NIRTRAKS - (NIRxcell TRial for a Post mArKet Study)
Phase: NA
Conditions: de Novo Stenotic Lesions in Native Coronary Arteries
Sponsor: Medinol Ltd.

 
 
 
 
 
 
 
 
NIRTRAKS – (NIRxcell TRial for a post mArKet Study) 
 
 
 
Clinical Protocol 
NIRxcell™ Stent System 
 
 
Study Number: CV103-02 
 
 
 
 
 
 
Revision history: 
Document #/Version/Date: 
CV103-02/ Version 1.2 / 03 March 2015 
Amended: 
 
Administrative Change: 
N/A 
 
 
CONFIDENTIAL 
DO NOT COPY 
 
This clinical protocol contains confidential information for use by the principal 
investigators and their designated representatives participating in this clinical 
investigation.  It should be held confidential and maintained in a secure location.  It should 
not be copied or made available for review by any unauthorized person or firm.  
 
NIRxcell™ is a trademark of Medinol Ltd., Israel.   
 
 
The protocol was developed in collaboration between Harvard Clinical Research Institute and Medinol. 
 

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Version 1.2 
NIRTRAKS –(NIRxcell TRial for a post mArKet Study)– Protocol Signature Page 
 
Site Name: ______________________________ 
 
Investigator’s Responsibility 
 
Prior to enrolling subjects in the NIRTRAKS Post-Market Study, the principal investigator must 
obtain written approval from his/her Institutional Review Board (IRB).  This approval must be in 
the principal investigator’s name and a copy sent to Medinol, among other essential documents, 
along with the IRB-approved informed consent and the signed clinical trial agreement.  
Additionally, the principal investigator must sign the declaration below:  
 
I have read this protocol and agree to adhere to the requirements.  I will provide copies of this 
protocol and all pertinent information to all site personnel involved in this study.  I will discuss 
this material with them and ensure they are fully informed regarding the investigational 
product and the conduct of the study. 
 
 
 
Date:
 
Principal Investigator’s Signature 
 
 
 
 
 
Principal Investigator’s Printed Name 
 
 
 
 
 
 
Date:
 
Sub- Investigator’s Signature 
 
 
 
 
 
Principal Investigator’s Printed Name 
 
 
 
 
 
 
 
Site Name 
Site # 
 
 
 

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Version 1.2 
 
CLINICAL INVESTIGATION PLAN REVISION SUMMARY 
 
Version 
Release 
Date 
Summary of Changes 
1.0 
To the FDA 
 
30-Oct-2014 
Initial Release 
1.1 
To the FDA 
12-Jan-2015 
Revisions made per FDA's requirements, as well as few 
corrections/clarifications added to the previous protocol version.  
See detailed list of changes below. 
1.2 
To the FDA 
03-Mar-2015 
Revisions made per FDA's requirements presented in the letter dated 
3 Feb, 2015. 
See detailed list of changes below. 
 
List of major changes versus Protocol ver. 1.1: 
 
Section (in 1.1 version) 
Revisions 
Rationale 
4.2 – Secondary Endpoints 
Addition of a secondary endpoint 
of TVF at 9 months 
Medinol’s answer to Q1 FDA 
letter dated Feb. 3, 2015 
4.2.4 
– All Cause MI at 30 Days, 
and 1, 2 and 3 Years 
Deletion of wording due to change 
of MI definition 
Medinol’s answer to Q3 FDA 
letter dated Feb. 3, 2015 
5.0 – Study Design 
Addition of 9 months follow‐up 
(FU) 
Medinol’s answer to Q1 FDA 
letter dated Feb. 3, 2015 
7.0 – Treatment Methodology  
Clarification that post procedure 
cardiac biomarkers will be 
routinely measured in all subjects 
Medinol’s answer to Q2 FDA 
letter dated Feb. 3, 2015 
9.0 – Follow‐Up Assessments  
Addition of a follow‐up telephone 
contact at 9 months 
Medinol’s answer to Q1 FDA 
letter dated Feb. 3, 2015 
9.0 – Follow‐Up Assessments 
Clarification that post procedure 
cardiac biomarkers will be 
routinely measured in all subjects 
Medinol’s answer to Q2 FDA 
letter dated Feb. 3, 2015 
12.1 – Determination of 
Performance Metrics 
Removal of the adjustment for 
non‐clinically relevant 
periprocedural MI 
Medinol’s answer to Q3 FDA 
letter dated Feb. 3, 2015 
 
Post‐procedure cardiac 
biomarkers will be routinely 
collected in all subjects as 
was done in the reference 
studies. Therefore, there is 
no need to adjust the 
periprocedural MI rates in 
the reference studies. 

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Version 1.2 
12.1 – Determination of 
Performance Metrics 
Table 5 
Updating the adjusted TVF rates in 
Table 5 to reflect the removal of 
the adjustment for non‐clinically 
relevant periprocedural MI 
Medinol’s answer to Q3 FDA 
letter dated Feb. 3, 2015 
12.1 – Determination of 
Performance Metrics 
Updating the meta‐analysis rate of 
3‐year TVF to 23.2% 
Medinol’s answer to Q3 FDA 
letter dated Feb. 3, 2015 
 
Following the removal of the 
adjustment for non‐clinically 
relevant periprocedural MI 
and the updated TVF rates in 
Table 5. 
12.2 – Performance Goal  
Updating the performance goal to 
34.8% 
Medinol’s answer to Q1 FDA 
letter dated Feb. 3, 2015 
To reflect the updated meta‐
analysis rate 
12.3 – Primary Endpoint and 
Sample Size Calculation 
Updating the power to 83% 
Medinol’s answer to Q1 FDA 
letter dated Feb. 3, 2015 
To reflect the  updated 
meta‐analysis rate and 
updated performance goal 
12.7 – Analysis of Primary 
Endpoint 
Updating the performance goal to 
34.8% 
Medinol’s answer to Q1 FDA 
letter dated Feb. 3, 2015 
12.9 – Analysis of secondary 
endpoint 
Addition of TVF at 9 months 
Per Medinol’s response to 
FDA's Q1 
16.2 – Sponsor’s Responsibilities 
for Preparing and Submitting 
Reports 
Updating the timelines for 
submission of PAS Progress 
Reports 
Medinol’s answer to Q4 FDA 
letter dated Feb. 3, 2015 
Appendix 1‐P Study Definitions –
MI definition  
Updating the definition of 
periprocedural MI to follow the 
ARC definition rather than the new 
definition of clinically relevant MI 
Medinol’s answer to Q3 FDA 
letter dated Feb. 3, 2015 
Editorial/minor corrections 
throughout the protocol 
 
 
 

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Version 1.2 
Table of Contents: 
 
NIRTRAKS –(NIRXCELL TRIAL FOR A POST MARKET STUDY)– PROTOCOL SIGNATURE PAGE .. 2 
PROTOCOL SUMMARY .......................................................................................................................................... 7 
1 
INTRODUCTION AND RATIONALE ......................................................................................................... 13 
2 
DEVICE DESCRIPTION AND INTENDED USE ....................................................................................... 15 
2.1 
DEVICE DESCRIPTION .................................................................................................................................... 15 
2.2 
INTENDED USE OF THE DEVICE ...................................................................................................................... 16 
3 
PURPOSE AND OBJECTIVES ..................................................................................................................... 17 
4 
ENDPOINTS .................................................................................................................................................... 18 
4.1 
PRIMARY ENDPOINT ....................................................................................................................................... 18 
4.2 
SECONDARY ENDPOINTS ................................................................................................................................ 18 
4.2.1 
TVF AT 9 MONTHS .................................................................................................................................... 18 
4.2.2 
ALL CAUSE DEATH AT 30 DAYS, AND 1, 2 AND 3 YEARS .......................................................................... 18 
5 
STUDY DESIGN .............................................................................................................................................. 20 
5.1 
CONTROL OF SYSTEMATIC ERROR/BIAS ........................................................................................................ 20 
5.2 
ELIGIBILITY, EXCLUSIONS AND SUBJECT DISCONTINUATIONS ....................................................................... 20 
6 
CRITERIA OF ELIGIBILITY ....................................................................................................................... 23 
6.1 
INCLUSION CRITERIA ..................................................................................................................................... 23 
6.2 
EXCLUSION CRITERIA .................................................................................................................................... 23 
7 
TREATMENT METHODOLOGY ................................................................................................................ 26 
7.1 
SUBJECT SCREENING/ASSESSMENT ................................................................................................................ 27 
7.2 
PROCEDURAL INFORMATION .......................................................................................................................... 27 
7.3 
POST-PROCEDURE ASSESSMENT (HOSPITAL DISCHARGE) ............................................................................. 29 
8 
CONCOMITANT MEDICATIONS .............................................................................................................. 30 
9 
FOLLOW-UP ASSESSMENTS...................................................................................................................... 31 
9.1 
30-DAY (±2 WEEKS) CONTACT ...................................................................................................................... 31 
9.2 
9-MONTH (±1 MONTH) CONTACT .................................................................................................................. 31 
9.3 
1-YEAR (±1 MONTH) CONTACT ..................................................................................................................... 31 
9.4 
2-YEAR (±1 MONTH) CONTACT ..................................................................................................................... 31 
9.5 
3-YEARS (±1 MONTH) CONTACT ................................................................................................................... 31 
9.6 
UNSCHEDULED VISIT/PHONE FOLLOW UP ....................................................................................................... 31 
10 
TOTAL EXPECTED DURATION OF THE CLINICAL INVESTIGATION .......................................... 33 
11 
ADVERSE EVENTS ........................................................................................................................................ 34 
11.1 
DEFINITION OF ADVERSE EVENT AND SERIOUS ADVERSE EVENT ............................................................. 34 
11.2 
DEVICE DEFICIENCIES ............................................................................................................................... 35 
11.3 
DOCUMENTATION ..................................................................................................................................... 36 
11.4 
REPORTING OF ADVERSE EVENTS ............................................................................................................. 37 
11.5 
REPORTING OF STUDY ENDPOINT ADVERSE EVENTS ................................................................................ 39 
12 
STATISTICAL METHODS ........................................................................................................................... 40 
12.1 
DETERMINATION OF PERFORMANCE METRIC ............................................................................................ 40 
12.2 
PERFORMANCE GOAL ................................................................................................................................ 44 
12.3 
PRIMARY ENDPOINT AND SAMPLE SIZE CALCULATION ............................................................................. 44 
12.4 
ANALYSIS SETS ......................................................................................................................................... 45 

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12.5 
ENDPOINT ANALYSES AND REPORTING OF RESULTS ................................................................................. 45 
12.6 
ANALYSIS OF BASELINE DEMOGRAPHICS AND PROCEDURAL CHARACTERISTICS ..................................... 45 
12.7 
ANALYSIS OF PRIMARY ENDPOINT ............................................................................................................ 46 
12.8 
HANDLING OF MISSING DATA IN THE ANALYSIS OF THE PRIMARY ENDPOINT .......................................... 46 
12.9 
ANALYSIS OF SECONDARY ENDPOINTS ..................................................................................................... 47 
12.10 
PRE-PLANNED SUBGROUP ANALYSES ....................................................................................................... 47 
12.11 
ANALYSIS OF POOLABILITY OF DATA ACROSS STUDY SITES .................................................................... 47 
12.12 
CLINICAL EVENTS COMMITTEE ................................................................................................................. 48 
13 
DATA HANDLING AND RECORD KEEPING .......................................................................................... 49 
13.1 
SOURCE DOCUMENTS ................................................................................................................................ 49 
13.2 
ELECTRONIC CASE REPORT FORM ............................................................................................................ 49 
13.3 
DATA REVIEW ........................................................................................................................................... 50 
13.4 
RECORDS RETENTION ................................................................................................................................ 50 
13.5 
STUDY DEVICE ACCOUNTABILITY ............................................................................................................ 50 
14 
QUALITY CONTROL AND QUALITY ASSURANCE ............................................................................. 51 
14.1 
INVESTIGATIONAL SITE MONITORING AND AUDITING .............................................................................. 51 
14.2 
TRAINING .................................................................................................................................................. 51 
14.3 
PROTOCOL DEVIATIONS AND MEDICAL EMERGENCIES ............................................................................. 52 
14.4 
INVESTIGATIONAL SITE TERMINATION ...................................................................................................... 52 
15 
ETHICAL AND REGULATORY CONSIDERATIONS ............................................................................. 53 
15.1 
COMPLIANCE STATEMENT ......................................................................................................................... 53 
15.2 
INSTITUTIONAL REVIEW BOARD ............................................................................................................... 53 
15.3 
INFORMED CONSENT FORM ....................................................................................................................... 53 
15.4 
CONFIDENTIALITY ..................................................................................................................................... 54 
16 
REPORTING REQUIREMENTS .................................................................................................................. 55 
16.1 
INVESTIGATOR REPORTING RESPONSIBILITIES .......................................................................................... 55 
16.2 
SPONSOR REPORTING REQUIREMENTS ...................................................................................................... 56 
17 
REFERENCES ................................................................................................................................................. 58 
Appendix 1-P: Study Definitions ........................................................................................................................ 61 
 
 
 

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Version 1.2 
Protocol Summary  
STUDY TITLE 
NIRTRAKS Post-Market Study 
DEVICE(S) 
NIRxcell™ CoCr Coronary Stent on RX System (NIRxcell™ Stent 
System) 
REGULATORY 
STATUS 
Approved device: FDA approved (PMA# P110004/S001); CE marking 
since May 31, 2013; Israeli registration number 7840404 since March 11, 
2014. 
STUDY DESIGN 
This is a prospective, post-marketing, non-randomized, multi-center, 
single-arm clinical study that will be conducted at up to 15 sites in the 
United States (US). All subjects will be treated with the NIRxcell Stent 
System and followed at 30 days, 9 months and 1, 2 and 3 years post–
index stenting procedure. An unscheduled follow up may be conducted 
as clinically warranted.  
OBJECTIVE 
The main objective of this study is to collect and analyze additional 
information about the safety and effectiveness of the NIRxcell Stent 
System in the treatment of de novo stenotic lesions in native coronary 
arteries in the US population. The primary endpoint will be the rate of 
target vessel failure (TVF) at 3 years of treatment with the NIRxcell 
Stent System. This rate will be compared with a performance goal 
derived from a meta-analysis of coronary stenting with bare metal 
stents (BMS).  
STUDY HYPOTHESIS 
Medinol NIRTRAKS Post-Market Study will have a primary endpoint 
(TVF) rate less than 34.8% at 3 years, and by that will meet the 
performance goal for BMS. 
NUMBER OF 
SUBJECTS 
131 subjects will be enrolled to account for loss to follow-up, which is 
conservatively estimated at approximately 7.0% per year (resulting in 
105 evaluable subjects), at up to 15 sites in the US. 
PRIMARY ENDPOINT 
Target vessel failure, defined as a composite of cardiac death, target 
vessel myocardial infarction (MI), or clinically driven target vessel 
revascularization (TVR) by percutaneous or surgical methods within 3 
years post-procedure. 
SECONDARY 
ENDPOINTS 
1. TVF at 9 months 

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SECONDARY 
ENDPOINTS (CONT.) 
2. All-cause death at 30 days, and 1, 2 and 3 years. 
3. Cardiac death at 30 days, and 1, 2 and 3 years. 
4. All cause MI at 30 days, and 1, 2 and 3 years. 
5. Target vessel MI at 30 days, and 1, 2 and 3 years. 
6. Clinically driven target lesion revascularization (TLR) 
at 30 days, and 1, 2 and 3 years. 
7. Clinically driven TVR at 30 days, and 1, 2 and 3 years. 
8. Acute success rates  
a. Device success: Attainment of <50% final 
residual stenosis of the target lesion using 
only the NIRxcell Stent System. 
b. Lesion Success: Attainment of <50% final 
residual stenosis of the target lesion using any 
percutaneous method. 
c. Procedure Success: Attainment of <50% 
residual stenosis of the target lesion and no in-
hospital death, MI, or TLR. 
9. Stent thrombosis at hospital discharge, 30 days, and 1, 2 
and 3 years. 
SUBJECT 
POPULATION 
Subjects with symptomatic ischemic heart disease due to a single de 
novo stenotic lesion contained within a native coronary artery with a 
reference vessel diameter between 2.5 mm and 4.0 mm and lesion 
length ≤30 mm that is amenable to percutaneous revascularization with 
stent deployment. 
SAMPLE SIZE 
CONSIDERATIONS 
 3-year TVF rate for BMS derived from the meta-analysis is 
23.2% (95% CI 19.8%, 26.7%). 
 Performance goal for BMS = 34.8%.  
 Type I error (α) = 0.05 (one-sided). 
 Statistical power (1 – β) = 83%%. 
 Expected 3-year TVF rate for NIRxcell Stent System = 23.2%. 
An evaluable sample size of 105 provides 83% power to demonstrate 
that NIRxcell Stent System meets the performance goal for TVF. Thus, 
131 subjects will be enrolled to account for loss to follow-up, which is 
conservatively estimated at approximately 7% per year. 

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INCLUSION 
CRITERIA 
General Inclusion Criteria  
1. Subject is ≥18 years old. 
2. Subject is eligible for percutaneous coronary intervention (PCI). 
3. Subject is eligible for dual anti-platelet therapy (DAPT) with aspirin 
plus either clopidogrel, prasugrel or ticagrelor for a minimum of 1 
month. 
4. Subject understands the nature of the procedure and provides 
written informed consent prior to the catheterization procedure. 
5. Subject is willing to comply with specified follow-up evaluation 
and can be contacted by telephone. 
6. Subject is an acceptable candidate for coronary artery bypass graft 
(CABG) surgery. 
7. Subject has stable angina pectoris (Canadian Cardiovascular 
Society Classification [CCSC] 1, 2, 3 or 4) or unstable angina 
pectoris (Braunwald Class 1-3, B-C) or a positive functional 
ischemia study (e.g. exercise tolerance test [ETT], single-photon 
emission computerized tomography [SPECT], stress 
echocardiography or cardiac computerized tomography [CT]). 
8. Female subjects of child bearing potential must have a negative 
pregnancy test within 7 days prior to enrollment in the study. 
Angiographic Inclusion Criteria  
1. Subject is indicated for elective stenting of a single stenotic lesion 
in a native coronary artery. 
2. Reference vessel ≥2.5 mm and ≤4.0 mm in diameter by visual 
estimate. 
3. Target lesion ≤30 mm in length by visual estimate (the intention 
should be to cover the whole lesion with 1 stent of adequate length). 
4. Target lesion stenosis ≥50% and <100% by visual estimate. 

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EXCLUSION 
CRITERIA 
General Exclusion Criteria  
1. Subject is currently enrolled in another investigational device or 
drug trial that has not completed the primary endpoint or that 
clinically interferes with the current study endpoints.  
2. Subject was enrolled in another stent trial within 2 years prior to 
the index procedure. 
3. Any planned elective surgery or percutaneous intervention within 
9 months post- procedure. 
4. A previous coronary interventional procedure of any kind within 
30 days prior to the procedure.  
5. The subject requires staged procedure of either the target vessel 
or any non-target vessel within 9 months post-procedure. 
6. The target lesion requires treatment with a device other than 
percutaneous transluminal coronary angioplasty (PTCA) prior to 
stent placement (such as, but not limited to, directional coronary 
atherectomy, excimer laser, rotational atherectomy, etc.). 
7. Previous drug-eluting stent (DES) deployment anywhere in the 
target vessel. 
8. Any previous DES deployment within the past 12 months. 
9.  Any previous stent placement within 15 mm proximal or distal 
to the target lesion. 
10. Co-morbid condition(s) that could limit the subject’s ability to 
participate in the trial or to comply with follow-up requirements, 
or impact the scientific integrity of the trial. 
11. Concurrent medical condition with a life expectancy of <3 years. 
12. Documented left ventricular ejection fraction (LVEF) <25% at 
the most recent evaluation. 
13. Evidence of an acute MI within 72 hours of the intended index 
procedure. 
14. History of cerebrovascular accident or transient ischemic attack 
within 6 months prior to the index procedure. 
15. Leukopenia (leukocytes <3.5  109/liter). 
16. Neutropenia (absolute neutrophil count <1,000/mm3) ≤ within 7 
days prior to enrollment. 
17. Thrombocytopenia (platelets <100,000/mm3) pre-procedure 
(within 7 days prior to enrollment). 
18. Active peptic ulcer or active gastrointestinal (GI) bleeding. 

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EXCLUSION 
CRITERIA (CONT.) 
 
19. Subjects who are ineligible for ≥1 month of DAPT because of 
bleeding diathesis or any other reason.  
20. Known hypersensitivity or contraindication to aspirin, 
thienopyridine, both heparin and bivalirudin, cobalt, nickel, L-
605 cobalt chromium alloy or sensitivity to contrast media which 
cannot be adequately pre-medicated. 
21.  Serum creatinine level >2.5 mg/dL within 7 days prior to the 
index procedure. 
22. Subject was previously enrolled in the PIONIR Study or the 
NIRTRAKS Post-Market Study. 
Angiographic Exclusion Criteria  
1. Unprotected left main coronary artery disease (obstruction >50% 
in the left main coronary artery that is not protected by ≥1 non-
obstructed bypass graft to the left anterior descending [LAD] or 
left circumflex [LCX] artery or a branch thereof). 
2. Target vessel exhibiting multiple lesions with >60% diameter 
stenosis outside of a range of 5 mm proximal and distal to the 
target lesion based on visual estimate or on-line quantitative 
coronary angiography (QCA). 
3. Target lesion exhibiting an intraluminal thrombus (occupying 
>50% of the true lumen diameter) at any time prior to the start of 
the intervention. 
4. Lesion location that is aorto-ostial or within 5 mm of the origin 
of the LAD or LCX. 
5. Target lesion with side branches >2.0 mm in diameter. 
6. Target lesion involving a bifurcation (either stenosis of both main 
vessel and major branch or stenosis of just major branch). 
7. Target lesion with severe calcification. 
8. Target vessel exhibiting excessive tortuosity that may impede 
stent delivery and deployment at target lesion.  
9. Target lesion that is located in a native vessel distal to an 
anastomosis with a saphenous vein graft or a left/right internal 
mammary artery (LIMA/RIMA) bypass. 
PRINCIPAL 
INVESTIGATOR 
Manesh R. Patel, MD, FACC 
Associate Professor of Medicine 
Division of Cardiology 
Director, Interventional Cardiology and Catheterization Labs 
Duke University Health System 
Telephone: 919-668-8917 
Email: Manesh.patel@duke.edu 

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STUDY MONITORING Harvard Clinical Research Institute (HCRI) 
930 Commonwealth Avenue, 3rd Floor 
Boston, MA 02215,  
USA 
DATA 
MANAGEMENT, EDC 
AND CEC 
Harvard Clinical Research Institute 
930 Commonwealth Avenue, 3rd Floor 
Boston, MA 02215, USA  
ECG CORE 
LABORATORY 
Harvard Clinical Research Institute 
930 Commonwealth Avenue, 3rd Floor 
Boston, MA 02215, USA 
ANGIOGRAPHIC 
CORE LABORATORY 
Beth Israel Deaconess Medical Center Angiographic Core Laboratory 
330 Brookline Avenue 
Boston, MA 02215, USA 
SPONSOR 
Medinol Ltd. 
PO Box 58165, Bldg. 8  
Kiryat Atidim, Tel Aviv, 6158101, Israel 
Study contact: Michal Hershkovitz, Vice President, Clinical 
Development  & Regulatory Affairs 
Telephone: +972-3-767-9000 /ext. 3209, Fax: +972-3-648-2310 
Email: MichalH@medinol.com 

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1 
Introduction and Rationale 
Coronary artery disease (CAD) is the most common cause of morbidity and mortality in the 
western hemisphere.  Since its introduction, coronary angioplasty has become a widely accepted 
treatment for CAD, providing high procedural success rates and symptom relief. However, 
coronary angioplasty alone is associated with a high rate of restenosis (30% to 50%), 
necessitating repeat revascularization procedures.[1] Treatment of CAD has been significantly 
advanced by interventional cardiology, particularly with the advent of coronary stents. In 
comparison with angioplasty alone, stents have reduced the incidence of angiographic and 
clinical restenosis, the recurrence of angina, the need for coronary arterial bypass graft (CABG) 
surgery, the need for repeat revascularization, and the occurrence of major adverse cardiac 
events (MACE).[2-4] This improvement in outcomes ushered in the bare metal stent (BMS) era, 
a variety of which were approved and used during the 1990s. Expanded indications for stenting 
of more complex lesion subsets (restenosed lesions, long lesions, small vessels, bifurcations, 
saphenous vein graft lesions, chronic total occlusions, acute myocardial infarctions, etc.) led to 
the exponential growth of the use of coronary stents. However, the long-term success of this 
therapy has been limited by the occurrence of in-stent restenosis.[3-6] Despite the effectiveness 
of intracoronary stents in maintaining a larger luminal diameter as compared to angioplasty 
alone, in-stent restenosis occurs within 6 to 9 months after stent placement in 15% to 35% of 
subjects.[3-6]  
The Food and Drug Administration (FDA) approval of drug-eluting stents (DES), together with 
their positive results seen in subjects, caused BMS usage to drop precipitously in the years 
immediately following DES introduction. However, concern regarding the long-term safety of 
DES, specifically the possibility of an increased frequency of late stent thrombosis relative to 
BMS, tempered the use of DES in favor of BMS beginning in 2007. The incidence of stent 
thrombosis in randomized trials of DES (either paclitaxel-eluting stents or sirolimus-eluting 
stents) was found to be comparable to that of BMS, and ranged from 0.4% to 0.6% at 12 
months.[7-10] Moreover, the observed rate of stent thrombosis in the ‘real-world’ clinical 
setting, where off-label use is common practice, is almost double the rate observed in clinical 
trials.[11] Further complicating matters is that stent thrombosis in subjects treated with DES can 
occur outside the 30-day period after stent placement typically seen in subjects treated with 
BMS. Several observational studies of subjects treated with DES in the ‘real-world,’ where off-
label use approaches 60%,[12, 13] suggested an increased incidence of late stent thrombosis, 
[14] death and myocardial infarction (MI)[15-17] relative to subjects treated with BMS, although 
more recent data suggest otherwise.[18, 19] Based in part on the uncertainty of the relative risks 
of stent thrombosis with  DES versus BMS, BMS continue to be used regularly in the treatment 
of coronary artery disease in routine clinical practice.[20]  
The NIR® coronary stent has been on the European market since 1996 and on the US market 
since 1998. Its design is characterized by a “closed cell” geometry, which forms the basis for 
continuous support and smooth scaffolding. This design was improved upon with the 
NIRFLEX™ stent. The NIRFLEX coronary stent was designed to retain the characteristic 
“closed cell” design of the NIR stent while offering improved flexibility both before and after 
expansion. This flexibility led to a reduction in trauma after implantation, as demonstrated in 
independent trials in both the United States and Europe. 

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The Presillion™ and Presillion™ plus Stent Systems are a modification of the currently 
approved NIRFLEX Coronary Stent System (CE mark since March 2002). The Presillion and 
Presillion plus Stent Systems are approved devices in Europe and Israel (CE mark since 
March 2008 and May 2009, respectively; Israeli registration numbers 784-0001 and 784-0003, 
respectively). The Presillion plus Stent System is approved in the US (FDA PMA #P110004) 
and Canada (Health Canada approval #86087). The NIRxcell Stent System is an upgraded 
version of the Presillion plus Stent System, FDA approved (PMA# P110004/S001); CE mark 
since May 31, 2013; Israeli registration number 7840404 since March 11, 2014. 
The NIRxcell Stent System is composed of the same L-605 CoCr Presillion stent (known as 
the PIONIR stent), but is mounted on a different, rapid exchange delivery system, with 
hydrophilic coating, and includes a semi-compliant balloon.  
The raw materials that are used in the manufacture of the NIRxcell Stent System are the same 
as the raw materials used for the manufacture of the Presillion Stent System. Both systems are 
integrated under the same environmental conditions using the same processes, with small 
changes in parameter settings that have no influence on the systems’ properties. 
The safety and effectiveness of the Presillion and Presillion plus Stent Systems were evaluated 
in the PIONIR study, a non-randomized, multi-center, prospective, single-arm clinical study 
(clinicaltrials.gov reference # NCT00840775- unpublished data). The study enrolled 278 
subjects at 16 sites in Europe (Germany, Sweden and Belgium) and Israel. The primary 
endpoint was the incidence of target vessel failure (TVF), defined as cardiac death, target 
vessel MI (Q wave or non–Q wave), or clinically driven target vessel revascularization (TVR) 
by percutaneous or surgical methods, within 270 days of treatment with the 
Presillion/Presillion plus Stent System. This rate was compared with a performance goal that 
was derived from a meta-analysis of the literature reporting outcomes with approved BMS. 
The 270-day TVF rate was 8.7% and the upper bound of the exact one-sided 95% confidence 
interval was 12.7%. Since this upper bound was less than the established performance goal of 
16.46%, the primary endpoint was considered to have been met. 
The NIRTRAKS Post-Market Study is designed to supplement the post-market requirements 
for the long-term safety and effectiveness of the NIRxcell Stent System in the U Sby 
collecting additional information about the safety and effectiveness of the device in the 
treatment of stenotic lesions in de novo native coronary arteries in the US population. The 
primary efficacy endpoint will be evaluated by comparing the incidence of TVF within 3 
years of treatment with NIRxcell Stent System with a performance goal derived from the 
development of a meta-analysis of 5 BMS trials.   

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2 
Device Description and Intended Use 
2.1 
Device Description 
2.1.1 General 
NIRxcell CoCr Coronary Stent on RX System (NIRxcell Stent System, P110004/S001) is a 
single-use device designed and manufactured by Medinol Ltd. It comprises a balloon-
expandable, intracoronary stent mounted on a rapid-exchange delivery catheter.  
For the purposes of this clinical investigation, the NIRxcell Stent System is available in 32 
device models to accommodate various reference vessel diameters and lesion lengths. For 
details refer to Table 1. 
2.1.2 Detailed Information 
NIRxcell Stent System 
The NIRxcell stents are cut from panels of flat sheets of L-605 cobalt-chromium alloy, after 
which the stents are folded into cylinders and welded. The NIRxcell stent geometry is made 
up of alternating wide and narrow struts to enable the stent to be flexible in the unexpanded 
configuration and to support the vessel, while conforming to its curvature, in the expanded 
configuration. At the distal end of the catheter is a delivery balloon designed to expand to a 
controlled diameter and length when inflated. The balloon delivery catheter has 2 platinum 
iridium radiopaque marker bands defining the length and location of the mounted stent.  
The usable length of the delivery system is 140 cm with a shaft profile of 2.1F (0.69 mm) / 
2.6F (0.86 mm) (proximal/distal). It has a distal port (hole) approximately 30 cm 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 also has 2 markers on the proximal catheter shaft 
that indicate, approximately, the exit of the balloon catheter tip from the guiding catheter 
(brachial: 93 cm; femoral: 103 cm). 
 
 

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Table 1: NIRxcell Stent System: Device Matrix for NIRTRAKS Post-Market Study 
MODEL 
DESCRIPTION 
 
Catalogue 
Number 
Nominal Stent 
System Size 
 
Stent 
Labeled 
Diameter 
(mm) 
Stent 
Labeled 
Length 
(mm) 
Maximum Post 
Deployment 
Stent Diameter
(mm) 
Nominal 
Pressure
(Atm) 
Rated 
Burst 
Pressure 
(Atm) 
NLT 
Minimum 
Guiding 
Catheter 
Compatibility 
(ID) 
NXL25008US 
2.5 
8 
3.0 
12 
18 
5F 
NXL25012US 
12 
3.0 
12 
18 
5F 
NXL25017US 
17 
3.0 
12 
18 
5F 
NXL25020US 
20 
3.0 
12 
18 
5F 
NXL27508US 
2.75 
8 
3.5 
12 
18 
5F 
NXL27512US 
12 
3.5 
12 
18 
5F 
NXL27517US 
17 
3.5 
12 
18 
5F 
NXL27520US 
20 
3.5 
12 
18 
5F 
NXL27524US 
24 
3.5 
12 
18 
5F 
NXL27528US 
28 
3.5 
12 
18 
5F 
NXL27533US 
33 
3.5 
12 
18 
5F 
NXL30008US 
3.0 
 
8 
3.75 
12 
18 
5F 
NXL30012US 
12 
3.75 
12 
18 
5F 
NXL30017US 
17 
3.75 
12 
18 
5F 
NXL30020US 
20 
3.75 
12 
18 
5F 
NXL30024US 
24 
3.75 
12 
18 
5F 
NXL30028US 
28 
3.75 
12 
18 
5F 
NXL30033US 
33 
3.75 
12 
18 
5F 
NXL35008US 
3.5 
8 
4.25 
12 
18 
5F 
NXL35012US 
12 
4.25 
12 
18 
5F 
NXL35017US 
17 
4.25 
12 
18 
5F 
NXL35020US 
20 
4.25 
12 
18 
5F 
NXL35024US 
24 
4.25 
12 
18 
5F 
NXL35028US 
28 
4.25 
12 
18 
5F 
NXL35033US 
33 
4.25 
12 
18 
5F 
NXL40008US 
4.0 
 
8 
4.75 
12 
18 
5F 
NXL40012US 
12 
4.75 
12 
18 
5F 
NXL40017US 
17 
4.75 
12 
18 
5F 
NXL40020US 
20 
4.75 
12 
18 
5F 
NXL40024US 
24 
4.75 
12 
18 
5F 
NXL40028US 
28 
4.75 
12 
18 
5F 
NXL40033US 
33 
4.75 
12 
18 
5F 
2.2 
Intended Use of the Device 
The NIRxcell Stent System is indicated for improving coronary luminal diameter in patients 
with symptomatic ischemic heart disease associated with stenotic lesions in de novo native 
coronary arteries (length ≤30 mm) with a reference vessel diameter of 2.50 mm to 4.00 mm. 

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3 
Purpose and Objectives 
The purpose of this study is to collect and analyze additional information about the safety and 
effectiveness of the NIRxcell stents in the treatment of de novo stenotic lesions in native 
coronary arteries. Data will be collected at 30 days, 9 months and 1, 2 and 3 years post–index 
stenting procedure. The primary objective is to compare the incidence of TVF within 3 years 
after treatment with the NIRxcell Stent System with a performance goal derived from a meta-
analysis of coronary stenting with BMS, per the results of the historical control group 
combined.  
The long-term safety of the stenting procedure, including the occurrence of complications, 
will be evaluated through clinical data obtained before, during and after stent placement. 
Initial effectiveness of stent placement will be evaluated by determining acute success, 
including device success, lesion success and procedure success. The primary clinical outcome 
of TVF at 3 years post–index stenting procedure as well as a number of secondary outcomes 
will be used to determine the long-term clinical effectiveness of treating native coronary 
artery lesions with the investigational product. TVF was selected as the primary clinical 
outcome to allow for conclusive comparisons of the efficacy of the NIRxcell Stent System 
with other historical results.  
The NIRTRAKS Post-Market Study will be performed according to the World Medical 
Association Declaration of Helsinki, and FDA regulation 21 CFR parts 803, 812, 50 & 54. 
The data collected will be used to support the post-market requirements for the NIRxcell Stent 
System.  

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4 
Endpoints 
The following study endpoints will be evaluated in all subjects enrolled in the NIRTRAKS 
Post-Market Study.  
4.1 
Primary Endpoint 
The primary endpoint for this study is TVF, which is defined as a composite of cardiac death, 
target vessel MI, or clinically driven TVR by percutaneous or  
4.2 
Secondary Endpoints 
4.2.1 TVF at 9 Months 
4.2.2 All Cause Death at 30 Days, and 1, 2 and 3 Years 
4.2.3 Cardiac Death at 30 Days, and 1, 2 and 3 Years 
Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output 
failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-
related deaths, including those related to concomitant treatment. 
4.2.4 All Cause MI at 30 Days, and 1, 2 and 3 Years 
4.2.5 MI is defined using the Academic Research Consortium (ARC) definitions (see 
Appendix 1-P). 
4.2.6 Target Vessel MI at 30 Days, and 1, 2 and 3 Years 
Target vessel MI is defined as any MI attributed to the target vessel.   
4.2.7 Clinically Driven TLR at 30 Days, and 1, 2 and 3 Years 
Clinically-driven target lesion revascularization (TLR) is defined as any revascularization at 
the target lesion associated with positive functional ischemia study or ischemic symptoms and 
an angiographic minimal lumen diameter stenosis 50% by quantitative coronary angiography 
(QCA), or revascularization of a target lesion with diameter stenosis 70% by QCA without 
either angina or a positive functional study. 
4.2.8 Clinically Driven TVR at 30 Days, and 1, 2 and 3 Years 
Clinically-driven TVR is defined as any revascularization in the target vessel that is associated 
with positive functional ischemia study or ischemic symptoms AND an angiographic minimal 
lumen diameter stenosis ≥50% by QCA, or revascularization of a target vessel with diameter 
stenosis ≥70% by QCA without either angina or a positive functional study.  
4.2.9 Acute Success Rates 
Device success is defined as the attainment of <50% final residual stenosis of the target lesion 
using only the NIRxcell Stent System. 
Lesion success is defined as the attainment of <50% final residual stenosis of the target lesion 
using any percutaneous method. 
Procedure success is defined as attainment of <50% residual stenosis of the target lesion and 
no in-hospital death, MI or TLR. 

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4.2.10 Stent Thrombosis at Discharge, 30 Days, and 1, 2 and 3 Years 
Acute stent thrombosis is defined as a thrombotic event occurring between 0 and 24 hours 
after stent implantation.  
Subacute stent thrombosis is defined as a thrombotic event occurring between 1 and 30 days 
after stent implantation.  
Late stent thrombosis is defined as a thrombotic event occurring between 30 days to 1 year 
after stent implantation.  
Three separate categories of stent thrombosis using the ARC classification are recognized and 
defined in Appendix 1-P.  

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5 
Study Design 
This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study 
to collect additional information about the safety and effectiveness of the NIRxcell Stent 
System in the treatment of de novo stenotic lesions in native coronary arteries in the US 
population. A total of 131 subjects will be enrolled in up to 15 sites in the US. The expected 
duration of subject enrollment is approximately 12 months. Clinical follow-up for all subjects 
will occur at 30 days, 9 months and 1, 2 and 3 years post–index stenting procedure. An 
unscheduled follow up may be conducted as clinically warranted. 
5.1 
Control of Systematic Error/Bias 
By the nature of the type of the proposed study, blinding of the investigator and/or subject is 
not possible.  However, several measures will be implemented for minimization of systematic 
error/bias: 
 Basic screening will be completed by investigational sites of all potential candidates. 
Subjects who fail to meet the clinical inclusion and exclusion criteria will not be included 
in this study. Subjects who have met all the clinical inclusion and exclusion criteria will 
then be screened for angiographic eligibility criteria. 
 All subjects who undergo angiographic screening will be entered onto the screening log. 
The screening log will include all subjects who have signed the informed consent.  
 Measurements made by angiography will be standardized by use of an angiographic core 
laboratory. The core laboratory measurements will be used in all cases for purposes of 
data analysis.  
In determining subject eligibility for the study, the investigator’s assessment of pre-
procedure angiographic parameters will be used. However, the angiographic core 
laboratory will provide feedback to the sponsor concerning accuracy of assessments in 
relation to inclusion criteria such as lesion parameters and anatomic location. 
 Electrocardiogram (ECG) tracings analysis will be standardized by use of an ECG core 
laboratory. The ECG core laboratory readings will be used in all cases for purposes of data 
analysis.   
 Clinical monitors will verify subjects’ data and ensure compliance with Good Clinical 
Practice (GCP), clinical protocol and other study requirements, according to the guidelines 
set forth in HCRI’s monitoring standard operating procedures (SOP). 
 An independent clinical events committee (CEC) will adjudicate all clinical endpoint 
events and investigator-reported adverse events that have the potential to be a clinical 
endpoint event. The CEC adjudication results will be used in all cases for purposes of data 
analysis.  
5.2 
Eligibility, Exclusions and Subject Discontinuations  
All subjects presented to the angiographic suite for possible coronary artery revascularization 
are potential study candidates and will be screened for eligibility, and consented for possible 
inclusion. Every effort will be made to establish eligibility of the participants prior to 
enrollment. Prior to enrollment, subjects will have screening clinical laboratory, medical 

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history and physical exams to verify qualification into the study. If conducted within the 
appropriate time windows, and the subjects meet the pre-angiography inclusion and exclusion 
criteria, the screening results will also serve as baseline parameters. Angiographic eligibility 
will be based solely on angiography performed at the time of index procedure. Once a subject 
has signed the informed consent, angiographic eligibility has been confirmed, and the 
NIRxcell Stent System introduced into the subject’s body, the subject is considered to be 
enrolled. Subjects who do not meet all inclusion (general and angiographic) criteria or meet 
any of the exclusion criteria should not be enrolled in the study. All subjects enrolled will be 
evaluated, regardless of sequence of treatment that ensues. 
Once a subject has been enrolled in the study, he/she may withdraw his/her consent to 
participate in the study at any time without prejudice. Participation in this clinical 
investigation is entirely voluntary.   
Possible reasons for subject discontinuation include but are not limited to the following:  
 Subject death  
 Subject voluntary withdrawal  
 Subject withdrawal by physician as clinically-indicated  
 Subject lost-to follow-up as described below  
Subjects withdrawn after treatment will not be required to undergo follow-up after 
withdrawal; however, they will still be considered part of the subject cohort.   
All subjects enrolled in the study are considered eligible for follow-up and will be required to 
adhere to the follow-up schedule outlined in Section  9. If a subject cannot be contacted for a 
follow-up assessment and follow-up information cannot be obtained, he/she will be counted as 
“missed contact” for that specific schedule. Attempts shall be made to contact the subject in 
next follow-up schedule. A subject will be considered “lost to follow-up” only after the last 
scheduled follow-up assessment for that subject (3 years). If a subject is lost to follow-up, the 
methods used to attempt to contact the subject should be documented. At least 3 attempts 
should be made to contact the subject through all available routes, and a certified letter should 
be sent to the permanent address in file. 
Figure 1 summarizes the above steps and follow-up period. 
 
 

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Figure 1: Study Flowchart 
 
 
 
Yes
Identify Potential Subjects
Does subject have coronary 
artery disease and qualify for 
coronary artery 
revascularization? 
Follow-up Visits
 Hospital discharge 
 1 month (± 14 days) 
 9 months (± 30 days) 
 1 year (± 30 days) 
 2 years (± 30 days) 
 3 years (± 30 days) 
Yes
Pre-Procedure Testing
Does subject qualify based on pre-procedure 
tests performed according to investigational 
site’s standard of care?
Index Procedure
Does subject satisfy angiographic eligibility 
criteria based on baseline coronary 
angiography? 
Subject is a screen 
failure 
No
Informed Consent
Did subject provide written informed 
consent? 
Subject is not a 
study candidate
No
Subject is a 
screen failure 
No
Yes
Subject is a 
screen failure 
No
Repeat any screening tests (e.g., ECG or labs) 
according to protocol requirements, if necessary.  
Are all test results acceptable? 
Subject is a screen 
failure 
Yes
No
Yes
Index Procedure
Was the NIRxcell™ Stent System introduced into 
patient’s vasculature?
Subject is a 
procedure failure
No
Yes
Enrollment
Subject is considered enrolled. 
Index Procedure
Treatment of target lesion with the NIRxcell™ 
Stent System

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6 
Criteria of Eligibility 
6.1 
Inclusion Criteria 
Prior to enrollment in this study, candidates must meet ALL of the following criteria: 
6.1.1 General Inclusion Criteria  
1. Subject is ≥18 years old. 
2. Subject is eligible for percutaneous coronary intervention (PCI). 
3. Subject is eligible for dual anti-platelet therapy (DAPT) with aspirin plus either 
clopidogrel, prasugrel or ticagrelor for a minimum of 1 month. 
4. Subject understands the nature of the procedure and provides written informed 
consent prior to the catheterization procedure. 
5. Subject is willing to comply with specified follow-up evaluation and can be contacted 
by telephone. 
6. Subject is an acceptable candidate for coronary artery bypass graft (CABG) surgery. 
7. Subject has stable angina pectoris (Canadian Cardiovascular Society Classification 
[CCSC] 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a 
positive functional ischemia study (e.g., exercise tolerance test [ETT], single-photon 
emission computerized tomography [SPECT], stress echocardiography or cardiac 
computerized tomography [CT]). 
8. Female subjects of child bearing potential must have a negative pregnancy test within 
7 days prior to enrollment in the study. 
6.1.2 Angiographic Inclusion Criteria  
1. Subject is indicated for elective stenting of a single stenotic lesion in a native 
coronary artery. 
2. Reference vessel ≥2.5 mm and ≤4.0 mm in diameter by visual estimate. 
3. Target lesion ≤30 mm in length by visual estimate (the intention should be to cover 
the whole lesion with 1 stent of adequate length). 
4. Target lesion stenosis ≥50% and <100% by visual estimate. 
6.2 
Exclusion Criteria 
Candidates must be excluded from this study if ANY of the following criteria is met: 
6.2.1 General Exclusion Criteria  
1. Subject is currently enrolled in another investigational device or drug trial that has not 
completed the primary endpoint or that clinically interferes with the current study 
endpoints.  
2. Subject was enrolled in another stent trial within 2 years prior to the index procedure. 
3. Any planned elective surgery or percutaneous intervention within nine (9) months 
post- procedure. 

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4. A previous coronary interventional procedure of any kind within 30 days prior to the 
procedure.  
5. The subject requires staged procedure of either the target vessel or any non-target 
vessel within 9 months post-procedure. 
6. The target lesion requires treatment with a device other than percutaneous 
transluminal coronary angioplasty (PTCA) prior to stent placement (such as, but not 
limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, 
etc.). 
7. Previous drug-eluting stent (DES) deployment anywhere in the target vessel. 
8. Any previous DES deployment within the past 12 months.  
9. Any previous stent placement within 15 mm proximal or distal to the target lesion. 
10. Co-morbid condition(s) that could limit the subject’s ability to participate in the trial 
or to comply with follow-up requirements, or impact the scientific integrity of the 
trial.  
11. Concurrent medical condition with a life expectancy of <3 years. 
12. Documented left ventricular ejection fraction (LVEF) <25% at the most recent 
evaluation. 
13. Evidence of an acute MI within 72 hours of the intended index procedure. 
14. History of cerebrovascular accident or transient ischemic attack within 6 months prior 
to the index procedure. 
15. Leukopenia (leukocytes <3.5  109/liter). 
16. Neutropenia (absolute neutrophil count <1,000/mm3) ≤ within 7 days prior to 
enrollment. 
17. Thrombocytopenia (platelets <1,00,000/mm3) (within 7 days prior to enrollment). 
18. Active peptic ulcer or active gastrointestinal (GI) bleeding. 
19. Subjects who are ineligible for ≥1 month of DAPT because of bleeding diathesis or 
any other reason.  
20. Known hypersensitivity or contraindication to aspirin, thienopyridine, both heparin 
and bivalirudin, cobalt, nickel, L-605 cobalt-chromium alloy or sensitivity to contrast 
media that cannot be adequately pre-medicated. 
21.  Serum creatinine level >2.5 mg/dL within 7 days prior to the index procedure. 
22. Subject was previously enrolled in the PIONIR Study or the NIRTRAKS Post-Market 
Study. 
6.2.2 Angiographic Exclusion Criteria  
1. Unprotected left main coronary artery disease (obstruction >50% in the left main 
coronary artery that is not protected by ≥1 non-obstructed bypass graft to the left 
anterior descending (LAD) or left circumflex (LCX) artery or a branch thereof. 

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2. Target vessel exhibiting multiple lesions with >60% diameter stenosis outside of a 
range of 5 mm proximal and distal to the target lesion based on visual estimate or on-
line quantitative coronary angiography (QCA). 
3. Target lesion exhibiting an intraluminal thrombus (occupying >50% of the true lumen 
diameter) at any time prior to the start of the intervention. 
4. Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX. 
5. Target lesion with side branches >2.0 mm in diameter. 
6. Target lesion involving a bifurcation (either stenosis of both main vessel and major 
branch or stenosis of just major branch). 
7. Target lesion with severe calcification. 
8. Target vessel exhibiting excessive tortuosity that may impede stent delivery and 
deployment at target lesion. 
9. Target lesion that is located in a native vessel distal to an anastomosis with a 
saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass. 

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7 
Treatment Methodology 
Table 2: Summary of Study Procedures from Screening through End of Follow-Up 
Study 
Requirement 
Screening 
Procedure 
Post-Procedure 
 
Within 7 
Days  Prior to 
Procedure 
24 Hours 
Prior to 
Procedure
Hospital 
Discharge 
30 Days  
(±2 Weeks) 
9 Months 
 (±1 Month) 
1 Year 
 (±1 Month) 
2 Years 
 (±1 Month) 
3 Years 
 (±1 Month) 
Unscheduled 
Visit /Phone 
Informed 
consent 
X 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
Clinical 
assessment and 
physical exam 
X 
 
 
X 
 
 
 
 
 
X(7) 
Telephone 
assessment 
 
 
 
 
X 
X 
X  
X 
X 
X 
CBC 
w/differential (1) 
X 
 
 
 
 
 
 
 
 
 
Serum 
creatinine 
X 
 
 
 
 
 
 
 
 
 
INR, APTT 
X 
 
 
 
 
 
 
 
 
X(7) 
Pregnancy test 
X(2) 
 
 
 
 
 
 
 
 
 
CK/CK-MB/ 
troponin 
 
X(3) 
 
X(6) 
 
 
 
 
 
X(7) 
12-lead ECG 
 
X(4) 
 
 
 
 
 
 
 
X(7) 
Record of 
relevant 
medications (5) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
Coronary 
angiography 
 
 
X 
 
 
 
 
 
 
 
Stenting 
 
 
X 
 
 
 
 
 
 
 
Record of 
adverse events 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
APTT: activated partial thromboplastin time; CBC: complete blood count; CK: creatinine kinase; CK-MB: creatinine kinase 
myocardial band; ECG: electrocardiogram; INR: international normalized ratio 
(1) Collection of CBC differentials during the index hospitalization should be done as per the respective 
institutions standard of care.  However, if the white blood count (WBC) is abnormal, it is recommended to 
perform the CBC differential before and after the procedure. 
(2) For females of childbearing potential. 
(3) Pre-procedure cardiac enzymes: CK, CK-MB or troponin performed within 24 hours prior to the procedure 
may be used as the baseline cardiac enzymes provided there have been no signs or symptoms of myocardial 
ischemia between the time of cardiac enzymes test and the time of arterial access.  
(4) Pre-procedure 12-lead ECG: an ECG performed within 7 days prior to the procedure may be used as the 
baseline ECG provided there have been no signs or symptoms of myocardial ischemia between the time of 
ECG and the time of arterial access.   
(5) Relevant medications: statins, angiotensin converting enzyme inhibitors (ACE-I), angiotensin receptor 
blockers (ARB), beta-blockers and anti-platelets. 

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(6) CK and CK-MB will be measured at 6- 8 hours post procedure, 12-16 hours post procedure and 20-24 hours 
post procedure (or upon discharge, whichever comes first). If any CK elevation (CK above ULN) is noted 
post procedure, CK and CK-MB measurements will continue to be performed every 8 hours for 24 hours 
starting from when the first elevation is noted and recorded on the appropriate eCRF. If total CK values are 
within normal ranges, CK-MB measurements may not be performed (per hospital standards). However, it is 
strongly encouraged that CK-MB measurements are obtained with every total CK drawn, even if CK values 
are within normal limits. It is also recommended that sites collect CK and CK-MB preferentially over 
troponin in the peri-procedural period subsequent to the index procedure.  In the case where CK and CK-MB 
are not available, troponin can be used. 
(7) These assessments and tests will be performed only if clinically warranted. 
 
7.1 
Subject Screening/Assessment 
Signed written informed consent must be obtained for all subjects who are potential study 
candidates prior to enrollment. Additionally, the following evaluations must be completed for 
all subjects unless otherwise specified:   
Within 7 Days of Enrollment: 
 Medical history. 
 Clinical assessment and physical examination. 
 Complete blood count (CBC) with differential (if possible as per the respective 
institutions standard of care). 
 Chemistry screen including serum creatinine.  
 Coagulation including international normalized ratio (INR), activated partial 
thromboplastin time (APTT). Note: must be checked prior to heparin therapy. 
 Pregnancy test (for females of childbearing potential). 
Within 24 hours of Enrollment: 
 CK, CK-MB or troponin levels. 
 12-lead ECG (an ECG performed within 7 days prior to the procedure may be used as 
the baseline ECG provided there have been no signs or symptoms of myocardial 
ischemia between the time of ECG and the time of arterial access). A copy of the ECG 
trace should be sent to the ECG core laboratory. 
 Record of relevant medications. 
7.2 
Procedural Information 
For information describing the procedural steps and materials necessary for appropriate use of 
the NIRxcell Stent System, refer to the US Instructions for Use. 
Additionally, note the following: 
 Start of the Procedure and Enrollment 
The start of the procedure is defined as the time of arterial cannulation. Actual enrollment 
in the study occurs at the time the study device is introduced into the body. If the 
angiogram performed at the index procedure indicates that the subject is not a candidate 
for the study, this subject is not considered enrolled. 

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 Angiographic Protocol Requirement 
o Following intracoronary injection of 50–200 g nitroglycerin (NTG), obtain 
baseline angiograms using at least ≥2 near orthogonal views, best demonstrating the 
coronary artery stenosis, as specified in the angiographic protocol. 
o Before stent placement, obtain a single working view of the coronary artery stenosis, 
as specified in the angiographic protocol. 
 Pre-Dilatation 
If the target lesion fulfills eligibility criteria, the target lesion must be pre-treated with 
standard percutaneous transluminal balloon angioplasty. This clinical protocol does not 
allow for direct stenting of the target vessel.  
Attention must be paid to the pre-dilatation technique to avoid balloon injury to any 
segment of the vessel that will not be entirely covered by the stent (‘geographical miss’).  
Pre-dilatation must be performed using a balloon with the following 3 characteristics:  
1. A diameter ≥0.5 mm smaller than the treatment stent. 
2. A length matching or shorter than the lesion length to be dilated (to avoid dilatation of 
the vessel wall adjacent to the stent). 
3. A length shorter than the stent to be implanted. 
The use of other therapy (e.g. cutting balloons, atherectomy, laser, thrombectomy, etc.) is 
not allowed.  
 Selection of Appropriately Sized Stent 
Select an appropriately sized stent based on angiographic vessel measurements 
(approximately 2–4 mm longer than the measured shoulder-to-shoulder lesion length, with 
a stent to distal reference vessel ratio of 1:1 or 1.1:1.0). The intention should be to cover 
the whole lesion with 1 stent of adequate length.  
Note: Additional NIRxcell Stent Systems should be used, at the physician’s discretion, for 
sub-optimal result, or in the event of bailout procedures, as defined below. 
 Bailout Procedures 
The intention should be to cover the index lesion with 1 stent of adequate length. Bailout 
procedures and additional stenting for sub-optimal results should be avoided unless 
required for subject safety. If a subject enrolled in the study experiences a major dissection 
or an occlusive complication (as evidenced by decreased target vessel flow, chest pain, or 
ischemic ECG changes that do not respond to repeat balloon inflations, NTG, 
intracoronary verapamil, intracoronary diltiazem, or lytic agents), bailout procedures may 
be performed. For bailout procedures or in the event of a sub-optimal result, further 
stenting may be employed, at investigator’s discretion, using the NIRxcell Stent Systems, 
as required.  
 End of the Procedure 
The end of the procedure is defined as the time that the final guiding catheter is withdrawn 
from the subject. Closure of the arterial puncture site will be performed as per laboratory 

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standards. The hemostasis introducer sheath(s) may be removed when the subject's 
activated clotting time (ACT) is <150 seconds or per the physician’s discretion. If a guide 
catheter is introduced once the procedure is considered over, as defined above, or the 
subject is returned to the procedure room and interventional therapy is performed, this 
should be considered a repeat intervention.   
 Adverse Events Recording 
All adverse events (AEs) occurring following informed consent signature must be 
recorded.   
Note: Bailout procedures performed during the same catheterization as the index stenting 
procedure shall be considered part of the index procedure. 
7.3 
Post-Procedure Assessment (Hospital Discharge) 
Clinical assessment of a subject’s condition must be performed according to the details below.  
The research coordinator will review the follow-up requirements with the subject to help 
ensure compliance with the follow-up schedule. Telephone numbers must be obtained from 
the subject to ensure the ability to contact him/her. These phone numbers should include all 
home numbers, work numbers and primary physician numbers. A phone number of a relative 
or friend should also be requested. 
 
The following assessments will be performed at hospital discharge: 
 Clinical assessment and physical examination. 
 CK and CK-MB will be measured at 6- 8 hours post procedure, 12-16 hours post 
procedure and 20-24 hours post procedure (or upon discharge, whichever comes first). 
If any CK elevation (CK above ULN) is noted post procedure, CK and CK-MB 
measurements will continue to be performed every 8 hours for 24 hours starting from 
when the first elevation is noted and recorded on the appropriate eCRF. If total CK 
values are within normal ranges, CK-MB measurements may not be performed (per 
hospital standards). However, it is strongly encouraged that CK-MB measurements are 
obtained with every total CK drawn, even if CK values are within normal limits. It is 
also recommended that sites collect CK and CK-MB preferentially over troponin in the 
peri-procedural period subsequent to the index procedure. In the case where CK and 
CK-MB are not available, troponin can be used.Record of relevant medications (statins, 
angiotensin converting enzyme inhibitors [ACE-I], angiotensin receptor blockers 
[ARB], beta-blockers and anti-platelets). 
 Record of all AEs that occurred since the end of the index procedure. 

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8 
Concomitant Medications 
Concomitant medications to be used before, during and after the stenting procedure are as 
follows: 
Table 3: Summary of Concomitant Medications Regimen 
 
Pre-Procedure 
Procedure 
Post-Procedure 
Aspirin 
A minimum of 150 mg 
(within 24 hours prior to 
procedure). 
--- 
75–100 mg daily 
indefinitely. 
Clopidogrel 
or 
Prasugrel/ 
Ticagrelor 
Loading dose of 600 mg 
clopidogrel within 24 
hours prior to index 
procedure or immediately 
post-procedure (within 30 
minutes). 
Alternatively, loading 
dose of 60 mg prasugrel 
or 180 mg ticagrelor. 
No loading dose is 
required for subjects on 
chronic thienopyridine 
therapy. 
--- 
Post-procedure 
treatment with the 
same thienopyridine 
agent for a minimum of 
1 month as follows:  
Clopidogrel: 75 mg 
daily. 
Prasugrel: 10 mg daily; 
a lower dose of 5 mg 
daily is allowed for 
subjects <60 kg.  
Ticagrelor: 90 mg twice 
daily. 
Heparin 
or  
Bivalirudin 
--- 
Per routine hospital 
practice.   
For heparin, a bolus of 50–
80 units/kg is recommended.  
If heparin is administered, it 
is recommended to maintain 
ACT of ≥250 seconds (or 
≥200 seconds if a 
glycoprotein IIb/IIIa 
receptor blocker is 
administered) throughout 
the interventional portion of 
the procedure. 
--- 
Glycoprotein 
IIb/IIIa 
Inhibitor 
--- 
Per investigator’s 
discretion. 
 
Intracoronary 
Nitroglycerin  
or 
Intracoronary 
Isosorbide 
or Dinitrate 
--- 
To eliminate coronary 
artery spasm that would 
interfere with accurate 
measurement of lumen 
obstruction due to plaque 
alone, 100–200 µg 
nitroglycerin or 1–3 mg of 
isosorbide or dinitrate must 
be administered prior to 
baseline and post-
intervention angiograms. 
--- 

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9 
Follow-Up Assessments 
Follow-up will be conducted at 30 days, 9 months, and 1, 2, and 3 years post-procedure via 
telephone call. Refer to the text below for details. 
Additional unscheduled follow up visits/phone calls may occur as clinically warranted.  
The window for the 30-day follow-up contact will be ±2 weeks. For the 1-, 2- and 3-year 
contacts, the window will be ±1 month.  
9.1 
30-Day (±2 Weeks) Contact 
 Record of relevant medications.  
 Record of all AEs that occurred since last subject contact. 
9.2 
9-Month (±1 Month) Contact 
 Record of relevant medications.  
 Record of all AEs that occurred since last subject contact. 
9.3 
1-Year (±1 Month) Contact 
 Record of relevant medications.  
 Record of all AEs that occurred since last subject contact. 
9.4 
2-Year (±1 Month) Contact 
 Record of relevant medications.  
 Record of all AEs that occurred since last subject contact. 
9.5 
3-Years (±1 Month) Contact 
 Record of relevant medications. 
 Record of all AEs that occurred since last subject contact. 
9.6 
Unscheduled visit/Phone follow up 
 Record of relevant medications.  
 Record of all AEs that occurred since last subject contact. 
 Additional assessments and tests may be performed if clinically warranted. 
During each specified evaluation, the corresponding electronic case report form (eCRF) must 
be completed per the written instructions provided by the sponsor. Although not anticipated, 
should the appropriate authorized regulatory bodies request additional follow-up, the 
physicians and subjects will be requested to adhere accordingly.  
Detailed Explanations 
Adverse Events: Adverse events occurring (1) from time of index procedure to 30 days follow-up 
contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up 
contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up 
contact, will be recorded. In the event of an AE that is associated with repeat 

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angiography/revascularization, the event related coronary angiograms and catheterization 
report must be captured and submitted to the data center within 10 working days of 
knowledge of the event. Angiographic data collected during any repeat procedure on the target 
vessel must be made available to the CEC for an independent review and assessment. 
Likewise, the angiographic images should be submitted to the core laboratory for an 
independent review and assessment of the target lesion and study stent. 
12-Lead ECG: According to each site’s standard of care.  
CBC With Differential: Hematology testing due to anti-platelet therapy should follow the 
routine standard of care. 
CK, CK-MB and Troponin: CK, CK-MB or troponin will be obtained pre-procedure (within 
24 hours of the index procedure). Post procedure, CK and CK-MB will be measured at 6- 8 
hours, 12-16 hours and 20-24 hours post procedure (or upon discharge, whichever comes 
first). If any CK elevation (CK above ULN) is noted post procedure, CK and CK-MB 
measurements will continue to be performed every 8 hours for 24 hours starting from when 
the first elevation is noted and recorded on the appropriate eCRF. If total CK values are within 
normal ranges, CK-MB measurements may not be performed (per hospital standards). 
However, it is strongly encouraged that CK-MB measurements are obtained with every total 
CK drawn, even if CK values are within normal limits. It is also recommended that sites 
collect CK and CK-MB preferentially over troponin in the peri-procedural period subsequent 
to the index procedure.  In the case where CK and CK-MB are not available, troponin can be 
used. 
Relevant Medications: Statins, ACE-I, ARB, beta-blockers and anti-platelets. 

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10 
Total Expected Duration of the Clinical Investigation 
 
The clinical investigation is estimated to commence in June 2015.  
 
The enrollment is estimated to commence in July 2015. 
 
Enrollment completion is estimated for October 2016. 
 
The last patient follow up at 3 years is estimated for October 2019. 
 
Total expected duration of the clinical investigation is approximately 4-5 years. 
 
 
 

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11 
Adverse Events 
In this study, subjects should be encouraged to report adverse events (AEs) spontaneously or 
in response to general, non-directed questioning (e.g. “How has your health been since the last 
contact?”). Any time during the study, the subject may volunteer information that resembles 
an AE. If it is determined that an AE has occurred, the Investigator should obtain all the 
information required to complete the AE eCRF. 
11.1 
Definition of Adverse Event and Serious Adverse Event 
11.1.1 Adverse Event  
An AE is defined as 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 study device. 
NOTE 1: This definition includes events related to the study device or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to the 
study device. 
In this study, AEs shall be assessed and documented at IC signing. All AEs are to be recorded 
through the end of the study on the appropriate subject case report forms and followed 
through to their resolution regardless of time window.    
11.1.2 Adverse Device Effect 
An adverse device effect (ADE) is defined as an AE related to the use of the study device. 
NOTE 1: This definition includes AEs resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the study device. 
NOTE 2: This definition includes any event resulting from user error or from intentional 
misuse of the study device. 
11.1.3 Serious Adverse Event   
A Serious Adverse Event (SAE) is any AE that leads to: 
1. Death 
2. Serious injury that: 
a. Is a life-threatening illness or injury or 
b. Results in permanent impairment of a body function or permanent changes to a body 
structure or 
c. Necessitates medical or surgical intervention to preclude permanent impairment of a 
body function or permanent damage to a body function. 
NOTE 1: Planned hospitalization for pre-existing condition, or a procedure required by 
the clinical study plan, and not meeting any of the serious criteria described above, is not 
considered to be an SAE. A planned hospitalization is one that is scheduled prior to the 
patient signing the informed consent for the study. 

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11.1.4 Serious Adverse Device Effect  
A serious adverse device effect (SADE) is any anticipated ADE that has resulted in any of the 
consequences characteristic of an SAE. 
11.1.5 Anticipated Adverse Event 
Any undesirable experience (sign, symptom, illness, abnormal laboratory value, or other 
medical event) occurring to a subject, whether or not considered related to the study 
product(s) prescribed as part of the clinical protocol, predefined in the clinical protocol and/or 
Instructions for Use (IFU), product label that is identified or worsens during a clinical study. 
11.1.6 Unanticipated Adverse Device Effect  
An unanticipated adverse device effect (UADE) is defined in 21 CFR 812.3(s) as any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity or degree of incidence in the protocol, or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of a subject.  
11.2 
Device Deficiencies 
All failures and NIRxcell deficiencies will be documented on the appropriate CRF. 
Investigators are instructed to report all possible device deficiencies, malfunctions or user 
errors or inadequate labeling observed during the course of the trial. These incidents will be 
documented in the electronic case report form. 
In case of a device deficiency, the device should be returned to Medinol, for analysis and be 
reported in the clinical results per the written instructions provided. 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, user errors, and 
inadequate labeling, as detailed below:  
Device malfunction:   
Failure of an investigational medical device to perform in accordance with its intended 
purpose when used in accordance with the instructions for use or Clinical Investigational Plan 
(CIP) 
Malfunction per FDA CFR [§803.3(m)] means the failure of a device to meet its performance 
specifications or otherwise perform as intended. Performance specifications include all claims 
made in the labeling for the device. The intended performance of a device refers to the 
intended use for which the device is labeled or marketed. 
Use error: 
Act or omission of an act that results in a different medical device response than intended by 
the manufacturer or expected by the user 
• 
NOTE 1 - Use error includes slips, lapses, and mistakes. 
• 
NOTE 2 - An unexpected physiological response of the subject does not in itself 
constitute a use error. 
 

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Inadequate labeling: 
Label is not legible; label is torn; label is missing. 
11.3 
Documentation  
AEs must be listed on the appropriate eCRF. 
All AEs will be characterized by the following criteria:  
 Intensity or Severity 
 Relatedness 
 Outcome 
 Treatment or Action Taken 
All AEs (serious and non-serious) will be reported for the entire study period in accordance 
with national laws.   
11.3.1 Intensity or Severity 
The following categories of the intensity of an AE are to be used:  
Mild: Awareness of a sign or symptom that does not interfere with the subject’s usual 
activity or is transient, resolved without treatment and with no sequelae; 
Moderate: Interferes with the subject’s usual activity, but the subject is still able to 
function; 
Severe: Events that interrupt a subject’s usual daily activity and generally require a 
systemic drug therapy or other treatment. 
11.3.2 Relatedness 
The Principal Investigator (PI) will evaluate if the AE or SAE is related to the investigational 
device or study procedure.  Relatedness is defined in the following manner: 
 UNRELATED: The event is clearly not related to the investigational trial 
device/procedures. 
 UNLIKELY RELATED: The event is unlikely to be related to the trial device/ 
procedure. 
 POSSIBLY RELATED: The event is possibly related to the trial device/procedure. 
 RELATED: The event is clearly related to the trial device/procedure. 
11.3.3 Outcome 
The clinical outcome of the event at the time of last observation will be characterized as 
follows: 
 Not Recovered/Not Resolved 
 Recovered/Resolved 
 Recovered/Resolved with Sequelae  

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 Recovering/Resolving 
 Fatal 
 Unknown 
11.4 
Reporting of Adverse Events 
11.4.1 Serious Adverse Events Reporting 
All participating study sites should report SAEs to Medinol and HCRI within 24 hours of 
knowledge of the event preferably by completing an AE eCRF and in accordance with 
applicable national regulations. Report of a subject death must be submitted using the Study 
Exit eCRF along with a brief statement of the pertinent details, and the death 
records/certificate or autopsy report, if available/performed. 
It is the responsibility of each Investigator to report all SAEs to the reviewing IRB, according 
to national regulations and IRB requirements. A copy of the IRB report should be forwarded 
to the sponsor or its authorized representative.  
Reportable events to be reported by the sponsor to the FDA under 21 CFR 803 Medical 
Device Reporting (MDR) 
“MDR reportable events” are events that the sponsor becomes aware of that reasonably 
suggest that one of their marketed devices may have caused or contributed to a death or 
serious injury, or has malfunctioned and the malfunction of the device or a similar device that 
they market would be likely to cause or contribute to a death or serious injury if the 
malfunction were to recur (21 CFR 803.3 and 803.50). 
Any event which meets both basic reporting criteria A and B listed below is considered a 
reportable event and must be reported to the FDA. The criteria are as follows: 
A. An event has occurred that led, or might have led, to one of the following outcomes: 
a) Death, 
b) Serious injury that: 
 Is a life-threatening illness or injury or 
 Results in permanent impairment of a body function or permanent changes to a 
body structure or 
 Necessitates medical or surgical intervention to preclude permanent impairment 
of a body function or permanent damage to a body function  
B. The sponsor’s device is suspected to be a contributory cause of the event. 
This means that a death or serious injury was or may have been attributed to a medical device 
or that a medical device was or may have been a factor in a death or serious injury, including 
events occurring as a result of [21 CFR 803.3]: 
a) Failure 
b) Malfunction 
c) Improper or inadequate design 

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d) Manufacture 
e) Labeling  
f) User error 
Additionally, it is the responsibility of the sponsor to submit the following reports to the FDA: 
1. A “30-day initial report” must be submitted within 30 calendar days after the day the 
sponsor becomes aware of a reportable device-related death or serious injury, or a 
reportable malfunction. 
2. A “5-day report” must be submitted to the FDA within 5 work days after the sponsor 
becomes aware of an MDR reportable event:  
 That necessitates remedial action to prevent an unreasonable risk of substantial harm 
to public health or  
 For which the FDA have made a written request for the submission of 5-day reports. 
3. A “supplemental” or “follow-up report” must be submitted whenever the sponsor obtains 
information not known or available at the time of submission of the initial 30-day or 5-day 
report. 
11.4.2 Unanticipated Adverse Device Effect Reporting under 21 CFR 803 & 812 
Investigational Device Exemption 
If a complication occurs that the Investigator believes may be a potential UADE, the site 
should immediately contact the sponsor or its authorized representative to determine reporting 
requirements. In addition, when there is a reason to believe a device may have malfunctioned, 
causing potential harm to a patient, the site should immediately notify the sponsor. 
The Investigator shall submit to the reviewing IRB a report of any UADE occurring during an 
investigation as soon as possible, but in no event later than 10 working days after the 
Investigator first learns of the effect. All UADEs must be documented by the Investigator 
including the date of onset, a complete description of the event, possible reason(s) for the 
event, severity, duration, actions taken, and outcome. Copies of all supporting documents 
should be submitted concurrently with the UADE eCRF. 
A report from the sponsor will be submitted to the FDA and to all reviewing IRBs and 
participating Investigators within 10 working days after the sponsor first receives notice of the 
effect. The sponsor will submit other reports as required by the FDA.  
11.4.3 Device Deficiencies  
All deficiencies and NIRxcell™ Stent System malfunctions will be documented on the 
appropriate eCRF and the malfunctioned device will be returned to Medinol, if applicable, per 
written instructions, for analysis and be reported in the clinical results. Device deficiencies 
should be reported to Medinol and HCRI within 24 hours, per the instructions of eCRF 
completion. The sponsor is responsible to report device deficiencies to the FDA per MDR 
regulations. 

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11.5 
Reporting of Study Endpoint Adverse Events 
Whenever a clinical event related to a study endpoint is suspected or identified, all supporting 
source documents (i.e. progress notes, discharge summaries, catheterization lab reports, 
ECGs, lab results, etc.) should be submitted according to CEC source documentation 
collection procedures as soon as they are available. The source documentation required for 
each reported event is listed in the CEC charter. 
 

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12 
Statistical Methods 
This is a prospective, multi-center, non-randomized, single-arm clinical study designed to 
collect additional information on the safety and efficacy of the NIRxcell Stent Systems in the 
treatment of de novo stenotic lesions in native coronary arteries in the US population.  The 
primary endpoint to be evaluated in this study is TVF at 3 years, defined as a composite of 
cardiac death, target vessel MI, or clinically driven TVR by percutaneous or surgical methods 
within 3 years post-procedure.  This rate will be formally compared against a performance 
goal, which is derived from a meta-analysis of coronary stenting with BMS as described 
below. The study will be conducted at a maximum of 15 centers in the United States, and will 
enroll 131 subjects.  
12.1 
Determination of Performance Metric 
The NIRTRAKS Post-Market Study is designed as a single-arm registry, which will be 
compared against a performance goal derived from a meta-analysis of the primary endpoint, 
TVF at 3 years post-procedure, in BMS patients.  To establish a TVF rate at 3 years following 
PCI with BMS, we performed a systematic search of the PubMed/MEDLINE literature 
database of articles published until November 25, 2011, with the following search criteria: 
“Stents”[Mesh] AND coronary AND (“long term”[title] OR “long-term”[title] OR “3 
year”[title] OR “three year”[title]).  We supplemented this search strategy with a manual 
search of secondary sources, including references cited in the primary articles.  Subsequently, 
we limited the results to include only those studies with at least 3 years of follow-up and in 
which TVF was reported or could be calculated based on the outcomes reported. 
The primary search criteria yielded 86 headings.  After scanning the titles and abstracts of 
these headings, 8 full-text publications from 6 trials/programs were retrieved for additional 
analysis.  One additional report was retrieved through manual search.  Finally, the following 5 
trials/programs were identified as relevant according to subject selection, type of intervention, 
and length of follow-up: TAXUS Clinical Program (I-IV),22 ENDEAVOR II,23 RAVEL,24 
SIRIUS,25 and the SPIRIT FIRST trials.26 
The studies identified employed diverse outcome criteria, and thus some adjustments for the 
reported data were made.  
1. Oculostenotic reflex: The current post-market study will evaluate subjects based on 
follow-up assessments performed by telephone, and without mandatory angiographic 
assessment.  Hence, any repeat interventions will be performed solely based on 
clinical symptoms.  The observation that angiographic follow-up increases TLR and 
TVR rates when compared against clinical follow-up alone (the “oculostenotic reflex”) 
has been made previously with both balloon angioplasty and BMS.5,27, 28  Thus, our 
expected TVR rate (as a component of TVF) will be lower than those observed in 
studies that utilized mandatory angiographic assessment.  To perform this adjustment, 
we analyzed 2 studies that reported differences in TVR rates between 
angiographically- and clinically-followed cohorts.  The first study, TAXUS IV,27 
reported a TVR rate at 1 year of 18.9% in the angiographic cohort and 14.3% in the 
clinical cohort – a difference of 4.6%.  The second study, ENDEAVOR II,28 reported 
TVR rate at 8 months of 16.8% in the angiographic cohort and 8.2% in the clinical 
cohort – a difference of 8.6%.  We averaged these 2 studies to assume the difference in 
TVR rate between angiographically and clinically followed cohorts to be 6.6%.  We 

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used this estimate to correct the rate of 1 year TVR according to the percentage of 
subjects undergoing repeat angiography in the trials included.  The number of non-
clinical TVR was then reduced from the overall TVR at 3–5 years. 
ܥ݈݈݈݅݊݅ܿܽݕ ܦݎ݅ݒ݁݊ ሺܸܴܶ௡ሻൌܸܴܶ௡െ 0.066 ∙ܻ∙ܸܴܶଵ 
Where Y = percentage of subjects undergoing protocol driven angiography at 9–12 
months. 
2. Target vessel MI: Only 1 of the trials identified reported target-vessel MI rate 
(TAXUS).  The 5-year ratio of target vessel MI to all MI in this trial was 0.75.  We 
searched the medical literature for long-term results of clinical trials assessing BMS in 
similar subject populations, in which target-vessel MI was reported, but no additional 
data were found.  We identified 1 trial in which target-vessel MI was adjudicated after 
DES implantations.29  In this trial, the 2-year ratio of target vessel MI to all MI was 
0.9.  Thus, we assume that overall, the 3-year target-vessel MI is approximately 0.825 
of the overall rate of MI reported in the trials identified. 
3. Target vessel non-fatal MI: Only 1 of the trials identified reported the fatality rate of 
MI.  In the RAVEL trial, the 3-year ratio of non-fatal MI to all MI was 0.75.  We used 
this proportion for the other studies included in our analysis. 
4. TVF: To match the TVF definition in the NIRTRAKS Post-Market Study, TVF was 
calculated as the sum of clinically driven TVR, target vessel non-fatal clinically 
relevant MI and cardiac death. 
5. TVF at 3 years: In the ENDEAVOR II trial, 50% of the combined long-term outcome 
of death, MI and TVR occurred in the first 9 months post-procedure.  For trials in 
which outcomes were reported for 4 or 5 years, we corrected the rates to 3 years by 
assuming that 50% of the events occurred during the first year, and the remainder were 
evenly distributed across the follow-up duration of years 2 to 5.  Thus, the 3-year event 
rate was calculated according to the following formula: 
ܸܶܨଷൌ ܸܶܨଵ൅ܸܶܨ௡
݊െ1 
Where  ܸܶܨଵൌ0.5 ∙ܸܶܨ௡ and n = number of follow-up years reported in original 
publication. 
We performed a random effects meta-analysis of the 3-year TVF rates from the BMS arms 
of included studies, following the approach in DerSimonian and Laird (1986).31 Based upon 
our analysis, the endpoint rate of TVF derived from the meta-analysis is 23.2% (95% CI 
19.8%, 26.7%). 
 

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Table 4: Subject and Lesion Characteristics in BMS Trials 
 
 
 
Subject Characteristics 
Lesion Characteristics 
Trial 
No. of BMS 
Subjects 
Mean Age (y) 
Women (%) 
Diabetes 
Mellitus (%) 
RVD (mm) 
MLD (mm) 
Length 
(mm) 
TAXUS I-IV  
1397 
62.2 
28.3% 
25.6% 
2.73 
0.91 
14.6 
RAVEL 
118 
59.7 
32% 
17.7% 
2.64 
Unknown 
9.61 
SPIRIT FIRST  
25 
61 
24% 
10% 
2.71 
Unknown 
10.9 
ENDEAVOR II 
599 
63 
24.5% 
22.2% 
2.76 
0.84 
14.38 
SIRIUS 
525 
62 
30% 
28% 
2.81 
0.97 
14.4 
 
 
 

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Table 5: Target Vessel Failure Rates in BMS Trials 
Trial 
No. of 
BMS 
Subjects 
Angio 
Follow-
Up 
N (%) 
TVR 
Clinically 
Driven TVR 
All MI 
Target 
Vessel MI 
Target 
Vessel 
Non-Fatal 
MI 
All 
Death 
Cardiac 
Death 
TVF  
 
TVF at 
3 Years 
 
5-Year Data 
 
TAXUS I-IV  
1397 
1102 
(78.9%) 
-- 
21.8%* 
6.6% 
5% 
3.75% 
9.1% 
3.8% 
29.35% 
 
22.01% 
SIRIUS 
525 
353 
(67.2%) 
30.5% 
29.5%** 
6.5% 
5.36% 
4.02% 
8.4% 
3.6% 
37.12% 
 
27.84% 
SPIRIT FIRST  
25 
25 
(100%) 
-- 
36% 
0% 
0% 
0% 
-- 
0% 
36% 
 
27% 
 
4-Year Data 
 
ENDEAVOR II 
599 
294 
(49.1%) 
-- 
17.2%† 
4.4% 
(non-fatal) 
3.63% 
(non-fatal) 
3.63% 
5.2% 
2.24%‡ 
23.07% 
 
19.23% 
 
3-Year Data 
 
RAVEL 
118 
118 
(100%) 
-- 
17.7%§ 
7.1% 
5.86% 
4.39% 
4.4% 
2.7% 
24. 79% 
 
24.79% 
BMS: bare metal stent; MI: myocardial infarction; TVF: target vessel failure; TVR: target vessel revascularization. 
* We assumed a 5-year clinically driven TLR rate of 16.8% based on a 5-year TLR rate of 16.8% in 295 subjects with no routine angiographic follow-up.  In this 
trial the ratio of TVR to TLR at 5 years was 1.3.  We therefore assumed the clinically driven TVR rate to be 1.3 times the clinically driven TLR rate.  
** Based on a 1-year TVR rate of 22.9%. 
† At 9 months, 26 events from the ENDEAVOR II cohort were reported as non-clinical (angio driven).  These were deducted from the 129 events reported at 4 
years. 
‡ At 5 years, the proportion of cardiac deaths of all deaths was 0.42 in the TAXUS program and 0.43 in the SIRIUS trial.  We used this proportion (0.43) to 
calculate the rate of cardiac deaths at 4 years in the ENDEAVOR II trial. 
§ The sum of clinically driven TLR (15.0%) and all non-TLR TVR (2.7%).  
 

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12.2 
Performance Goal 
The goal of the primary analysis will be to assess the comparability of the observed primary 
endpoint rate for the study stent to the meta-analysis derived rate (23.2%).  Based upon the 
meta-analysis, the expectation for the true primary endpoint rate for the study stent is equal to 
23.2%.  However, since strict equality cannot be assessed statistically, this non-randomized, 
single-arm study will assess if the study stent 3-year TVF rate falls significantly below 34.8%.  
Specifically, this study will assess the ability of the study stent to meet a performance goal of 
34.8%, which is a 50% increase over the expected rate of 23.2% obtained from the meta-
analysis.  
12.3 
Primary Endpoint and Sample Size Calculation 
The null hypothesis for this study states that the NIRxcell will have a primary endpoint rate 
greater than or equal to 34.8%.  The alternative hypothesis states that the NIRxcell will have a 
primary endpoint rate less than 34.8%.  
Specifically:   
Ho: 
 NIRTRAKS ≥ 34.8% 
HA: 
 NIRTRAKS < 34.8% 
where 
 NIRTRAKS is the true primary endpoint rate for the study stent and the 34.8% is the 
meta-analytically derived performance goal (PG) for the primary endpoint rate.  Rejection of 
the null hypothesis will signify that the performance goal has been met, and that the study 
stent’s primary endpoint rate is less than 34.8%. 
The primary hypothesis test will be carried out by comparing the upper bound of the exact 1-
sided 95% confidence interval of the 3-year TVF rate to 34.8%, the PG.  If this upper bound is 
less than 34.8%, then it will be considered that the study stent meets the performance goal.  
The necessary sample size for testing the primary hypothesis was estimated with PASS 
software using exact hypothesis testing based on the exact distribution with the following 
assumptions: 
 Type I error (α) = 0.05 (1-sided). 
 Statistical power (1 – β) = 83%. 
 PG = 34.8%. 
 
 NIRTRAKS = 23.2%. 
An evaluable sample size of 105 provides 83% power to reject the above null hypothesis in 
favor of the alternative. Thus, 131 subjects will be enrolled to account for loss to follow-up, 
which is expected to be approximately 7.0% per year. 
The loss to follow-up in previously published stent trials with long-term follow-up is low.  In 
the SIRIUS25 trial, complete data compliance for all 5-year follow-up end points was 93.6% 
and 94% in the intervention and control groups, respectively.  At 9 months the clinical 
compliance was 100%32 in both groups.  In the ENDEAVOR II trial,23 out of 1,197 enrolled 
subjects, 1,167 were followed for 4 years (97.4%).  In the RAVEL trial24, complete data sets 
were available for 94.2% of subjects randomly assigned to sirolimus-eluting stents and for 
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94.1% of subjects randomized to BMS.  In the TAXUS IV trial,22 out of 1,314 intention-to-
treat (ITT) subjects, 5-year data were available for 1,294 (98.4%) subjects. In view of these 
data, we believe a yearly 7% loss-to-follow-up estimate is conservative and encompasses wide 
margins of safety. 
12.4 
Analysis Sets 
12.4.1 Intention-to-Treat 
The primary analysis set will be based on the principle of intention-to-treat.  All statistical 
analyses in this study will be performed on the ITT population with each enrolled subject 
analyzed regardless of the actual treatment received.   
12.4.2 Per-Protocol 
Per-protocol (PP) analysis will also be conducted. Per-protocol is defined as all subjects who 
sufficiently comply with the study protocol. Compliance covers treatment received, 
availability of follow-up data (follow-up of at least 3 years, allowing for a visit window of 3 
years ± 1 month), and absence of major protocol deviations.   
12.5 
Endpoint Analyses and Reporting of Results 
Descriptive statistics will be used to present the data and to summarize the results. Categorical 
variables will be presented using counts and percentages. Proportions will be calculated using 
known non-missing values. Continuous variables will be summarized by presenting the 
number of observations (N), mean, 2-sided 95% confidence interval of the mean, standard 
deviation, median, minimum and maximum values. Unless otherwise indicated, all statistical 
tests and/or confidence intervals will be performed at α = 0.05 (2-sided). 
For adverse event reporting, which includes the primary and secondary safety endpoints, the 
primary analysis will be based on subject counts, not event counts. A subject with more than 
one event will be counted only once toward the event rate based on the total number of 
subjects with adverse events. Additionally, an event rate based on event counts will also be 
presented. Unless specified otherwise, statistical significance will be declared if the two-sided 
p-value is < 0.05. 
All statistical analyses will be performed using Statistical Analysis System (SAS) for 
Windows (version 9.1 or higher, SAS Institute Inc. Cary, NC) or other widely accepted 
statistical or graphical software. In general, data for all study subjects will be combined and 
presented. Individual data will be presented in subject listings. 
12.6 
Analysis of Baseline Demographics and Procedural Characteristics 
Descriptive statistics will be generated for baseline demographics, procedural characteristics, 
and follow-up data collected.  Categorical variables will be analyzed using frequency, 
incidence and event rate.  For continuous variables collected in the study, analysis will include 
mean, median, standard deviation and range. 

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12.7 
Analysis of Primary Endpoint 
An assessment of the null and alternative hypotheses from Section  12.3,  
Ho: 
 NIRTRAKS ≥ 34.8% 
HA: 
 NIRTRAKS < 34.8% 
will be carried out using the exact test of the binomial distribution at the 1-sided 0.05 level of 
significance on ITT subjects who experienced the primary endpoint or who had follow-up 
within 1 month (the allowable window for the 3-year contact) of 3-years post-procedure.  If 
this upper interval is below 34.8%, the null hypothesis above will be rejected in favor of the 
alternative (the results of the exact confidence interval approach will yield the same 
conclusion as the 1-sided exact test of the null hypothesis).  In addition, the assessment of the 
hypotheses will be carried out on all ITT subjects by (a) comparing the 1-sided upper 95% 
confidence interval of the Kaplan-Meier estimate of the primary endpoint rate to 34.8%; 
subjects not experiencing the endpoint will be censored at 3 years post-procedure or day of 
withdrawal, whichever is earlier; and (b) multiply imputing the primary endpoint incidence 
for subjects prematurely withdrawing prior to 3 years minus 1 month post-procedure and prior 
to experiencing the primary endpoint, followed by a test of hypothesis on the imputed data 
(see details in Section  12.8 below). The results of the various ITT analyses on the primary 
endpoint will be compared descriptively to assess the sensitivity of results to missing data. 
Finally, the analysis will be carried out on the PP population (secondary analysis) using the 
exact test of the binomial distribution and an exact 1-sided upper 95% confidence interval.  
12.8 
Handling of Missing Data in the Analysis of the Primary Endpoint 
The primary analysis set will be the ITT population, which includes all subjects enrolled into 
the study.  Subjects who prematurely withdraw prior to the 3-year (minus the allowable 1-
month window) contact and prior to experiencing the primary endpoint will have their missing 
primary endpoint result handled using the following 3 approaches; results will be compared 
across the 3 approaches for consistency: 
1. Only subjects with appropriate follow up (at least 3 years minus 1 month) or who 
experienced the primary endpoint by 3 years will be included in the exact hypothesis 
testing, as discussed above.  This is the primary analysis.. 
2. Multiple imputation: This will be used to impute primary endpoint status (yes/no) for 
subjects with missing primary endpoint data.  The logistic regression approach to 
multiple imputation will be carried out using SAS PROC MI.  The covariates to be 
used in the imputation model will be age, sex, prevalence of diabetes, target lesion 
length and reference vessel diameter.  Five data sets will be imputed, and a 1-sided test 
of the above null hypothesis will be carried out on each data set using the normal 
approximation to the binomial distribution.  SAS PROC MIANALYZE on the results 
of the 5 significance tests will then be used to obtain an overall assessment of the 
significance of the 1-sided test across the 5 data sets. 
3. As a third analysis and as discussed above, the Kaplan-Meier estimate of the 3-year 
primary endpoint rate, and its 1-sided upper 95% confidence interval will be 
calculated. Subjects not experiencing the primary endpoint within 3 years will be 
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censored at 3 years or the date of withdrawal from the study, whichever is earlier. The 
upper confidence limit will be compared to 34.8%; if less than 34.8%, the primary 
endpoint rate will be considered to be significantly less than the performance goal in 
this analysis. 
12.9 
Analysis of Secondary Endpoints 
All secondary endpoints (listed below) are dichotomous variables.  Secondary endpoints will 
not be tested formally.  Instead, secondary endpoints will be presented as the number and 
percentage of subjects experiencing the outcome, along with 2-sided exact 95% confidence 
intervals of the percentages.  In addition, a Kaplan-Meier (K-M) estimate of the event-free 
survival rate and its corresponding standard error will be presented for death, MI, clinically 
driven TLR and TVR, with a corresponding K-M curve. 
The secondary endpoints that will be reported are as follows: 
1. TVF at 9 Months. 
2. All cause death at 30 days, and 1, 2 and 3 years. 
3. Cardiac death at 30 days, and 1, 2 and 3 years. 
4. All cause MI at 30 days, and 1, 2 and 3 years. 
5. Target vessel MI at 30 days, and 1, 2 and 3 years. 
6. Clinically driven TLR at 30 days, and 1, 2 and 3 years. 
7. Clinically driven TVR at 30 days, and 1, 2 and 3 years. 
8. Acute success rates  
Device success: Attainment of <50% final residual stenosis of the target lesion 
using the NIRxcell Stent System only. 
Lesion success: Attainment of <50% final residual stenosis of the target lesion 
using any percutaneous method. 
Procedure success: Attainment of <50% residual stenosis of the target lesion 
and no in-hospital death, MI or TLR. 
9. Stent thrombosis at hospital discharge, at 30 days, and 1, 2 and 3 years. 
12.10 Pre-Planned Subgroup Analyses 
A subgroup analysis will be performed according to the following characteristics: ethnicity, 
race, gender, age group (less than and over 65), obesity (less than and over body mass index 
[BMI] of 30), diabetes mellitus, and site of arterial access (trans-radial versus trans-femoral 
access).  The TVF rate with 95% CIs will be provided for each subgroup.  There will be no 
formal statistical analysis to compare TVR rates across these subgroups, as the study is not 
powered to detect such differences. 
12.11 Analysis of Poolability of Data Across Study Sites 
This is a multi-center clinical study, with standardization of subject enrollment, data entry and 
AE reporting.  All investigational sites will follow the requirements of a common protocol, 
data collection procedures and forms.  To present the data from this clinical study in a 

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summary form, a comparison across all sites on the primary endpoint will be completed via 
logistic regression to determine if the primary endpoint data can be pooled for the primary 
analysis.  A 0.15 level of significance will be used to assess site poolability.  A poolability P 
value < 0.15 will not necessarily preclude patients from being pooled across sites for the 
primary analysis.  Rather, further analysis will be carried out to assess if it is appropriate to 
pool sites, such as (1) inspection of the primary endpoint rate in each site to assess if the 
primary endpoint rate is at least descriptively less than the performance goal at each site; (2) a 
comparison of the following variables across sites to assess if potential lack of site poolability 
on the primary endpoint may be due to differences in the following variables across sites: 
baseline demographics, procedural characteristics and protocol deviations.  
The distributions of the above variables across the sites will be tabulated.  To detect site 
differences, the Kruskal-Wallis test will be used for continuous variables and the Chi-Square 
test or the Fisher’s exact test will be used for categorical variables, depending on sample size. 
12.12 Clinical Events Committee 
The clinical events committee (CEC) will be comprised of both interventional and non-
interventional cardiologists who are not participants in the study and who have no conflict of 
interest with the study or the study 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 clinical study endpoint events.  At the 
onset of the trial, the CEC will establish explicit rules outlining the minimum amount of data 
required, and the algorithm followed in order to classify a clinical endpoint event.  The CEC 
will then meet regularly in approximately every 12 months following start of enrollment. The 
CEC will review and adjudicate study endpoint–related clinical events in which the required 
minimum data are available.  The committee will also review and rule on all deaths that occur 
throughout the trial.   
Once the specific criteria for clinical endpoints are established by the CEC, HCRI will be 
responsible for categorizing all clinical endpoint events when all necessary data are available. 
 
 

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13 
Data Handling and Record Keeping 
13.1 
Source Documents 
Source data is all information, original records of clinical findings, observations or other 
activities in a clinical study necessary for the reconstruction and evaluation of the study. 
Source data are contained in source documents.  Examples of these original documents and 
data records include but are not limited to: hospital records, clinical and office charts, 
laboratory notes, memoranda, subjects’ evaluation checklists, recording media such as DVD 
and video tapes, X-rays, subject files, and records kept at the laboratories and at other 
departments involved in the clinical trial.  
Source documents will be used: 
 For verification of the data documented in subjects’ eCRF during monitoring visits.  
 For adjudication of AEs.  Standardized forms will be designed to ensure proper collection 
of all requested source documentation from the sites.   
13.2 
Electronic Case Report Form 
A web-based clinical data collection and presentation system will be used in this study.  The 
eCRF is the primary data collection instrument and will be provided to the sites as a secured, 
private facility over the internet.  This system will include: 
 Complete eCRF-based data collection, clarification and archival system. 
 Online query creation and resolution. 
 Electronic signatures compliant with 21 CFR Part 11. 
 Complete audit trail history. 
All data requested on the eCRF must be recorded.  All missing data must be explained: 
 If a space on the eCRF is left blank because the procedure was not done or the question 
was not asked, a comment must be created on the field to explain the blank field.  
 If the item is not applicable to the individual case, a comment must be created on the field 
to explain the blank field.  
 If any entry error has been made, to correct such an error, the data must be edited 
including a reason for the correction and the eCRF re-submitted. 
Detailed description of the eCRF components as well as completion and handling instructions 
are provided in the eCRF Completion Guidelines.  
The eCRF must be fully completed for each subject, electronically signed by the authorized 
personnel, and submitted to the data center.  eCRFs documenting SAEs, UADEs, device 
failures and device malfunctions should be submitted via the Electronic Data Capture (EDC) 
system as soon as possible, preferably within 24 hours after the investigator becomes aware of 
the event.   
All other eCRFs should be completed in a timely manner, preferably within 5 to 7 days of the 
subject’s enrollment or follow-up visit.  

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All angiographic and ECG media should be prepared and sent to the corresponding core 
laboratory, preferably within 7 working days of data collection.   
All collected study data will be made available (and sent in the appropriate format) to the 
sponsor, if requested, after the study has reached its primary endpoint at 3 years post-
procedure.  
13.3 
Data Review 
Primary data collection, based on source-documented hospital chart reviews, will be 
performed by the research coordinators at each investigational site.  eCRFs will be completed 
prospectively in an expedited fashion.  Sponsor-appointed monitors will provide clinical 
monitoring, including review of eCRF and parity checks with the source documentation. 
eCRFs will be reviewed for completeness and clarity by the data center.  Missing or unclear 
data will be requested as necessary throughout the study.  The data center may request further 
documentation such as physician and/or catheter laboratory procedure notes when SAEs are 
reported. 
Data entry and development of the primary database for the study will be managed by the data 
center.  The data center will also be responsible for the quality control of the database and 
confirming the overall integrity of the data. 
13.4 
Records Retention 
All study-related records and reports must be maintained in designated NIRTRAKS Post-
Market Study administrative files at each investigational site.  These files should be retained 
for a minimum of 5 years after: the date on which the study is terminated or completed, OR 
the date on which there is no pending/contemplated action in any International Conference on 
Harmonisation (ICH) region, OR the date that the records are no longer required for purposes 
of supporting a marketing approval in ICH regions, OR according to national regulatory 
requirements, whichever is later.  The files may be discarded only upon notification from the 
sponsor.  To avoid error, the principal investigator should contact the sponsor before the 
destruction of any records and reports pertaining to the study to ensure they no longer need to 
be retained. 
The subject data for the study will be housed within the database at the data center. At the 
completion of the study, the site will be sent a CD with the final subject data for the particular 
site. 
13.5 
Study Device Accountability 
The Primary Investigator will maintain adequate records of the receipt and disposition of the 
NIRxcell on the device inventory log or case report form (CRF), including stent 
size/dimensions; date implanted; subject identification number; and implanting Investigator.  
  
 

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14 
Quality Control and Quality Assurance 
14.1 
Investigational Site Monitoring and Auditing 
The study will be monitored according to applicable provisions of the sponsor’s monitoring 
procedures, in conformance with World Medical Association Declaration of Helsinki, and 
local regulations for post-approval clinical studies.  Additionally, applicable provisions of 
FDA regulation 21 CFR parts 812, 50 and 54 will be followed. 
Monitoring visits to the investigational sites will be made periodically during the study to 
ensure that: 
 The rights and well-being of study subjects are protected. 
 The reported study data are accurate, complete and verifiable from source documents. 
 The conduct of study is in compliance with approved protocol/amendment, with GCP, and 
with applicable regulatory requirements. 
A monitoring plan will be prepared and shall include information such as:  
 Parties (clinical research organization [CRO]/monitor and sponsor) and signatures. 
 Purpose. 
 Responsibilities. 
 Processes, such as: 
o Types of visits and expected scope of activities in each. 
o Level of source document verification and the key data to be monitored. 
o Communication paths and data flow to be followed. 
o Frequency of visits. 
o Reporting and documentation of monitoring activities. 
The principal investigator guarantees direct access to the study files, subject eCRFs and subject 
medical records, to staff of the sponsor and the sponsor’s study contractor(s) personnel, as well 
as regulatory authorities that govern the conduct of clinical investigations. 
The investigational sites may also be subject to a quality assurance audit by staff of the sponsor 
or the sponsor’s study contractor(s) personnel, as well as inspection by regulatory authorities that 
govern the conduct of clinical investigations. 
It is important that the investigators and the relevant site personnel are available during the 
monitoring visits and possible audits and that sufficient time is devoted to the process. 
14.2 
Training  
The training of clinical site personnel, as well as other personnel related to the study (i.e., CRO 
personnel) will be the responsibility of the sponsor.  To insure uniform data collection and 
protocol compliance, training will cover topics such as investigational product, study protocol 
(with reference to applicable regulations), eCRF and completion instructions, and study 
processes and documentation (e.g., informed consent, safety handling and reporting, compliance 
handling and reporting).  All users of the EDC system will be trained in accordance to 21 CFR 

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Part 11 guidelines.  Training can take place via on-line EDC system training modules, webinars, or 
dedicated meetings, initiation visits, conference calls, specific letters to investigators, etc. 
14.3 
Protocol Deviations and Medical Emergencies 
Protocol deviations are instances, in which the investigator or site personnel did not conduct the 
study according to the clinical protocol or the investigator agreement.  In this study protocol 
deviations will be classified as follows: 
Major deviation: any deviation from subject inclusion and exclusion criteria or subject 
informed consent procedures. 
Minor deviation: deviation from a clinical protocol requirement such as incomplete/inadequate 
subject tests or examinations, non-compliance with medication regimens, missed follow-ups, 
follow-ups performed outside specified time windows, etc.  
Investigators will not deviate from the protocol without the prior written approval of their IRB 
and the sponsor except when the change is necessary to eliminate apparent immediate hazards to 
the human subject or to protect the life or physical well-being of the subject or in unforeseen, 
isolated instances, where minor changes are made that will not increase the subject's risk or 
affect the validity of the study.   
Study sites should report all protocol deviations on the applicable eCRF.  Any deviation from the 
protocol made to protect the life or physical well-being of a subject in an emergency should be 
reported as soon as possible but no later than 5 working days after the emergency occurs.  
Investigators will also adhere to procedures for reporting protocol deviations to their IRB in 
accordance with their specific IRB reporting policies and procedures.  
14.4 
Investigational Site Termination 
The sponsor reserves the right to terminate an investigational site for any of the following 
reasons: 
 Repeated failure to complete eCRFs. 
 Failure to obtain informed consent. 
 Failure to report SAE within 24 hours of knowledge 
 Repeated protocol violations. 
 Failure to enroll an adequate number of subjects. 
 
 

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15 
Ethical and Regulatory Considerations 
15.1 
Compliance Statement 
This trial will be conducted in accordance with this protocol, the Declaration of Helsinki and US 
Good Clinical Practice (21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 812), and the 
applicable regulatory requirements (such as 21 CFR Part 54, 21 CFR Part 11).  The conduct of 
the trial will be approved by the appropriate Institutional Review Board (IRB) of the respective 
investigational site and the US Food and Drug Administration.  
15.2 
Institutional Review Board 
This protocol and any amendments will be submitted to a properly constituted independent IRB 
for formal approval of the study conduct.  The decision of the IRB concerning the conduct of the 
study will be made in writing to the investigator and a copy of this decision will be provided to 
the sponsor before commencement of this study.  The investigator should provide a list of IRB 
members and their affiliations to the sponsor.  If a membership list is not available, a waiver 
letter or minutes from the IRB meeting is required to indicate that none of the physicians 
involved in this study are members of the IRB or, if they are, that they are non-voting members 
or did not vote in the approval of this protocol.  Investigators are responsible for obtaining and 
maintaining approval of the study by the IRB. 
The sponsor may propose changes to the clinical protocol.  Changes to the protocol must be 
approved in writing by the IRB; these changes will be considered as protocol amendments.  A 
significant change is one that may increase risk or present new risk to the subject, or may 
adversely affect the validity of the study.  Each investigator must receive approval for the 
amendment prior to implementing it at his/her investigational site.   
15.3 
Informed Consent Form 
Signed written informed consent is mandatory and must be obtained from all subjects prior to 
their participation in the NIRTRAKS Post-Market Study.  The investigator will explain to the 
subject in layman’s terms all aspects of the consent.  Informed consent must be obtained in 
accordance with ISO 14155:2011, FDA regulation (21 CFR Part 50) and the Declaration of 
Helsinki and shall inform the subject as to the objective and procedures of the study and possible 
risks involved.  The subjects must be informed of their right to withdraw from the study at any 
time and for any reason without sanction, penalty or loss of benefits to which they are otherwise 
entitled, and that withdrawal from the study will not jeopardize their future medical care.  
The NIRTRAKS Post-Market Study template informed consent form (ICF) that will be provided 
to the participating sites may be adjusted by site personnel but any such modification must be 
approved by the sponsor.  The NIRTRAKS Post-Market Study ICF must be used in addition to 
the institution standard consent form.  The IRB-approved study ICF must be sent to the sponsor 
for approval and a copy must be placed at the investigational site in the NIRTRAKS Post-Market 
Study binder.  The ICF form must be signed and dated by the subject or the subject’s legally 
authorized representative, and the investigator-designated research professional obtaining the 
consent.  A signed copy of the ICF must be given to each subject enrolled in the study.  
Modifications to the NIRTRAKS Post-Market Study ICF (e.g., additional safety or procedural 
information) and any written subject information throughout the study period, must be approved 
by the sponsor and, as necessary, the IRB and other regulatory authorities as required by country 

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law.  If the modification of the ICF relates to any study methodology, then the subjects must be 
re-consented.  The ICF may also be revised for minor non-procedural changes.  For these 
changes, the site should check with its IRB to see if subject re-consent is required.   
15.4 
Confidentiality 
At all times throughout the study, confidentiality shall be observed by all parties involved.  All 
information and data sent to the data center, core laboratories and/or the sponsor concerning 
subjects or their participation in this study will be considered confidential.  All data used in the 
analysis and reporting of this evaluation will be used in a manner without identifiable reference 
to the subject.  The principal investigator consents to visits by the staff of the sponsor and the 
sponsor’s study contractor(s) personnel, as well as regulatory authorities that govern the conduct 
of clinical investigations.  
 
 

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16 
Reporting Requirements 
16.1 
Investigator Reporting Responsibilities 
Investigators are required to prepare and submit the following data completely and accurately 
and within the time required: 
Table 6: Investigator’s Responsibilities for Preparing and Submitting Reports 
Investigator reporting responsibilities 
Data Form 
Action Required 
Requirements 
Subject enrollment 
eCRF page 
Complete via EDC system 
Within 7 days of enrollment. 
Subject angiograms  
Provide to angiographic core 
laboratory 
Within 7 working days of exam 
Subject ECG 
Provide to ECG core laboratory 
Within 7 working days of exam 
SAE and UADE 
 
* Source documents 
should be sent to 
Monitoring CRO, upon 
request 
Complete via EDC system 
Within 24 hours of knowledge. 
Provide to IRB and FDA 
As required. 
AE 
Complete via EDC system 
If possibly or probably related to 
study device / procedure– 
complete eCRF within 24 hours 
of knowledge. Otherwise – 
complete within 10 working days 
of knowledge. 
Subject death during 
the study 
Complete via EDC system 
Within 24 hours of knowledge. 
Provide to IRB and FDA 
As required. 
Subject withdrawal 
Complete via EDC system 
Within 7 working days of 
knowledge. 
Device deficiencies 
Complete via EDC system 
Within 24 hours of knowledge. 
Withdrawal of IRB 
approval 
Provide to Medinol either 
verbally or via email 
Within 5 working days of 
knowledge. 
Deviations from the 
clinical protocol 
 
 
 Failure to obtain 
informed consent 
prior to procedure 
Provide to Medinol (either 
verbally or via email) as well as 
to IRB and FDA. 
Also complete via EDC system 
Within 5 working days of 
occurrence. The report will 
include a brief description of the 
circumstances justifying failure. 

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Investigator reporting responsibilities 
Data Form 
Action Required 
Requirements 
 Other deviation 
Complete via EDC system 
Within 7 working days of 
knowledge. 
Provide to IRB and FDA 
As required. 
Progress reports / 
notifications of site 
activity (e.g.: end of 
enrollment, end of 
study, etc.) 
Provide to IRB 
Annually for the duration of the 
clinical study. 
Final clinical summary 
report 
Provide to IRB, once available 
Report must be submitted within 
3 months after termination or 
completion of the study. 
16.1.1 Investigator’s Final Report 
Upon completion or termination of the study a final report will be prepared.  This report will 
contain a critical evaluation of all data collected during the course of the study at each institution.  
The report must be signed by the principal investigator of the study and will be provided to the 
IRB as required.  Any modifications to this final report must be reviewed and approved by the 
sponsor. 
16.2 
Sponsor Reporting Requirements 
The sponsor and HCRI will prepare written progress reports and a final report.  Medinol will 
submit the required reports as required by local law.  This includes the following reports to the 
FDA according to 21 CFR 803: 
Table 7: Sponsor’s Responsibilities for Preparing and Submitting Reports 
What to Report 
Report Form 
To Whom 
When 
30 day reports of deaths, serious 
injuries and malfunctions 
Form FDA 
3500A 
FDA 
Within 30 calendar days of 
becoming aware of an event 
5-day reports for an event 
designated by FDA or an event 
that requires remedial action to 
prevent an unreasonable risk of 
substantial harm to the public 
health 
Form FDA 
3500A 
FDA 
Within 5 work days of 
becoming aware of an event 
18-month Progress Report* 
PAS Progress 
Report 
FDA 
23 July 2015 
24-month Progress Report* 
PAS Progress 
Report 
FDA 
23 January 2016 

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What to Report 
Report Form 
To Whom 
When 
Progress Report* 
PAS Progress 
Report 
FDA 
Annually on January 23  
Final Report 
Final Study 
Report  
FDA 
Anticipated - Dec 2019 
 
*PAS progress reports provided to FDA after start of enrollment will be based on CEC adjudicated data.

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17 
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Holmes DRJ, Vlietstra RE, Smith HC, Vetrovec GW, Kent KM, Cowley MJ, Faxon DP, 
Gruentzig AR, Kelsey SF, Detre KM, al. e. Restenosis after percutaneous transluminal coronary 
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Am J Cardiol. 1984;53:77C-81C 
2. 
Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, 
Nobuyoshi M, al. e. A randomized comparison of coronary-stent placement and balloon 
angioplasty in the treatment of coronary artery disease. Stent restenosis study investigators. N 
Engl J Med. 1994;331:496-501 
3. 
Salam AM, Al Suwaidi J, Holmes DRJ. Drug-eluting coronary stents. Curr Probl Cardiol. 
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Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006;354:483-495 
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Cutlip DE, Chauhan MS, Baim DS, Ho KK, Popma JJ, Carrozza JP, Cohen DJ, Kuntz RE. 
Clinical restenosis after coronary stenting: Perspectives from multicenter clinical trials. J Am Coll 
Cardiol. 2002;40:2082-2089 
6. 
Mauri L, O'Malley AJ, Cutlip DE, Ho KK, Popma JJ, Chauhan MS, Baim DS, Cohen DJ, Kuntz 
RE. Effects of stent length and lesion length on coronary restenosis. Am J Cardiol. 2004;93:1340-
1346, A1345 
7. 
Bavry AA, Kumbhani DJ, Helton TJ, Bhatt DL. What is the risk of stent thrombosis associated 
with the use of paclitaxel-eluting stents for percutaneous coronary intervention?: A meta-analysis. 
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8. 
Holmes DR, Jr., Leon MB, Moses JW, Popma JJ, Cutlip D, Fitzgerald PJ, Brown C, Fischell T, 
Wong SC, Midei M, Snead D, Kuntz RE. Analysis of 1-year clinical outcomes in the sirius trial: 
A randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for 
coronary restenosis. Circulation. 2004;109:634-640 
9. 
Moreno R, Fernández C, Hernández R, Alfonso F, Angiolillo DJ, Sabaté M, Escaned J, Bañuelos 
C, Fernández-Ortiz A, Macaya C. Drug-eluting stent thrombosis: Results from a pooled analysis 
including 10 randomized studies. J Am Coll Cardiol. 2005;45:954-959 
10. 
Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, 
Bergin P, Greenberg J, Popma JJ, Russell ME. One-year clinical results with the slow-release, 
polymer-based, paclitaxel-eluting taxus stent: The taxus-iv trial. Circulation. 2004;109:1942-
1947 
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Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, 
Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. 
Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting 
stents. Jama. 2005;293:2126-2130 
12. 
Rao SV, Shaw RE, Brindis RG, Klein LW, Weintraub WS, Peterson ED, Registry. ACoCNCD. 
On- versus off-label use of drug-eluting coronary stents in clinical practice (report from the 
american college of cardiology national cardiovascular data registry [ncdr]). Am J Cardiol. 
2006;97:1478-1481 
13. 
Urban P, Gershlick AH, Guagliumi G, Guyon P, Lotan C, Schofer J, Seth A, Sousa JE, Wijns W, 
Berge C, Deme M, Stoll HP, Investigators. e-C. Safety of coronary sirolimus-eluting stents in 
daily clinical practice: One-year follow-up of the e-cypher registry. Circulation. 2006;113:1434-
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Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos 
G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. 
Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in 
routine clinical practice: Data from a large two-institutional cohort study. Lancet. 2007;369:667-
678 
15. 
Eisenstein EL, Anstrom KJ, Kong DF, Shaw LK, Tuttle RH, Mark DB, Kramer JM, Harrington 
RA, Matchar DB, Kandzari DE, Peterson ED, Schulman KA, Califf RM. Clopidogrel use and 
long-term clinical outcomes after drug-eluting stent implantation. Jama. 2007;297:159-168 
16. 
Lagerqvist B, James SK, Stenestrand U, Lindback J, Nilsson T, Wallentin L. Long-term 
outcomes with drug-eluting stents versus bare-metal stents in sweden. N Engl J Med. 
2007;356:1009-1019 
17. 
Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, 
Bader F, Osswald S, Kaiser C. Late clinical events after clopidogrel discontinuation may limit the 
benefit of drug-eluting stents: An observational study of drug-eluting versus bare-metal stents. J 
Am Coll Cardiol. 2006;48:2584-2591 
18. 
Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D'Ascenzo F, Kimura T, 
Briguori C, Sabate M, Kim HS, De Waha A, Kedhi E, Smits PC, Kaiser C, Sardella G, Marullo 
A, Kirtane AJ, Leon MB, Stone GW. Stent thrombosis with drug-eluting and bare-metal stents: 
Evidence from a comprehensive network meta-analysis. Lancet. 2012;379:1393-1402 
19. 
Bangalore S, Kumar S, Fusaro M, Amoroso N, Attubato MJ, Feit F, Bhatt DL, Slater J. Short- 
and long-term outcomes with drug-eluting and bare-metal coronary stents: A mixed-treatment 
comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation. 
2012;125:2873-2891 
20. 
Yeh RW, Vasaiwala S, Forman DE, Silbaugh TS, Zelevinski K, Lovett A, Normand SL, Mauri L. 
Instrumental variable analysis to compare effectiveness of stents in the extremely elderly. 
Circulation. Cardiovascular quality and outcomes. 2014;7:118-124 
21. 
Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, 
Stone GW. Consideration of a new definition of clinically relevant myocardial infarction after 
coronary revascularization: An expert consensus document from the society for cardiovascular 
angiography and interventions (scai). J Am Coll Cardiol. 2013;62:1563-1570 
22. 
Stone GW, Ellis SG, Colombo A, Grube E, Popma JJ, Uchida T, Bleuit JS, Dawkins KD, Russell 
ME. Long-term safety and efficacy of paclitaxel-eluting stents final 5-year analysis from the 
taxus clinical trial program. JACC: Cardiovascular interventions. 2011;4:530-542 
23. 
Eisenstein EL, Wijns W, Fajadet J, Mauri L, Edwards R, Cowper PA, Kong DF, Anstrom KJ. 
Long-term clinical and economic analysis  of the endeavor drug-eluting stent versus the driver 
bare-metal stent. 4-year results from the endeavor ii trial (randomized controlled trial to evaluate 
the safety and efficacy of the medtronic ave abt-578 eluting driver coronary stent in de novo 
native coronary artery lesions). JACC Cardiovasc Interv. 2009 2:1178-1187 
24. 
Fajadet J, Morice MC, Bode C, al. e. Maintenance of long-term clinical benefit with sirolimus-
eluting coronary stents. Three-year results of the ravel trial. Circulation. 2005;111:1040-1044 
25. 
Giora Weisz G, Leon MB, Holmes DR, al. e. Five-year follow-up after sirolimus-eluting stent 
implantation. Results of the sirius (sirolimus-eluting stent in de-novo native coronary lesions) 
trial. J Am Coll Cardiol. 2009;53:1488–1497 
26. 
Marcus Wiemer PWS, Karine Miquel-Hebert, Franz-Josef Neumann,Jan J. Piek, Eberhard 
Grube,Ju¨ rgen Haase,Leif Thuesen, and Christian Hamm. Five-year long-term clinical follow-up 

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of the xience v everolimus eluting coronary stent system in the treatment of patients with de novo 
coronary artery lesions: The spirit first trial. Catheterization and Cardiovascular Interventions. 
2010;75:997–1003 
27. 
Pinto DS, Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Mehran R, Na 
Y, Turco M, Caputo R, Popma JJ, Cutlip DE, Russell ME, Cohen DJ. Impact of routine 
angiographic follow-up on the clinical benefits of paclitaxel-eluting stents: Results from the 
taxus-iv trial. J Am Coll Cardiol. 2006;48:32-36 
28. 
Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, 
Bonan R, Kuntz RE. Randomized, double-blind, multicenter study of the endeavor zotarolimus-
eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: 
Clinical and angiographic results of the endeavor ii trial. Circulation. 2006;114:798-806 
29. 
Stone gW, Rizvi A, Sudhir K, al. e. Randomized comparison of everolimus- and paclitaxel-
eluting stents 2-year follow-up from the spirit (clinical evaluation of the xience v everolimus 
eluting coronary stent system) iv trial. JACC.58:19–25 
30. 
Wang TY, Peterson ED, Dai D, Anderson HV, Rao SV, Brindis RG, Roe MT, Registry NCD. 
Patterns of cardiac marker surveillance after elective percutaneous coronary intervention and 
implications for the use of periprocedural myocardial infarction as a quality metric: A report from 
the national cardiovascular data registry (ncdr). J. Am. Coll. Cardiol. 2008;51:2068-2074.  
31. 
DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled Clinical Trials. 1986;7:177-
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32. 
Moses JW, Martin B. Leon, Jeffrey J. Popma, Peter J. Fitzgerald, David R. Holmes, Charles 
O’Shaughnessy, Ronald P. Caputo, Dean J. Kereiakes, David O. Williams, Paul S. Teirstein, 
Judith L. Jaeger, Richard E. Kuntz MD, Investigators ftS. Sirolimus-eluting stents versus standard 
stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315-1323 
33. 
Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon 
V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, 
Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for 
cardiovascular clinical trials: A consensus report from the bleeding academic research 
consortium. Circulation. 2011;123:2736-2747 
 
 
 

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Appendix 1-P: Study Definitions 
ABRUPT CLOSURE 
Abrupt Closure: Defined as the occurrence of new (during the index procedure) severely reduced 
flow (Thrombolysis in Myocardial Infarction [TIMI] grade 0–1) within the target vessel that 
persists and requires rescue by stenting or other treatment, or results 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 
patent but has reduced flow.  Abrupt closure also does not connote transient closure with reduced 
flow in which the index treatment application does reverse the closure.  
Subabrupt Closure: Defined as abrupt closure that occurs after the index procedure is completed 
(and the subject has left the catheterization laboratory) and before the 30-day follow-up 
evaluation.  
Threatened Abrupt Closure: Defined as a grade B dissection and ≥50% diameter stenosis or any 
dissection of grade C or higher. 
ACUTE SUCCESS1  
Device Success:  Attainment of <50% residual stenosis of the target using only the NIRxcell 
Stent System.  
Lesion Success: Attainment of <50% residual stenosis of the target lesion using any 
percutaneous method.  
Procedure Success: Attainment of <50% residual stenosis of the target lesion and no in-hospital 
death, MI or TLR. 
ADVERSE DEVICE EFFECT (ADE) 
An ADE is defined as an AE related to the use of the study device. 
NOTE 1: This definition includes AEs resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the study device. 
NOTE 2: This definition includes any event resulting from user error or from intentional 
misuse of the study device. 
ADVERSE EVENT (AE) 
An AE is defined as 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 study device. 
NOTE 1: This definition includes events related to the study device or the comparator. 
                                                     
1 All analyses to determine acute success measures will be conducted utilizing in-stent residual stenosis values.  
When in-stent % residual stenosis is not available, in-lesion % residual stenosis will be used to complete the 
analysis. 

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NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to the 
study device. 
ANTICIPATED ADVERSE EVENT  
Any undesirable experience (sign, symptom, illness, abnormal laboratory value or other medical 
event) occurring to a subject, whether or not considered related to the study product(s) prescribed 
as part of the clinical protocol, predefined in the clinical protocol and/or Instructions for Use 
(IFU), product label that is identified or worsens during a clinical study. 
BRAUNWALD CLASSIFICATION OF UNSTABLE ANGINA 
Severity 
Class 1:  New onset of severe or accelerated angina. 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. 
Class 2:  Angina at rest, subacute. Subjects with 1 or more episodes of angina at rest during the 
preceding month but not within the preceding 48 hours. 
Class 3:  Angina at rest, acute. Subjects with 1 or more episodes of angina at rest within the 
preceding 48 hours. 
Clinical Circumstances in Which Unstable Angina Occurs 
Class A:  Secondary unstable angina. Subjects in whom unstable angina develops secondary to a 
clearly identified condition extrinsic to the coronary vascular bed that has intensified myocardial 
ischemia.  Such conditions reduce myocardial oxygen supply or increase myocardial oxygen 
demand and include anemia, fever, infection, hypotension, uncontrolled hypertension, 
tachyarrhythmia, unusual emotional stress, thyrotoxicosis, and hypoxemia secondary to 
respiratory failure. 
Class B:  Primary unstable angina.  Subjects who develop unstable angina pectoris in the absence 
of an extracardiac condition that have intensified ischemia, as in class A. 
Class C:  Postinfarction unstable angina. Subjects who develop unstable angina within the first 2 
weeks after a documented acute myocardial infarction. 
CANADIAN CARDIOVASCULAR SOCIETY CLASSIFICATION (CCSC) OF ANGINA 
Class I:  Ordinary physical activity does not cause angina, such as walking and climbing stairs.  
Angina with strenuous or rapid or prolonged exertion at work or recreation.  
Class II:  Slight limitation of ordinary activity.  Angina upon walking or climbing stairs rapidly, 
walking uphill, walking or stair climbing after meals, or in cold, wind or under emotional stress, 
or only during the first hours after awakening.  Angina if walking more than 2 blocks on the 
level and climbing more than one flight of ordinary stairs at a normal pace and in normal 
conditions.  
Class III:  Marked limitations of ordinary physical activity.  Walking 1 to 2 blocks on the level 
and climbing 1 flight of stairs in normal conditions and at a normal pace.  

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Class IV:  Inability to carry on any physical activity without discomfort.  Angina syndrome may 
be present at rest.  
CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (TLR)  
Revascularization at the target site associated with positive functional ischemia study or ischemic 
symptoms AND an angiographic minimal lumen diameter stenosis ≥50% by QCA, or 
revascularization of a target site with diameter stenosis ≥70% by QCA without either angina or a 
positive functional study.  
CLINICALLY-DRIVEN TARGET VESSEL REVASCULARIZATION (TVR)  
Revascularization in the target vessel associated with positive functional ischemia study or 
ischemic symptoms AND an angiographic minimal lumen diameter stenosis ≥50% by QCA, or 
revascularization of a target vessel with diameter stenosis ≥70% by QCA without either angina 
or a positive functional study.  
CEREBROVASCULAR ACCIDENT (CVA; see Stroke)  
The occurrence of cerebral infarction (ischemic stroke) and intracerebral hemorrhage and 
subarachnoid hemorrhage (hemorrhagic stroke).  
DE NOVO LESION  
Defined as a native coronary artery lesion not previously treated.  
DEATH  
Cardiac Death:  Any death due to proximate cardiac cause (e.g., MI, low-output failure, fatal 
arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, 
including those related to concomitant treatment, will be classified as cardiac death.  
Vascular Death:  Death caused by non-coronary vascular causes, such as cerebrovascular 
disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm or other vascular 
diseases. 
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.  
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. 
Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac 
disease (e.g., cancer, infection) should be classified as cardiac. 
DISSECTION, NHLBI (National Heart, Lung, and Blood Institute) CLASSIFICATION 
Grade A:  Small radiolucent area within the lumen of the vessel disappearing with the passage of 
the contrast material. 
Grade B:  Appearance of contrast medium parallel to the lumen of the vessel disappearing within 
a few cardiac cycles. 
Grade C:  Dissection protruding outside the lumen of the vessel persisting after passage of the 
contrast material. 
Grade D:  Spiral-shaped filling defect with or without delayed run-off of the contrast material in 
the antegrade flow. 

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Grade E:  Persistent luminal filling defect with delayed run-off of the contrast material in the 
distal lumen. 
Grade F:  Filling defect accompanied by total coronary occlusion.  
EMERGENT BYPASS SURGERY  
Defined as coronary bypass surgery performed on an urgent or emergent basis for severe vessel 
dissection or closure, or treatment failure resulting in new ischemia.  
IN-SEGMENT MEASUREMENT  
Defined as the measurements either within the stented segment or within 5 mm proximal and 
distal to the stent edges.  
IN-STENT MEASUREMENT  
Defined as the measurements within the boundaries of the stent.  
LESION CLASS (American College of Cardiology/American Heart Association Class) 
Type A Lesions:  Minimally complex, discrete (length <10 mm), concentric, readily accessible, 
non angulated segment (<45°), smooth contour, little or no calcification, less than totally 
occlusive, not ostial in location, no major side branch involvement, and an absence of thrombus. 
Type B Lesions:  Moderately complex, tubular (length 10–20 mm), eccentric, moderate tortuosity 
of proximal segment, moderately angulated segment (>45°, <90°), irregular contour, moderate or 
heavy calcification, total occlusions <3 months old, ostial in location, bifurcation lesions 
requiring double guide wires, and some thrombus present.  
Type C Lesions:  Severely complex, diffuse (length >20 mm), excessive tortuosity of proximal 
segment, extremely angulated segments >90°, total occlusions >3 months old and/or bridging 
collaterals, inability to protect major side branches, and degenerated vein grafts with friable 
lesions.  
MINIMAL LUMINAL DIAMETER (MLD) 
The average of 2 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.  
 
 

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MYOCARDIAL INFARCTION ARC Definition2 
Classification 
Biomarker Criteria* 
Additional Criteria 
Peri-procedural PCI  
Troponin >3 times URL or
CKMB >3 times URL 
Baseline value <URL 
Peri-Procedural CABG 
Troponin >5 times URL or 
CKMB >5 times URL 
Baseline value <URL AND any of the 
following: new pathologic Q waves‡ or 
LBBB, new native or graft vessel occlusion, 
imaging evidence of loss of viable 
myocardium  
Spontaneous 
(>48 h following PCI,  
>72 h following CABG) 
Troponin >URL or 
CKMB >URL. 
Baseline value <URL and any of the 
following: symptoms of ischemia, ECG 
changes indicative of new ischemia (new ST-
T changes or new LBBB), development of 
pathological Q waves, or imaging evidence of
new loss of viable myocardium or new 
regional wall motion abnormality. 
Silent 
No biomarker data 
available. 
New pathologic‡ Q waves or LBBB. 
Sudden Death 
Death before biomarkers 
obtained or before expected 
to be elevated. 
Symptoms suggestive of ischemia and any of 
the following: new ST elevation or LBBB, 
documented thrombus by angiography or 
autopsy. 
Reinfarction, spontaneous 
and periprocedural (base 
definition; infarction 
extension) 
Stable or decreasing values 
on 2 samples >6 h apart and 
20% increase  
3–6 h after second sample. 
If biomarkers not stable (increasing or peak 
not reached), then insufficient data to 
diagnose recurrent myocardial infarction. 
Adapted from Global Task Force Universal Definition of Myocardial Infarction, Thygesen et al. 
PCI: percutaneous coronary intervention; h: hour; URL: upper range limit (99th percentile of normal 
reference range); CKMB: creatinine kinase myocardial band isoenzyme; CABG: coronary artery bypass 
graft; LBBB: left bundle branch block; ECG: electrocardiogram. 
*Baseline biomarker value required before study procedure and presumes a typical rise and fall. 
‡Pathologic Q waves may be defined according to the Global Task Force, Minnesota code or Novacode. 
 
NO REFLOW  
Defined as a sustained or transient reduction in antegrade flow that is not associated with an 
obstructive lesion at the treatment site.  
PERCENT DIAMETER STENOSIS 
The value calculated as 100 x (RVD – MLD)/RVD using the mean values from 2 orthogonal 
views (when possible) by QCA.  
                                                     
2 Cutlip DE, Windecker S, Mehran R et al. for the Academic Research Consortium. Clinical endpoints in coronary 
stent trials: A case for standardized definition. Circulation 2007;115:2344–2351. 

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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.  
PERCUTANEOUS CORONARY INTERVENTION (PCI) 
Refers to all interventional cardiology methods for treatment of coronary artery disease.  
RESTENOTIC LESION 
Defined as a lesion in a vessel segment that has undergone prior percutaneous treatment with or 
without a stent placement.   
REFERENCE VESSEL DIAMETER (RVD) 
Defined as the average of normal segments within 10 mm proximal and distal to the target lesion 
from 2 orthogonal views using QCA.   
SERIOUS ADVERSE EVENT (SAE) 
A Serious Adverse event (SAE) is any AE event that leads to: 
1. Death, 
2. Serious injury that : 
a. Is life-threatening illness or injury 
b. Results in permanent impairment of a body  function or permanent changes to a body 
structure or 
c. Necessitates medical or surgical intervention to preclude permanent impairment of a 
body function or permanent damage to a body function. 
NOTE 1: Planned hospitalization for pre-existing condition, or a procedure required by the 
clinical study plan, and not meeting any of the serious criteria described above  , is not 
considered to be an SAE.  A planned hospitalization is one that is scheduled prior to the 
patient signing the informed consent for the study. 
STENT THROMBOSIS - ARC DEFINITION 
Stent thrombosis should be reported as a cumulative value at the different time points and with 
the different separate time points.  Time 0 is defined as the time point after the guiding catheter 
has been removed and the subject has left the catheterization lab. 
Timing 
 
Acute stent thrombosis* 
 
0 to 24 hours post–stent implantation 
 
Subacute stent thrombosis*  
>24 hours to 30 days post–stent implantation 

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Late stent thrombosis† 
 
30 days to 1 year post–stent implantation 
 
Very late stent thrombosis† 
 
>1 year post–stent implantation 
*Acute/subacute can also be replaced by early stent thrombosis.  Early stent 
thrombosis (0–30 days) is a definition currently used in the community. 
†Including primary as well as secondary late stent thrombosis.  Secondary late stent 
thrombosis is a stent thrombosis after a target segment revascularization. 
Categories (Definite, Probable, and Possible) 
Definite Stent Thrombosis 
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic 
confirmation. 
Angiographic Confirmation of Stent Thrombosis* 
Presence of an intracoronary thrombus that originates in the stent or in the segment 5 mm 
proximal or distal to the stent, and presence of at least 1 of the following criteria within a 
48-hour time window: 
 Acute onset of ischemic symptoms at rest. 
 New ischemic ECG changes that suggest acute ischemia. 
 Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous MI). 
Non-occlusive: intracoronary thrombus is defined as a spheric, ovoid, or irregular non-
calcified 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. 
Occlusive Thrombus: TIMI 0 or TIMI 1 intra-stent or proximal to a stent up to the most 
adjacent proximal side branch or main branch (if originates from side branch). 
Pathological Confirmation of Stent Thrombosis 
Evidence of recent thrombus within the stent determined at autopsy or via examination of 
tissue retrieved following thrombectomy. 
*The incidental angiographic documentation of stent occlusion in the absence of clinical signs or symptoms 
is not considered a confirmed stent thrombosis (silent occlusion). 
Probable Stent Thrombosis 
Probable stent thrombosis is considered to have occurred after intracoronary stenting in the 
following cases: 
 Any unexplained death within first 30 days.† 
 Regardless of time after index procedure, any MI related to documented acute ischemia 
in the territory of the implanted stent without angiographic confirmation of stent 
thrombosis 
and 
in 
the 
absence 
of 
any 
other 
obvious 
cause. 
†For studies with ST-elevation MI population, exclusion of unexplained death within 30 
days may be considered evidence of probable stent thrombosis. 
Possible Stent Thrombosis 

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Possible stent thrombosis is considered to have occurred with any unexplained death from  
30 days after intracoronary stenting until end of trial follow-up. 
STROKE 
Defined as 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.  
PROTOCOL DEVIATION 
An incident in which the investigator or site personnel did not conduct the study according to the 
clinical protocol or the investigator agreement.   
Major deviation: any deviation from subject inclusion and exclusion criteria or subject informed 
consent procedures. 
Minor deviation: deviation from a clinical protocol requirement such as incomplete/inadequate 
subject tests or examinations, non-compliance with medication regimens, missed follow-ups, 
follow-ups performed outside specified time windows, etc. 
TARGET LESION 
The lesion intended to be treated with the treatment device.  
TARGET LESION REVASCULARIZATION (TLR) 
TLR is defined as any percutaneous intervention of the target lesion or bypass surgery of the 
target vessel performed for restenosis or other complication of the target lesion.  All TLRs 
should be classified prospectively as clinically indicated or not clinically indicated by the 
investigator prior to repeat angiography.  An independent angiographic core laboratory should 
verify that the severity of percent diameter stenosis meets requirements for clinical indication 
and will overrule in cases in which 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 FAILURE (TVF) 
Defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically 
driven target vessel revascularization (TVR) by percutaneous or surgical methods.  
TARGET VESSEL REVASCULARIZATION (TVR) 
TVR is defined as any 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. 
THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) CLASSIFICATION 
TIMI 0: No perfusion.  
TIMI 1: Penetration with minimal perfusion.  Contrast fails to opacify the entire bed distal to the 
stenosis for the duration of the cine run.  
TIMI 2: Partial perfusion.  Contrast opacifies the entire coronary bed distal to the stenosis.  
However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction 
than in comparable areas not perfused by the dilated vessel.  

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TIMI 3: Complete perfusion.  Filling and clearance of contrast equally rapid in the coronary bed 
distal to stenosis as in other coronary beds.  
TRANSIENT ISCHEMIC ATTACK (TIA) 
Defined as 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.  
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) 
A UADE is defined in 21 CFR 812.3(s) as any serious adverse effect on health or safety or any 
life-threatening problem or death caused by, or associated with, a device, if that effect, problem, 
or death was not previously identified in nature, severity or degree of incidence in the protocol, 
or any other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of a subject.  

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ACRONYMS AND/OR ABBREVIATIONS 
Acronym/ 
Abbreviation 
Term 
ACE-I 
Angiotensin converting enzyme inhibitor 
ACT 
Activated clotting time 
ADE 
Adverse device effect 
AE 
Adverse event 
APTT 
Activated partial thromboplastin time 
ARB 
Angiotensin receptor blocker 
ARC 
Academic Research Consortium 
atm 
Atmospheric pressure 
AVF 
Arteriovenous fistula 
BMI 
Body mass index 
BMS 
Bare metal stent 
CABG 
Coronary artery bypass graft 
CAD 
Coronary artery disease 
CBC 
Complete blood count 
CCSC 
Canadian Cardiovascular Society Classification 
CE 
Conformité Européenne 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CK 
Creatine kinase 
CK-MB 
Creatine kinase myocardial-band isoenzyme 
cm 
Centimeter 
CoCr 
Cobalt-chromium 
CRO 
Contract research organization 
CT 
Computed tomography 
CVA 
Cerebrovascular accident 
DAPT 
Dual antiplatelet therapy 
DES 
Drug-eluting stent 
dL 
Deciliter 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
ETT 
Exercise tolerance test 

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Acronym/ 
Abbreviation 
Term 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practices 
GI 
Gastrointestinal 
HCRI 
Harvard Clinical Research Institute 
HIPAA 
Health Insurance Portability and Accountability Act 
IC 
Informed consent 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation  
IFU 
Instructions for Use 
INR 
International normalized ratio 
IRB 
Institutional Review Board 
ITT 
Intention-to-treat 
K-M 
Kaplan-Meier 
LAD 
Left anterior descending coronary artery 
LBBB 
Left bundle branch block 
LCX 
Left circumflex coronary artery 
LIMA 
Left internal mammary artery 
LVEF 
Left ventricular ejection fraction 
MACE 
Major adverse cardiac event 
MDR 
Medical device reporting 
mg 
Milligram 
MI 
Myocardial infarction 
MLD 
Minimum luminal/lumen diameter 
mm 
Millimeter 
NHLBI 
National Heart, Lung, and Blood Institute [Dissection Grade Classification] 
NQWMI 
Non–Q-wave myocardial infarction 
NTG 
Nitroglycerin 
PCI 
Percutaneous coronary intervention 
PG 
Performance goal 
PMA 
Premarket approval 
PP 
Per-protocol 
PTCA 
Percutaneous transluminal coronary angioplasty 
QCA 
Quantitative coronary angiography 
QWMI 
Q-wave myocardial infarction 

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Acronym/ 
Abbreviation 
Term 
RIMA 
Right internal mammary artery 
RVD 
Reference vessel diameter 
SAE 
Serious adverse event 
SAS 
Statistical analysis system 
SOP 
Standard operating procedure 
SPECT 
Single-photon emission computed tomography 
TIA 
Transient ischemic attack 
TIMI 
Thrombolysis in Myocardial Infarction 
TLR 
Target lesion revascularization 
TVF 
Target vessel failure 
TVR 
Target vessel revascularization 
UADE 
Unanticipated adverse device effect 
ULN 
Upper limit of normal 
URL 
Upper reference limit 
US 
United States 
USA 
United States of America 
WBC 
White blood cell