻ
൅ TLF12 ሺBIONICSሻሾ1 െ TLF12 ሺBIONICSሻሿ
ܰሺBIONICSሻ
 
where ܰሺݔሻ is the number of ݔ patients. 
 
Propensity-score matching 
Propensity score matching will identify a covariate-unbiased population of patients between the 
JNIR and BIONICS patient population. The probability a patient (x) belongs to JNIR versus 
BIONICS, conditional on set of potential confounding covariates (C), defines the propensity 
score ߩሺݔ |ܥሻ. Logistic regression will model this probability as 
ߩሺݔ |ܥሻൌlogitିଵ൭෍ܿ
௖ ∈஼
൱ 
where logitିଵሺݔሻൌ 
ଵ
ଵା௘షೣ . 
 
We will match patients from JNIR to patients from BIONICS using the following covariates 
known to confound the relationship between study-stent and outcome: 
 
Covariates considered in propensity-score matching: 
Clinical Parameters: 
Age  
Gender 
Prior MI 

 
 
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Diabetes Mellitus 
Prior Revascularization 
Acute Coronary Syndrome 
Angiographic Parameters: 
Diameter Stenosis 
Reference Vessel Diameter 
Calcification 
TIMI Flow (Pre-procedure) 
Tortuosity 
SYNTAX Score 
Lesion located at LAD 
 
After each patient in both JNIR and BIONICS has received a propensity score, these two groups 
will be combined and partitioned into propensity score quintiles. 
Finally, we will match each JNIR patient in quintile x with a random BIONICS patient from the 
same quintile x. If no remaining BIONICS patients are left to match with JNIR patients in one of 
the five quintiles, we use the next closest quintile to choose a BIONICS patient. 
7.2.2 Secondary Endpoint 
Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 2, 3, 4 and 5, except 
as noted:  
 Device, Lesion, and Procedure Success at time of baseline procedure 
 TLF at 30 days, 6 months, and 2, 3, 4 and 5 years defined as the composite of cardiac 
death, target vessel-related MI, or ischemia-driven TLR. 
 Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or 
ischemia-driven TLR)  
 Target vessel failure (TVF; the composite rate of death, target vessel related MI or 
ischemia-driven TVR)  
 All-cause mortality  
 Cardiac death  
 Myocardial Infarction  
 Target Vessel Related MI  
 Ischemia-driven TLR  
 Ischemia-driven TVR  
 Stent Thrombosis (ARC definite and probable) 
 
Analyses of secondary clinical endpoints will be performed on the FAS group.  
Data will be summarized with patient counts, percentages, and exact 95% confidence intervals. 
Treatment group differences will be summarized with 95% confidence intervals.  
The secondary endpoints (with the exception of angiographic in-stent late loss) will not be 
formally tested for non-inferiority and testing will be considered descriptive. 

 
 
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See further details in the Statistical Analysis Plan. 
7.3 Analysis of Safety 
All adverse events collected will be coded using MedDRA, to preferred term and system organ class 
and summarized for the Safety Analysis Set and de-registered subjects. AEs will be summarized 
showing the number of events and the number of patients with each event.  
A by-patient listing of (serious) adverse events / UADE, including identification of the event by 
investigator term, date and time started, intensity, relationship to study drug, action taken, and date 
and time resolved, will be presented in the data listings.  
A by-patient listing of deaths will be presented.  
 
Device deficiency is defined as the inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance. Device deficiencies include malfunctions, use 
errors, and inadequate labeling.  
Device malfunction/deficiencies and any (serious) adverse events associated with device 
malfunction/deficiencies will be tabulated by treatment arm and overall. All randomized subjects, 
including de-registered subjects, will be included in the analysis. 
7.4 Other subjects related to statistical analysis 
1) Handling of Missing Values and Outlier 
1. Missing values 
Handling of the missing values is indicated in the Statistical Analysis Plan. Final decision will 
be made at the Case Review Meeting. 
2. Outlier 
Outlier is not expected in the plan. The effect of the outlier to the analysis will be reviewed 
when necessary. 
2) Change of Data 
If bias of data distribution is found, appropriate data will be used instead when necessary. 
3) Interim Analysis 
No interim analysis will be performed in this trial. 
4) Handling of the bail-out lesion 
Stents used for bail-out will be included in efficacy and safety analysis.  
5) Others 
When necessary, additional exploratory analysis will be performed. 
 

 
 
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7.5 Sample Size Considerations 
Power 
The Farrington-Manning test, with a TLF12 event-rate of 0.058, margin of 0.05, Type I error  of 
0.10, and propensity-score matching 1 JNIR to 4 BIONIC patients provides enrollment of 100 
subjects will provide 80% power expecting a 5% loss to follow up. We derive the 0.058 event 
rate from a sample-weighted average of the same 8 related trials used to design BIONICS: 
SPIRIT (III/IV), PLATINUM, RESOLUT (All Comers / US), TWENTE, and COMPARE (I/II). 
A margin of 0.05 (5%) , 1.5 times that of BIONICS, leverages a reasonable clinical threshold 
with safety concerns over sample size. Likewise, propensity-score matching every one JNIR 
patient to 4 BIONICS patients allows higher power without a higher burden on enrollment. 
8 DATA MANAGEMENT 
8.1 
Procedures Used for Data Review, Database Cleaning, and Issuing and 
Resolving Data Queries 
Medidata will provide Rave electronic data capture (EDC) system for the trial. The sites are 
responsible for completing the clinical electronic CRF (eCRF) from Rave. The data cleaning 
routines are performed during data entry through automatic edit checks that occur during data 
entry by the sites into Rave. The auto-queries are generated by Rave and are resolved by the site. 
Those auto-queries will be cleared when the revised data entry meets the edit check criteria or 
the monitor accepts the revised entry. The manual queries are created by the site monitors. The 
Data Manager can create manual queries on data as well for the sites to review. Rave system 
flags the records with data queries which are resolved by the site, and the manual queries are 
cleared by the originating personnel. Tracking of data cleaning query status is facilitated by 
standard reports from Rave. Data listings needed for data review are created outside of Rave. 
Please see the separate Data Management Plan for specific details.   
8.2 
Procedures for Verification, Validation, and Securing of Electronic 
Clinical Data Systems 
Rave EDC system hosted by Medidata will be programmed and maintained by Quintiles DM. 
Rave EDC system will enforce restricted access control mechanisms under the management of 
Quintiles CPM. And will incorporate encrypted point-to-point data transfer via secure HTTP 
protocols. Trial Investigators/sites will enter data online; data will be stored at a secure and 
confidential location, and will be downloaded via SAS on Demand function in Rave for review 
and analyses on a regular basis. Further details of verification, validation, and securing of 
electronic clinical data systems can be found in the trial specific Data Management Plan.   

 
 
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8.3 
Procedures for Data Retention and Specified Retention Period 
All core laboratories and clinical sites will maintain study records pertaining to this trial for 
15 years following trial completion, or as otherwise instructed by the Sponsor, or per local 
requirements whichever is longer. 
ICH guidelines require that essential documents be retained until at least 2 years after the last 
approval of a marketing application in an ICH region and until there are no pending or 
contemplated marketing applications in an ICH region or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the investigational product. 
To comply with these requirements, the investigator will not dispose of any records relevant to 
this trial without either (1) written permission from the Sponsor, or (2) providing an opportunity 
for the Sponsor to archive the records. The investigator shall take responsibility for maintaining 
adequate and accurate source documents of all observations and data generated as required 
during this trial, including any data clarification forms received from the Sponsor or its 
designees. Such documentation is subject to inspection by the Sponsor or its agents, the IRB, or 
other regulatory agencies. 
The Investigator will be notified by the Sponsor of the date of marketing approval or 
discontinuation of the trial. The Investigator will obtain permission from the Sponsor in writing 
before destroying or transferring control of any trial records. 
8.4 
Other Aspects of Clinical Quality Assurance 
8.4.1 
Clinical Events Committee 
The Clinical Events Committee (CEC) will be comprised of cardiologists who are not 
participants in the trial and who have no conflict of interest with the trial or the trial sponsor. All 
members of the CEC will be blinded to the primary results of the trial. 
The CEC will be responsible for the adjudication of the clinical trial endpoint events. At the 
onset of the trial, the CEC will establish explicit rules outlining the process for adjudication and 
the algorithms followed in order to classify a clinical endpoint event. The CEC will also review 
and rule on all deaths that occur throughout the trial. In addition, the CEC will review and 
adjudicate device non-success. Definitions are provided in Section  21.1. 
Once the specific criteria for clinical endpoints are established by the CEC, Cardiovascular 
Research Foundation will be responsible for preparing all clinical endpoint event dossiers and for 
the conduct of the CEC meetings. 
8.4.2 
Selection of Clinical Sites and Investigators 
The sponsor will select Investigators who are qualified by training and experience, and are 
legally entitled to perform clinical research and to participate in the investigation of the study 
device. Sites will be selected based upon review of a recent site assessment and the qualifications 
of the Primary Investigator at the site.  

 
 
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8.4.3 
Clinical Investigational Plan and Informed Consent Approval at 
Investigative Sites 
Institutional Review Board (IRB) approval for the clinical investigation plan, informed consent 
form and other trial related documents will be obtained by the head of medical institution at each 
investigational site prior to participation in this trial. The approval letter must be signed by the 
IRB chairperson or authorized representative prior to the start of this trial and a copy must be 
provided to the Sponsor. In addition, the Investigator or designee will provide the Sponsor with 
all required documentation necessary for initial and ongoing trial approval at their site.  
In accordance with the investigational site IRB requirements, the Investigator will (a) advise the 
IRB of the progress of this trial on a regular basis until trial completion. The head of medical 
institution will (b) obtain written IRB approval at predetermined time points to continue the trial; 
and (c) submit any amendments to the clinical investigation plan as well as associated informed 
consent form changes and obtain written IRB approval obtained prior to implementation.  
8.4.4 
Source Documents 
For the duration of the trial, the Investigator will maintain complete and accurate documentation 
including but not limited to medical records, trial progress records, laboratory reports, case report 
forms, signed informed consent forms, device accountability records, and correspondence with 
the IRB and Sponsor, adverse event reports, and information regarding subject discontinuation or 
completion of the trial. 
Source documents are defined as original documents, data, and records. Regulations require that 
the Investigator maintain source documents in the subject’s medical records, which confirm the 
data entered on the case report forms. All data provided to the Sponsor on the CRFs must be also 
part of the subject’s medical record as noted in Section  6.5.2. 
8.4.5 
Case Report Form (CRF) Completion 
Primary data collection based on source-documented hospital and/or clinic chart reviews will be 
performed clearly and accurately by site personnel trained on the clinical investigation plan and 
CRF completion. The Sponsor or designee will provide clinical monitoring as specified in 
Section  6.5.1. 
9 AMENDMENTS TO CIP 
If the clinical investigational plan needs an amendment, the Sponsor is required to submit such 
amendment to the Regulatory Agencies and/or other regulating body in each participating 
country for approval. Approved clinical investigational plan amendments will be provided to the 
Investigators by the Sponsor prior to implementing the amendment. For administrative changes 
the Primary Investigator is responsible for notifying the IRB of the clinical investigational plan 
amendment. For changes involving subject care or safety the Primary Investigator is responsible 
for obtaining IRB approval of the clinical investigational plan amendment according to the 
instructions provided by the Sponsor with the clinical investigational plan amendment.   

 
 
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Acknowledgement/approval by the IRB of the clinical investigational plan amendment must be 
documented in writing prior to implementation of the clinical investigation plan amendment. 
Copies of this documentation must also be provided to the Sponsor. 
10 DEVIATIONS FROM CLINICAL INVESTIGATION PLAN 
10.1 Statement Specifying That the Investigator Is Not Allowed to Deviate 
from the CIP 
No investigative procedures other than those defined in this clinical investigational plan will be 
undertaken on the enrolled subjects without the written agreement of the IRB and Sponsor. 
It is the Investigator’s responsibility to ensure that there are no deviations from the clinical 
investigational plan and full compliance with all established procedures of the IRB is maintained. 
The Investigator will not deviate from the clinical investigational plan for any reason except in 
cases of medical emergencies, when the deviation is necessary to protect the life or physical 
well-being of the subject.  
10.2 Procedures for Recording, Reporting, and Analyzing CIP Deviations 
A deviation is an instance(s) of failure to follow, intentionally or unintentionally, the 
requirements of the Clinical Investigation Plan. All deviations must be reported to the Sponsor. 
The occurrence of clinical investigational plan deviations will be monitored by the Sponsor or 
designee. It is the Investigator’s responsibility to inform their IRB of clinical investigational plan 
deviations in accordance with their specific IRB reporting policies and procedures.  
In the event that an investigative site does not comply with the Investigator Agreement or 
clinical investigational plan, the Sponsor will notify the Investigator of the site’s non-
compliance. Continued non-compliance may result in further escalation in accordance with the 
Sponsor’s standard procedures.  
10.3 Notification Requirements and Time Frames 
Major protocol deviations shall be notified to the trial Sponsor and Ethics Committee. Sponsor 
nominated personnel will also observe and record any protocol deviations during routine 
monitoring visits and follow up accordingly. 
10.4 Corrective and Preventative Actions and Principal Investigator 
Disqualification Criteria 
Protocol deviations and site/PI non-compliance will be closely monitored by the Sponsor and 
appointed study personnel.  Identifying deviations and taking corrective actions at the earliest 
possible stage increases the potential for clinical trial success and reduces patient risk. The 
initiation of a corrective and preventative action (CAPA) to investigate and establish corrective 
actions may be required in some cases. The Sponsor reserves the right to close a clinical study 
site or replace a PI if non-compliance is observed 

 
 
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11 DEVICE ACCOUNTABILITY 
11.1 Investigational Product Accountability 
The Sponsor will ship the MedJ-01 to the Primary Investigator (or designee) at each site. The 
Primary Investigator will maintain adequate records of the receipt and disposition of the MedJ-
01 on the device inventory log or case report form (CRF), including stent size/dimensions; date 
implanted; subject identification number; and implanting Investigator. The Inventory 
Accountability Report must document the disposition of all investigational devices including 
those that have been returned to the Sponsor. Use of any investigational device outside of the 
clinical investigation plan (e.g. compassionate use) is strictly forbidden and may constitute 
grounds for removal of the Investigator/Site from the trial. 
11.2 Investigational Product Return 
Investigators will be notified in writing of enrollment completion. All unused MedJ-01 products 
must be returned to the Sponsor when enrollment is complete according to the returned goods 
process. All MedJ-01 or any remaining components that are associated with a device malfunction 
must be returned to the Sponsor. 
12 STATEMENTS OF COMPLIANCE  
The trial will be conducted in compliance with the Japanese Drug Medical Device Law Act 
23.2.5 Part 3 and Act 80.2, and MHLW Ministerial Ordinance No. 36, Mar 23, 2005 (GCP of 
Medical Device), Article 273 and Article 274, Part 2, clinical investigation plan, ISO 14155:2011 
(Clinical investigation of medical devices for human subjects – good clinical practice), and the 
ethical principles of the Declaration of Helsinki as well as local regulations, and applicable 
regional regulatory requirements. 
The clinical investigation shall not begin until the required approvals/favorable opinions from the 
respective regulatory authority and IRB have been obtained. Any additional requirements 
imposed by the respective regulatory authority and/or IRB will also be followed, where 
specified. 
All subjects must provide written informed consent in accordance with the site’s IRB, using an 
IRB-approved informed consent form. The final eligibility for the trial will be confirmed based 
on the final pre-stenting angiographic qualification.  
Trial-specific procedures must not be performed until a signed informed consent has been 
obtained. The Investigator/designee, who has been trained on the clinical investigation plan, will 
explain the nature and scope of the trial, potential risks and benefits of participation, and answer 
questions for the patient. If the patient agrees to participate, the informed consent form must be 
signed and personally dated by the patient or legally authorized representative. The 
Investigator/designee must also sign the informed consent form prior to patient enrollment. Any 

 
 
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additional persons required by the site’s IRB to sign the informed consent form must also 
comply. 
All subjects are to be fully informed and trial conduct must be in accordance to the World 
Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving 
Human Subjects. 
The trial Sponsor has taken out appropriate insurance for this clinical investigation. 
13 INFORMED CONSENT PROCESS 
13.1 General Process for Obtaining Informed Consent 
CIP-specific procedures or alterations of patient care must not be performed until the prospective 
subject has provided a signed informed consent. The informed consent will be in the prospective 
subject’s native language and will contain non-technical language to describe the investigational 
procedures. The informed consent should also include a clause that ensures important new 
information will be provided to the subject throughout the clinical investigation. 
After a review of the prospective subject’s medical records to determine general eligibility, the 
investigator or authorized designee who has been trained on the CIP, will approach the 
prospective subject to explain the purpose and scope of the clinical trial, prospective risks, and 
benefits of participation. The prospective subject must be given the opportunity to ask questions 
about the trial and must be given sufficient time to decide to participate in the trial or not. 
Additional information requested by the prospective subject should be provided. Any coercion or 
undue improper influence on the prospective subject is to be avoided. 
If the prospective subject agrees to participate, the informed consent form must be signed and 
personally dated by the prospective subject. The investigator or an authorized member of the 
research team who has witness the prospective subject’s signature must also sign and date the 
informed consent, prior to enrollment of the prospective subject. A copy of the completed 
informed consent form must be provided to the subject. Local IRB regulations regarding 
obtaining informed consent must be followed. The subject’s medical record should have a 
notation regarding the signing of the informed consent. 
The subject is to be made aware that their participation in the trial is voluntary, their legal rights 
will not be waived, and that they may withdraw from the trial at any time, without giving 
specific reason for doing so. The subject must also be informed that withdrawal from the trial 
will not affect their future treatment.  
The investigator is responsible for the achievement of written consent from the prospective 
subject before they are included in the trial. All subjects must provide informed consent in 
accordance with the local IRB requirements, using an IRB-approved informed consent form. 
Error! Reference source not found. outlines the screening process and illustrates the point 

 
 
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where informed consent should be obtained. The final eligibility for the clinical trial will be 
confirmed based on the pre-intervention angiography. 
In case that study coordinators are involved in obtaining the informed consent, the study 
coordinators must co-sign on the informed consent form.  
14 ADVERSE EVENTS, ADVERSE DEVICE/DRUG EFFECTS, AND 
DEVICE DEFICIENCIES 
All definitions for adverse events, adverse device effects, and device deficiencies are taken from 
Ministerial Ordinance on Good Clinical Practice for Medical Devices (MHW Ordinance No. 36, 
2005, Devices-GCP), and Pharmaceutical and Medical Device Act, Enforcement Regulations. A 
summary of adverse events and adverse device effects is shown in Error! Reference source not 
found.8. 
14.1 Definition of AE and ADE 
14.1.1 
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 and drug constituting the medical device.  
This definition includes events related to the investigational medical device and drug constituting 
the medical device or the comparator. It also includes events related to the procedures involved. 
For users or other persons, this definition is restricted to events related to the investigational 
medical device. 
However, symptoms that are not associated with aggravation of primary disease or complications 
prior to usage of medical device and hospitalization that is planned prior to usage of medical 
device are not defined as adverse events. 
14.1.2 
Adverse Device/Drug Effect (ADE) 
An ADE is an adverse event (untoward medical occurrence) that is related to the investigational 
device and drug constituting the medical device. 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. This definition includes any 
event resulting from use error or from intentional misuse of the investigational medical device.   
14.2 Definition of Device Deficiencies 
Device deficiency is defined as the inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance. Device deficiencies include malfunctions, 
use errors, and inadequate labeling. 

 
 
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14.3 Definition of SAE, SADE, and USADE 
14.3.1 
Serious Adverse Event (SAE) 
An adverse event that:  
 Led to a death 
 Led to a serious deterioration in health of the subject, that either resulted in: 
o a life threatening illness or injury, or 
o a permanent impairment of a body structure or body function, or 
o in-patient or prolonged hospitalization, or 
o medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to body structure or a body function, 
 Led to fetal distress, fetal death, or a congenital abnormality or birth defect 
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. 
For the purpose of this trial, all myocardial infarctions, unscheduled revascularizations, and stent 
thromboses are classified as SAEs. 
14.3.2 
Serious Adverse Device/Drug Effect (SADE) 
An SADE is an adverse device effect that has resulted in any of the consequences characteristic 
of a serious adverse event. 
14.3.3 
Anticipated Serious Adverse Device/Drug Effect (ASADE) 
An SADE is an effect which by its nature, incidence, severity, or outcome has been previously 
identified in the risk analysis report or IB. 
14.3.4 
Unanticipated Serious Adverse Device/Drug Effect (USADE) 
An SADE is an effect which by its nature, incidence, severity or outcome has not been identified 
in the current version of the risk analysis report, IB, or labeling. 
Table 8: Categories of Adverse Events 
Adverse Events 
Non-device related 
Device-, Drug- or procedure-related 
Non-serious 
Adverse Event  
(AE)a 
Adverse Device/Drug Effect  
(ADE) 
Serious 
Serious Adverse Event 
(SAE)b 
Serious Adverse Device/Drug Effect  
(SADE) 
Anticipated 
Unanticipated 
Anticipated Serious 
Adverse Device/Drug 
Effect (ASADE) 
Unanticipated Serious 
Adverse Device/Drug 
Effect (USADE) 
a Includes all categories 
b Includes all categories that are serious 

 
 
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14.4 Time Period in Which the Investigator Shall Report All AE and Device 
Deficiencies to the ICCC (Quintiles) 
Each complication meeting the definition for SAE or device deficiency will be reported upon 
discovery to the ICCC (Quintiles) and within 24 hours of the Investigator’s knowledge of the 
event. The Investigator will further report the event or device deficiency to the IRB according to 
the institution’s IRB reporting requirements. The subject’s course must be monitored until the 
event has subsided or, in a case of permanent impairment, until the event stabilizes and the 
overall clinical outcome has been ascertained. 
14.5 Details of Process for Reporting AE and Device Deficiencies 
14.5.1 
Reporting AE and Device Deficiencies 
The Investigator will monitor the occurrence of adverse events or device deficiencies for each 
subject during the course of the trial. All adverse events (AEs) reported by the subject, observed 
by the Investigator, or documented in medical records will be recorded on the adverse event 
CRF, whether believed by the Investigator to be related or unrelated to the study stent and drug 
constituting the stent. Starting with the trial enrollment, any new event/experience that was not 
present at screening, or worsening of an event presents at baseline, is considered an adverse 
event. All adverse events will be monitored until they are adequately resolved or stabilized.  
Unchanged, chronic conditions are not adverse events and should not be recorded on the adverse 
event CRF. All unanticipated adverse device/drug effects and cardiac related serious adverse 
events will be collected and monitored throughout the entire course of the trial. Non-cardiac 
SAEs and AEs will be collected and monitored throughout the trial, i.e. until 5 years from 
enrollment. 
14.5.2 
Reporting USADE 
If the Investigator determines that an adverse event meets the definition of an unanticipated 
adverse device/drug effect, the Investigator must report the event to the Sponsor, preferably 
within 24 hours of the Investigators’ knowledge of the effect. The Primary Investigator must 
report the effect to the reviewing IRB according to the institution’s IRB reporting requirements. 
If the relationship of the unanticipated effect to the investigational device/drug is unknown, the 
Investigator is also required to follow these reporting obligations.  
The Sponsor will ensure that all reported USADEs and product experience handling reporting 
requirements are followed for the investigational device. 
RELATIONSHIP TO STUDY Device / Procedure / Drug should be reported with the following 
categories:   
 NOT RELATED: The event is clearly not related to the investigational 
device/procedure/drug. 
 UNLIKELY RELATED: The event is unlikely to be related to the investigational device/ 
procedure/drug. 

 
 
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 POSSIBLY RE LATED: The event is possibly related to the investigational device/ 
procedure/drug. 
 RELATED: The event is clearly related to the investigational device/ procedure/drug. 
AEs that were classified as “RELATED” and “POSSIBLY RELATED”, or undetermined 
relationship to the study device / drug are considered “related”, and are classified as adverse 
reactions. “UNLIKELY RELATED” and “NOT RELATED” events are regarded as AEs that 
can be denied a causal relationship to the study device / drug, that will be handled as “not related 
to study device / drug” for reporting purposes. 
14.6 List of Foreseeable AE and ADE 
Foreseeable adverse events and adverse device effects based on years of clinical experience with 
rapid exchange DES implantation are summarized in Error! Reference source not found.9. 
These events as well as mitigation or treatment are also included in the IB.  
Table 9: Foreseeable AE and ADE for DES Implantation 
Access site complications* 
Failure to deliver stent to intended site 
Acute myocardial infarction 
Fever or pyrogenic reactions 
Allergic reaction or hypersensitivity to stent 
components or contrast media 
Hypertension 
Hypotension 
Aneurysm 
Infections 
Angina pectoris 
Myocardial ischemia 
Anxiety 
Nausea and vomiting 
Bleeding complications which may require 
transfusions or surgical repair 
Palpitations 
Perforation of the heart or great vessels 
Need for CABG – emergent or non-emergent 
Pericardial effusion 
Cardiac arrhythmias 
Pulmonary failure 
Cardiac failure 
Renal failure 
Cardiac tamponade 
Stent compression 
Cardiac shock 
Stent misplacement / migration / embolization 
Coronary artery complications** 
Stent thrombosis 
Death 
Stroke / CVA / TIA 
Delayed endothelialization 
Vasovagal reaction 
Distal emboli 
Ventricular fibrillation 
Endocarditis 
Volume overload 
* includes arteriovenous fistula, hematoma, infection, nerve injury, pain, peripheral ischemia, phlebitis, pseudoaneurysm 
** includes abrupt closure, dissection, embolism, injury, perforation, plaque rupture/shift, restenosis, rupture, spasm, thrombosis, 
total occlusion 
Foreseeable adverse events for ridaforolimus are summarized in Error! Reference source not 
found.10. These events as well as mitigation or treatment are also included in the IB. Note: 
These Aes are based on experience with ridaforolimus in cancer trials where there is systemic 

 
 
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exposure in concentrations that are many fold greater than foreseeable with the MedJ-01. The 
Aes are included here for completeness. 
Table 10: Foreseeable AE and ADE for Ridaforolimus 
Anemia 
Hypertriglyceridemia 
Pyrexia 
Dehydration 
Mucosal inflammation 
Renal failure acute 
Diarrhea 
Nausea 
Stomatitis 
Febrile neutropenia 
Pneumonia 
Thrombocytopenia 
Hyperglycemia 
Pneumonitis 
Vomiting 
14.7 List of Foreseeable Device Deficiencies 
Foreseeable device deficiencies based on years of clinical experience with rapid exchange DES 
implantation are summarized in Error! Reference source not found.11. These events as well as 
mitigation or treatment are also included in the IB.  
Table 11: Foreseeable Device Deficiencies for DES Implantation 
Failure to deliver the stent to the intended site 
Balloon burst, tear 
Stent deform, migration, dropout, tear 
Balloon expansion defect, deflation defect 
Stent expansion defect  
Shaft breakage, damage 
Stent compression  
Failure to insert the catheter or pull it out 
Stent misplacement 
 
14.8 Emergency Contact Details for Reporting SAE and SADE 
When sites encounter trouble related to SAE reporting (e.g. when having trouble 
entering/submitting SAE related information on EDC or having trouble sending SAE form by 
fax while EDC is down due to technical trouble) please use the following methods to contact 
Quintiles Safety: 
* Please note that the contact information below should not be used to report the actual SAE. 
Contact Quintiles Safety by phone during business hours from Monday through Friday from 
9AM to 5PM. 
 Phone: 03-6859-9603  
Contact Quintiles Safety by e-mail out of business hours. 
 Email: qjpnsafety@quintiles.com 
14.9 Information Regarding the DSMB 
The Data Safety Monitoring Board (DSMB) is comprised of at least three members who are not 
directly involved in the conduct of the trial. The DSMB will review the trial on a periodic basis 
to be defined at their first meeting 

 
 
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All adverse events will be reported to the DSMB and reviewed on an on-going basis throughout 
the subject enrollment and follow-up period as specified in the DSMB charter to ensure the 
safety of subjects enrolled in this trial. The DSMB may request additional information as needed. 
Based on safety data, the DSMB may recommend that the Executive Committee modify or 
discontinue the trial. All final decisions, regarding trial modifications, however, rest with the 
Executive Committee. 
14.10 Adjudication of Clinical Endpoints 
The Clinical Event Committee (CEC) will review and adjudicate all clinical endpoint events.  
The CEC will as appropriate determine if the event occurred, (in the case of procedures) whether 
the procedure was clinically indicated vs. non-clinically indicated, if the event was cardiac or 
non-cardiac related, and if the event is target lesion/vessel related and if primary and/or 
secondary endpoints have occurred. Definitions are provided in Section  21.1. 
14.10.1 
Death 
The Clinical Events Committee (CEC) will adjudicate all subject deaths. 
14.10.2 
Myocardial Infarction 
The CEC will adjudicate all cases of myocardial infarction (MI) and the relationship of the event 
to the target vessel. If an angiogram is available for these events, the Angiographic Core 
Laboratory will provide information to the CEC as to the culprit lesions. All infarcts that cannot 
be clearly attributed to a vessel other than the target vessel will be considered related to the target 
vessel. The CEC will also adjudicate whether the MI was spontaneous or procedure-related. 
14.10.3 
Revascularization 
The Angiographic Core Laboratory will be responsible for reviewing all baseline procedure 
angiograms, as well as clinically-indicated and protocol-required angiograms during the follow-
up period, to characterize the target lesion. The Angiographic Core Laboratory will be 
responsible for adjudication of revascularization type (TLR, TVR, non-TVR) as well as 
angiographic evidence of stent thrombosis. The CEC will determine whether any 
revascularization event was ischemia driven.  
14.10.4 
Stent Thrombosis 
The CEC will adjudicate all cases of stent thromboses according to the ARC definitions for 
confirmation and outcomes. If an angiogram is available, the Angiographic Core Laboratory will 
provide their evaluation to the CEC.  
14.10.5 
Vascular and Bleeding Complications 
All vascular and bleeding complications that are reported as serious adverse events and/or 
require transfusion or surgical intervention will be adjudicated by the CEC. 

 
 
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14.10.6 
Other Adverse Events  
The Sponsor will submit other cases for CEC adjudication as necessary. Non-safety endpoint 
adverse events (including events associated with any standard usage of contrast agents) will not 
be provided to the CEC for adjudication.  
14.10.7 
Follow-up of Subjects after Adverse Events 
Subjects should be followed after adverse events until resolution or until end of trial, whichever 
comes first. Additional trial visits may be scheduled as necessary to allow for adequate 
follow-up. 
15 VULNERABLE POPULATION 
There is no expectation that any individuals from a vulnerable population will be approached for 
enrollment in the JNIR Trial. 
16 SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL 
INVESTIGATION 
There is no expectation that the JNIR Trial will encounter events or trial conduct that will lead 
the DMC or the Executive Committee to recommend termination. 
16.1 Criteria and Arrangements for Suspension or Premature Termination 
of the Clinical Investigation or of the Clinical Investigation in One or 
More Sites 
In case one or more sites are incapable of continuing to follow the patients in accordance with 
GCP (for example due to lack of staff), the site may be suspended or terminated by the Sponsor. 
Arrangements will then be made to reassign subjects to a nearby site, conditional to consent by 
the affected subjects. 
16.2 Requirements for Subject Follow-Up 
All patients will continue to receive standard of care follow-up in the event of suspension or 
premature termination of the clinical investigation. 
17 PUBLICATION POLICY 
17.1 Statement Indicating Whether the Results of the Clinical Investigation 
Will Be Submitted for Publication 
The Sponsor of this trial, recognizing the seminal importance of this investigation, is committed 
to the unrestricted and widespread dissemination of all primary and secondary endpoint results 
and tertiary analyses. At the conclusion of the trial, a multicenter abstract reporting the primary 
results will be prepared by the Principal Investigators (in collaboration with the Executive 
Committee) and presented at an annual scientific meeting. A multicenter publication will 

 
 
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similarly be prepared for publication in a reputable scientific journal. The publication of the 
principal results from any single center experience within the trial is not allowed until both the 
publication of the multicenter results.  
17.2 Statement Indicating the Conditions under Which the Results of the 
Clinical Investigation Will Be Offered for Publication 
Following analysis and presentation of the primary endpoint results, active participation of all 
committee members, Investigators from high enrolling sites, and core laboratory personnel will 
be solicited for data analysis and abstract and manuscript preparation. Submission of all abstracts 
and publications regarding the primary endpoint and secondary endpoints from the trial requires 
approval by the Executive Committee.  
18 COMPENSATION FOR HEALTH HAZARD 
1) Sponsor will compensate the subject based on the clinical trial insurance policy set when any 
kind of health hazard occurred due to the trial, except the case where the cause of the health 
hazard can be proved to be totally unrelated to the trial. 
2) When health hazard occurred due to the trial which lead to the subject to dispute with a third 
party, or likely lead to a dispute, clinical site and sponsor will discuss to support the subject to 
find a solution. 
3) The clinical trial insurance of the sponsor will be responsible for the indemnity liability 
caused by the health hazard of the trial except the case where the clinical site is found to be 
responsible.  
4) Sponsor will be responsible according to applicable law and regulation for the compensation 
caused by the health hazard of the trial according to the clinical trial insurance. 
5) Sponsor has to take measures such as preparing insurance to ensure sponsors legal liability. 
19 PRIVACY POLICY 
Identifying code will be assigned to each subject in the Case Report Form in order to protect the 
privacy of the subject.  For monitoring, audit and other operation, privacy of the subject will be 
protected.  All data collected in the Case Report Form will be used only for this trial.  For the 
publication of the trial result, privacy of subject will also be protected. 
 
 

 
 
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20 BIBLIOGRAPHY 
                                                 
 
 
1.  
Levine GN, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary 
Intervention: A Report of the American College of Cardiology Foundation/American 
Heart Association Task Force on Practice Guidelines and the Society for 
Cardiovascular Angiography and Interventions. J Am Coll Cardiol, 2011. 58(24): 
p. e44-e122. 
2.  
Garg S, Serruys PW. Coronary stents: current status. J Am Coll Cardiol, 2010. 56(10 
Suppl): p. S1-42. 
3.  
Holmes DR, et al. Stent thrombosis. J Am Coll Cardiol, 2010. 56(17): p. 1357-65. 
4.  
Mitsutake Y, et al. Coronary endothelial dysfunction distal to stent of first-generation drug-
eluting stents. JACC Cardiovasc Interv, 2012. 5(9): p. 966-73. 
5.  
Serruys PW, Kutryk MJB, Ong ATL. Coronary-Artery Stents. N Engl J Med, 2006. 354(5): 
p. 483-495. 
6.  
Dangas GD, et al. Frequency and predictors of stent thrombosis after percutaneous 
coronary intervention in acute myocardial infarction. Circulation, 2011. 123(16): 
p. 1745-56. 
7.  
Sievert H, Popma JJ. Nine-month outcomes in the treatment of stenotic lesions in de novo 
coronary arteries implanted with Presillion/Presillion Plus stent system: Results from 
the PIONIR Study. J Am Coll Cardiol, 2011. 57(14) Supplement: E1967. 
8. 
Guidelines for elective percutaneous coronary intervention in patients with stable coronary 
disease (JCS 2011) 
9.  
Stone GW, et al. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent 
in patients with coronary artery disease: A randomized trial. JAMA, 2008. 299(16): p. 
1903-13.   
10.  Stone GW, et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery 
disease. N Engl J Med, 2010. 362(18): p. 1663-74.  
11.  Stone GW, et al. A prospective, randomized evaluation of a novel everolimus-eluting 
coronary stent: the PLATINUM (a prospective, randomized, multicenter trial to assess 
an everolimus-eluting coronary stent system [PROMUS Element] for the treatment of 
up to two de novo coronary artery lesions) trial. J Am Coll Cardiol, 2011. 57(16): p. 
1700-8.  
12.  Yeung AC, et al. Clinical evaluation of the Resolute zotarolimus-eluting coronary stent 
system in the treatment of de novo lesions in native coronary arteries: the RESOLUTE 
US clinical trial. J Am Coll Cardiol, 2011. 57(17): p. 1778-83.  
13.  Serruys PW, et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary 
stents. N Engl J Med, 2010. 363(2): p. 136-46.  

 
 
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14.  Birgelen C, et al. A randomized controlled trial in second-generation zotarolimus-eluting 
Resolute stents versus everolimus-eluting Xience V stents in real-world patients : the 
TWENTE trial. J Am Coll Cardiol, 2012. 59(15): p. 1350-61. 
15.  Kedhi E, et al. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-
life practice (COMPARE): a randomised trial. Lancet, 2010. 375(9710): p. 201-9.  
16.  Smits PC, et al. Abluminal biodegradable polymer biolimus-eluting stent versus durable 
polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-
inferiority trial. Lancet, 2013. 381(9867): p. 651-60. 

 
 
 
 
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21 DEFINITIONS AND ACRONYMS 
21.1 Definitions 
ABRUPT CLOSURE 
 
Abrupt closure is defined as the occurrence of new (during the baseline 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 connote “no reflow” due to microvascular flow limitation, in which the 
epicardial artery is paten but had reduced flow. Abrupt closure also does not connote 
transient closure with reduced flow in which the baseline treatment application reverses 
the closure. 
 
Sub-abrupt closure is defined as abrupt closure that occurred after the baseline procedure 
is completed and the patient left the catheterization laboratory and before the 30-day 
follow-up evaluation. 
 
Threatened abrupt closure is defined as a grade B dissection and ≥50% diameter stenosis 
or any dissection of grade C or higher. 
ACUTE CORONARY SYNDROME 
Acute coronary syndrome (ACS) refers to a spectrum of clinical presentations ranging from 
those for ST-segment elevation myocardial infarction (STEMI) to presentations found in non–
ST-segment elevation myocardial infarction (NSTEMI) or in unstable angina. For the purpose of 
this CIP, ACS will be defined as hospitalization for angina pain or discomfort within the 
previous 24 hours to their hospitalization with any one (or more) of the following criteria: 
 
Elevated troponin or creatine kinase-MB (CK-MB) consistent with MI, as reported by 
local laboratory and measured prior to baseline PCI 
 
Electrocardiographic changes (including transient changes) comprising new or 
presumably new ST segment depression ≥ 0.1 mV (≥ 1 mm), or ST segment elevation ≥ 
0.1 mV (≥ 1 mm) in at least 2 contiguous leads, or new or presumably new Left Bundle 
Branch Block 
ACUTE SUCCESS 
Acute Success is classified according to the following definitions: 
 
Device Success 
Device success is defined as achievement of a final in-stent residual diameter stenosis of 
<50% (by QCA), using the assigned device only and without a device malfunction.  
 

 
 
 
 
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 
Lesion Success 
Lesion success is defined as achievement of a final in-stent residual diameter stenosis of 
<50% (by QCA) using any percutaneous method. 
 
Procedure Success 
Procedure success is defined as achievement of a final in-stent diameter stenosis of <50% 
(by QCA) using the assigned device and/or with any adjunctive devices, without the 
occurrence of cardiac death, Q wave or non-Q wave MI, or repeat revascularization of the 
target lesion during the hospital stay. 
ADVERSE DEVICE/DRUG EFFECTS 
See Section  14 for definitions of adverse device/drug effects (serious, anticipated, and 
unanticipated) 
ADVERSE EVENTS  
See Section  14 for definitions of adverse events (non-serious and serious) 
ANALYSIS DATA SETS 
Full Analysis Set (FAS) 
Patients are considered enrolled after the guidewire has successfully been passed beyond the 
target lesion. If the study stent could not be implanted due to reasons that are not related to study 
device, the patient will be de-registered and will not be considered part of the full analysis set. 
Patients not receiving the study stent after it has been advanced beyond the guiding catheter will 
be analyzed in the full analysis set. Patients enrolled in the trial with major deviations will also 
be analyzed in the full analysis set. 
Per Protocol (PP Population) 
Patients who receive the study stent with no major protocol deviations as detailed in section 7.1 
will be included in the Per Protocol Analysis Set. 
Safety Analysis Set 
The safety analysis set will include all subjects who signed an informed consent and have had 
any trial related activities including de-registered subjects. 
ANGINA PECTORIS 
CCS Classification of Stable Angina 
I. 
Ordinary physical activity does not cause angina, such as walking or climbing stairs. 
Angina occurs with strenuous or rapid or prolonged exertion at work or recreation. 
II. 
Slight limitation of ordinary activity. Angina occurs 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 few hours after awakening. Angina occurs if 

 
 
 
 
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walking more than two blocks on the level or climbing more than one flight of ordinary 
stairs at a normal pace and in normal conditions. 
III. Marked limitation of ordinary activity. Angina occurs upon walking one or two blocks 
on the level or climbing one flight of stairs in normal conditions and at a normal pace. 
IV. Inability to carry on any physical activity without discomfort. Angina syndrome may be 
present at rest. 
Braunwald Classification of Unstable Angina 
Severity 
Clinical Circumstances
A
B
C 
Develops in presence of 
extracardiac condition 
that intensifies 
myocardial ischemia 
(secondary UA) 
Develops in the 
absence of 
extracardiac 
condition  
(primary UA) 
Develops within 2 
weeks after acute 
myocardial infarction 
(post infarction UA) 
I 
New onset of severe angina 
or accelerated angina; no 
rest pain1 
IA 
IB 
IC 
II 
Angina at rest within past 
month but not within 
preceding 48 hours (angina 
at rest, subacute) 
IIA 
IIB 
IIC 
III 
Angina at rest within 
48 hours (angina at rest, 
acute) 
IIIA 
IIIB 
IIIC 
1 Subjects with new onset (< 2 months in duration) exertional angina pectoris that is severe or frequent 
(>3 episodes/day) or subjects with chronic stable angina who develop accelerated angina (that is, angina 
distinctly more frequent, severe, longer in duration, or precipitated by distinctly less exertion than previously) 
but who have not experienced pain at rest during the preceding 2 months. 
BLEEDING (HEMORRHAGIC) COMPLICATIONS 
Bleeding will be classified and reported by both the TIMI bleeding classification and the BARC 
classification. 
TIMI Bleeding Classification  
Major: 
Intracranial or clinically significant overt signs of hemorrhage associated with a 
hemoglobin decrease greater than 5g/L*.The diagnosis of intracranial bleeding 
requires confirmation by computed tomography or magnetic resonance imaging 
of the head.  
Minor:   
Observed blood loss and a decrease in hemoglobin level of 3 to 5 g/dL* 
Bleeding Academic Research Consortium (BARC) Classification: 
Type 0 
No bleeding 
Type 1 
Bleeding that is not actionable and does not cause the patient to seek unscheduled 

 
 
 
 
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performance of studies, hospitalization, or treatment by a health care professional.  May 
include episodes leading to self-discontinuation of medical therapy by the patient, 
without consulting a health care professional. 
Type 2 
Any overt, actionable sign of hemorrhage (e.g. more bleeding than would be expected 
for a clinical circumstance; including bleeding found by imaging alone) that does not fit 
the criteria for Types 3, 4, or 5 but does meet at least one of the following criteria: 
 
Requiring non-surgical, medical intervention by a health care professional 
 
Leading to hospitalization or increased level of care 
 
Prompting evaluation 
Type 3a 
 
Overt bleeding plus hemoglobin drop of 3 to <5** g/dL (provided hemoglobin drop 
is related to bleed) 
 
Any transfusion with overt bleeding 
Type 3b 
 
Overt bleeding plus hemoglobin drop ≥5** g/dL (provided hemoglobin drop is 
related to bleed) 
 
Cardiac tamponade 
 
Bleeding requiring surgical intervention for control (excluding dental / nasal / skin / 
hemorrhoid) 
 
Bleeding requiring intravenous vasoactive agents 
Type 3c 
 
Intracranial 
hemorrhage 
(does 
not 
include 
microbleeds 
or 
hemorrhagic 
transformation; does include intraspinal) 
o Subcategories: confirmed by autopsy or imaging or LP 
 
Intra-ocular bleed compromising vision 
Type 4 
CABG-related bleeding 
 
Perioperative intracranial bleeding within 48 hours 
 
Reoperation following closure of sternotomy for the purpose of controlling bleeding 
 
Transfusion of ≥ 5 units of whole blood or packed red blood cells within 48 hour 
period* 
 
Chest tube output ≥ 2 L within a 24 hour period 
Type 5a 
Probable fatal bleeding; no autopsy or imaging confirmation, but clinically suspicious 
Type 5b 
Definite fatal bleeding: overt bleeding or autopsy or imaging confirmation 
Obs: Platelet transfusions should be recorded and reported, but are not included in these definitions until further 
information is obtained about the relationship to outcomes. 
* Cell saver products will not be counted. 
** Corrected for transfusion (1 unit PRBC or 1 unit of whole blood = 1 g/dL Hgb) 
CEREBROVASCULAR ACCIDENT (CVA) (See STROKE) 
 
Ischemic stroke (cerebral infarction); or 
 
Hemorrhagic stroke (intracerebral hemorrhage or subarachnoid hemorrhage). 
CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) 
Acute CABG is defined as immediate transfer from the cath lab to the operative room for 
emergent bypass surgery during the initial treatment phase. 

 
 
 
 
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CABG during follow-up is only considered as a clinical-indicated Target Lesion 
Revascularization if coronary angiography indicates a diameter of stenosis greater than 50% of 
the stented coronary segment associated with one of the following conditions: 
 
A positive history of recurrent angina pectoris presumably related to the target vessel.  
 
Objective signs of ischemia (exercise test or equivalent) presumably related to the target 
vessel. 
 
Abnormal results of any invasive functional diagnostic test (e.g. Doppler flow velocity 
reserve, fractional flow reserve).  
DEATH (per ARC definition, Circulation 2007;115:2344-51) 
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 proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), 
unwitnessed death and death of unknown cause, all procedure related deaths including those 
related to concomitant treatment. 
Vascular death: 
Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary 
embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. 
Non-cardiovascular death: 
Any death not covered by the above definitions such as death caused by infection, malignancy, 
sepsis, pulmonary causes, accident, suicide or trauma. 
DEVICE DEFICIENCY  
See Section  14 for definition of device deficiency. 
DIABETES MELLITUS (DM)  
History of diabetes mellitus. The condition will be further categorized as treated by diet, oral 
hypoglycemic medications, or insulin. 
DISSECTION  
NHLBI Dissection Classification System: 
 
Grade A: Minor radiolucencies within the lumen during contrast injection with no 
persistence after dye clearance. 
 
Grade B: Parallel tracts or double lumen separated by a radiolucent area during contrast 
injection with no persistence after dye clearance. 

 
 
 
 
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 
Grade C: Extraluminal cap with persistence of contrast after dye clearance from the 
lumen. 
 
Grade D: Spiral luminal filling defects. 
 
Grade E: New persistent filling defects. 
 
Grade F: Non-A-E types that lead to impaired flow or total occlusion. 
Note: Grade E and F dissections may represent thrombus. 
DISTAL EMBLOIZATION  
Distal embolization is defined as new abrupt cut off or filling defect distal to the treated lesion. 
IN-STENT RESTENOSIS - MEHRAN CLASSIFICATION [20] 
 
Class I: Focal ISR group. Lesions are 10 mm in length and are positioned at the 
unscaffolded segment (i.e., articulation or gap), the body of the stent, the proximal or 
distal margin (but not both), or a combination of these sites (multifocal ISR); 
 
Class II: “Diffuse intra-stent” ISR. Lesions are >10 mm in length and are confined to the 
stent(s), without extending outside the margins of the stent(s). 
 
Class III: “Diffuse proliferative” ISR. Lesions are >10 mm in length and extend beyond 
the margin(s) of the stent(s).  
 
Class IV: ISR with “total occlusion.” Lesions have a TIMI flow grade of 0. 
MAJOR EPICARDIAL VESSELS 
 
Left anterior descending artery (LAD) with septal and diagonal branches; 
 
Left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches; 
 
Right coronary artery (RCA) and any of its branches. 
MAJOR ADVERSE CARDIAC EVENTS (MACE) 
The composite rate of cardiac death, any MI or ischemia-driven TLR 
MINIMUM LUMEN DIAMETER (MLD) 
MLD is defined 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 angiography by the Investigator; it is measured during QCA by the Angiographic Core 
Laboratory. 
MYOCARDIAL INFARCTION (MI)  
Post-PCI (Type 4a) and post-CABG (Periprocedural) Mis (Type 5):  
Periprocedural MIs will be defined based on the SCAI definitions [21] as follows: 
                                                 
 
 
20 Mehran R, Dangas G, Abizaid AS, et al. Angiographic patterns of In-stent restenosis: Classification and 
implications for long-term outcome. Circulation. 1999. 100: p. 1872-78. 

 
 
 
 
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1) 
In patients with normal baseline CK-MB: The peak CK-MB measured within 48 hours 
of the procedure rises to ≥10x the local laboratory ULN, or to ≥5x ULN with new 
pathologic Q-waves in ≥2 contiguous leads or new persistent LBBB, OR in the absence 
of CK-MB measurements and a normal baseline cTn, a cTn (I or T) level measured 
within 48 hours of the PCI rises to ≥70x the local laboratory ULN, or ≥35x ULN with 
new pathologic Q-waves in ≥2 contiguous leads or new persistent LBBB. 
2) 
In patients with elevated baseline CK-MB (or cTn) in whom the biomarker levels are 
stable or falling: The CK-MB (or cTn) rises by an absolute increment equal to those 
levels recommended above from the most recent pre-procedure level. 
3) 
In patients with elevated CK-MB (or cTn) in whom the biomarker levels have not been 
shown to be stable or falling: The CK-MB (or cTn) rises by an absolute increment equal 
to those levels recommended above plus new ST-segment elevation or depression plus 
signs consistent with a clinically relevant MI, such as new onset or worsening heart 
failure or sustained hypotension. 
In addition the following additional definitions will be used to assess peri-procedural 
MIs for the purpose of sensitivity analyses: 
 The Universal Definition of MI definition (JACC Vol. 60, 2012) 
 A modification of the SCAI definition of periprocedural MI that utilizes a threshold 
CK-MB of ≥5x ULN (rather than ≥10x) in subjects with a normal baseline CK-MB 
without a requirement for associated clinical signs or symptoms 
 A modification of the SCAI definition of periprocedural MI that utilizes a threshold 
CK-MB of ≥3x (rather than ≥10x) in subjects with a normal baseline CK-MB 
without a requirement for associated clinical signs or symptoms 
Spontaneous MI (MI Type I):  
Spontaneous MI (MI Type I) will be defined based on the Universal Definition of Myocardial 
Infarction [22] as follows: 
Symptoms suggestive of ischemia/infarction in association with ECG, cardiac biomarker or 
pathologic evidence of infarction as follows: 
 
Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin T 
or I) with at least one value above the 99th percentile upper reference limit and with at 
least one of the following: 
 
Symptoms of ischemia 
                                                                                                                                                             
 
 
21 Moussa, ID, et al. Consideration of a new definition of clinically relevant myocardial infarction after coronary 
revascularization an expert consensus document from the society for cardiovascular angiography and 
interventions (SCAI). Catheter Cardiovasc Interv, 2013. 
22 Thygesen, K, et al. Third universal definition of myocardial infarction. J Am Coll Cardiol, 2012. 60(16): 
p. 1581-98. 

 
 
 
 
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 
New or presumed new significant ST segment-T wave (ST-T) changes or new LBBB 
 
Development of new Q waves in the ECG 
 
Imaging evidence of new loss of viable myocardium or new regional wall motion 
abnormality 
 
Identification of an intracoronary thrombus by angiography or autopsy 
Spontaneous MI typically occurs after the periprocedural period and may be secondary to late 
stent complications or progression of native disease (e.g., non-culprit lesion plaque rupture). 
Performance of ECG and angiography supports adjudication to either a target or non-target 
vessel or lesion in most cases.  
 NO-REFLOW 
An acute reduction in coronary flow (TIMI grade 0-1) in the absence of dissection, thrombus, 
spasm, or high-grade residual stenosis at the original target lesion. Also see ‘Acute Closure’. 
PERCENT DIAMETER STENOSIS (%DS) 
The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views 
(when possible) by QCA. 
PERCUTANEOUS CORONARY INTERVENTION (PCI) 
Refers to all interventional cardiology methods for treatment of coronary artery disease. 
PERFORATION 
Perforations will be classified as follows: 
 
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, 
abrupt closure, myocardial infarction, or death. 
 
Pericardial hemorrhage/tamponade: perforation resulting in cardiac tamponade. 
PERSISTING DISSECTION 
Dissection at follow-up that was present post baseline procedure. 
PRIMARY INVESTIGATOR 
The physician responsible for conducting the clinical trial at each investigational site. 
PRINCIPAL INVESTIGATOR 
A physician-specialist, related to the trial, who is responsible for the overall conduct of the trial 
at all sites and compliance with clinical investigation plan and relevant regulations.  
PROTOCOL DEVIATIONS - MAJOR 
Major protocol deviations include, but are not limited to, enrollment of a subject: 
 
whose informed consent was not properly obtained 

 
 
 
 
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 
who did not meet all of the inclusion or exclusion criteria 
 
who did not receive the study stent 
 
who did not receive at least 12 months of DAPT post baseline procedure 
REFERENCE VESSEL DIAMETER (RVD) 
Average diameter of proximal and distal healthy segments by QCA. 10 mm “normal” reference 
segments are selected proximal and distal to the stenosis and averaged to define the reference 
vessel diameter. A computer-defined interpolated normal segment will be used to calculate 
percent diameter stenosis. 
RESTENOSIS 
Re-narrowing of the artery following the removal or reduction of a previous narrowing.  
REVASCULARIZATION (per ARC definition, Circulation 2007;115:2344-51) 
Target Lesion Revascularization (TLR) 
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of 
the target vessel performed for restenosis or other complication of the target lesion. All TLR 
should be classified prospectively as clinically indicated (CI) or not clinically indicated by the 
investigator prior to repeat angiography. An independent Angiographic Core Laboratory should 
verify that the severity of percent diameter stenosis meets requirements for clinical indication 
and will overrule in cases where investigator reports are not in agreement. The target lesion is 
defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent. 
Target Vessel Revascularization (TVR) 
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the 
target vessel). The target vessel is defined as the entire major coronary vessel proximal and distal 
to the target lesion, which includes upstream and downstream branches, and the target lesion 
itself.  
Non Target Lesion Revascularization (Non-TLR) 
Any revascularization in the target vessel for a lesion other than the target lesion is considered a 
non-TLR. 
Non Target Vessel Revascularization (Non-TVR) 
Any revascularization in a vessel other than the target vessel is considered a non-TVR. 
Clinically Driven Revascularization (TLR/TVR) 
Revascularization at the target site (TLR) or in the target vessel (TVR) that is associated with:  
 
A positive functional ischemia study or ischemic symptoms; AND  angiographic lumen 
minimal lumen diameter stenosis ≥50% by QCA; OR  
 
A TLR or TVR with a diameter stenosis ≥ 70% by QCA without either angina or a 
positive functional study.  

 
 
 
 
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SERIOUS ADVERSE DEVICE/DRUG EFFECT 
See Section  14 for definitions of adverse device/drug effects (serious, anticipated, and 
unanticipated) 
SERIOUS ADVERSE EVENT (SAE) 
See Section  14 for definitions of adverse events (non-serious and serious) 
STENT THROMBOSIS (per ARC definition, Circulation 2007;115:2344-51) 
Stent Thrombosis should be reported as a cumulative value at the different time points and with 
the different separate time points. Time 0 is defined as the time point after the guiding catheter 
has been removed and the patient left the catheterization lab after the baseline procedure.  
Timing 
Acute 
Subacute 
Late 
Very late  
≤ 24 hours post stent implantation 
> 24 hours to 30 days post stent implantation 
> 30 days to 1 year post stent implantation 
> 1 year post stent implantation 
Type 
Primary 
Occurs in target lesion or margins after baseline procedure 
 
Secondary 
Occurs after revascularization (TLR, TVR, or non-TVR) 
Category 
Definite 
Definite stent thrombosis is confirmed by either angiographic* or pathologic† analysis 
 
Probable 
Probable stent thrombosis is considered to have occurred after intracoronary stenting for 
either: 
 any unexplained death within the first 30 days unless that patient had baseline 
procedure for ST elevation MI 
 any MI, irrespective of time after baseline procedure, that is related to documented 
acute ischemia in the territory of the implanted stent without angiographic 
confirmation of stent thrombosis and in the absence of any other obvious cause 
 
Possible 
Possible stent thrombosis is considered to have occurred with any unexplained death 
from 30 days after intracoronary stenting until end of trial follow-up 
*Angiographic confirmation of stent thrombosis 
The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or 
distal to the stent and presence of at least one of the following criteria within a 48-hour time window:  
 Acute onset of ischemic symptoms at rest – The incidental angiographic documentation of stent occlusion 
in the absence of clinical signs or symptoms is not considered a confirmed stent thrombosis (silent 
occlusion)  
 New ischemic ECG changes that suggest acute ischemic  
 Typical rise and fall in cardiac biomarkers (refer to spontaneous MI definition) 
 Intracoronary thrombus is defined as a spheric, ovoid, or irregular noncalcified filling defect or lucency 
surrounded by contrast material on 3 sides or within a coronary stenosis seen in multiple projections, or 
persistence of contrast material within the lumen, or a visible embolization of intraluminal material 
downstream.  
 Nonocclusive or occlusive thrombus  
 TIMI 0 or TIMI 1 intrastent or proximal to a stent up to the most adjacent proximal side branch or main 
branch if originates from the side branch.  
†Pathological confirmation of stent thrombosis  
Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved 
following thrombectomy.  

 
 
 
 
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STROKE 
Stroke is defined as the 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 >24 hours. 
SUBINVESTIGATOR 
A physician-member of a clinical study team who administers investigational products, used in 
the clinical trial, to a subject. 
SUCCESSFUL PRE-DILATION 
Pre-dilation has been successfully completed without complications if all of the following apply: 
 
Diameter stenosis < 50% 
 
TIMI Grade III flow 
 
Lesion length still within the requirements of the protocol 
 
No angiographic complications or prolonged chest pain 
TARGET LESION 
Lesion that has met the angiographic inclusion and exclusion criteria and that is to be treated 
during the baseline procedure.  
TARGET LESION FAILURE (TLF) 
The composite rate of cardiac death, target-vessel MI or ischemia-driven TLR 
TARGET VESSEL 
The entire epicardial vessel in which the treated lesion is located. 
TARGET VESSEL FAILURE (TVF) 
The composite rate of death, target vessel-related MI or ischemia-driven TVR 
TIMI FLOW GRADES  
0. 
No contrast flow through the stenosis. 
1. 
A small amount of contrast flows through the stenosis but fails to fully opacify the 
artery beyond. 
2. 
Contrast material flows through the stenosis to opacify the terminal artery segment. 
However, contrast enters the terminal segment perceptibly more slowly than more 
proximal segments. Alternatively, contrast material clears from a segment distal to a 
stenosis noticeably more slowly than from a comparable segment not preceded by a 
significant stenosis. 
3. 
Anterograde flow into the terminal coronary artery segment through a stenosis is as 
prompt as anterograde flow into a comparable segment proximal to the stenosis. 
Contrast material clears as rapidly from the distal segment as from an uninvolved, more 
proximal segment. 
 

 
 
 
 
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VASCULAR COMPLICATIONS 
These may include access-site hematoma, pseudoaneurysm, arteriovenous fistula, peripheral 
ischemia or nerve injury. 
 
 

 
 
 
 
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21.1.1 
Acronyms 
Acronym 
Term 
ACE 
Angiotensin Converting Enzyme 
ACS 
Acute Coronary Syndrome 
ADE / SADE 
Adverse Device/Drug Effect / Serious Adverse Device/Drug Effect 
AE / SAE 
Adverse Event / Serious Adverse Event 
ARB 
Angiotensin Receptor Blocker 
ASADE / USADE 
Anticipated Serious Adverse Device Effect / Unanticipated Serious 
Adverse Device Effect 
BMS 
Bare Metal Stent 
CABG 
Coronary Artery Bypass Graft 
CAD 
Coronary Artery Disease 
CAPA 
Corrective and Preventative Action 
CEC 
Clinical Events Committee 
CK 
Creatine Kinase 
CK-MB 
Creatine Kinase Muscle-Brain Isoenzyme 
CoCr 
 
Cobalt Chromium 
CRF / eCRF 
Case Report Form / electronic Case Report Form 
cTn 
Cardiac troponin 
CTO 
Chronic Total Occlusion 
DAPT 
Dual Antiplatelet Therapy 
DSMB 
Data Safety Monitoring Board 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
EES 
Everolimus-eluting Stent 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
FFR 
Fractional Flow Reserve 
IB 
Investigator’s Brochure 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
IVUS 
Intravascular Ultrasound 

 
 
 
 
JNIR01 Protocol, version 2.0, 18-Sep-2016 
  
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Acronym 
Term 
LAD 
Left Anterior Descending Artery 
LCX 
Left Circumflex 
LVEF 
Left Ventricular Ejection Fraction 
MACE 
Major Adverse Cardiac Events 
MI 
Myocardial Infarction 
MLD 
Minimum Luminal Diameter 
mTOR 
Mammalian Target of Rapamycin 
NIH 
Neointimal Hyperplasia (IVUS) 
NSTEMI 
Non ST Elevation Myocardial Infarction 
PBMA 
poly n-butyl methacrylate 
PCI 
Percutaneous Coronary Intervention 
PMA 
Premarket Approval 
PP 
Per Protocol Analysis Dataset 
PTCA 
Percutaneous Transluminal Coronary Angioplasty 
QCA 
Quantitative Coronary Angiography 
RCA 
Right Coronary Artery 
RES 
Ridaforolimus-eluting Stent 
RVD 
Reference Vessel Diameter 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
STEMI 
ST Elevation Myocardial Infarction 
TLF 
Target Lesion Failure 
TLR 
Target Lesion Revascularization 
TVF 
Target Vessel Failure 
TVR 
Target Vessel Revascularization 
USADE 
Unanticipated Serious Adverse Device/Drug Effect 
ZES 
Zotarolimus-eluting Stent 
 
 

 
 
 
 
JNIR01 Protocol, version 2.0, 18-Sep-2016 
  
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21.1.2 
Abbreviations from Clinical Trials, Academic Bodies, or Regulations 
Abbreviation 
Term 
ACC / AHA / SCAI 
American College of Cardiology / American Heart Association / 
Society for Cardiovascular Angiography and Interventions (dual anti-
platelet therapy guideline) 
ARC 
Academic Research Consortium (definitions for bleeding, death, 
myocardial infarction, and stent thrombosis)  
BARC 
Bleeding Academic Research Consortium (BARC) (classification for 
bleeding) 
CCS 
Canadian Cardiovascular Society (angina grading scale) 
HIPAA 
Health Insurance Portability and Accountability Act (U.S. privacy 
rule for protected health information ) 
JAAC 
Journal of the American College of Cardiology 
JCS 
 
Japanese Circulation Society 
MHLW 
Ministry of Health, Labour and Welfare (Japan) 
NHLBI 
National Heart, Lung, and Blood Institute (coronary artery dissection 
scale) 
NYHA 
New York Heart Association (heart failure classification) 
TIMI 
Thrombolysis In Myocardial Infarction (bleeding definition and 
coronary artery blood flow scale) 
 
 
 

 
 
 
 
JNIR01 Protocol, version 2.0, 18-Sep-2016 
  
Page 83 of 83 
 
Appendix 1: Primary Investigators in JNIR Study 
Primary Investigator 
Specialty 
Institution 
Institution’s Address 
Dr. Shigeru Saito 
Interventional 
Cardiologist 
Shonan Kamakura 
General Hospital 
1370-1 Okamoto, 
Kamakura-City, 
Kanagawa 
Dr. Seiji Yamazaki 
Interventional 
Cardiologist 
Sapporo Higashi 
Tokushukai Hospital 
3-1, Kita 33-jo Higashi 
14-chome, Higashi-ku, 
Sapporo, Hokkaido 
Dr. Atsuo Namiki 
Interventional 
Cardiologist 
Kanto Rosai Hospital 
1-1 Kizukisumiyoshi-
cho, Nakahara-ku, 
Kawasaki City, 
Kanagawa Prefecture 
Dr. Yoshisato Shibata 
Interventional 
Cardiologist 
Miyazaki Medical 
Association Hospital 
738-1 Funado, 
Shinbeppu-cho, 
Miyazaki City, 
Miyazaki Prefecture 
Dr. Satoru Otsuji 
Interventional 
Cardiologist 
Higashi Takarazuka 
Satoh Hospital 
2-1 Nagao-cho, 
Takarazuka City, 
Hyogo Prefecture 
Dr. Shigeu Nakamura 
Interventional 
Cardiologist 
Kyoto Katsura Hospital 
17 Yamadahirao-cho, 
Nishikyo-ku, Kyoto 
City, Kyoto-fu 
Dr. Akihiko Takahashi 
Interventional 
Cardiologist 
Takahashi Hospital 
5-18-1 Oike-cho, 
Suma-ku, Kobe City, 
Hyogo Prefecture 
Dr. Tomohiro Kawasaki 
Interventional 
Cardiologist 
Shin Koga Hospital 
120 Tenjin-machi, 
Kurume City, Fukuoka 
Prefecture 
Dr. Yasuhiro Makita 
Interventional 
Cardiologist 
Hospital Hakodate 
Hokkaido 
1-10-1 Minato-cho, 
Hakodate City, 
Hokkaido