The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the EverfLex NitInol STent System Post Approval Study
Phase: NA
Conditions: Peripheral Arterial Disease, Lower Extremity Arterial Disease
Sponsor: Medtronic Endovascular

DURABILITY PAS 
The US Study for Evaluating Endovascular Treatments of Lesions in the  
Superficial Femoral Artery and Proximal Popliteal By using the Everflex Nitinol 
Stent System Post Approval Study 
 
Clinical Investigation Plan Version 3.1 
17 November 2016 
 
NCT01680835 
 
 

Medtronic 
CONFIDENTIAL 
 
 
 
 
 
Clinical Protocol 
 
 
 
The US StuDy for  
EvalUating EndovasculaR TreAtments of Lesions in the  
Superficial Femoral Artery and Proximal Popliteal  
By usIng the   
EverfLex NitInol STent System Post Approval Study  
 
 
DURABILITY PAS  
 
Version 3.1 
 
 17November2016 
 
CP-1001 
 
 
 
 
 
 
 
Sponsor:  Medtronic  
3033 Campus Drive 
Suite N550 
Plymouth, MN 55441 
 
 

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Clinical Protocol Acceptance 
 
 
I have read this clinical protocol and agree to adhere to the requirements.  I will provide 
copies of this protocol and all pertinent information to the study personnel.  I will discuss this 
material with them and ensure they are fully informed regarding the investigational device 
and the conduct of the study according to 21 CFR Parts 50, 54, 56 and 812, to other 
applicable regulations, to applicable laws and to hospital Institutional Review Board (IRB) 
requirements. 
 
 
 
 
 
_______________________________ 
 
 
_____/______/_____ 
Principal Investigator Signature 
 
 
 
  DD MMM   YY 
 
 
________________________________ 
Principal Investigator Printed Name 
 
________________________________ 
Investigational Site 
 
 

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Protocol Synopsis 
 
The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral 
Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol STent SYstem Post 
Approval Study (DURABILITY PAS) 
Protocol Number CP-1001 
Test Device EverFlex™ Self-Expanding Peripheral Stent System 
Primary 
Objective 
To confirm the long-term safety and effectiveness of the EverFlex™ 
Self-Expanding Stent System through three years post-procedure. 
Study Design A prospective, multi-center, non-randomized, single arm study to confirm 
the safety and effectiveness of primary stenting using the EverFlex™ 
stent compared to a performance goal of PTA in the treatment of 
atherosclerotic superficial femoral artery (SFA) and proximal popliteal 
lesions 4-18 cm long in subjects with Rutherford Clinical Categories 2-4.   
Follow-Up Schedule Follow-up assessments will occur at pre-discharge, 30 days, 1 year, 2 
years and 3 years. 
Number of Subjects 
108 subjects will be enrolled     
Number of Sites 
20 to 30 investigational sites in the United States.  
Primary Endpoint Composite endpoint defined as freedom from acute death, freedom from 
36-month amputation, and freedom from 36-month clinically-driven 
target lesion revascularization compared to a PTA performance goal. 
Secondary 
Endpoints 
1. Freedom from Stent Fracture 
Determined by x-ray at 1, 2 and 3 years using the following 
classifications:   
Class 0 – No strut fractures 
Class I – Single tine fracture  
Class II  – Multiple tine fractures  
Class III – Stent fracture(s) with preserved alignment of the 
components  
Class IV – Stent fracture(s) with mal-alignment of the 
components 
Class V – Stent fracture(s) in a trans-axial spiral configuration  

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AND the following categories: 
Category A – Restenosis ≤ 50% at site of fracture 
Category B – Restenosis > 50% at site of fracture 
Category C – Occlusion at site of fracture 
Category D – Unable to determine 
 
2. Freedom from acute death, freedom from amputation and 
freedom from clinically-driven target lesion revascularization 
at 1 and 2 years 
Defined as the absence of all-cause mortality occurring within 30-days, 
absence of any major amputation within 12-/24- months and the absence 
of any clinically-driven repeat invasive procedure, including angioplasty, 
stenting, endarterectomy, bypass, or thrombolysis, performed to open or 
increase the lumen diameter inside or within 10 mm of the previously 
treated lesion due to the return of clinical symptoms within 12-/24- 
months of the procedure. 
3. Freedom from 36-month amputation  
Defined as the absence of any major amputation (removal of the target 
limb or a part of the target limb above the metatarsal line) within 36 
months of the procedure. 
4. Freedom from 36-month clinically-driven target lesion 
revascularization 
Defined as the absence of any clinically-driven repeat invasive procedure, 
including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, 
performed to open or increase the lumen diameter inside or within 10 mm 
of the previously treated lesion due to the return of clinical symptoms 
within 36 months of the procedure.  
5. Freedom from acute death 
 Defined as the absence of all-cause mortality occurring within 30 days of 
the procedure. 
6. Device Success 
Defined as the ability to deploy the stent as intended at the treatment site. 
7. Improvement in Rutherford Clinical Category at 1 Year 
Defined as an improvement in clinical status indicated by a decrease of 
one or more in Rutherford Clinical Category compared to baseline.  
8. Improvement in Ankle-Brachial Index at 1 Year 
Defined as an increase in the ankle-brachial index (ABI) compared to 
baseline in subjects with compressible arteries and baseline ABI < 0.9. 
9. Walking Improvement at 1 Year 
Defined as an increase in Walking Impairment Questionnaire score in 

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subjects who did not have iliac disease treated at the time of the index 
procedure compared to baseline.   
10. Adverse Event Rates 
Defined as the rate of adverse events that occur during the course of the 
study; event and subject counts as well as proportions of subjects with 
events categorized by type will be reported.   Note that adverse events are 
captured at each study assessment.  Counts and rates of all-cause 
mortality will be reported both as part of the overall adverse event profile 
as above, and separately as a specific outcome. 
Timeline 
Date of First IRB Approval: Q3 2012 
Date of Last IRB Approval: Q2 2014 
Date of First Subject Enrolled: 14 January 2013 
Estimated Date of Last Subject Enrolled: Q1 2015 
Estimated Enrollment Rate: 0.33 subjects/site/month 
Date of 6 Month Report: 15 August 2012 
Date of 12-Month Report: 27 February 2013  
Date of 18-Month Report: 29 August 2013  
Date of 2-Year Report: 19 February 2014  
Estimated Study Completion Date: Q4 2018 
Estimated Date of Final Report Submission: Q4 2018 
 
 
 
 

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TABLE OF CONTENTS 
1.0 
INTRODUCTION....................................................................................................... 9 
Purpose 9 
Device Name ................................................................................................................................ 9 
Indication for use ......................................................................................................................... 9 
Study Overview ............................................................................................................................ 9 
Duration of the Investigation ....................................................................................................... 9 
Number of Sites and Subjects ...................................................................................................... 9 
2.0 
DEVICE DESCRIPTION ........................................................................................ 10 
EverFlex Device Sizes ............................................................................................................... 10 
EverFlex Device Components and Principles of Operation ....................................................... 10 
3.0 
BACKGROUND AND SIGNIFICANCE ............................................................... 10 
Disease Overview ...................................................................................................................... 10 
Summary of Clinical Trials in the SFA with the EverFlex Stent ............................................... 10 
Clinical Experience with the EverFlex Stent ............................................................................. 12 
4.0 
METHODOLOGY ................................................................................................... 12 
Study Design .............................................................................................................................. 12 
Study Objective and Primary Endpoints .................................................................................... 13 
Subject Selection Criteria ........................................................................................................... 14 
Overview of Study Conduct ....................................................................................................... 19 
Baseline Requirements ............................................................................................................... 20 
Procedure Requirements ............................................................................................................ 20 
Medical Anticoagulant/Antiplatelet Therapy ............................................................................. 22 
Follow-Up Requirements ........................................................................................................... 23 
Termination of Participation ...................................................................................................... 25 
Deviations to the Investigation................................................................................................... 26 
Device Malfunctions .................................................................................................................. 27 
Adverse Events .......................................................................................................................... 27 
Deaths 28 
Core Laboratory Requirements .................................................................................................. 28 
Clinical Events Committee ........................................................................................................ 29 
Case Report Forms ..................................................................................................................... 29 

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5.0 
STATISTICAL METHODS .................................................................................... 30 
Primary Endpoint and Sample Size Adjustment ........................................................................ 30 
Hypothesis Testing ..................................................................................................................... 30 
Justification of Performance Goal .............................................................................................. 30 
Potential Outcomes .................................................................................................................... 31 
Sample Size and Power .............................................................................................................. 32 
Data Analysis Plan ..................................................................................................................... 33 
6.0 
RISK/BENEFIT ANALYSIS ................................................................................... 34 
Potential Benefits ....................................................................................................................... 34 
Potential Risks............................................................................................................................ 34 
POTENTIAL ADVERSE EVENTS .......................................................................................... 35 
7.0 
SITE REQUIREMENTS ......................................................................................... 37 
Site Selection.............................................................................................................................. 37 
Training/Initiation Visit ............................................................................................................. 37 
8.0 
MONITORING PROCEDURES ............................................................................ 38 
Monitoring Procedures ............................................................................................................... 38 
Monitoring Reports .................................................................................................................... 38 
Final Monitoring Visit ............................................................................................................... 39 
9.0 
RESPONSIBILITIES, RECORDS and REPORTS .............................................. 39 
Responsibilities and Record Retention ...................................................................................... 39 
Reports 39 
10.0 
DEFINITIONS .......................................................................................................... 41 

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List of Tables 
 
Table 1: Study Assessment Requirements .............................................................................. 19 
Table 2: Baseline Requirements ............................................................................................. 20 
Table 3: Angiographic Screening and Procedure Requirements ............................................ 22 
Table 4: Pre-Discharge Assessment Requirements ................................................................ 23 
Table 5: 30-Day Follow-Up Assessment Requirements ......................................................... 23 
Table 6: 1-Year Follow-up Assessment Requirements .......................................................... 24 
Table 7: 2-Year and 3-Year Follow-up Assessment Requirements ........................................ 25 
Table 8: PTA Performance Goals – Safety Data .................................................................... 30 
Table 9: Approximation to Possible Outcomes and Corresponding 97.5% Lower Confidence 
Bound .............................................................................................................................. 31 
Table 10: Sample Size Freedom from Stent Fracture ............................................................. 32 
Table 11: Risks Associated with Peripheral PTA and Stenting .............................................. 35 
Table 12: Principal Investigator Reporting Responsibilities .................................................. 39 
 
List of Figures 
 
Figure 1: PA View of Distal Femur and Definition of Cortical Margin ................................. 15 
Figure 2: Study Flow Diagram from Subject Screening to Follow-up ................................... 18 
 
 
 
List of Appendices 
 
Appendix A: Contacts ............................................................................................................. 50 
Appendix B: References ......................................................................................................... 51 
Appendix C: Declaration of Helsinki ..................................................................................... 53 
Appendix D: Protocol Revisions ............................................................................................ 58 
 
 

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1.0 INTRODUCTION 
Purpose 
The purpose of this study is to confirm the safety and effectiveness of primary stenting with 
the EverFlex™ Self-Expanding Peripheral Stent System (EverFlex stent) when used in 
subjects with atherosclerotic stenoses, restenoses or occlusions of the native superficial 
femoral artery or superficial femoral and proximal popliteal arteries. 
Device Name 
EverFlex™ Self-Expanding Peripheral Stent System (EverFlex device) manufactured by ev3. 
Indication for use 
The EverFlex™ Self-Expanding Peripheral Stent System is intended to improve luminal 
diameter in the treatment of symptomatic de novo or restenotic lesions up to 180 mm in 
length in native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with 
reference vessel diameters ranging from 4.5 – 7.5 mm. 
Study Overview  
This is a prospective, multi-center, non-randomized, single arm study to confirm the safety 
and effectiveness of  PTA and primary stenting using the EverFlex stent versus a 
performance goal of PTA alone in the treatment of atherosclerotic superficial femoral artery 
(SFA) and proximal popliteal lesions 4-18 cm long in subjects with Rutherford Clinical 
Categories 2-4.   
 Duration of the Investigation 
The estimated duration of the study is approximately five years from the time of first subject 
enrollment to the last follow-up visit.  Subjects will be followed for three years.  ev3 plans to 
submit a final report when all available subjects have completed the 3-year follow-up visit. 
Number of Sites and Subjects 
One hundred eight (108) subjects will be enrolled at between 20 to 30 investigational sites in 
the United States.  To ensure adequate enrollment, it is expected that participating 
investigational sites screen all potential subjects for this study. 

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2.0 DEVICE DESCRIPTION 
EverFlex Device Sizes 
The EverFlex™ Self-Expanding Stent System is provided in multiple stent lengths (20, 30, 
40, 60, 80, 100, 120, 150, and 200 mm) and diameters (6, 7, and 8 mm). 
EverFlex Device Components and Principles of Operation 
The EverFlex™ Self-Expanding Peripheral Stent System is a self-expanding Nitinol stent 
system intended for permanent implantation. The self-expanding stent is made of a nickel 
titanium alloy (Nitinol) and comes pre-mounted on a 6F, 0.035” over-the-wire delivery 
system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum 
radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent 
achieves its predetermined diameter and exerts a constant, gentle outward force to establish 
patency. 
For specific information on device components and steps on how to operate the EverFlex 
device, refer to the Instructions for Use. 
3.0 BACKGROUND AND SIGNIFICANCE 
Disease Overview 
Atherosclerosis is a thickening, hardening and loss of elasticity of the walls of arteries 
characterized by the focal accumulation of lipids, fibrous tissue and calcium deposits in the 
arteries.  Atherosclerotic disease within the superficial femoral and proximal popliteal 
arteries can lead to flow-limiting stenoses or occlusions that are observed clinically as 
intermittent claudication, asymptomatic functional impairment or critical limb ischemia.1 A 
primary therapeutic goal among patients with atherosclerotic disease is the maintenance of 
patency in the superficial femoral and proximal popliteal arteries.  Treatment by 
percutaneous angioplasty with or without stenting of stenotic and occluded lesions within the 
SFA has demonstrated success in treating short, focal lesions, but limited success in 
maintaining long-term patency in longer lesions.2-15 
Summary of Clinical Trials in the SFA with the EverFlex Stent 
DURABILITY I 
DURABILITY I (Study Measuring the Durability of the Protégé® EverFlex™ Stent in 
Lesions of the Superficial Femoral Artery), was a multi-center, non-randomized, prospective 
study.  It was designed to evaluate the safety and efficacy of the EverFlex stent in the 
treatment of de novo, restenotic or reoccluded SFA lesions in symptomatic PAD patients.  
Bosiers et al. published a report on DURABILITY I Study one-year outcomes.16  The study 
enrolled 151 subjects (151 target lesions) between August, 2006 and June, 2007 at 13 centers 
is Europe.  A total of 161 stents (158 EverFlex) were implanted: single stents in 93.4% 
(141/151) and a second stent in 6.6% (10/151).  The primary endpoint of the study, the 

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primary patency rate determined by duplex ultrasound, defined as a target vessel with less 
than 50% diameter stenosis at 12 months and no reintervention of the target vessel, was 
72.2%.  Freedom from restenosis data was available for 99.3% (133/134) of the subject who 
completed a 12-month follow-up visit.  The mean Rutherford classification fell from 2.8±0.8 
(range 1-5) at baseline to 0.6±1.1 (range 0-5) at 12 months.  The mean ankle-brachial index 
rose from 0.6±0.2 (range 0-1.4) at baseline to 0.9±0.2 (range 0-1.2) at 12 months.  The rates 
for freedom from >50% restenosis at 6 and 12 months were 91.3% (95% CI 84.92 to 95.2%) 
and 72.2% (95% CI 63.8% to 79.6%), respectively.  The freedom from the target lesion 
revascularization rate at 12 months was 79.1% (95% CI 71.2 to 85.6%).  The 1-year stent 
fracture rate was 8.1% (95% CI 4.0 to 14.4%).  Elongation of the PROTÉGÉ EverFlex stent 
during implantation was identified in 90% (9/10) of the fractured stents at 12 months. The 
author concluded that the high freedom from >50% restenosis and low fracture rate at 12 
months suggested that the PROTÉGÉ EverFlex stent offered a safe and acceptably 
efficacious means of treating SFA lesions in symptomatic subjects with PAD. 
DURABILITY II 
ev3 conducted a study titled “The US Study for Evaluating Endovascular Treatment of 
Lesions in the Superficial Femoral Artery and Proximal Popliteal by using the Protégé 
EverFlex Nitinol Stent System II (DURABILITY II).  DURABILITY II was a prospective, 
multi-center, non-randomized, single arm study to evaluate the safety and effectiveness of 
primary stenting with a single EverFlex stent compared to PTA performance goals for the 
treatment of stenotic, restenotic or occluded lesions (non-stented) of the native superficial 
femoral artery or the superficial femoral and proximal popliteal arteries.  
The primary safety endpoint of the study was major adverse event rate at 30-days, defined as 
clinically-driven target lesion revascularization, amputation of treated limb, or all-cause 
mortality. The primary effectiveness endpoint, stent patency (defined as PSVR <2.0 at the 
stented targeted lesion with no clinically-driven reintervention) rate at 12 months was 
determined by duplex ultrasound. Subjects were followed yearly for 3 years with duplex 
ultrasound to determine stent patency, radiograms of the stented extremity to assess stent 
fractures and ankle brachial indices. Clinical assessment of change in Rutherford Category 
was planned for 1-year post intervention.  
DURABILITY II enrolled 287 subjects at 44 investigational sites in both the United States 
and Europe.  A total of 303 stents were implanted: single stents in 95% (272/287), and 5.0% 
(15/287) received multiple stents.  The mean age of subjects was 68 years, with 66% male.  
Co-morbidities include hypertension (88%), hyperlipidemia (86%), and diabetes (43%).  The 
mean lesion length measured by core laboratory was 89.1 mm.  The mean normal-to-normal 
lesion length measured by sites was 109.6 mm.  Deployment of the stent at the intended 
treatment site was achieved in 99.3% of subjects.  No major adverse events occurred at 30 
days.  Primary duplex ultrasound stent patency at 1 year in all subjects including single-stent 
and multi-stent implants was 67.7%.  The primary patency by Kaplan Meier estimate at 1 
year was 77.2%.  At 2 and 3 years, primary patency was 66.1% and 60.0%, respectively. The 
mean Rutherford classification fell from 2.8±0.6 (range 2-5) at baseline to 0.6±1.1 (range 0-
5) at 1 year.  The mean ankle-brachial index rose from 0.65 ± 0.15 (range 0.06-0.89) at 
baseline to 0.89 ± 0.20 (range 0.25-1.77), 0.88 ± 0.19 (range 0.26, 1.27) and 0.89 ± 0.19 

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(range 0.31, 1.33) at 1, 2, and 3 years, respectively.  The 1-year stent fracture rate was 0.4%; 
and was 0.9% at 2 and 3 years, respectively. 
 
DURABILITY 200 
DURABILITY 200 was an investigator–sponsored, prospective, nonrandomized study 
performed at two centers in Belgium designed to evaluate primary stenting with the Protégé 
EverFlex 200 mm long self-expanding nitinol stent in femoropopliteal TransAtlantic Inter-
Society Consensus (TASC) C and D lesions of at least 150 mm in length.17  The primary 
study endpoint, primary patency at 12 months, defined as the absence of hemodynamically 
significant stenosis on duplex ultrasound imaging (systolic velocity ratio <2.4) at the target 
lesion and without target lesion revascularization (TLR) <12 months.  Stent fracture 
occurrence was assessed at the 12–month follow-up by conventional x-ray imaging.   
Between March 2008 and June 2009, 100 patients with symptomatic TASC C and D 
femoropopliteal lesions were treated with at least one 200-mm-long EverFlex stent.  A total 
of 158 EverFlex stents were implanted: one stent in 49% (49/100), two stents in 44% 
(44/100) and three stents in7% (7/100) of patients.  The average lesion length was 242 mm 
(range, 160-450mm).  The primary patency rate by Kaplan-Meir estimate at 12 months was 
64.8%.  The 12-month freedom from target lesion revascularization by Kaplan-Meier 
estimate was 68.2%.  Stent fractures were identified in 6 of 100 patients, resulting in a 12-
month stent fracture rate of 6%.   
Clinical Experience with the EverFlex Stent 
Ruef et al.18 were the first to report clinical experience with the EverFlex stent in the SFA.  A 
total of 12 subjects were treated for total occlusions (n=9) or long stenoses (n=3) in the SFA, 
with a mean lesion length of 14.9 cm.  One subject had a thrombus detected prior to pre-
dilatation that was resolved by treatment with Abciximab (ReoPro®).  Subjects returned for 
follow-up visits 6-8 weeks after the procedure.  All subjects were free of claudication in the 
treated leg, ankle-brachial indices revealed a 100% patency rate in all treated legs, and 
duplex ultrasound confirmed 100% stent patency (no definition provided) at 6-8 weeks post-
implant.  These results demonstrate good short-term clinical results for stenting in the SFA 
using the EverFlex stent. 
 
4.0 METHODOLOGY 
Study Design 
DURABILITY PAS is a prospective, multi-center, non-randomized, single arm study with 
sequential enrollment of all qualified subjects undergoing treatment of atherosclerotic lesions 
in the native superficial femoral artery or the superficial femoral and proximal popliteal 
arteries.  All eligible subjects who provide informed consent will undergo PTA and stenting 
using the EverFlex device.  Follow-up will take place at pre-discharge, 30 days, 1 year, 2 
years and 3 years.   

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Study Objective and Primary Endpoints 
The objective of the study is to confirm the safety and effectiveness of primary stenting using 
the EverFlex device compared to a percutaneous transluminal Angioplasty (PTA) 
performance goal for the treatment of stenotic, restenotic or occluded lesions (non-stented) of 
the native superficial femoral artery or the superficial femoral and proximal popliteal arteries. 
Primary Endpoint 
The primary endpoint of the study is composite endpoint defined as freedom from acute 
death, freedom from 36-month amputation, and freedom from 36-month clinically-driven 
target lesion revascularization compared to a PTA performance goal.  
Secondary Endpoints 
The secondary endpoints are:  
1. Freedom from Stent Fracture:  Determined by x-ray at 1, 2 and 3 years using the 
following classifications:  
 
Class 0 – No strut fractures 
Class I – Single tine fracture  
Class II – Multiple tine fractures  
Class III – Stent fracture(s) with preserved alignment of the components  
Class IV – Stent fracture(s) with mal-alignment of the components 
Class V – Stent fracture(s) in a trans-axial spiral configuration 
AND the following categories: 
Category A – Restenosis ≤ 50% at site of fracture 
Category B – Restenosis > 50% at site of fracture 
Category C – Occlusion at site of fracture 
Category D – Unable to determine 
   
2. Freedom from acute death, freedom from amputation and freedom from clinically-
driven target lesion revascularization at 1 and 2 years: Defined as the absence of 
all-cause mortality occurring within 30-days, absence of any major amputation 
within 12-/24- months and the absence of any clinically-driven repeat invasive 
procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, 
performed to open or increase the lumen diameter inside or within 10 mm of the 
previously treated lesion due to the return of clinical symptoms within 12-/24- 
months of the procedure. 
3. Freedom from 36-month amputation:  Defined as the absence of any major 
amputation (removal of the target limb or a part of the target limb above the 
metatarsal line) within 36 months of the procedure. 
4. Freedom from 36-month clinically-driven target lesion revascularization:  Defined 
as the absence of any clinically-driven repeat invasive procedure, including 

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angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or 
increase the lumen diameter inside or within 10 mm of the previously treated lesion 
due to the return of clinical symptoms within 36 months of the procedure.  
5.  Freedom from acute death: Defined as the absence of all-cause mortality occurring 
within 30-days of the procedure. 
6. Device Success:  Defined as the ability to deploy the stent as intended at the 
treatment site. 
7. Improvement in Rutherford Clinical Category at 1 Year: Defined as an 
improvement in clinical status indicated by a decrease of one or more in Rutherford 
Clinical Category compared to baseline. 
8. Improvement in Ankle-Brachial Index at 1 Year:  Defined as an increase in the 
ankle-brachial index (ABI) compared to baseline in subjects with compressible 
arteries and baseline ABI < 0.9. 
9. Walking Improvement at 1 Year:  Defined as an increase in Walking Impairment 
Questionnaire score in subjects who did not have iliac disease treated at the time of 
the index procedure compared to baseline.   
10. Adverse Event Rate: Defined as the rate of adverse events that occur during the 
course of the study; event and subject counts as well as proportions of subjects with 
events categorized by type will be reported.   Note that adverse events are captured at 
each study assessment.  Counts and rates of all-cause mortality will be reported both 
as part of the overall adverse event profile as above, and separately as a specific 
outcome. 
Subject Selection Criteria 
Assessment is performed based on data available to the investigator at the time of enrollment. 
General Inclusion Criteria 
Subjects must meet all of the following general inclusion criteria.   
1. Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent 
grafts), or occluded lesion(s) located in the native superficial femoral artery or 
superficial femoral and proximal popliteal arteries suitable for primary stenting. 
2. Has a Rutherford Clinical Category Score of 2, 3 or 4. 
3. Is willing to comply with all follow-up evaluations at the specified times. 
4. Is ≥ 18 years old. 
5. Provides written informed consent prior to enrollment in the study.     
Angiographic Inclusion Criteria 
Subjects must meet all of the following angiographic inclusion criteria.  The implanting 
physician bases all angiographic inclusion criteria on visual determination at the time of 
the procedure. 

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1. Target lesion(s) located within the native SFA/proximal popliteal: distal point at least 
3 cm above the cortical margin of the femur and proximal point at least 1 cm below 
the origin of the profunda femoralis measured by straight posteroanterior (PA) view 
for distal lesions, ipsilateral oblique view for proximal lesions.  Refer to Figure 1 for 
a diagram of a PA view of the distal femur and identification of the cortical margin. 
2. Evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not 
including stents or stent grafts), or occlusion of target lesion(s). 
3. Target lesion(s) total length is ≥ 4 cm and ≤ 18 cm.  
4. Target vessel diameter is ≥ 4.5 mm and ≤ 7.5 mm. 
5. There is evidence of at least one runoff vessel to the ankle/foot of the limb to be 
treated that does not also require treatment for significant (> 50% stenosis or 
occlusion) stenosis during the index procedure. 
 
 
Figure 1: PA View of Distal Femur and Definition of Cortical Margin  
The line defining the cortical margin is perpendicular to the femur and includes the highest 
point in the cortical arch.  No part of the lesion should be closer than 3 cm from the line 
defining the cortical margin. 

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General Exclusion Criteria 
The subject must not meet any of the following general exclusion criteria.  
1. Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.  
2. Has a contraindication or known allergy to antiplatelet therapy, anticoagulants, 
thrombolytic drugs, contrast media or any other drug used in study according to the 
protocol. 
3. Has known hypersensitivity to nickel-titanium. 
4. Has bleeding diathesis, coagulopathy, known hypercoagulable condition, or refuses 
blood transfusion. 
5. Female currently breastfeeding, pregnant, or of childbearing potential not using 
adequate contraceptive measures. 
6. Has life expectancy of less than 1 year. 
7. Has planned use of thrombectomy, atherectomy, brachytherapy or laser devices 
during procedure. 
8. Has previously been enrolled in the DURABILITY PAS study. 
9. Has received endovascular treatment of target lesion by percutaneous transluminal 
angioplasty or any other means of previous endovascular treatment (e.g. cutting 
balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or 
laser devices) within six months of the index procedure. 
10. Has any planned surgical intervention or endovascular procedure 14 days before or 
30 days after the index procedure. 
11. Is currently participating in an investigational drug or another device study that has 
not completed the primary endpoint or that clinically interferes with the current study 
endpoints. 
12. Has any co-morbid condition that precludes endovascular treatment.  
Angiographic Exclusion Criteria 
The subject must not meet any of the following angiographic exclusion criteria.  The 
implanting physician bases all angiographic exclusion criteria on visual determination at 
the time of the procedure. 
1. Exchangeable guidewire cannot cross the target lesion and/or re-enter true vessel 
lumen distal to lesion(s).  
2. Presence of significant (> 50% stenosis or occlusion) ipsilateral common femoral 
stenosis. 
3. Aneurysmal target vessel. 
4. Presence of an acute intraluminal thrombus at the proposed lesion site. 
5. Perforation, dissection or other injury of the access or target vessel requiring 
additional stenting or surgical intervention prior to start of PTA procedure.   

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6. Focal popliteal disease in the absence of femoral disease. 
Patient Screening 
It is expected that all potentially eligible patients be approached for enrollment in the study 
and be screened at the investigational site.  Eligible patients will be given an explanation of 
the study, educated on the possible risks and benefits to participating, and be asked to 
provide written informed consent  prior to any study-specific screening or testing. Patients 
will be informed that, despite signing the informed consent document, screening procedures 
may demonstrate that the patient is not a suitable candidate for the study. 
Subject Enrollment 
The subject is enrolled in the study after he/she has signed the subject informed consent and 
it has been determined that he/she meets all of the inclusion criteria and none of the exclusion 
criteria.  The point of enrollment is defined as the moment an exchangeable guidewire 
crosses the lesion and/or re-enters the true vessel lumen distal to the target lesion(s).  
Figure 2 provides a flow diagram from the point of subject screening through continuing 
follow-up visits. 
 
 

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Figure 2: Study Flow Diagram from Subject Screening to Follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient is considered a candidate for primary stenting in the SFA, 
informed consent process is initiated 
Patient is screened for general 
inclusion and exclusion criteria 
Angiography is performed prior to 
initiating PTA and stenting 
treatment. 
Patient is screened for angiographic 
inclusion and exclusion criteria 
Patient signs written informed consent 
Patient does not meet all general 
criteria, not enrolled; 
screening information updated 
Patient does not meet angiographic 
criteria, not enrolled; 
screening information updated 
Deployment of EverFlex stent 
PTA procedure  
Follow-up at pre-discharge,  
30 days, 
 1, 2 and 3 years 
Exchangeable guidewire crosses 
lesion and/or enters true vessel 
lumen distal to target lesion(s) – 
Patient is enrolled 
Patient is given explanation of the study,  
including testing requirements and follow-up 
Patient does not consent to 
participate, not enrolled:  
no screening data collected 

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Overview of Study Conduct 
Table 1 provides an overview of the assessment requirements for the study, and Tables 2-7 
provide the specific requirements at each stage of the study. 
Table 1: Study Assessment Requirements  
 
Assessment Schedule 
(Timeframe Window) 
Baseline 
(45 days prior,  
labs 30 days prior) 
Procedure 
Pre- 
Discharge 
30 Days 
(25-40 Days) 
 
1 Year 
(335-395 Days) 
 
2 Years 
(685-775 Days) 
3 Years 
(1050-1140 Days) 
Medical history 
X 
 
 
 
 
 
 
Physical exam 
X 
 
 
 
 
 
 
Clinical status by 
Rutherford Clinical 
Category 
X 
 
 
X 
X 
 
 
Ankle-brachial index† 
X 
 
 
X 
X 
X 
X 
Walking Impairment 
Questionnaire 
X 
 
 
X 
X 
X 
X 
Angiogram† 
 
X 
 
 
 
 
 
Laboratory tests‡ 
X 
 
 
 
 
 
 
X-ray (fracture 
assessment) † 
 
 
 
 
X 
X 
X 
Adverse event 
documentation 
 
X 
X 
X 
X 
X 
X 
Amputation 
 
X 
X 
X 
X 
X 
X 
Death 
 
X 
X 
X 
X 
X 
X 
Clinically Driven 
Target Lesion 
Revascularization 
 
X 
X 
X 
X 
X 
X 
†If a subject requires a re-intervention of the target vessel, a resting ABI, x-ray evaluation for stent fracture and angiogram 
are to be performed prior to the procedure.  If possible, all non-invasive assessments should be captured for the study, 
including ABI, and x-ray evaluation, even if the re-intervention and angiogram are declined. 
‡Creatinine and White Blood Cell count 
 
Performance of study assessments at unscheduled follow-up visits should be done as 
clinically indicated and corresponding data must be submitted to the sponsor.  
 
 
 

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Baseline Requirements 
Baseline data collection requirements are identified in Table 2.  Baseline assessment results 
will be submitted to the sponsor. 
Table 2: Baseline Requirements 
Baseline Requirements 
Timeframe Window 
Medical history 
Within 45 days 
Physical exam 
Clinical status by Rutherford Clinical Category 
Ankle-brachial index 
Walking Impairment Questionnaire 
Laboratory tests (creatinine and white blood cell count) 
Within 30 days 
 
 
Procedure Requirements 
The subject will undergo percutaneous revascularization of the SFA, which may include the 
proximal popliteal artery using the EverFlex device in conjunction with any FDA approved 
angioplasty balloon. 
The following describes the required assessments and activities during the procedure. 
Angiogram  
A sheath will be inserted and after insertion the subject should be anticoagulated according to 
the discretion of the implanting physician.  Selective angiography of the leg to be treated 
including the distal aorta, bilateral iliac, ipsilateral femoral, popliteal and tibial vessels (to the 
level of the ankle) will be performed to identify the anatomical characteristics of the 
vasculature and to best isolate and define the lesion.  The distal-most point of the lesion 
should be at least 3 cm above the plane defining the cortical margin of the femur measured 
by straight posteroanterior (PA) view.  (Refer to Figure 1 for a diagram of a PA view of the 
distal femur, identifying the cortical margin.)  Angiography must be conducted according the 
angiographic core lab protocol (see Manual of Operations).  
During angiography the implanting physician will assess the subject for the angiographic 
inclusion and exclusion criteria.  This includes verifying that the target lesion(s) total length 
is ≥ 4 cm and ≤ 18 cm.  If the subject meets all the angiographic inclusion criteria and does 
not meet any of the angiographic exclusion criteria, the subject is enrolled when an 
exchangeable guidewire crosses the lesion and/or re-enters the true vessel lumen distal to the 
target lesion(s).   

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Angiograms will be obtained immediately prior to and after the angioplasty and stenting 
procedure to document pre- and post-treatment results.  Copies of all angiograms must be 
sent to the angiographic core lab. 
The angiographic core lab values will supersede the implanting physician’s measurement 
assessments for data analysis purposes; however, the implanting physician’s assessment will 
be used to determine subject eligibility at the time of enrollment.   
Angioplasty and Stenting 
Standard PTA techniques will be followed for balloon dilatation prior to stent deployment 
and documented.  Use of any devices other than PTA balloons, cutting balloons, and scoring 
balloons for recanalization (e.g. thrombectomy, atherectomy, brachytherapy or laser devices) 
during the index procedure will be considered a deviation of the clinical protocol.  The use of 
PTA balloons, guidewires, and devices to facilitate placement of a guidewire distal to the 
target lesion, (e.g.  Covidien Viance™, Covidien Enteer™, Cordis Frontrunner® CTO Re-
Entry Catheter, and the Cordis Outback® LTD™ Re-Entry Catheter) during the index 
procedure will not be considered a deviation of the clinical protocol. 
If the subject requires treatment of an atherosclerotic lesion in the iliac artery, this will be 
ALLOWED during the index procedure, either prior to or after the treatment of the SFA 
lesion.  If the iliac artery treatment is completed prior to the SFA treatment, iliac artery 
treatment success (< 30% residual stenosis with no perforation, dissection or other injury 
requiring additional stenting or surgical intervention) must occur prior to the point of 
enrollment.  If the iliac artery treatment is completed after the SFA treatment, < 30% iliac 
artery residual stenosis must be accomplished and verification of patency in the stented SFA 
segment must be completed via angiography.  Documentation of the results for the iliac 
procedure either prior to or after the SFA treatment will be recorded. 
The selection of the EverFlex stent size, deployment and withdrawal of the delivery system 
will follow the procedures described in the Instructions for Use provided in the Manual of 
Operations.  Only one EverFlex stent should be used to treat the target lesion(s).  The 
treatment of diffuse lesions is only allowed under the condition that the entire target area can 
be covered using a single stent.  The distal-most point of the stent should be at least 3 cm 
above the line defining the cortical margin of the femur measured by straight posteroanterior 
(PA) view.  The line defining the cortical margin is perpendicular to the femur and includes 
the highest point in the cortical arch.   
While the intent of the study is to confirm the safety and effectiveness of primary stenting 
using a single EverFlex stent, should the implanting physician deem it necessary for the 
safety of the subject to implant a second stent over the target lesion, the second implant must 
also be an EverFlex stent.  The selection of the additional stent size, deployment and 
withdrawal of the delivery system will follow the procedures described in the Instructions for 
Use provided in the Manual of Operations.   
Standard PTA techniques will be followed for balloon dilatation after stent deployment.  
Using fluoroscopy, the stent should be visualized to verify full deployment.  If stent 

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expansion is incomplete at any point along the lesion, post deployment balloon dilation via 
standard PTA technique should be performed.   Note that the EverFlex stent cannot be 
expanded past its predetermined diameter.  
Interventions below the knee will only be allowed for restoration of patency that was 
compromised as a result of the index procedure. 
Any adverse events that occur during the procedure must be documented. 
The end of the procedure is defined as the time the last guidewire and catheter have been 
removed AND a complete angiogram, including runoff, has been performed post-treatment.  
If the subject returns to the procedure room and a guiding catheter is reinserted and dilation is 
performed, this is considered a re-intervention and should be documented accordingly.  The 
sheath(s) may be removed at the implanting physician’s discretion. 
Angiographic screening and procedure requirements are specified in Table 3. 
Table 3: Angiographic Screening and Procedure Requirements  
Angiographic Screening and Procedure Requirements 
1. Selective angiography of the distal aorta, bilateral iliac, ipsilateral femoral, popliteal and tibial 
vessels (to the level of the ankle), films to document pre-treatment vasculature (per core lab 
protocol). 
2. Verification that the subject meets all angiographic inclusion criteria and none of the 
angiographic exclusion criteria. 
3. Verification that the target lesion(s) total length is ≥ 4 cm and ≤ 18 cm.  
4. Verify an exchangeable guidewire has crossed the lesion and/or re-entered the true vessel lumen 
distal to the target lesion(s). 
5. Subject enrollment. 
6. Balloon angioplasty pre-dilatation using standard PTA techniques prior to stent placement. 
7. EverFlex stent deployment and delivery system withdrawal according to Instructions for Use. 
8. Post-deployment dilatation using standard PTA techniques, if incomplete stent expansion exists. 
9. Selective angiography, including runoff, of the vessel to document final results (per core lab 
protocol). 
10. Guidewire and catheter are removed, end of procedure. 
11. Record device use assessment. 
12. Adverse event documentation, including any procedural complications.  
13. Primary Endpoint Assessments: Amputation, Death, Clinically Driven Target Lesion 
Revascularization 
 
 
Medical Anticoagulant/Antiplatelet Therapy  
Subjects should receive anticoagulation and antiplatelet therapy according to the 
implanting physician’s standard of care.  The medical regiment must be recorded on 
the subjects case report form. 

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Follow-Up Requirements 
Pre-Discharge Requirements 
All subjects will be assessed pre-discharge.  At this time, an evaluation for adverse events 
(AEs) will be completed and documented.  Pre-discharge assessment requirements are listed 
in Table 4. 
 
Table 4: Pre-Discharge Assessment Requirements 
Pre-Discharge Requirements 
Timeframe 
Adverse event documentation 
Prior to discharge 
Primary Endpoint Assessments: Amputation, 
Death, Clinically Driven Target Lesion 
Revascularization 
 
 
30-Day Follow-up Requirements 
All subjects are required to have a follow-up visit at 30 days.  At this time, clinical staging by 
Rutherford Clinical Category, ankle-brachial index, Walking Impairment Questionnaire, and 
an evaluation for AEs will be completed and documented.  Table 5 lists the 30-day follow-up 
assessment requirements. 
Table 5: 30-Day Follow-Up Assessment Requirements  
30-Day Follow-up Requirements 
Follow-up Window 
Clinical status by Rutherford Clinical Category 
25-40 Days 
Post-Procedure 
Ankle-brachial index 
Walking Impairment Questionnaire 
Adverse event documentation 
Primary Endpoint Assessments: Amputation, Death, 
Clinically Driven Target Lesion Revascularization 
 
 
1-Year Follow-Up Requirements 
All subjects are required to have a follow-up visit at 1 year.  Clinical staging by Rutherford 
Clinical Category, ankle-brachial index, Walking Impairment Questionnaire, and an 
evaluation for AEs will be completed and documented.  X-ray imaging to identify stent 
fracture is also required.  Refer to the Manual of Operations for the x-ray imaging and 
transmission requirements.   

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X-rays should be sent out to the core laboratory for evaluation within five business days.  
The core laboratory will review the x-rays for quality and the presence of stent fracture.  The 
core laboratory will communicate to the investigational site within seven business days after 
receiving the x-rays if the image quality is inadequate to make an assessment of stent fracture 
and will also provide guidance on specific measures for the site to take in order to adequately 
assess for stent fracture.  If the image quality of the x-ray is inadequate to make an 
assessment of stent fracture, the investigational site must request that the subject return for a 
second series of x-rays. 
Study coordinators will be trained on the quality assessment measures used for x-ray 
acquisition for stent fracture assessment.  It is recommended that the study coordinators be 
present at the time of the x-ray acquisition to provide direction and guidance to the x-ray 
personnel.  Each site must review x-rays for image quality prior to sending to core lab. 
Table 6 lists the 1-year follow-up assessment requirements. 
 
Table 6: 1-Year Follow-up Assessment Requirements  
1-Year Follow-up Requirements 
Follow-up Window 
Clinical status by Rutherford Clinical Category 
1-Year Visit: 
335-395 Days Post-Procedure 
 
Ankle-brachial index 
Walking Impairment Questionnaire 
X-ray 
Adverse event documentation 
Primary Endpoint Assessments: Amputation, Death, 
Clinically Driven Target Lesion Revascularization 
 
2-Year and 3-Year Follow-Up Requirements 
All subjects are required to have follow-up visits at 2 and 3 years.  Ankle-brachial index 
Walking Impairment Questionnaire, and an evaluation for AEs will be completed and 
documented at each visit.  X-ray imaging to identify stent fracture is also required.  Refer to 
the Manual of Operations for the x-ray imaging and transmission requirements.   
X-rays should be sent out to the core laboratory for evaluation within five business days.  
The core laboratory will review the x-rays for quality and the presence of stent fracture.  The 
core laboratory will communicate to the investigational site within seven business days after 
receiving the x-rays if the image quality is inadequate to make an assessment of stent fracture 
and will also provide guidance on specific measures for the site to take in order to adequately 
assess for stent fracture.  If the image quality of the x-ray is inadequate to make an 
assessment of stent fracture, the investigational site must request that the subject return for a 
second series of x-rays. 
Study coordinators will be trained on the quality assessment measures used for x-ray 
acquisition for stent fracture assessment.  It is recommended that the study coordinators be 

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present at the time of the x-ray acquisition to provide direction and guidance to the x-ray 
personnel.  Each site must review x-rays for image quality prior to sending to core lab. 
Table 7 lists the 2-year and 3-year follow-up assessment requirements. 
 
 
Table 7: 2-Year and 3-Year Follow-up Assessment Requirements 
2-Year and 3-Year Follow-up Requirements 
Follow-up Window 
Ankle-brachial index 
 
2-Year Visit: 
685-775 Days Post-Procedure 
 
3-Year Visit: 
1050-1140 Days Post-Procedure 
Walking Impairment Questionnaire 
X-ray 
Adverse event documentation 
Primary Endpoint Assessments: Amputation, 
Death, Clinically Driven Target Lesion 
Revascularization 
 
All-cause mortality at 1, 2 and 3 years will be reported. 
 
Unscheduled Assessments During Follow-up 
Performance of study assessments at other follow up visits should be done as clinically 
indicated and corresponding data must be documented and submitted to the sponsor. 
If a subject is clinically indicated for a re-intervention of the target vessel, a resting ABI, x-
ray evaluation for stent fracture and angiogram are to be performed and documented prior to 
the endovascular procedure. If possible, all non-invasive assessments should be captured for 
the study, including ABI, and x-ray evaluation, even if the re-intervention and angiogram are 
declined.  If the subject does not want to undergo an angiogram, re-intervention, or non-
invasive assessments it will not be considered a deviation from the clinical protocol.  In the 
event a subject declines to proceed with an angiogram,re-intervention, or non-invasive 
testing, the reason will be documented in the subject’s medical record. 
Termination of Participation 
All subjects have the right to terminate themselves from participation at any point during the 
study.  In addition, Principal Investigators also have the ability to terminate subject 
participation in the study (see page 26, “Subject Withdrawal” for rationale for physician-
directed withdrawal).  A description of the reason for their termination will be documented.  
Reasons for termination include: completion of study, subject withdrawal, physician-directed 
subject withdrawal, lost-to-follow-up, and death.   

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Loss to Follow-Up 
Every attempt must be made to have all subjects complete the follow up visit schedule.  A 
subject will not be considered lost-to-follow-up unless efforts to obtain compliance are 
unsuccessful.  At a minimum, the effort to obtain follow-up information must include three 
attempts to make contact via telephone and if contact via phone is not successful, then a 
certified letter from the Principal Investigator must be sent to the subject’s last known 
address.  Both telephone and letter contact efforts to obtain follow up must be documented in 
both the subject’s medical records and on the study case report forms (CRFs).   
Subject Withdrawal 
All study subjects have the right to withdraw their consent at any time during the study.  
Whenever possible, the site staff should obtain written documentation from the subject that 
wishes to withdraw his/her consent for future follow-up visits and contact.  If the site staff is 
unable to obtain written documentation, all information regarding the subject’s withdrawal 
must be recorded in the subject’s medical record.  In addition, the appropriate CRFs must be 
completed for the subject and clear documentation of the subject’s withdrawal be provided to 
the sponsor.   
Withdrawal of a subject from the study can occur at the direction of the Principal Investigator 
or the sponsor.  Acceptable reasons for physician-directed subject withdrawal are; the subject 
is not adhering to the protocol requirements, the subject has enrolled in another study that 
conflicts with the DURABILITY PAS primary endpoint, or if the physician deems it in the 
best interest for the safety or welfare of the subject to withdraw. 
Deviations to the Investigation 
Principal Investigators and site staffs must avoid all protocol deviations. Use of any devices 
other than PTA balloons for recanalization (e.g. cutting balloon, scoring balloon, 
thrombectomy, atherectomy, brachytherapy or laser devices) during the index procedure will 
be considered a deviation of the clinical protocol.  Use of embolic protection devices during 
the index procedure will also be considered a deviation of the clinical protocol.  Only the use 
of PTA balloons, guidewires, and devices to facilitate placement of a guidewire distal to the 
target lesion (e.g. Cordis Frontrunner® CTO Re-Entry Catheter, the Cordis Outback® 
LTD™ Re-Entry Catheter, and the Kensey Nash Safe-Cross® System) during the index 
procedure will not be considered a deviation of the clinical protocol.  The sponsor will not 
make any exceptions to the protocol and will not provide waivers to subjects with any 
protocol deviations.  Any emergency deviations (deviations from the protocol to protect the 
life or physical well being of a subject; e.g. use of a device not approved for use in the 
superficial femoral artery) that occur must be reported to the sponsor and the site IRB per 
their guidelines.   
While this clinical protocol is designed to study the safety and effectiveness of the EverFlex 
device in subjects who received only one stent, the sponsor recognizes there may be 
circumstances necessitating the need to implant more than one stent in the superficial femoral 
artery during the index procedure.  Implantation of a second stent in the SFA during the 

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index procedure is not considered a protocol deviation.  The sponsor will track and report all 
instances when more than one stent is implanted in the SFA during the index procedure, 
including information on the reason(s) why the additional stent was needed, as well as the 
investigator and site.   
Device Malfunctions 
A device malfunction occurs in any case when the device does not perform in its intended 
function when used in accordance with the Instructions for Use.  All device malfunctions 
must be reported to the sponsor. 
If a device malfunction results in an adverse event for the subject, this adverse event will be 
considered a reportable adverse event and must be reported as an adverse event.  Device 
malfunctions that do not result in an adverse event for the subject do not need to be recorded 
as an AE, as they are not considered an AE. 
If a device malfunction occurs with the EverFlex device, return the device to ev3, following 
the procedure outlined in the Regulatory Binder. 
Adverse Events 
The following adverse events, as defined below, will be reported in this study. 
Procedural Adverse Events (AEs) are defined as any event, regardless of severity, that 
occurs during the index procedure through the pre-discharge visit. The sponsor should be 
notified in a timely manner.  If the Procedural AE is determined to be an SAE, follow 
reporting guidelines for SAEs below. 
Major Adverse Events (MAEs) are defined as: clinically-driven target lesion 
revascularization, amputation of treated limb, and all-cause mortality.  All MAEs should be 
reported as soon as possible after the investigational site’s knowledge of the event.  A written 
report will be provided to the sponsor within 10 business days after the investigator learns of 
an MAE and must be provided to the IRB according to the board’s reporting guidelines.  
Serious Adverse Events (SAEs) are any adverse events that result in death, are life 
threatening, require inpatient hospitalization greater than 24 hours, or prolongation of an 
existing hospitalization, require intervention to prevent permanent impairment/damage, or 
result in persistent or significant disability/incapacity.  A written report will be provided to 
the sponsor within 10 business days after the investigator learns of an SAE and must be 
provided to the IRB according to the board’s reporting guidelines. 
An Unanticipated Adverse Device Effect (UADE) is defined as any serious adverse 
experience (event) leading to injury, illness, or death of a subject not previously identified in 
nature, severity or degree of incidence in the protocol that may be directly related to the use 
of the device. 

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In the event of a UADE the investigational site will inform the sponsor and IRB as soon as 
possible. A written report will be provided to the sponsor within 10 business days after the 
investigator learns an unanticipated adverse device effect and will be provided to the IRB 
according to the board’s reporting guidelines.   
Deaths 
Each subject death must be reported to the sponsor.  A death must be reported to the sponsor 
as soon as possible after the site’s knowledge of the event.  A written report will be provided 
to the sponsor within 10 business days after the investigator learns of a death and will be 
provided to the IRB according to the board’s reporting guidelines.   It is requested that a copy 
of the death certificate and a copy of the autopsy report, if applicable, be sent to the sponsor 
when available.  Any other source documents related to the death should also be provided to 
the sponsor.  In the event that no source documents are available the PI will be required to 
submit a letter to the sponsor describing the circumstances of the subject’s death. 
Core Laboratory Requirements 
Angiographic Core Laboratory 
An independent Angiographic Core Laboratory will review all scheduled and unscheduled 
angiographic procedure data.  See Angiographic Core Laboratory Procedures in the Manual 
of Operations.  
The Angiographic Core Laboratory is: 
Jeffrey J. Popma, MD 
Medical Director  
Beth Israel Deaconess Medical Center Angiographic Core Laboratory  
940-W Commonwealth Ave, 2nd Floor 
Boston, MA 02215 
Phone: 617-307-5520 
Fax: 617-307-5612 
X-ray Core Laboratory 
An independent x-ray Core Laboratory will review all scheduled and unscheduled x-ray data.  
See X-ray Core Laboratory Procedures in the Manual of Operations.  
The X-ray Core Laboratory is:  
Jeffrey J. Popma, MD 
Medical Director  
Beth Israel Deaconess Medical Center Angiographic Core Laboratory  
940-W Commonwealth Ave, 2nd Floor 
Boston, MA 02215 
Phone: 617-307-5520 
Fax: 617-307-5612 

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X-rays should be sent out to the core laboratory for evaluation within two to five business 
days.  The core laboratory will review the x-rays for quality and the presence of stent fracture 
using the “Stent Location and Integrity Grid”.  The core laboratory will communicate to the 
investigational site within seven business days after receiving the x-rays if the image quality 
is inadequate to make an assessment of stent fracture and will also provide guidance on 
specific measures for the site to take in order to adequately assess for stent fracture.  If the 
image quality of the x-ray is inadequate to make an assessment of stent fracture, the 
investigational site must request that the subject return for a second series of x-rays. 
There will be a Stent Fracture Adjudication Committee formed to adjudicate the 
classification and categorization of stent fractures.  Clinical summaries describing baseline 
demographic information, physical findings, medical history and clinical symptomatology 
will be prepared for the Stent Fracture Adjudication Committee. 
Clinical Events Committee 
An independent Clinical Events Committee (CEC) will be established.  The CEC will consist 
of physicians who are not investigators in the study and who do not have any significant 
investment in ev3 or any of their entities.  The committee will include, but not be limited to, 
the specialties of interventional cardiology, vascular surgery, and interventional radiology. 
The CEC is responsible for conducting a review of all adverse events, including SAEs and 
MAEs, reported for study subjects in the study.  The CEC will adjudicate and classify all 
primary and secondary endpoint events as defined in the clinical protocol.  In addition, the 
CEC will be responsible for adjudicating and classifying any site reported device-related, 
procedure-related or study requirement-related adverse events. The CEC will determine if 
any device-related adverse event is an unanticipated adverse device effect. 
Case Report Forms 
Electronic case report forms (eCRFs) will be used to collect study data.  The eCRFs will be 
electronically viewed and signed by the Principal Investigator.  All appropriate sections of 
the eCRFs must be completed.   
Case report forms related to the index procedure should be completed within two weeks 
following subject discharge.  The follow-up forms must be completed in a timely manner 
after the follow-up visit.  
Study monitors designated by the sponsor will review the information documented in the 
eCRFs and verify the information recorded is consistent with medical records and other 
source documents.  Errors or incomplete entries will be rectified.   
The sponsor will use the study data for statistical and tracking purposes and will treat the 
information as confidential.  A representative of the FDA may review or copy study records 
during an audit. 
 
 

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5.0 STATISTICAL METHODS  
Primary Endpoint and Sample Size Adjustment 
Hypothesis Testing 
The study’s primary endpoint has been previously defined.  The associated statistical 
hypothesis is that the resulting event-free rate at 36 months is greater than the Performance 
Goal (PG), which is adapted from RESILIENT 3-year data on freedom from TLR for PTA 
subjects. 
The null and alternative hypotheses for the primary endpoint are: 
H0: 
 pt ≤ ppg   
Ha:       pt  > ppg   
where pt  is the event-free rate in subjects treated with an EverFlex device and ppg  is the PG 
of 35%. 
Analysis of this endpoint will be carried out by Kaplan-Meier methods.  The point estimate 
of the event-free rate at 36 months (1095 days) from the date of the index procedure will be 
computed along with its one-sided 97.5% lower confidence bound.  If the lower bound is 
greater than 35%, it will be declared that the PG and the corresponding primary study 
objective have been met. 
Justification of Performance Goal 
The structure of the composite endpoint is derived from a 12-month composite endpoint 
described by VIVA Physicians Inc. (VPI) as part of their development of safety and 
effectiveness Performance Goals (PG) for the use of bare nitinol stents in the treatment of 
femoropopliteal lesions.19, 20  The VPI 12-month composite was defined as acute death, index 
limb amputation and target vessel revascularization (TVR) through 12-months.  This 
composite event rate in the studies reviewed was 30.5% at 12 months (Table 8). However, 
there were no long-term follow-up to 3 years reported. 
Table 8: PTA Performance Goals – Safety Data 
 
 
Company A 
(n=29) 
Company B 
(n=24) 
Company C 
(n=63) 
Combined 
(n=116) 
12 month Composite 
(acute death, 12m 
TVR, 12m 
amputation 
38.5% (10/26) 
33.3% (6/18) 
25.5% (13/51) 
30.5% (20/95) 
 

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Recently, 3-year data on freedom from TLR was presented on the PTA arm of the 
RESILIENT study.21  The reported event-free rate at 3 years among RESILIENT subjects 
randomized to PTA treatment was 41.8%, a value which is adjusted as follows to account for 
longer lesions enrolled in DURABILITY II. 
 
The statistical model employed is a Cox regression on the outcome of freedom from TLR 
applied to DURABILITY II data.  Lesion length (in mm) as measured by the core laboratory 
was the predictor of outcome, resulting in a point estimate of 0.01543 for the logarithm of the 
hazard ratio, and therefore a hazard ratio of e0.01543=1.0155 per mm of lesion length (with 
longer lesions associated with lower freedom-from-TLR rates). 
 
As the mean lesion length in RESILIENT was 68 mm versus 89 mm in DURABILITY II, the 
resulting adjusted event-free rate can be obtained using a formula analogous to adjusting with 
odds ratios: 
 
ppg/(1-ppg) = (0.418/(1-0.418))*1.0155(89-68) 
 
Solving this equation gives ppg  = 0.342, which is rounded up to give the PG of 35%.  Note 
that this PG is conservative in that it (1) does not attempt to account for any other systematic 
differences between RESILIENT and DURABILITY II and (2) does not explicitly account 
for the other elements of the composite endpoint (since these were not presented for 
RESILIENT), which if included would lower the expected freedom-from-event rate below 
that seen for TLR alone. 
Potential Outcomes 
Table 9 summarizes approximate outcomes under potential results for freedom from event, 
using binomial estimation.  Note that the actual analysis will be conducted using time-to-
event methods and is subject to currently unknown censoring times, and that therefore the 
actual success criteria will vary slightly from those noted below. 
Table 9: Approximation to Possible Outcomes and Corresponding 97.5% Lower 
Confidence Bound 
 
 
Primary Endpoint (PG=35%) 
Sample Size  
 Count of subjects with  
freedom from event 
36-Month Freedom 
From Event Rate 
97.5% lower 
confidence bound 
108 
48 
44.4% 
35.1% 
108 
49 
45.4% 
36.0% 
108 
50 
46.3% 
36.9% 
108 
51 
47.2% 
37.8% 

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Sample Size and Power 
The required sample size for evaluating the primary endpoint can be approximated using the 
normal method for testing a single proportion (as above, under Kaplan-Meier methods the 
actual power will vary slightly from this calculation): 
 
                     
2
2
1
1
)
(
))
)
1(
/(
)
1(
(
))
1(
(
pg
t
pg
pg
t
t
pg
pg
n
p
p
p
p
p
p
p
p
β
α
−
−
−
Ζ
+
Ζ
×
−
×
=
−
−
 
 
Where, 
• Type I error (α) = 0.025 (one-sided) 
• Statistical power (1 – β) = 90% 
• Z is the standard normal deviate for α =0.025 and β=0.10.  
• 
t
π is estimated freedom-from-event at 36 months 
• 
pg
p
is the PG  
 
Using this approximation with πt = 0.55 (estimated from current DURABILITY II data), πpg 
= 0.35 (the a priori performance goal), Z1-α = 1.96 and Z1-β = 1.28 gives a sample size of 62.  
Allowing for approximately 30% of subjects lacking a 3-year follow-up visit, the needed 
sample size under this approximation for 90% power is a minimum of 89. 
 
An additional sample size requirement is based on the secondary endpoint of freedom from 
stent fracture at 1 year.  In DURABILITY I and DURABILITY II, 1-year stent fracture rates 
of 8.1% (n=151) and 0.4% (n=287), respectively, were observed.  The pooled fracture rate of 
these two studies is 3.0% (13/438), around which a confidence interval of specified width is 
desired.  The desired precision is 7.2% (half-width of 3.6%); we therefore find a 95% two-
sided normal confidence interval with upper bound 3.0% + 3.6% = 6.6%, and extract the 
relevant sample size. 
 
Table 10: Sample Size Freedom from Stent Fracture 
 
 
From the above table, the required sample size at 1 year is 97 subjects. Considering a 10% 
rate of attrition, a minimum of 108 subjects are needed, which is larger than the sample size 
Sample Size for Freedom from Stent Fracture 
Sample Size  
 Count of subjects with  
event 
Event Rate 
97.5% upper 
confidence bound 
(95% two-sided) 
95 
3 
3.16% 
6.67% 
96 
3 
3.13% 
6.61% 
97 
3 
3.09% 
6.54% 
98 
3 
3.06% 
6.47% 

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of 89 calculated for the primary endpoint.  The enrolled sample size is therefore 108.  Please 
note that multiple stents are allowed in each subject in the study. The stent fracture endpoint 
will be analyzed on stent level.  To be conservative, sample size calculation is performed on 
subject level.  Therefore more stents than the above assumption may be included in the 
analysis.  
Data Analysis Plan 
All statistical analyses will be performed using Statistical Analysis System (SAS) for 
Windows (version 9.2 or above, SAS Institute Inc. Cary, N.C.) or other widely accepted 
statistical or graphical software.  In general, data for all study subjects combined will be 
presented. Individual data will be presented in subject listings. 
Descriptive statistics will be used to present the data and to summarize the results.  Discrete 
variables will be presented using frequency distributions and cross-tabulations.  Continuous 
variables will be summarized by presenting the number of observations (N), mean, standard 
deviation, median, minimum, and maximum values.    
For adverse event reporting, 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. 
Unless otherwise specified, statistical significance will be declared when p<0.05 for two-
sided tests and p<0.025 for one-sided tests such as the primary endpoint. 
Analysis of Secondary Endpoints 
For secondary endpoints, descriptive statistics will be provided.  No formal statistical 
hypothesis testing will be performed.  Categorical variables will be analyzed using frequency 
tabulation and event rate.  For continuous variables, analysis will include mean, median, 
standard deviation, and ranges.  Time-to-event variables including the primary endpoint and 
the secondary endpoint of freedom from stent fracture will be analyzed using survival 
analysis and reported at 1 year (365 days), 2 years (730 days) and 3 years (1095 days), with 
Kaplan-Meier plots provided. 
Analysis of Ability to Pool Data Across Investigational Sites 
This is a multi-center clinical study, with standardization of subject enrollment, data entry 
and adverse event 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 summary form, a comparison across all sites will be completed to 
determine if the generated data could be pooled. The following variables will be completed 
to assess the appropriateness of pooling data from across all sites:   
• Baseline demographics such as age and gender 
• Lesion characteristics such as lesion length and percent stenosis 

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The distributions of the above variables across the sites will be tabulated.  To detect site 
differences, t-tests or Wilcoxon’s rank-sum test will be used for continuous variables and 
Fisher’s exact test for categorical variables.   
6.0 RISK/BENEFIT ANALYSIS 
The study is designed to minimize risk through observance of strict site and investigator 
selection criteria, careful subject selection and management, and rigorous adherence to a 
standardized schedule of post-procedure evaluations. 
Potential Benefits 
There are no guaranteed benefits from participation in this study; however, it is possible that 
treatment with the EverFlex stent may improve blood flow through the treated artery.  This 
may result in subjects experiencing fewer or less severe leg symptoms. 
Information gained from the conduct of this study may be of benefit to other persons with the 
same medical condition.   
Potential Risks  
Risks Associated with Peripheral PTA and Stenting 
The risks associated with PTA and stenting of the SFA, including the proximal popliteal 
artery may include but are not limited to the following. 
 

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Table 11: Risks Associated with Peripheral PTA and Stenting  
POTENTIAL ADVERSE EVENTS 
The potential adverse effects (e.g., complications) that may occur and/or require intervention 
with the use of this device include, but are not limited to:   
  
• 
Abrupt or sub-acute closure 
• 
Allergic reaction to device materials or 
procedure medications 
• 
Allergic reaction to Nitinol 
• 
Amputation 
• 
Aneurysm 
• 
Angina 
• 
Arrhythmia 
• 
Arterio-venous fistula 
• 
Artery perforation or rupture 
• 
Bleeding requiring transfusion 
• 
Bruising 
• 
Contrast medium reaction/renal failure 
• 
Death 
• 
Device breakage 
• 
Dissection or intimal flap 
• 
Edema 
• 
Embolism 
• 
Failure to deploy stent 
• 
Fever 
• 
Gastrointestinal bleeding due to 
anticoagulation 
• 
Hematoma 
• 
Hypertension/hypotension 
• 
  
• 
Infection 
• 
Inflammation 
• 
Intraluminal thrombus 
• 
Myocardial infarction 
• 
Pain 
• 
Partial stent deployment 
• 
Pseudoaneurysm 
• 
Renal failure requiring dialysis 
• 
Renal insufficiency (new or 
worsening) 
• 
Restenosis 
• 
Sepsis 
• 
Shock 
• 
Stent collapse or fracture 
• 
Stent migration 
• 
Stent misplacement 
• 
Stroke 
• 
Surgical or endovascular 
intervention 
• 
Thrombosis/occlusion of the stent 
• 
Transient ischemic attack 
• 
Venous thromboembolism 
• 
Vessel spasm 
  
 
 
 
As with any device requiring mechanical deployment and retraction, such as the EverFlex 
device, there exists a risk of mechanical failure of the device resulting in potential surgical 
intervention to remove the stent or delivery system. 
It is expected that the fluoroscopy time of the stenting procedure will be minimally longer (in 
order to confirm angiographic inclusion and exclusion criteria) than the time required for 
stenting procedures using other devices and will not pose additional risks to the subject or 
laboratory personnel.   
All of the above could cause prolonged illness, permanent impairment of daily function, or, 
in rare cases, death.  Possible treatments could include, but are not limited to cardiac surgery 
and vascular surgery. 

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Extensive reliability engineering testing has been performed on the EverFlex device to 
mitigate risks to the subject due to product failure.  Additionally, studies using the EverFlex 
device have been conducted to ensure that the system performs as intended without 
introducing more risks during the index procedure or during follow-up.  Risks of the 
EverFlex stent may be further limited by providing medications such as aspirin or 
clopidogrel and continuing to monitor subjects following stent implantation.   
While some of the potential risks identified have occurred in prior stent implantation studies, 
and while ev3 believes that the risk for significant injury or death due to the EverFlex device 
is quite low, these risks have yet to be adequately and fully quantified.  Eligibility criteria 
that exclude subjects who are at higher risk for experiencing an anticipated adverse event 
have been selected in order to reduce the potential risks to subjects that participate in this 
study. 
Risks Associated with Required Medications 
There are also anticipated risks associated with recommended medications. 
Subjects should receive anticoagulation and antiplatelet therapy according to the implanting 
physician’s standard of care. 
It is recommended that subjects receive aspirin indefinitely for atherosclerotic therapy.  The 
standard risks associated with long-term aspirin therapy as described in the product labeling 
apply.  These risks may include gastrointestinal symptoms such as nausea, vomiting, stomach 
pain and gastrointestinal bleeding.  Other complications such as ringing in the ears, liver 
toxicity, rash, kidney impairment, vertigo and lightheadedness can also occur. 
Subjects also should receive clopidogrel for at least four weeks following their EverFlex 
stent implantation.  The standard risks associated with short-term use of clopidogrel as 
described in the product labeling apply.  The risks of clopidogrel may include chest pain, flu-
like symptoms, pain, headache, dizziness, upset stomach, bruising and respiratory infection.  
The major risk of taking a combination of aspirin and clopidogrel for any period of time is 
possible increase in the risk of a bleeding event.  
 Risks Associated with Magnetic Resonance Imaging 
The use of Magnetic Resonance Imaging (MRI) can induce electrical voltages and currents 
on the implanted stent, causing heating around the device that may potentially result in tissue 
damage.  Non-clinical testing demonstrates that the EverFlex stent is MR Conditional. 
Refer to the Instructions for Use for additional safety information on MRI use.  
 
 

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7.0 SITE REQUIREMENTS 
Site Selection  
The sponsor or a representative of the sponsor will assess each potential site to ensure the 
Principal Investigator and his/her staff has the facilities and expertise required for the study. 
Principal Investigators and sites will be selected based upon the following factors: 
• Previous experience with clinical research and percutaneous procedures, 
including substantial experience treating the superficial femoral artery in the past 
12 months  
• Currently treating subjects who meet the inclusion/exclusion criteria 
• Ability to enroll an adequate number of subjects 
• Ability to perform required clinical testing, including: fluoroscopy and x-ray. 
• Ability and willingness to provide the sponsor’s representatives access to the 
hospital records, study files, and subject files as they pertain to the study 
• Willingness to participate, including compliance with all aspects of the study 
• Adequate staffing to conduct the study. This includes: 
 
Principal Investigator 
Responsible for overall clinical management of subjects enrolled at 
his/her institution. Assumes overall responsibility and accountability 
for the clinical team and for data obtained from each subject 
participating in the study. Ensures compliance with the protocol, 
applicable laws, and applicable regulations; ensures informed 
consents are signed, and reviews and signs CRFs indicating 
documents are accurate and complete. 
 
Sub-Investigator(s) 
Responsible for study activities in coordination with Principal 
Investigator and in accordance to the investigational plan.  A site is 
not required to have a sub-investigator. 
 
Study Coordinator 
Assists Principal Investigator with study activities as delegated by 
the Principal Investigator, including tracking subjects involved in the 
study, scheduling testing and follow-up visits, maintaining study 
records, completing and providing CRFs to the sponsor in a timely 
manner. 
Training/Initiation Visit 
The sponsor or a representative of the sponsor will conduct a training session with each 
Investigator and his/her staff to review the protocol, Instructions for Use of the EverFlex 
device, CRFs, the informed consent process, IRB involvement and guidelines, 
responsibilities and obligations, reporting requirements and general guidelines for good 
clinical practices. 

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Prior to enrolling subjects at an investigational site, the following documentation must be 
provided to the sponsor: 
IRB approval for the Clinical Protocol  
IRB approval for the Principal Investigator to conduct the study 
IRB and sponsor approved Informed Consent Form for the study 
Investigator(s’) curriculum vitae (CV) 
Laboratory Certification 
Financial Disclosure(s) for the Principal Investigator and sub-investigators 
Signed Investigator Agreement and if applicable, Sub-Investigator Agreement(s)  
Training Log documenting each implanting physician has been trained on the 
EverFlex device. 
Training Log documentation to verify the appropriate study staff has been trained 
in on the protocol, device, CRFs and study conduct. 
8.0 MONITORING PROCEDURES 
Monitoring Procedures 
ev3 as the sponsor will be responsible for ensuring that adequate monitoring at each site is 
completed to ensure protection of the rights of subjects, the safety of subjects, and the quality 
and integrity of the data collected and submitted.  Appropriately trained personnel appointed 
by ev3 will conduct monitoring at each site.  Monitors will conduct site visits to ensure 
accuracy of data, timeliness of data submissions, adequate subject enrollment, investigational 
device accountability, compliance with applicable laws and regulations, compliance with the 
protocol, compliance with the signed investigator agreement, and compliance with IRB 
conditions and guidelines.  Any non-compliance with these items that is not adequately 
addressed by the Principal Investigator/site staff is cause for the sponsor to put the 
investigator/site staff on probation or withdraw the investigator/site staff from the study.  
Frequency of monitoring will be based upon enrollment, study duration, compliance, and any 
suspected inconsistency in data that requires investigation. 
Monitoring Reports 
After each monitoring visit, the monitor will send to the Principal Investigator a letter 
summarizing the monitoring visit.  A monitoring report will be sent to the sponsor. The 
report will include the date of the monitoring visit, the site name, the name of the monitor, 
the name of the investigator, the names of other individuals present for the monitoring visit, 
items reviewed during the visit, findings, and any required follow-up.  The Principal 
Investigator will be responsible for ensuring that follow-up actions needed to resolve issues 
at the site are completed in an accurate and timely manner. 

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Final Monitoring Visit 
Final monitoring visits at the sites will be conducted at the close of the study.  The purpose of 
the final visit is to collect all outstanding study data documents, ensure that the Principal 
Investigator’s files are accurate and complete, review record retention requirements with the 
Principal Investigator, make a final accounting of all study supplies shipped to the Principal 
Investigator/site, provide for appropriate disposition of any remaining supplies, and ensure 
that all applicable requirements are met for the study. 
9.0 RESPONSIBILITIES, RECORDS and REPORTS 
Responsibilities and Record Retention 
The Principal Investigator/site must maintain adequate records on all aspects of the study, 
including the following: 
• 
IRB approvals 
• 
Adverse Event Form and information 
• 
Device disposition 
• 
Protocol Deviations 
• 
Informed Consent Forms 
• 
Correspondence file regarding study 
• 
Case Report Forms 
• 
Subject termination information 
The Principal Investigator/site must maintain the study records for at least two years after 
cessation of the study, or the date that the records are no longer required for purposes of 
supporting a PMA or notice of completion of a product development protocol, and must 
contact the sponsor prior to disposal of study records. Records custody may be transferred to 
another person who will accept responsibility for them. Notice of transfer should be provided 
in writing by the principal investigator to the sponsor and follow reporting requirements of 
21CRF812. 
Reports 
Reports that are the Principal Investigator’s responsibility to generate are listed in Table 11.  
The table also displays information regarding to whom this information is to be sent, and the 
frequency and time constraints around report submission.  If applicable laws, regulations, or 
IRB requirements mandate stricter reporting requirements then those listed, the stricter 
requirements must be followed.   
 
Table 12: Principal Investigator Reporting Responsibilities 
Type of Report 
Principal Investigator Reporting Responsibilities 
Report 
Prepared For 
Reporting Time Frame 
Adverse Events 
Sponsor 
At the time of procedure. 
Major Adverse Events 
Sponsor and 
IRB 
ASAP, but to Sponsor no later than 10 working 
days after Principal Investigator is first aware of 
the event.  To IRB according to their guidelines. 

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Type of Report 
Principal Investigator Reporting Responsibilities 
Report 
Prepared For 
Reporting Time Frame 
Serious Adverse Events 
Sponsor and 
IRB 
ASAP, but to Sponsor no later than 10 working 
days after Principal Investigator is first aware of 
the event.  To IRB according to board guidelines. 
Unanticipated Adverse 
Device Effects 
Sponsor and 
IRB 
Written -ASAP, but to sponsor no later than 10 
working days after investigators are first aware 
of the effect.  To IRB according to board 
guidelines. 
Withdrawal of IRB 
Approval or other action 
on part of the IRB that 
affects the study 
Sponsor 
Written – Within 5 working days of IRB 
decision. 
Progress Reports 
IRB 
At intervals dictated by the IRB, but no less than 
yearly. 
Emergency Deviations 
from Protocol 
Sponsor and 
IRB 
ASAP but to sponsor no later than 5 working 
days after the deviation occurs.  To IRB 
according to board guidelines. 
Inappropriate Informed 
Consent 
Sponsor and 
IRB 
To sponsor within 5 working days after the 
deviation occurs.  To IRB according to board 
guidelines. 
Final Report 
Sponsor and 
IRB 
To sponsor within 3 months after termination or 
completion of study or investigator’s 
participation.  To IRB according to board 
guidelines. 
Other 
IRB, FDA 
Upon request, provide accurate, complete, and 
current information about any aspect of the study 
 
 
  
 
 

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10.0 
DEFINITIONS 
Abrupt Closure: Vessel occlusion at the site of treatment within 24 hours after successful 
index procedure. 
Adverse Event Definitions  
Procedural 
Adverse Event 
(AE) 
Any adverse event, regardless of severity, that occurs during the index 
procedure through the pre-discharge visit. 
Major Adverse 
Event (MAE) 
A primary safety endpoint adverse event.  MAEs are defined as: 
clinically-driven target lesion revascularization, amputation of treated 
limb, and all-cause mortality. 
Serious Adverse 
Event (SAE) 
Any adverse event that results in death, is life threatening, requires 
inpatient hospitalization greater than 24 hours, or prolongation of an 
existing hospitalization, requires intervention to prevent permanent 
impairment/damage, or results in persistent or significant 
disability/incapacity. 
Unanticipated 
Adverse Device 
Effect (UADE) 
Any serious adverse experience (event) leading to injury, illness, or 
death of a subject not previously identified in nature, severity or degree 
of incidence in the study protocol, literature, or application (including a 
supplementary plan or application) that may be directly related to the 
use of the device. 
 
Allergic Reaction: Allergic reaction which could result in nausea, rash, wheezing, edema, 
induced thrombotic events, urticaria or shock.  
Amputation: Surgical removal of the target limb or a part of the target limb above the 
metatarsal line that was unanticipated prior to the index procedure.  
Aneurysm: A localized, pathological, blood-filled dilatation of a blood vessel caused by a 
weakening of the vessel wall. 
Ankle-Brachial Index (ABI): The ratio of the highest ankle systolic pressure to the highest 
brachial systolic pressure as determined by Doppler ultrasound. 
Artery Perforation: Extravasation of contrast media outside the arterial adventitial space. 
Artery Rupture: Large transmural disruption of a vessel with gross extravasation and 
hemorrhage. 

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As-Treated Analysis: An “as-treated” analysis is one in which all the participants in a study 
are analyzed according to the treatment received, regardless of the initial assignment and 
regardless of the amount of follow-up.  
Arterio-venous Fistula: A communication between an artery and a vein in which the arterial 
blood flows directly into a neighboring vein. 
Bleeding: Blood loss resulting from the percutaneous interventional procedure or adjunctive 
drug therapy that may require transfusion of blood products. 
Compressible Artery1: An artery without significant calcification that can be evaluated by 
duplex ultrasound; an artery that results in an ABI value < 1.3.  
Contrast Medium Reaction: A reaction to the contrast media used in endovascular 
procedures.  Reactions include but are not limited to urticaria, nausea, vomiting, headache 
and renal failure. 
Death: The termination of life.  
Device Malfunction: Defined as a malfunction of the EverFlex stent or a component of the 
delivery system such that it did not perform its intended function when used in accordance 
with the Instructions for Use. 
Device-Relatedness Categories for Adverse Events: 
Device-Related Adverse Event:  AE that has a strong temporal relationship to the 
presence or performance of the investigational device/system and an alternative 
etiology is highly unlikely. 
Probably Device-Related Adverse Event:  AE has a strong temporal relationship to 
the presence or performance of the investigational device/system and an alternative 
etiology is less likely compared to the potential relationship to the investigational 
device/system. 
Probably Not Device-Related Adverse Event:  AE had minimal or no temporal 
relationship to the use of the investigational device/system and/or a more likely 
alternative etiology exists. 
Not Device-Related Adverse Event:  AE is due to the underlying disease state or 
concomitant medication or therapy, and was not caused by the investigational 
device/system. 
Device Success: The ability to deploy the stent as intended at the treatment site. 
Diabetes (History of): Defined as subjects who have been diagnosed with either Type I or 
Type II diabetes and are currently taking oral hypoglycemics or insulin. 
                                                 
1 Creager Mark, Victor Dzau, and Joseph Loscalzo, eds.  Vascular Medicine: A Companion to Braunwald’s 
Heart Disease.  Philadelphia, PA: Saunders Elsevier, 2006. 

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Discharge: The time point when the subject is released from the admitting hospital, 
transferred to another facility, or has expired. 
Dissection: Intimal disruption of vessel the wall with or without medial or adventitial 
contrast staining.  See also National Heart, Lung and Blood Institute (NHLBI)  
Classification of Dissection. 
Distal Embolization: Migration of air, plaque, thrombus, or debris that occludes the distal 
target vessel or one of its branches. 
Embolism: Obstruction of a blood vessel by a foreign substance (air, plaque, or debris) or a 
blood clot. 
Emergent Surgical Revascularization: Surgery performed on an urgent or emergent basis 
as a result of the PTA procedure and/or use of the EverFlex device. 
Enrollment: The subject is enrolled in the study after he/she has signed the patient informed 
consent and has been determined to meet all inclusion and none of the exclusion criteria.  
The point of enrollment is defined as the moment an exchangeable guidewire crosses the 
lesion and/or enters the true vessel lumen distal to the target lesion(s).   
Fever: An increase in internal body temperature to levels that are above normal (37°C, 
98.6°F). 
Focal Popliteal Disease: Entire lesion is located distal to adductor canal on AP view. 
Hematoma: Localized mass of extravasated blood ≥ 5 cm that prolongs hospitalization. 
Hemorrhage: Bleeding requiring hospitalization, repeat procedure, operation or transfusion.  
Hypertension: Increase in systolic blood pressure above 140 mm Hg or a diastolic blood 
pressure above 90 mm Hg. 
Hypotension: Fall in systolic blood pressure that requires intravenous treatment with 
vasopressors or inotropic agents. 
Index Procedure: The procedure in which the subject has the EverFlex stent implanted or an 
implant is attempted. 
Infection: Inflammation caused by bacterial or viral sources, such as, urinary tract infection, 
puncture site infection, sepsis, endocarditis, and bacteremia from IV site.   
Inflammation: An immunologic response to infection or trauma that can result in localized 
redness, swelling, heat, pain and dysfunction of the organs involved. 
Intimal Flap: Superficial dissection of the vessel that does not result in medial or adventitial 
contrast staining (NIHLBI Type A dissection). 

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Intention-to-treat (ITT) Analysis: An intention-to-treat analysis is one in which data from 
all participants in a study are analyzed according to the allocated treatment, regardless of the 
treatment actually received. 
Intraluminal Thrombus: A blood clot within a vessel. 
Invasive Intervention: Any intervention or therapy that penetrates the skin, excluding 
administration of parenteral fluids or drugs. 
Myocardial Infarction (MI): Per the ESC/ACC definition2: 
Criteria for acute, evolving or recent MI. 
Either one of the following criteria satisfies the diagnosis for an acute, evolving or 
recent MI: 
1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of 
biochemical markers of myocardial necrosis with at least one of the following: 
a) ischemic symptoms; 
b) development of pathologic Q waves on the ECG; 
c) ECG changes indicative of ischemia (ST segment elevation or depression); or 
coronary artery intervention (e.g., coronary angioplasty). 
d) Pathologic findings of an acute MI. 
Criteria for established MI. 
Any one of the following criteria satisfies the diagnosis for established MI: 
1. Development of new pathologic Q waves on serial ECGs. The patient may or may 
not remember previous symptoms. Biochemical markers of myocardial necrosis 
may have normalized, depending on the length of time that has passed since the 
infarct developed. 
2. Pathologic findings of a healed or healing MI. 
 
 
                                                 
2 Alpert JS, Thygesen K, Antman E, Bassand JP.  Myocardial infarction redefined--a consensus document of 
The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of 
myocardial infarction. J Am Coll Cardiol. 2000 Sep;36(3):959-69. 

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National Heart, Lung and Blood Institute (NHLBI) Classification of Dissection3: 
Dissection Description 
Type A 
Small radiolucent area within the lumen of the vessel disappearing 
with the passage of contrast material 
Type B 
Appearance of contrast medium parallel to the lumen of the vessel 
disappearing within a few cardiac cycles 
Type C 
Dissection protruding outside the lumen of the vessel persisting 
after passage of the contrast material 
 
Type D 
Spiral shaped filling defect with delayed runoff of the contrast 
material in the distal vessel 
Type E 
Persistent luminal filling defect with delayed runoff of the contrast 
material in the distal vessel 
Type F 
Filling defect accompanied by total coronary occlusion 
New York Heart Association (NYHA) Heart Failure Classification4: 
Class 
Description 
Class I:  
Subject has no physical limitation and is asymptomatic 
Class II:  
Subject has mild symptoms while doing light exercise or activities 
of daily living 
Class III:  
Subject has difficulty doing simple activities of daily living 
Class IV: 
Subject is frequently bed- or chair-ridden for most of the day and 
is too weak and short of breath to do simple activities 
Occlusion: 100% stenosis within an artery. 
Percent Stenosis:  Native vessel diameter as measured at the most narrow point of the lesion 
divided by the estimated native vessel diameter (the mean of the vessel diameters proximal 
and distal to the lesion) at that location.   
   % Stenosis = (
)
[
]
2
/
)
(
int
diameter
vessel
distal
diameter
vessel
proximal
mm
lesion
of
po
narrow
most
at
Diameter
+
  
Physician-Directed Subject Withdrawal: Withdrawal of a subject from the study at the 
direction of the Principal Investigator.  Reasons for physician-directed subject withdrawal 
include, but are not exclusive to: the subject is not adhering to the protocol requirements, the 
subject has enrolled in another study that conflicts with the DURABILITY PAS primary 
endpoints, or if the physician deems it in the best interest for the safety or welfare of the 
subject to withdraw. 
                                                 
3 Huber MS, Mooney JF, Madison J, Mooney MR.  Use of a morphologic classification to predict clinical outcome after 
dissection from coronary angioplasty.  Am J Cardiol 1991; 68: 467-71. 
4 The Criteria Committee of the New York Heart Association: Physical capacity with heart disease, in Diseases of the Heart 
and Blood Vessels, Nomenclature and Criteria for Diagnosis, ed 6. Boston, Little, Brown & Co, 1964, pp 110-114 

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Pre-Procedure: The time until the PTA and stenting procedure begins (before the femoral 
artery access is obtained). 
Principal Investigator: Physician responsible for overall clinical management of subjects 
enrolled at his/her institution. Assumes overall responsibility and accountability for the 
clinical team and for data obtained from each subject participating in the study. Ensures 
compliance with the protocol, applicable laws, and applicable regulations; ensures informed 
consents are signed, and reviews and signs CRFs indicating documents are accurate and 
complete. 
Procedure-Relatedness Categories for Adverse Event:  
Procedure-Related Adverse Event:  AE that has a strong temporal relationship to 
the implantation procedure and an alternative etiology is highly unlikely. 
 
Probably Procedure-Related Adverse Event:  AE has a strong temporal 
relationship to the implantation procedure and an alternative etiology is less likely 
compared to the potential relationship to the implantation procedure. 
 
Probably Not Procedure-Related Adverse Event:  AE had minimal or no temporal 
relationship to the implantation procedure and/or a more likely alternative etiology 
exists. 
 
Not Procedure-Related Adverse Event:  AE is due to the underlying disease state 
or concomitant medication or therapy, and was not caused by the implantation 
procedure. 
Protocol Deviation:  Any divergence from the study protocol (investigational plan); this 
does not include implantation of a second stent.   
Pseudoaneurysm:  Perforation of the vessel with arterial blood flow outside of the vessel. 
Renal Failure:  Failure of the kidneys to perform essential functions that requires dialysis. 
Renal Insufficiency:  A 30% increase in serum creatinine from baseline.  
Restenosis:  The recurrence of abnormal narrowing of an artery after treatment. 
Runoff Vessel:  An artery distal to treated vessel, including the popliteal, anterior tibial and 
posterior tibial arteries. 
Rutherford Clinical Category5:  A classification system of clinical categories of chronic 
limb ischemia ranging from 0 to 6.   
The categories, clinical descriptions and objective criteria are:   
                                                 
5 Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for 
reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. 

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Category 
Clinical Description 
0 
Asymptomatic--no 
hemodynamically significant 
occlusive disease 
1 
Mild claudication 
2 
Moderate claudication 
3 
Severe claudication 
4* 
Ischemic rest pain 
5* 
Minor tissue loss--nonhealing 
ulcer, focal gangrene with 
diffuse pedal ischemia 
6* 
Major tissue loss--extending 
above TM level, functional foot 
no longer salvageable 
*Categories 4, 5, and 6 are embraced by the term chronic critical ischemia. 
Sepsis:  Systemic inflammatory response to infection. 
Shock:  A condition in which the cells of the body receive inadequate amounts of oxygen 
secondary to changes in perfusion; most commonly secondary to blood loss or sepsis. 
Stenosis:  An abnormal narrowing of an artery. 
Stent Fracture: Determined by x-ray at 1, 2 and 3 years using the following classifications:   
Class 0 – No strut fractures 
Class I – Single tine fracture  
Class II – Multiple tine fractures  
Class III – Stent fracture(s) with preserved alignment of the components  
Class IV – Stent fracture(s) with mal-alignment of the components 
Class V – Stent fracture(s) in a trans-axial spiral configuration  
AND the following categories: 
Category A – Restenosis < 50% at site of fracture 
Category B – Restenosis > 50% at site of fracture 
Category C – Occlusion at site of fracture 
Category D – Unable to determine 
Stent Migration:  Substantial movement of the EverFlex stent from the initial deployment 
position, noted during the index procedure or via follow-up imaging. This does not include 
mis-measurement of the lesion, foreshortening or mis-sizing of the vessel. 
Stent Misplacement:  A stent that is not deployed at the target location. 

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Stroke:  A neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a 
brain imaging study showing infarction6.   
Study Coordinator:  Employee at investigational site who assists Principal 
Investigator with study activities as delegated by the Principal Investigator, including 
tracking subjects involved in the study, scheduling testing and follow-up visits, 
maintaining study records, completing and providing CRFs to the sponsor in a timely 
manner. 
Sub-acute Closure:  Vessel occlusion at the site of treatment between 24 hours and 4 
weeks after successful index procedure. 
Sub-Investigator(s): Physician(s) responsible for study activities in coordination with 
Principal Investigator and in accordance to the investigational plan.  A site is not 
required to have a sub-investigator. 
Target Lesion Revascularization:  Any repeat invasive procedure, including 
angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or 
increase the lumen diameter inside or within 10 mm of the previously treated lesion. 
Clinically-Driven Target Lesion Revascularizations are those in which the patient 
has a ≥ 50% diameter stenosis in the presence of recurrent symptoms or a ≥ 70% 
stenosis without any symptoms (i.e. decreased ABI, symptomatic claudication, etc) in 
the treated segment. 
Non-Clinically-Driven Target Lesion Revascularizations are those in which the 
patient undergoes a non-emergent revascularization for a diameter stenosis < 70% in 
the absence of recurrent claudication, a positive functional study (if available), or 
worsened ABI. 
Target Vessel Revascularization:  Any re-treatment by an invasive procedure, 
including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to 
open or increase the lumen diameter of the target vessel. 
Clinically-Driven Target Vessel Revascularizations are those in which the patient 
has a ≥ 50% diameter stenosis in the presence of recurrent symptoms or a ≥ 70% 
stenosis without any symptoms (i.e. decreased ABI, symptomatic claudication, etc) in 
the treated vessel. 
Non-Clinically-Driven Target Vessel Revascularizations are those in which 
the patient undergoes a non-emergent revascularization for a diameter stenosis 
< 70% in the absence of recurrent claudication, a positive functional study (if 
available), or worsened ABI. 
Thrombosis:  The formation or development of a blood clot.  
                                                 
6 Albers GW, Caplan LR, Easton JD, et al. Transient ischemic attack--proposal for a new definition. N Engl J 
Med. Nov 21 2002;347(21):1713-1716. 

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Transient Ischemic Attack (TIA):  A neurological deficit lasting less than 24 hours 
and, if an imaging study is performed, shows no evidence of infarction.6 
Unanticipated Adverse Device Effect:  Any serious adverse experience (event) 
leading to injury, illness, or death of a subject not previously identified in nature, 
severity or degree of incidence in the protocol, literature, or application (including a 
supplementary plan or application) that may be directly related to the use of the device. 
Vessel Spasm:  A sudden, brief tightening of a blood vessel. 
Walking Impairment Questionnaire (WIQ): A self-reported quality of life assessment 
focused on difficulty in walking.  Refer to the Manual of Operations for a copy of the WIQ.

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Appendix A: Contacts 
 
Sponsor: 
Medtronic 
3033 Campus Dr 
Suite N550 
Plymouth, MN 55441 
Phone: 763-591-3321 
Fax: 763-398-7200 
Attn: 
 
National Principal Investigators: 
Jon S. Matsumura, MD  
Chief, Division of Vascular Surgery  
University of Wisconsin School of 
Medicine and Public Health 
G5/325 CSC 
600 Highland Ave 
Madison, WI 53792 
(608)265-4420 
 
Krishna J. Rocha-Singh, MD 
Director, Vascular Medicine Program  
Prairie Heart Institute 
619 East Mason Street  
Suite 4P57  
Springfield, IL 62701 
(217) 544-6464, ext. 44574 
  
Angiographic and X-ray Core Laboratory: 
Jeffrey J. Popma, MD 
Medical Director  
Beth Israel Deaconess Medical Center Angiographic Core Laboratory 
940-W Commonwealth Ave, 2nd Floor 
Boston, MA 02215 
Phone: 617-307-5520 
Fax: 617-307-5612 
 
 

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Appendix B: References 
 
1. 
Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 Practice Guidelines for the 
management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, 
and abdominal aortic): a collaborative report from the American Association for Vascular 
Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and 
Interventions, Society for Vascular Medicine and Biology, Society of Interventional 
Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to 
Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): 
endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; 
National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-
Society Consensus; and Vascular Disease Foundation. Circulation. Mar 21 
2006;113(11):e463-654. 
2. 
Capek P, McLean GK, Berkowitz HD. Femoropopliteal angioplasty. Factors influencing 
long-term success. Circulation. Feb 1991;83(2 Suppl):I70-80. 
3. 
Johnston KW. Factors that influence the outcome of aortoiliac and femoropopliteal 
percutaneous transluminal angioplasty. Surg Clin North Am. Aug 1992;72(4):843-850. 
4. 
Moore WS. Therapeutic options for femoropopliteal occlusive disease. Circulation. Feb 
1991;83(2 Suppl):I91-93. 
5. 
Cheng SW, Ting AC, Wong J. Endovascular stenting of superficial femoral artery stenosis 
and occlusions: results and risk factor analysis. Cardiovasc Surg. Apr 2001;9(2):133-140. 
6. 
Conroy RM, Gordon IL, Tobis JM, et al. Angioplasty and stent placement in chronic 
occlusion of the superficial femoral artery: technique and results. J Vasc Interv Radiol. Sep 
2000;11(8):1009-1020. 
7. 
Gray BH, Sullivan TM, Childs MB, Young JR, Olin JW. High incidence of 
restenosis/reocclusion of stents in the percutaneous treatment of long-segment superficial 
femoral artery disease after suboptimal angioplasty. J Vasc Surg. Jan 1997;25(1):74-83. 
8. 
Minar E, Pokrajac B, Maca T, et al. Endovascular brachytherapy for prophylaxis of restenosis 
after femoropopliteal angioplasty : results of a prospective randomized study. Circulation. 
Nov 28 2000;102(22):2694-2699. 
9. 
Pokrajac B, Potter R, Wolfram RM, et al. Endovascular brachytherapy prevents restenosis 
after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study. 
Radiother Oncol. Jan 2005;74(1):3-9. 
10. 
Zdanowski Z, Albrechtsson U, Lundin A, et al. Percutaneous transluminal angioplasty with 
or without stenting for femoropopliteal occlusions? A randomized controlled study. Int 
Angiol. Dec 1999;18(4):251-255. 

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11. 
Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol 
stents in the superficial femoral artery. N Engl J Med. May 4 2006;354(18):1879-1888. 
12. 
van der Zaag ES, Legemate DA, Prins MH, Reekers JA, Jacobs MJ. Angioplasty or bypass 
for superficial femoral artery disease? A randomised controlled trial. Eur J Vasc Endovasc 
Surg. Aug 2004;28(2):132-137. 
13. 
Jahnke T, Voshage G, Muller-Hulsbeck S, Grimm J, Heller M, Brossmann J. Endovascular 
placement of self-expanding nitinol coil stents for the treatment of femoropopliteal 
obstructive disease. J Vasc Interv Radiol. Mar 2002;13(3):257-266. 
14. 
Morgan JH, 3rd, Wall CE, Jr., Christie DB, Harvey RL, Solis MM. The results of superficial 
femoral, popliteal, and tibial artery stenting for peripheral vascular occlusive disease. Am 
Surg. Nov 2005;71(11):905-909; discussion 909-910. 
15. 
Conrad MF, Cambria RP, Stone DH, et al. Intermediate results of percutaneous endovascular 
therapy of femoropopliteal occlusive disease: a contemporary series. J Vasc Surg. Oct 
2006;44(4):762-769. 
16. 
Bosiers M, Torsello G, Gissler HM, et al. Nitinol stent implantation in long superficial 
femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. Jun 
2009;16(3):261-269. 
17. 
Bosiers M, Deloose K, Callaert J, et al. Results of the Protege EverFlex 200-mm-long nitinol 
stent (ev3) in TASC C and D femoropopliteal lesions. J Vasc Surg. Oct 2011;54(4):1042-
1050. 
18. 
Ruef J, Hofmann M, Haase J. Initial clinical experience with the Protege EverFlex long self-
expanding nitinol stent in the superficial femoral artery. J Interv Cardiol. Dec 
2006;19(6):544-546. 
19. 
Rocha-Singh KJ. Proposed Performance Goals for Single-Arm Clinical Trials of Bare Nitinol 
Stents in the Femoral Popliteal Artery. Vascular InterVentional Advances. Las Vegas, 
NV2006. 
20. 
Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G. Performance goals and 
endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with 
symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. May 1 2007;69(6):910-
919. 
21. 
Katzen B. Long-Term RESILIENT Data for Nitinol Stenting in the SFA. Vascular 
Interventional Advances (VIVA). Las Vegas2011. 
 

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Appendix C: Declaration of Helsinki 
 
Accessed: February 9, 2009. 
http://www.wma.net/e/policy/b3.htm 
 
 
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI 
Ethical Principles for Medical Research Involving Human Subjects 
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 
29th WMA General Assembly, Tokyo, Japan, October 1975 
35th WMA General Assembly, Venice, Italy, October 1983 
41st WMA General Assembly, Hong Kong, September 1989 
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 
52nd WMA General Assembly, Edinburgh, Scotland, October 2000 
53th WMA General Assembly, Washington 2002 (Note of Clarification on paragraph 29 added) 
55th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added) 
59th WMA General Assembly, Seoul, October 2008 
 
A. INTRODUCTION 
1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a 
statement of ethical principles for medical research involving human subjects, including 
research on identifiable human material and data. The Declaration is intended to be read as a 
whole and each of its constituent paragraphs should not be applied without consideration of 
all other relevant paragraphs. 
2. Although the Declaration is addressed primarily to physicians, the WMA encourages other 
participants in medical research involving human subjects to adopt these principles. 
3. It is the duty of the physician to promote and safeguard the health of patients, including 
those who are involved in medical research. The physician's knowledge and conscience are 
dedicated to the fulfillment of this duty. 
4. The Declaration of Geneva of the WMA binds the physician with the words, “The health 
of my patient will be my first consideration,” and the International Code of Medical Ethics 
declares that, “A physician shall act in the patient's best interest when providing medical 
care.” 
5. Medical progress is based on research that ultimately must include studies involving 
human subjects. Populations that are underrepresented in medical research should be 
provided appropriate access to participation in research. 
6. In medical research involving human subjects, the well-being of the individual research 
subject must take precedence over all other interests. 
7. The primary purpose of medical research involving human subjects is to understand the 
causes, development and effects of diseases and improve preventive, diagnostic and 
therapeutic interventions (methods, procedures and treatments). Even the best current 

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interventions must be evaluated continually through research for their safety, effectiveness, 
efficiency, accessibility and quality. 
8. In medical practice and in medical research, most interventions involve risks and burdens. 
9. Medical research is subject to ethical standards that promote respect for all human subjects 
and protect their health and rights. Some research populations are particularly vulnerable and 
need special protection. These include those who cannot give or refuse consent for 
themselves and those who may be vulnerable to coercion or undue influence. 
10. Physicians should consider the ethical, legal and regulatory norms and standards for 
research involving human subjects in their own countries as well as applicable international 
norms and standards. No national or international ethical, legal or regulatory requirement 
should reduce or eliminate any of the protections for research subjects set forth in this 
Declaration. 
 
B. PRINCIPLES FOR ALL MEDICAL RESEARCH 
11. It is the duty of physicians who participate in medical research to protect the life, health, 
dignity, integrity, right to self-determination, privacy, and confidentiality of personal 
information of research subjects. 
12. Medical research involving human subjects must conform to generally accepted scientific 
principles, be based on a thorough knowledge of the scientific literature, other relevant 
sources of information, and adequate laboratory and, as appropriate, animal experimentation. 
The welfare of animals used for research must be respected. 
13. Appropriate caution must be exercised in the conduct of medical research that may harm 
the environment. 
14. The design and performance of each research study involving human subjects must be 
clearly described in a research protocol. The protocol should contain a statement of the 
ethical considerations involved and should indicate how the principles in this Declaration 
have been addressed. The protocol should include information regarding funding, sponsors, 
institutional affiliations, other potential conflicts of interest, incentives for subjects and 
provisions for treating and/or compensating subjects who are harmed as a consequence of 
participation in the research study. The protocol should describe arrangements for post-study 
access by study subjects to interventions identified as beneficial in the study or access to 
other appropriate care or benefits. 
15. The research protocol must be submitted for consideration, comment, guidance and 
approval to a research ethics committee before the study begins. This committee must be 
independent of the researcher, the sponsor and any other undue influence. It must take into 
consideration the laws and regulations of the country or countries in which the research is to 
be performed as well as applicable international norms and standards but these must not be 
allowed to reduce or eliminate any of the protections for research subjects set forth in this 

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Declaration. The committee must have the right to monitor ongoing studies. The researcher 
must provide monitoring information to the committee, especially information about any 
serious adverse events. No change to the protocol may be made without consideration and 
approval by the committee. 
16. Medical research involving human subjects must be conducted only by individuals with 
the appropriate scientific training and qualifications. Research on patients or healthy 
volunteers requires the supervision of a competent and appropriately qualified physician or 
other health care professional. The responsibility for the protection of research subjects must 
always rest with the physician or other health care professional and never the research 
subjects, even though they have given consent. 
17. Medical research involving a disadvantaged or vulnerable population or community is 
only justified if the research is responsive to the health needs and priorities of this population 
or community and if there is a reasonable likelihood that this population or community stands 
to benefit from the results of the research. 
18. Every medical research study involving human subjects must be preceded by careful 
assessment of predictable risks and burdens to the individuals and communities involved in 
the research in comparison with foreseeable benefits to them and to other individuals or 
communities affected by the condition under investigation. 
19. Every clinical trial must be registered in a publicly accessible database before recruitment 
of the first subject. 
20. Physicians may not participate in a research study involving human subjects unless they 
are confident that the risks involved have been adequately assessed and can be satisfactorily 
managed. Physicians must immediately stop a study when the risks are found to outweigh the 
potential benefits or when there is conclusive proof of positive and beneficial results. 
21. Medical research involving human subjects may only be conducted if the importance of 
the objective outweighs the inherent risks and burdens to the research subjects. 
22. Participation by competent individuals as subjects in medical research must be voluntary. 
Although it may be appropriate to consult family members or community leaders, no 
competent individual may be enrolled in a research study unless he or she freely agrees. 
23. Every precaution must be taken to protect the privacy of research subjects and the 
confidentiality of their personal information and to minimize the impact of the study on their 
physical, mental and social integrity. 
24. In medical research involving competent human subjects, each potential subject must be 
adequately informed of the aims, methods, sources of funding, any possible conflicts of 
interest, institutional affiliations of the researcher, the anticipated benefits and potential risks 
of the study and the discomfort it may entail, and any other relevant aspects of the study. The 
potential subject must be informed of the right to refuse to participate in the study or to 
withdraw consent to participate at any time without reprisal. Special attention should be 

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given to the specific information needs of individual potential subjects as well as to the 
methods used to deliver the information. After ensuring that the potential subject has 
understood the information, the physician or another appropriately qualified individual must 
then seek the potential subject’s freely-given informed consent, preferably in writing. If the 
consent cannot be expressed in writing, the non-written consent must be formally 
documented and witnessed. 
25. For medical research using identifiable human material or data, physicians must normally 
seek consent for the collection, analysis, storage and/or reuse. There may be situations where 
consent would be impossible or impractical to obtain for such research or would pose a threat 
to the validity of the research. In such situations the research may be done only after 
consideration and approval of a research ethics committee. 
26. When seeking informed consent for participation in a research study the physician should 
be particularly cautious if the potential subject is in a dependent relationship with the 
physician or may consent under duress. In such situations the informed consent should be 
sought by an appropriately qualified individual who is completely independent of this 
relationship. 
27. For a potential research subject who is incompetent, the physician must seek informed 
consent from the legally authorized representative. These individuals must not be included in 
a research study that has no likelihood of benefit for them unless it is intended to promote the 
health of the population represented by the potential subject, the research cannot instead be 
performed with competent persons, and the research entails only minimal risk and minimal 
burden. 
28. When a potential research subject who is deemed incompetent is able to give assent to 
decisions about participation in research, the physician must seek that assent in addition to 
the consent of the legally authorized representative. The potential subject’s dissent should be 
respected. 
29. Research involving subjects who are physically or mentally incapable of giving consent, 
for example, unconscious patients, may be done only if the physical or mental condition that 
prevents giving informed consent is a necessary characteristic of the research population. In 
such circumstances the physician should seek informed consent from the legally authorized 
representative. If no such representative is available and if the research cannot be delayed, 
the study may proceed without informed consent provided that the specific reasons for 
involving subjects with a condition that renders them unable to give informed consent have 
been stated in the research protocol and the study has been approved by a research ethics 
committee. Consent to remain in the research should be obtained as soon as possible from the 
subject or a legally authorized representative. 
30. Authors, editors and publishers all have ethical obligations with regard to the publication 
of the results of research. Authors have a duty to make publicly available the results of their 
research on human subjects and are accountable for the completeness and accuracy of their 
reports. They should adhere to accepted guidelines for ethical reporting. Negative and 
inconclusive as well as positive results should be published or otherwise made publicly 

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available. Sources of funding, institutional affiliations and conflicts of interest should be 
declared in the publication. Reports of research not in accordance with the principles of this 
Declaration should not be accepted for publication. 
 
C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH 
MEDICAL CARE 
31. The physician may combine medical research with medical care only to the extent that 
the research is justified by its potential preventive, diagnostic or therapeutic value and if the 
physician has good reason to believe that participation in the research study will not 
adversely affect the health of the patients who serve as research subjects. 
32. The benefits, risks, burdens and effectiveness of a new intervention must be tested 
against those of the best current proven intervention, except in the following circumstances: 
• The use of placebo, or no treatment, is acceptable in studies where no current 
proven intervention exists; or 
• Where for compelling and scientifically sound methodological reasons the use of 
placebo is necessary to determine the efficacy or safety of an intervention and the 
patients who receive placebo or no treatment will not be subject to any risk of serious 
or irreversible harm. Extreme care must be taken to avoid abuse of this option. 
33. At the conclusion of the study, patients entered into the study are entitled to be informed 
about the outcome of the study and to share any benefits that result from it, for example, 
access to interventions identified as beneficial in the study or to other appropriate care or 
benefits. 
34. The physician must fully inform the patient which aspects of the care are related to the 
research. The refusal of a patient to participate in a study or the patient’s decision to 
withdraw from the study must never interfere with the patient-physician relationship. 
35. In the treatment of a patient, where proven interventions do not exist or have been 
ineffective, the physician, after seeking expert advice, with informed consent from the patient 
or a legally authorized representative, may use an unproven intervention if in the physician's 
judgment it offers hope of saving life, re-establishing health or alleviating suffering. Where 
possible, this intervention should be made the object of research, designed to evaluate its 
safety and efficacy. In all cases, new information should be recorded and, where appropriate, 
made publicly available. 
 
 

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Appendix D: Protocol Revisions  
 
Revision 
Level  
Change 
Order 
Description of Changes 
1.0  
 
Initial Release 
2.0 
 
Changes made to reduce number of subjects, revise 
inclusion/exclusion criteria, and change study sponsor to Covidien 
from ev3.  
3.0 
 
Updated number of subjects to 108 enrolled subjects in the protocol 
synopsis, Section 1.0 Introduction, and Section 5.0 Statistical 
Method .  Appendix A has also been updated to reflect new 
Medtronic Contact Information.  
3.1 
 
Protocol revision: 
• Protocol version updated to version 3.1 
• Protocol version date updated to 17November2016 
• Updated Table 9, Approximation to Possible Outcomes and 
Corresponding 97.5% Lower Confidence Bound. 
• Formatting to remove blank tables. 
• Added table header (table 10) to Sample Size Freedom from Stent 
Fracture table, and updated all table numbers.