Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
Phase: NA
Conditions: Peripheral Artery Disease, Vascular Disease
Sponsor: W.L.Gore & Associates

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Nothing herein is to be disclosed in any way without the prior express 
permission of W. L. Gore & Associates, Inc. 
 
 
Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of 
In-Stent Restenosis in the Superficial Femoral Artery 
 
 
 
Protocol Number:   ISR 14-04 
 
 
Protocol Date: December 10, 2015 (Revision 2) 
April 10, 2015 (Original, Revision 1) 
 
NCT Number: NCT02542267 
 
 
 
 
 
 
 
W. L. Gore and Associates, Inc. 
Medical Products Division 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Nothing herein is to be disclosed in any way without the prior 
express written permission of W. L. Gore & Associates, Inc. 
 
 
 
 
Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of 
In-Stent Restenosis in the Superficial Femoral Artery 
 
Protocol Number:   ISR 14-04 
 
 
 
 
 
Amendment 1 (Rev. 2) 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SUMMARY 
Study Title 
Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for 
Treatment of In-Stent Restenosis in the Superficial Femoral Artery 
Protocol Number 
ISR 14-04 
IDE or PMA Number  
Post approval w/PMA# P040037 S060 
Sponsor 
W. L. Gore & Associates, Inc.  
Medical Products Division 
3250 W. Kiltie Lane 
Telephone: 800-437-8181 
Study Device 
The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive 
Surface (US); GORE® VIABAHN® Endoprosthesis with 
PROPATENTM Bioactive Surface (EU); and subsequently referred 
to as GORE® VIABAHN® Endoprosthesis throughout this protocol. 
Study Design 
Prospective, multicenter, single-arm study 
Study Objective 
The objective is to evaluate post-market safety and effectiveness 
of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent 
Restenosis of the SFA 
Primary Endpoints 
Effectiveness Endpoint: Primary Patency at 12 months by Kaplan-
Meier analysis 
 
Safety Endpoint: Device- and procedure-related Serious Adverse 
Events within 30 days of the procedure 
Secondary Endpoint(s) 
 
Acute Procedural Success 
 
Primary Patency at 30 days, 12, 24, & 36 months 
 
Primary Assisted Patency at 30 days, 12, 24, & 36 months  
 
Secondary Patency at 30 days, 12, 24, & 36 months 
 
Freedom from TLR at 30 days, 12, 24, & 36 months 
 
Freedom from Major Amputation at 30 days, 12, 24, & 36 
months 
 
Change in Ankle-Brachial Index from pre-procedure at 30 
days, 12, 24, & 36 months 
 
Change in Rutherford Category from pre-procedure at 30 
days, 12, 24, & 36 months 
 
Stent Fracture Assessment at 12, 24, & 36 months 
Subject Population 
The Subject population will include symptomatic PAD patients 
(Rutherford 2-5) with occlusive lesion(s) within and adjacent to 
previously implanted non-covered stent(s) located in the 
superficial femoral artery   
Number of Subjects 
108 (minimum 81 (75%) of Subjects in the US) 
A minimum of 20 Subjects will be enrolled with a lesion length of 
230-270 mm.  
Number of Sites 
A minimum of 15 Sites in the U.S.   
Up to 5 OUS Sites may be included. 
Expected Time to 
Complete Enrollment  
24 months   

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Schedule of Events 
Screening:  Informed Consent, Medical History, Demographics 
Treatment:  Angiographic confirmation of final eligibility, 
Deployment of study device, Post-procedural angiography, 
Adverse Events 
Follow-up Schedule:  30 days, 12, 24 and 36 months 
Follow-up Assessments:  Adverse events, ABI, Rutherford, X-
ray (12, 24, 36 months), Duplex ultrasound 
Expected Study 
Timeline 
 
Study Initiation: SEP 2015 
Number of sites with IRB approvals/month: 2 
Number of subjects enrolled/month: 0.5/site 
Enrollment Completion: SEP 2017 
Study Follow-Up Completion: SEP 2020 
Final Report Submission: Submitted within 3 months of 
completion of the last patient follow-up 
 
 
 

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LIST OF ABBREVIATIONS 
ABI 
Ankle-Brachial Index 
AE 
Adverse Event 
CAD 
Coronary Artery Disease 
CBC 
Complete Blood Count 
CDMS 
Clinical Data Management System 
CE 
CEC 
Conformité Européenne 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
cm 
Centimeters 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
ePTFE 
Expanded Polytetrafluoroethylene 
EU 
European Union 
FDA 
Food and Drug Administration (United States) 
Fr 
French (sizing) 
GCP 
Good Clinical Practice 
HCG 
Human Chorionic Gonadotropin 
HIT 
Heparin-Induced Thrombocytopenia 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
IRB 
ISR 
Institutional Review Board (U.S.) 
In-stent Restenosis 
mm 
OUS 
Millimeters 
Outside the United States 
PAD 
Peripheral Artery Disease 
PI 
Principal Investigator 
PMA 
Premarket Approval 
PSV 
Peak Systolic Velocity 
PSVR 
Peak Systolic Velocity Ratio 
PTA 
Percutaneous Transluminal Angioplasty  
SAE 
Serious Adverse Event 
SFA 
Superficial Femoral Artery 
TBI 
Toe-brachial Index 
TLR 
Target Lesion Revascularization 
TVR 
Target Vessel Revascularization 
U.S. 
United States 
 

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PROTOCOL SUMMARY ............................................................................................................................. iii 
1. Introduction ........................................................................................................................................... 1 
1.1. 
Disease ...................................................................................................................................... 1 
1.2. 
Historical Treatments ................................................................................................................. 1 
1.3. 
Study Device Description .......................................................................................................... 2 
1.4. 
Clinical Data............................................................................................................................... 4 
2. Study Objectives................................................................................................................................... 5 
2.1. 
Primary Objective(s) .................................................................................................................. 5 
3. Study Design ......................................................................................................................................... 6 
3.1. 
Description of Study Design ...................................................................................................... 6 
3.2. 
Study Endpoint(s) ...................................................................................................................... 6 
3.2.1. 
Definitions ................................................................................................................... 6 
3.2.2. 
Primary Endpoints ...................................................................................................... 7 
3.2.3. 
Secondary Endpoints ................................................................................................. 7 
4. Study Population .................................................................................................................................. 8 
4.1. 
Description of Population ........................................................................................................... 8 
4.2. 
Inclusion Criteria ........................................................................................................................ 8 
4.3. 
Exclusion Criteria ....................................................................................................................... 9 
5. Study Procedures/Evaluations .......................................................................................................... 10 
5.1. 
Schedule of Events .................................................................................................................. 10 
5.2. 
Informed Consent Process ...................................................................................................... 10 
5.3. 
Pre-Screening/Screening ........................................................................................................ 11 
5.4. 
Enrollment ................................................................................................................................ 11 
5.5. 
Procedure ................................................................................................................................ 11 
5.6. 
Repeat Interventions ............................................................................................................... 13 
5.7. 
Follow-Up ................................................................................................................................. 13 
5.8. 
Subject Withdrawal from the Study ......................................................................................... 14 
5.9. 
Subject Retention Strategy and Loss to Follow-Up ................................................................. 15 
5.10. 
Subject Study Completion ....................................................................................................... 15 
5.11. 
Device Deficiencies ................................................................................................................. 15 
5.12. 
Explant Procedures ................................................................................................................. 15 
6. Study Administration ......................................................................................................................... 15 
6.1. 
Training .................................................................................................................................... 15 
6.2. 
Monitoring ................................................................................................................................ 16 
6.3. 
Device Accountability and Storage .......................................................................................... 16 
6.4. 
Core Lab .................................................................................................................................. 16 
6.5. 
Protocol Deviations .................................................................................................................. 16 
6.6. 
Protocol Amendments ............................................................................................................. 17 
6.7. 
Sponsor Representatives ........................................................................................................ 17 
6.8. 
Access to Source Data/Documents ......................................................................................... 17 
6.9. 
Study Records Retention ......................................................................................................... 17 
6.10. 
Publication Plan ....................................................................................................................... 18 
7. Data Collection and Submission ....................................................................................................... 18 
7.1. 
Data Collection Methods ......................................................................................................... 18 
7.2. 
Data Clarification and Correction............................................................................................. 19 
7.3. 
CRF Completion Schedule ...................................................................................................... 19 

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8. Risk Assessment ................................................................................................................................ 19 
8.1. 
Potential Risks ......................................................................................................................... 19 
8.2. 
Minimization of Risks ............................................................................................................... 20 
8.3. 
Summary of Expected Benefits ............................................................................................... 20 
9. Adverse Events and Safety Monitoring ............................................................................................ 20 
9.1. 
Anticipated Adverse Events ..................................................................................................... 20 
9.1.1. 
Adverse Event Relationship ..................................................................................... 21 
9.1.2. 
Adverse Event Classification .................................................................................... 21 
9.1.3. 
Adverse Event Reporting and Coding ...................................................................... 22 
9.1.4. 
Subject Death ........................................................................................................... 22 
9.2. 
Clinical Events Committee ....................................................................................................... 23 
10. Statistical Analysis ............................................................................................................................. 23 
10.1. 
Primary Endpoint Analysis ....................................................................................................... 23 
10.1.1. 
Primary Effectiveness ............................................................................................... 23 
10.1.2. 
Primary Safety .......................................................................................................... 23 
10.2. 
Secondary Endpoint Analysis .................................................................................................. 23 
10.2.1. 
Acute Procedural Success ....................................................................................... 23 
10.2.2. 
Primary Patency ....................................................................................................... 24 
10.2.3. 
Primary Assisted Patency ........................................................................................ 24 
10.2.4. 
Secondary Patency .................................................................................................. 24 
10.2.5. 
Freedom from Target Lesion Revascularization (TLR) ............................................ 24 
10.2.6. 
Freedom from Major Amputation ............................................................................. 24 
10.2.7. 
Change in Ankle-Brachial Index (ABI) ...................................................................... 24 
10.2.8. 
Change in Rutherford Category ............................................................................... 24 
10.2.9. 
Stent Fracture ........................................................................................................... 25 
10.3. 
Additional Analysis .................................................................................................................. 25 
10.4. 
Sample Size............................................................................................................................. 25 
10.5. 
Blinding Scheme ...................................................................................................................... 25 
10.6. 
Data Analysis ........................................................................................................................... 25 
10.6.1. 
Timing of Analyses ................................................................................................... 25 
10.6.2. 
Analysis Populations ................................................................................................ 25 
10.6.3. 
Pooling of Data ......................................................................................................... 25 
11. Ethical and Regulatory Considerations ........................................................................................... 26 
11.1. 
Statement of Compliance ........................................................................................................ 26 
11.2. 
Compliance Responsibilities.................................................................................................... 26 
11.3. 
Informed Consent .................................................................................................................... 26 
11.4. 
Independent Ethical Review .................................................................................................... 27 
11.5. 
Conflict of Interest .................................................................................................................... 27 
11.6. 
Confidentiality .......................................................................................................................... 27 
11.7. 
Study Discontinuation or Suspension ...................................................................................... 27 
12. References .......................................................................................................................................... 28 
  
 

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1. 
Introduction  
1.1. Disease 
Patients with lifestyle-limiting claudication from atherosclerotic stenosis and occlusion 
of the Superficial Femoral Artery (SFA) exhibit a decreased quality of life, e.g. pain or 
cramping in the legs or buttocks upon exertion1.  Vascular surgeons have traditionally 
managed claudication conservatively, given the morbidity and mortality associated 
with surgical bypass procedures2.  If indicated, interventional techniques and devices 
provide clinicians with a less invasive alternative to surgery for the treatment of 
claudication and limb ischemia3. 
 
Plain Old Balloon Angioplasty (POBA) of the SFA in longer lesion lengths (>10cm) 
has yielded reported primary patency rates of 22%4.  Bare metal stents (BMS) have 
demonstrated better primary patency rates when compared to POBA alone5.  Still, 
one-year restenosis rates remain high and continue to plague both therapies (PTA 
64% vs BMS 37%) 6. 
 
Similar to coronary stenting, the leading cause of in-stent restenosis (ISR) has been 
identified as neointimal formation.  Implant-induced hyperplasia, endothelial 
denudation, thrombus reorganization and negative arterial remodeling are factors that 
contribute to ISR.  Characteristics of the originally treated lesion have been shown to 
predict future occurrence of ISR.  Long, diffuse stenotic or occluded lesions treated 
with BMS commonly become restenotic7, 8, 9. 
 
1.2. Historical Treatments  
The following treatment modalities have been used globally to treat in-stent 
restenosis of the superficial femoral artery: 
 
Conventional percutaneous transluminal angioplasty 
 
Cutting balloon 
 
Cryoplasty 
 
Atherectomy 
 
Re-stenting 
 
Drug covered balloons 
 
Drug-eluting stents 
 
The GORE® VIABAHN® Endoprosthesis has been utilized as a treatment option for 
SFA ISR.  The flexibility of the VIABAHN® Endoprosthesis, as exemplified by its low 
rate of fracture in long lesion lengths, allows it to withstand the mechanical forces of 
the SFA10.  Additionally, the ePTFE can provide a physical barrier between the 
arterial lumen and in-growth from neointimal formation. Since this has been 
hypothesized to be the failure mechanism of the original stent, it would stand to 
reason that blocking further neointimal ingrowth via an ePTFE covering would provide 
a promising treatment strategy. 
 
 
 
 
 

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1.3. Study Device Description  
The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (marketed as 
GORE® VIABAHN® Endoprosthesis with PROPATENTM Bioactive Surface in the EU) 
is a flexible, self-expanding endoluminal endoprosthesis consisting of two 
components:  1) a tubular section of ePTFE which has been modified with Heparin 
Bioactive Surface and 2) an external supporting structure, constructed from nitinol, 
extending along its entire length.  Refer to Figure A. 
 
Figure A:  The GORE® VIABAHN® Endoprosthesis 
 
The endoprosthesis is compressed and attached to a dual lumen delivery catheter.  
The larger central catheter lumen is utilized for flushing and introduction of a 
guidewire.  The smaller lumen contains elements of the deployment mechanism.  The 
delivery catheter hub assembly has one port for the deployment system and one port 
for flushing and guidewire insertion.  To facilitate accurate endoprosthesis placement, 
two radiopaque markers are attached to the catheter shaft marking the ends of the 
compressed endoprosthesis.  Refer to Figure B. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure B:  Delivery System for the GORE® VIABAHN® Endoprosthesis 
 
The luminal surface of the GORE® VIABAHN® Endoprosthesis is heparinized based 
upon the Carmeda BioActive Surface (CBAS) technology.  The USP porcine heparin 
used in creating the device has been derivatized by a proprietary process established 
by Carmeda AB, Stockholm, Sweden.  The derivatized heparin contains a single-
point aldehyde moiety for covalent attachment to a base surface.  The base surface 
consists of polyethyleneimine and dextran sulfate on the luminal surface of the 
ePTFE graft.  Heparin activity is retained in the binding process due to a single-point 
attachment through the aldehyde group that does not interfere with the heparin active 
site. 

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Table 1:  GORE® VIABAHN® Endoprosthesis Configurations and Vessel Sizing 
Guidelines 
Device Sizing 
Introducer 
Sheath Size (Fr) 
 
Guidewire 
Diameter 
0.035" (0.889 
mm) 
Introducer 
Sheath Size (Fr) 
 
Guidewire 
Diameter 
0.018" (0.460 
mm) 
Available 
Device Lengths1 
(cm) 
Recommended 
Balloon Diameter 
for Device Touch-
up (mm) 
Labeled 
Device 
Diameter 
(mm) 
Recommended 
Vessel Diameter 
(mm) 
5 
4.0 – 4.7 
7 
6 
2.5, 5, 10, 15, 25 
5.0 
6 
4.8 – 5.5 
7 
6 
2.5, 5, 10, 15, 25 
6.0 
7 
5.6 – 6.5 
8 
7 
2.5, 5, 10, 15, 25 
7.0 
1Labeled device lengths are nominal. 
 
The U.S. regulatory history for the GORE® VIABAHN® Endoprosthesis is as follows:   
 
The original PMA P040037, GORE® VIABAHN® Endoprosthesis, was approved 
on June 14, 2005 for improving blood flow in patients with symptomatic 
peripheral arterial disease in superficial femoral artery lesions with reference 
vessel diameters ranging from 4.8 to 7.5 mm. 
 
PMA supplement P040037/S003 was approved on April 24, 2007 to add 5mm 
diameter device configurations and to make associated modifications to the 
indications to add reference vessel diameters from 4.0 – 4.7mm. 
 
PMA supplement P040037/S004 (GORE® VIABAHN® Endoprosthesis with 
Heparin Bioactive Surface) was approved on July 31, 2007 to add device 
configurations containing a Heparin Bioactive Surface. 
 
PMA supplement P040037/S007 was approved on August 14, 2008 for the 
addition of an indication for treatment of iliac artery lesions.   
 
PMA supplement P040037/S050 was approved on October 18, 2013 for the 
addition of a 25cm length for the 5-8mm diameter endoprostheses and where the 
indication statement was modified to specify lesion lengths.   
 
PMA P130006 was approved on December 5, 2013 for the addition of an 
indication to treat stenosis or thrombotic occlusion in AV access grafts.  
 
PMA supplement P040037/S060 was approved on September 19, 2014 for an 
addition of the indication to treat SFA in-stent restenosis.  
 
 
 
 
 
 

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Currently, the GORE® VIABAHN® Endoprosthesis is approved for the following 
indications in the US:  
 
The GORE® VIABAHN® Endoprosthesis is indicated for improving blood flow in 
patients with symptomatic peripheral arterial disease in superficial femoral artery 
de novo and restenotic lesions up to 270 mm in length with reference vessel 
diameters ranging from 4.0 – 7.5 mm. 
 
The GORE® VIABAHN® Endoprosthesis is indicated for improving blood flow in 
patients with symptomatic peripheral arterial disease in superficial femoral artery 
in-stent restenotic lesions up to 270 mm in length with reference vessel 
diameters ranging from 4.0 – 6.5 mm. 
 
The GORE® VIABAHN® Endoprosthesis is indicated for improving blood flow in 
patients with symptomatic peripheral arterial disease in iliac artery lesions up to 
80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. 
 
The GORE® VIABAHN® Endoprosthesis is also indicated for the treatment of 
stenosis or thrombotic occlusion at the venous anastomosis of synthetic 
arteriovenous (AV) access grafts. 
 
Regulatory History and Indications - International Markets  
The GORE® VIABAHN® Endoprosthesis and the GORE® VIABAHN® 
Endoprosthesis with PROPATEN Bioactive Surface are intended to be used for 
endovascular grafting of peripheral arteries. The non-heparin configuration of the 
device, the GORE® VIABAHN® Endoprosthesis (0.035" guidewire catheter), has 
been a CE-marked device since June 2000.  The device configuration with a 
heparin bioactive surface, the GORE® VIABAHN® Endoprosthesis with 
PROPATEN Bioactive Surface  (0.035" guidewire catheter), has been a CE-
marked device since December 2008.  An additional configuration of the GORE® 
VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface that uses a 
0.018" guidewire catheter has been a CE-marked device since October 2010. 
 
1.4. Clinical Data   
The Study Device has been utilized as a treatment option for SFA ISR, as evidenced 
by the number of studies reporting on the device usage in Table 2. 
 
 
 

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Table 2:  Clinical Data for ISR treatment with the GORE® VIABAHN® 
Endoprosthesis 
 
RELINE was a physician-initiated study conducted at 7 EU investigative Sites to demonstrate 
the safety and effectiveness of Study Device for the treatment of in-stent restenosis in the 
superficial femoral artery.  This was the first randomized trial performed to compare treatment 
modalities for in-stent restenosis of the SFA.  One hundred Subjects were randomized to 
treatment with the Study Device or conventional PTA. Results showed a highly significant 
benefit of the Study Device in the treatment of in-stent restenosis in both the primary endpoint of 
primary patency (72.5% vs. 24.2%, p<0.001) and the secondary endpoint of freedom from 
target lesion revascularization (81.2% vs. 40.6%, p<0.001). No increase in adverse events was 
seen in evaluation of the primary safety endpoint, indicating that the Study Device is a safe 
treatment when compared with conventional PTA. 
 
Based on results from the RELINE trial, the Study Device received PMA approval on 19 
September 2014 for the treatment of in-stent restenosis of the SFA in lesions up to 270mm in 
length and with reference vessel diameters of 4.0 - 6.5mm. 
      
2. 
Study Objectives  
2.1. Primary Objective(s) 
The primary objective of ISR 14-04 is to evaluate the post-market performance of 
GORE® VIABAHN® Endoprosthesis for the treatment of in-stent restenosis of the 
superficial femoral artery in a primarily U.S. population (at least 75% of patients being 
treated in the U.S.). 
 
 
 
 
Author/Study 
Year 
Study Design 
Treatment 
Limbs 
(VIABAHN 
arm)  
Follow Up 
(months) 
Primary 
Patency (%) 
TLR 
(%) 
Laird et al11 
2012 
Prospective, registry 
Laser w/Adjunctive 
PTA and VIABAHN® 
27 
12 
48 
17.4 
Kazemi12 
2006 
Prospective, single-
center 
VIABAHN® 
20 
12 
65 
NR 
Ansel13 
2007 
Prospective, single-
center 
VIABAHN® 
27 
18 
52 
NR 
 
Al Shammeri 
et al14 
2010 
Retrospective, single-
center 
VIABAHN® 
28 
12 
85 
NR 
 
Monahan et 
al15 
2011 
Retrospective, single-
center 
VIABAHN® 
24 
12 
62 
NR 
RELINE Study 
2013 
Prospective, multi-
center, randomized 
VIABAHN® VS PTA   
47 
12 
72.5 
18.8 

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3. 
Study Design 
3.1. Description of Study Design 
This study is a prospective, multicenter, non-randomized single-arm study to evaluate 
the post-market performance of the GORE® VIABAHN® Endoprosthesis for the 
treatment of in-stent restenosis in the superficial femoral artery.  
 
A minimum of 15 Clinical Investigative Sites (referred to as “Sites” in the remainder of 
this document) in the U.S. and a maximum of 5 OUS Sites will participate in this 
study.   
 
A total of 108 Subjects (a minimum of 81 Subjects from the U.S. and a maximum of 
27 OUS Subjects) will be enrolled in this study with a limit of 30 Subjects per U.S. 
Site.   
 
A minimum of 20 Subjects (out of the total 108 Subjects) will be enrolled with lesion 
lengths of 230-270mm.  The study will be actively monitored to ensure the minimum 
enrollment threshold for this long lesion length cohort is met.  
 
The anticipated accrual period is 24 months assuming an accrual rate is 
approximately 0.5 Subjects per month/Site.   
 
Patients are to be enrolled into the study provided all inclusion and no exclusion 
criteria are met as specified in Section 4. Subjects will be evaluated through hospital 
discharge and will be scheduled for follow-up visits at 30 days and at 12, 24 and 36 
months post treatment.  Accounting for the expected period of enrollment, the total 
estimated duration of the study is 60 months. 
 
3.2. Study Endpoint(s) 
3.2.1. 
Definitions 
Ankle Brachial Index:  the ankle systolic pressure in the study limb divided by 
the highest brachial systolic pressure in either arm 
 
Acute Procedural Success:  successful delivery of study device and 
complete coverage of the target lesion without a procedure or device-related 
Serious Adverse Event prior to hospital discharge  
 
Major Amputation:  removal of the lower limb above the metatarsals in the 
study limb, resulting from a vascular event 
 
Patency: blood flow through the study device 
 
Primary Patency:  patent blood flow through the study device, which requires 
either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, 
and without repeat intervention  
 
Primary Assisted Patency: blood flow through the study device regardless of 
repeat interventions to maintain patency prior to occlusion   
 

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Secondary Patency:  blood flow through the study device regardless of 
repeat interventions to maintain or restore patency after occlusion 
 
Target Lesion(s):  stenotic or occluded segment(s) within and adjacent to a 
previously implanted non-covered stent(s) (>30 days) in the superficial 
femoral artery. An adjacent lesion is an extension of the stenotic or occluded 
segment that is contiguous with that lesion within the previously implanted 
non-covered stent  
 
Target Lesion Revascularization (TLR):  repeat intervention within the study 
device and 5 mm proximal or distal to the edge of the study device to 
maintain or re-establish patency  
 
Toe Brachial Index:  the toe systolic pressure in the study limb divided by the 
highest brachial systolic pressure in either arm   
 
Stent Integrity:  freedom from study device stent fracture which is clearly 
distinguishable on imaging from the previously implanted non-covered stent  
 
3.2.2. 
Primary Endpoints  
The primary effectiveness endpoint is Primary Patency at 12 months post-
procedure.  This will be estimated through 365 days along with a 95% 
confidence interval using Kaplan-Meier analysis.      
 
The primary safety endpoint is procedure or device-related Serious Adverse 
Events within 30 days of the index procedure. The total number of events as 
well as the number of Subjects experiencing them will be tabulated along 
with a 95% confidence interval.  
  
3.2.3. 
Secondary Endpoints  
The secondary endpoints for this study include: 
 
Acute Procedural Success 
 
Primary Patency at 30 days, 12, 24 and 36 months 
 
Primary Assisted at 30 days, 12, 24 and 36 months 
 
Secondary Patency at 30 days, 12, 24 and 36 months 
 
Freedom from Target Lesion Revascularization at 30 days, 12, 24 
and 36 months 
 
Freedom from Major Amputation at 30 days, 12, 24 and 36 months 
 
Change in Ankle-Brachial Index from pre-procedure at 30 days, 12, 
24 and 36 months 
 
Change in Rutherford Category from pre-procedure at 30 days, 12, 
24 and 36 months 
 
Stent Fracture Assessment at 12, 24 and 36 months 
 
 
 
 

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4. 
Study Population  
4.1. Description of Population 
Patients presenting with ≥ 50% in-stent restenosis and/or an occlusion in a previously 
implanted non-covered stent(s) located in the superficial femoral artery are eligible for 
participation in the study.  The previously implanted non-covered stent(s) must have 
been implanted greater than 30 days prior to the index procedure.  Eligible patients 
must present with life-limiting claudication, resting leg pain or minor tissue loss 
(Rutherford Category 2-5).  Patients must be candidates for endovascular treatment.   
 
Patients presenting with the following lesion characteristics are eligible for enrollment: 
 
Total lesion length of up to 270 mm, consisting of in-stent and adjacent 
occlusive disease 
 
Reference vessel diameter between approximately 4.0 and 6.5 mm 
 
The study has been designed with standard eligibility criteria to address any known or 
foreseeable factors that may compromise the outcome of the study or the 
interpretation of results.  Only patients who meet all of the Inclusion Criteria and none 
of the Exclusion Criteria will be enrolled. 
 
4.2. Inclusion Criteria  
Potential Subjects must meet all of the following Clinical Inclusion Criteria: 
1. Patient is ≥ 18 years old at the time of informed consent signature 
2. Patient is willing to give written informed consent  
3. Patient has a previously implanted (>30 days) non-covered stent(s) located in the 
superficial femoral artery 
4. Patient has life-style limiting claudication, resting leg pain or minor tissue loss 
(Rutherford Category 2-5) 
5. Patient demonstrates an ABI ≤ 0.9.  If ABI > 0.9 or not measureable, patient is 
eligible for study if toe-brachial index (TBI) is ≤ 0.5 
6. Patient is male, infertile female or female of childbearing potential with a negative 
beta hCG pregnancy test within 7 days of the index procedure 
7. Patient is capable of complying with protocol requirements, including follow-up 
visits 
 
Potential Subjects must meet all of the following Angiographic Inclusion Criteria: 
1. Patient has ≥ 50% in-stent restenosis and/or an occlusion in a previously 
implanted (>30 days) non-covered stent(s) located in the superficial femoral 
artery defined as beginning at least 1 cm below the origin of the profunda femoris 
artery and ending at least 1 cm above the intercondylar notch 
2. Patient has a maximum total lesion length of 270 mm, consisting of in-stent and 
adjacent occlusive disease 
3. Patient has a minimum of 1 cm of non-stenosed vessel both proximal and distal 
to the target lesion(s) 
4. Patient has a reference vessel diameter between 4.0 and 6.5 mm 
5. The guidewire and delivery system must cross the target lesion(s) intraluminally 
6. Patient has a patent popliteal artery (<50% stenosis) distal to the target vessel 
7. Patient has at least 1 patent infrapopliteal runoff vessel (<50% stenosis) not 
requiring intervention  

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8. Angioplasty balloon can be fully expanded in the target lesion during pre-
treatment step 
 
4.3. Exclusion Criteria 
Potential Subjects will not be eligible for study participation if they meet any of the 
following Clinical Exclusion Criteria: 
1. Patient has a known allergy to stent graft components (nickel-titanium or ePTFE) 
2. Patient has known allergy to contrast media that cannot be adequately pre-
medicated prior to the study procedure 
3. Patient with known hypersensitivity to heparin, including those patients who have 
had a previous incidence of heparin-induced thrombocytopenia (HIT) type II 
4. Patient has a known intolerance to anticoagulation or antiplatelet therapy 
5. Patient has an uncorrected bleeding disorder (platelet count <80,000/µL) 
6. Patient has any known coagulation disorder, including hypercoagulability 
7. Patient has severe chronic renal insufficiency (creatinine level ≥ 2.5mg/dL) within 
30 days prior to study procedure unless currently on hemodialysis 
8. Patient has septicemia or uncontrolled infection 
9. Patient has any planned surgical intervention/procedure within 30 days of the 
study procedure 
10. Patient has major distal amputation (above the transmetatarsals) in the study or 
non-study limb 
11. Patient has prior ipsilateral femoral artery bypass 
12. Patient has severe medical comorbidities (untreated CAD/CHF, severe COPD, 
metastatic malignancy, dementia, etc.) or other medical condition that would 
preclude compliance with the study protocol or 3-year life expectancy 
13. Patient has severe ipsilateral common or deep femoral disease requiring 
intervention 
14. Patient has any previous surgery in the target vessel 
15. Patient has had vascular access via the lower extremities within 30 days of the 
index procedure  
16. Patient has had previous target vessel in-stent restenosis treated by relining with 
another stent 
17. Patient is currently participating in another clinical research trial, unless approved 
by Sponsor 
 
Potential Subjects will not be eligible for study participation if they meet any of the 
following Angiographic Exclusion Criteria: 
1. Patient has untreated flow-limiting aortoiliac stenotic disease 
2. Patient has an aneurysm adjacent to the target lesion(s) 
3. Patient has perioperative unsuccessful ipsilateral percutaneous vascular 
procedure to treat inflow prior to enrollment during the index study procedure 
4. Patient has femoral or popliteal aneurysm located in the target vessel 
5. Patient has non-atherosclerotic disease resulting in occlusion (e.g. embolism, 
Buerger’s disease, vasculitis) 
6. Patient has angiographic evidence of intra-arterial thrombus or atheroembolism 
from inflow treatment 
7. Patient has target lesion access not performed by transfemoral approach  
 

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5. 
Study Procedures/Evaluations  
Any Site staff performing study-specific duties must be qualified by training and experience 
and must also be appropriately trained on the study protocol and procedures.  Delegation of 
study-specific duties at each Site must be acknowledged by the Site’s Principal Investigator 
and documented on the Delegation of Authority Log.  
 
5.1. Schedule of Events 
Table 3:  Schedule of Events 
 
Pre-
Procedure1 
Procedure 
 
Discharge 
 
Follow-Up Visit 
30 Days 
12, 24 & 
36 
Months 
Unscheduled 
Informed Consent 
X 
 
 
 
 
 
Medical History and 
Demographics 
X 
 
 
 
 
 
Height and Weight 
X 
 
 
 
 
 
CBC 
X 
 
 
 
 
 
Creatinine, serum 
X 
 
 
 
 
 
beta-hCG test, if 
indicated 
X within 7 
days of 
study 
procedure  
 
 
 
 
 
ABI/TBI, resting2 
X 
 
X 
X 
X 
X 
Rutherford 
Classification 
X 
 
 
X 
X 
X 
Anti-Platelet/Anti-
Coagulation Therapy 
Assessment 
X 
 
X 
X 
X 
X 
Clinical 
Inclusion/Exclusion 
X 
 
 
 
 
 
Angiography 
 
X 
 
If 
indicated 
If 
indicated 
If indicated 
Angiographic 
Inclusion/Exclusion  
 
X 
 
 
 
 
Adverse Events 
 
X 
X 
X 
X 
X 
X-Ray3  
 
X4  
 
 
X 
 
Duplex Ultrasound 3 
 
 
 
X 
X 
If indicated 
1 Pre-procedure assessments required within 30 days of study procedure unless noted 
2 If TBI used to qualify patient for study participation, TBI must be collected throughout duration of all study follow-up 
intervals. 
3 Imaging sent to Core Lab for Assessment 
4 Required imaging: X-ray image of non-covered stent(s) prior to deployment of Study Device AND X-ray image of 
Study Device post-deployment 
 
5.2. Informed Consent Process 
All patients must provide informed consent prior to any study related procedures 
being performed.  The case history (i.e., source documents/Subject chart) for each 
Subject shall document that such informed consent was obtained.  The current 
IRB/EC approved consent form will be signed and personally dated by the Subject, 
and the person who conducted the informed consent discussion.  The original signed 
informed consent form will be retained in the Subject records.  A copy of the informed 
consent document will be given to the Subject for their records.    
 
 
 
 
 
 

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5.3. Pre-Screening/Screening 
Patients who appear to meet clinical eligibility criteria via initial screening and review 
of existing medical records will be scheduled for a clinical evaluation.  The informed 
consent must be signed prior to any study-related activity or procedure.  All patients 
who sign an ICF will be considered entered into the screening phase of the study and 
should be recorded on the Screening and Enrollment Log.   
 
The clinical evaluation must be performed within 30 days prior to the study procedure, 
unless noted, and will include: 
 
Informed consent 
 
Medical history and demographics 
 
Height and weight 
 
CBC 
 
Creatinine, serum 
 
b (beta)-hCG pregnancy testing within 7 days of the study procedure, if indicated 
 
ABI/TBI, resting (Note: If TBI is used to qualify patient for study participation, TBI 
must be collected throughout duration of all study follow-up intervals) 
 
Rutherford Classification 
 
Anti-platelet/anti-coagulation therapy assessment 
 
Review of clinical inclusion and exclusion criteria 
 
5.4. Enrollment   
The patient is considered enrolled when all inclusion criteria and no exclusion criteria 
have been met (as defined in Section 4.2 & 4.3).  
 
5.5. Procedure 
Patients may be admitted the day prior to the procedure for hydration, if deemed 
medically necessary.  Alternatively, Subjects may be admitted the day of the 
procedure.  Antiplatelet medication should be initiated prior to placement of the study 
device at a dose deemed appropriate by the Investigator.  
 
On the day of the procedure, the patient will be prepped for percutaneous intervention 
per institutional standards.  Ultrasound-guided vascular access is recommended.  
When possible, a percutaneous Seldinger technique is preferred; however a cut-
down may be performed when indicated.  The guidewire must cross the target 
lesion(s) intraluminally.  Use of image-centered, magnified-view contrast angiography 
(including a marker guidewire or catheter) is recommended. 
 
Assessment of Lesion Characteristics   
Procedural angiography will be utilized to assess target lesion characteristics and to 
determine final eligibility for enrollment.  Lesion characteristics, including total lesion 
length, percent stenosis, presence of occlusion and calcification will be recorded.  
Additionally, target lesion location should be recorded, confirming the presence of in-
stent restenosis and noting any adjacent disease (if present).   
 
 
 
 

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Assessment of Non-covered Stent 
A baseline image of the previously implanted non-covered stent prior to any study 
treatment is required.  This image can be captured during the baseline angiogram (X-
ray shot without contrast) or by plain film X-ray.  Imaging will be sent to the Core Lab 
for assessment.  
 
Treatment of Target Lesion and Device Deployment 
Prior to study device implantation, pre-dilation of the target lesion is required with full 
expansion of the balloon within the lesion(s).  The margins of the angioplasty 
treatment should be carefully marked to ensure complete coverage with the study 
device.  The results of the pre-dilation should be evaluated angiographically.  Any 
other pre-treatment procedures prior to balloon angioplasty may be conducted at the 
discretion of the Investigator.  
 
Study device sizing, introduction, positioning and deployment should be performed in 
compliance with Instructions for Use (IFU).  Refer to Table 1, GORE® VIABAHN® 
Endoprosthesis Configurations and Vessel Sizing Guidelines. 
 
All areas that were pre-dilated should be covered with the study device.  In addition, 
the study device should extend into healthy vessel a minimum of 1 cm proximal and 
distal to the target lesion(s).  If overlapping devices is required to ensure complete 
coverage, there should be at least 1 cm of overlap between devices and device 
diameters should not differ by more than 1 mm.  Post-dilation should be performed 
after each study device deployment to ensure seating against the vessel wall.  
 
Procedural Completion Imaging 
Final post-procedure angiogram will be performed to assess technical results.  A 
post-procedure image is required.  This image can be captured during final 
angiogram (X-ray shot without contrast) or by plain film X-ray.  Imaging will be sent to 
the Core Lab for assessment.  
 
Approved closure devices may be utilized at the Investigator’s discretion.  If a closure 
device is not used, sheath removal will be performed in accordance with institutional 
standard of care.  Adequate hemostasis at the arterial puncture site as determined by 
the Investigator should be achieved prior to discharge.    
 
Adverse events will be collected from the study procedure forward.  
 
Discharge 
Prior to discharge, a resting ABI/TBI will be measured. Discharge anti-platelet/anti-
coagulation therapy and any additional adverse events will be documented.  
 
Anti-platelet/Anti-coagulation Therapy 
 
The Subject should be discharged and maintained on anti-platelet/anti-coagulation 
therapy at a dosage deemed appropriate by the Investigator.   
 
 
 

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The following medication regime is recommended: 
 
Dual anti-platelet therapy should be continued for a minimum of 6 months 
including Clopidogrel 75 mg PO QD (Other members of the thienopyridine class 
of ADP receptor inhibitors may be prescribed in place of Clopidogrel if subject 
intolerant to Clopidogrel) and Aspirin 81 – 325 mg PO QD  
 
Aspirin 81 – 325 mg PO QD should be continued through study follow-up 
 
5.6. Repeat Interventions 
In some Subjects, a repeat intervention may be required following the index 
procedure.  Investigators should use standard of care at their institution for 
performing repeat interventions.  An angiogram of the study lesion both pre- and 
post-intervention should be taken and recorded on the appropriate CRFs.  All 
commercially available sizes of the GORE® VIABAHN® Endoprosthesis may be used 
for repeat interventions. 
 
Angiography performed without subsequent intervention to maintain or re-establish 
patency is not considered a repeat intervention.  
 
5.7. Follow-Up 
All Subjects are required to return to the Investigator for follow-up evaluations at 30 
days, 12, 24 and 36 months after the index procedure.  The schedule of events is 
outlined in Table 3. 
 
Follow-up visits will be scheduled at appointed times after the date of index 
procedure.  The Sponsor recognizes that Subjects may not be able to return for 
follow-up visits on the exact date required.  Thus, a period during which each visit is 
allowed (window) is presented in Table 4. 
 
Table 4 Study Visit Windows 
Follow-up Visit 
Window 
30 days 
30 ± 7 days 
12 months 
365 ± 45 days 
24 months 
730 ± 45 days 
36 months 
1095 ± 45 days 
 
The following data are required and will be collected at 30 days post-procedure: 
 
ABI/TBI, resting  
 
Rutherford Classification 
 
Anti-platelet/Anti-coagulant therapy assessment 
 
Adverse Events 
 
Duplex Ultrasound  
 
The following data are required and will be collected at 12, 24 and 36 months post-
procedure: 
 
ABI/TBI, resting  
 
Rutherford Classification 
 
Anti-platelet/Anti-coagulant therapy assessment 
 
Adverse Events 

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 
X-ray  
 
Duplex Ultrasound  
 
The following data is required and will be collected at any Unscheduled Study-
Related Visit or  
 
 
ABI/TBI, resting  
 
Rutherford Classification 
 
Anti-platelet/Anti-coagulant therapy assessment 
 
Angiography, if indicated 
 
Adverse Events 
 
Duplex Ultrasound, if indicated 
 
5.8. Subject Withdrawal from the Study 
It is important that the Investigator encourage Subjects to return for all required 
follow-up visits.  A Subject may withdraw from the study at any time and should notify 
the Investigator in this event.  The Investigator may also withdraw the Subject from 
the study at any time based on his/her medical judgment.  
 
If a Subject voluntarily withdraws or is withdrawn from the study for any reason, all 
end-of-study procedures must be performed.  Any adverse events not resolved at the 
time of withdrawal will be classified as ongoing and the Study 
Completion/Discontinuation CRF will be completed.  The reason for exclusion or 
withdrawal will be recorded and the appropriate CRFs submitted to the Sponsor. 
 
Subjects must be withdrawn from the study for the following reasons: 
 
Withdrawal of informed consent (the Subject’s decision to withdraw for any 
reason); 
 
Any clinical event, laboratory abnormality, or concurrent illness which, in the 
opinion of the Investigator, indicates that continued treatment with study 
therapy and participation in the study is not in the best interest of the 
Subject (Investigator withdrawal); 
 
Termination of the study by the Sponsor; 
 
The Subject becomes a prisoner or becomes involuntarily incarcerated for 
treatment of either a psychiatric or physical illness (e.g., infectious disease) 
 
It is the right and duty of the Investigator to interrupt the treatment of any Subject 
whose health or well-being maybe threatened by continuation in this study or who 
may be experiencing unmanageable factors that may interfere with the study 
procedures or the interpretation of study results.  Such Subjects will be withdrawn 
from the study rather than be allowed to continue under a modified regimen. 
 
 
 
 
 
 
 

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5.9. Subject Retention Strategy and Loss to Follow-Up  
Subject retention is important to the validity of study outcomes. At the time of subject 
enrollment and execution of the patient informed consent, the Investigator and/or 
designee, will discuss the importance of complying with protocol requirements and 
the follow-up visit schedule (Refer to Section 4.2, Clinical Inclusion Criteria #7). 
Individual considerations that may preclude a Subject from returning for a study 
follow-up visit (e.g., transportation, distance, scheduling constraints) should be 
identified and adequately addressed prior to enrolling a Subject into the study to 
mitigate future loss to follow-up. At the time of the follow-up visit, the Investigator or 
designee will again discuss the expectation that the Subject will comply with the 
protocol’s follow-up schedule and address any individual concerns that would prevent 
continued compliance.    
 
The study objectives may not be realized if a significant number of Subjects are lost 
to follow-up.  A Subject will be considered lost to follow-up and withdrawn from the 
study once they have missed two consecutive follow-up visits and three documented 
attempts have been made by the Investigator or designee to contact the Subject or 
next of kin.  One of the three documented attempts must include a certified letter. 
 
5.10. Subject Study Completion 
A Subject has completed the study when the 36 month follow-up visit has been 
completed.  Any Subject that does not complete these requirements due to voluntary 
withdrawal, physician withdrawal, death, or any other reason will be considered a 
withdrawal.  Subjects will not be provided with any medical care by the Sponsor after 
study completion or withdrawal.  Subjects will continue to receive care per institutional 
standards.  All Subjects, regardless of completion or withdrawal, will need a 
completed Study Completion/Discontinuation CRF. 
 
5.11. Device Deficiencies 
The Study Devices are commercially available in the U.S and the EU.  Device 
deficiencies and complaints should be reported through normal product surveillance 
mechanisms.     
 
5.12. Explant Procedures 
The Study Device may be explanted during a surgical procedure or as part of an 
autopsy. Sites are requested to return explanted device to the Sponsor for gross and 
histological evaluation. Prior to planned or potential device retrieval, contact the Gore 
Associate managing the study to communicate that a specimen is being retrieved 
from a study Subject. A specimen shipping kit will be immediately sent to the Site. 
The specimen kit provides specific packaging and handling instructions for the 
specimen and contains a shipping container. 
 
6. 
Study Administration  
6.1. Training 
All Investigators implanting devices in this clinical study must be trained on the 
protocol and Instructions for Use (IFU) by Sponsor associates, designees or another 
appropriately trained physician at the study Site.   
 
 

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6.2. Monitoring 
Site monitoring for this study will be provided by the Sponsor or designee. Monitoring 
oversight will be provided by the Sponsor.  
 
The Site monitors are qualified by training and experience to oversee the progress of 
the study at the Site and will ensure that the Investigators and their staff understand 
and adhere to both the applicable regulatory requirements and the study Protocol.  In 
addition, they may assist in resolution of any problems that may arise during the 
study.   
 
Site Initiation  
Site initiation will be performed to assure that each Investigator and his/her staff 
understands the Protocol, applicable regulations, human subject protection 
requirements, and the Investigator’s obligations.  This visit will ensure that required 
documentation with the appropriate approval is in place prior to Subject enrollment.    
 
Periodic Site Monitoring  
Periodic Site monitoring will occur as necessary to ensure continuing adequacy of 
facilities and adherence to the study Protocol, the GCPs, and applicable regulations 
and laws that pertain to the conduct of the study.  These activities will also review the 
CRFs and source documentation, the timely submission of accurate records to the 
Sponsor, and the maintenance of proper records.  A report will be written following 
each Site visit and a follow up letter will be provided to the Site with a summary of 
findings. Each Site will also be visited at close-out to ensure all documentation is 
complete.  
 
6.3. Device Accountability and Storage  
The Study Device is commercially available in the U.S. and applicable OUS markets.  
Each Site will manage devices according to their standard process for commercial 
devices. 
 
6.4. Core Lab 
Core Lab services for this study will be provided by a Sponsor designee for study 
imaging. 
 
6.5. Protocol Deviations 
A Protocol deviation is defined as any change, divergence, or departure from the 
study design or procedures of a research protocol.  The Investigator is responsible for 
promptly recording and reporting Protocol Deviations to the Sponsor and the 
reviewing IRB/EC per IRB/EC policy.  The Sponsor will determine the effect of the 
protocol deviation on the scientific soundness of the study and Subject safety and 
determine if additional reports or actions are required.  Additional action may include 
Site retraining, removal of devices from the Site, and/or Site termination.    
 
The Investigator will not implement any changes to the protocol without first obtaining 
written agreement from the Sponsor and documented approval from the IRB/EC, 
except in the event of an immediate hazard(s) to a Subject.  The Investigator will 
report the Protocol Deviation in accordance with the applicable regulations.  
          

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6.6. Protocol Amendments 
The Investigator will obtain IRB/EC approval on all amendments in a timely manner. 
The Sponsor will ensure proper training of Investigator and Site staff on all protocol 
amendments. 
 
6.7. Sponsor Representatives 
Sponsor representatives may be present during study procedures to provide technical 
assistance to the Investigator in the use of the device.  The activities of these 
Sponsor representatives will be supervised by the Investigator.  
 
6.8. Access to Source Data/Documents 
Source data are defined as all information necessary for the reconstruction and 
evaluation of the Clinical Investigation.  
 
The Investigator will keep all study records, source data and investigational devices 
available for inspection by the Sponsor, Sponsor’s monitors, IRB/EC, and regulatory 
authorities. 
 
6.9. Study Records Retention  
The Investigator will maintain complete, accurate and current study records as 
required by applicable regulatory requirements.  Records will be maintained during 
the study and for a minimum of two years after the latter of the date on which the 
study is terminated or completed, or the date the records are no longer required to 
support regulatory approval of the device.  In any event, study records will not be 
disposed of, nor custody of the records transferred, without prior written Sponsor 
approval.    
 
Investigator records will include, but not be limited to:  
 
All correspondence with another Investigator, an IRB/EC, the Sponsor, a monitor, 
or Regulatory Authority, including required reports. 
 
Records of each Subject’s case history and exposure to the device.  Case 
histories include the case report forms and supporting data including, for 
example, signed and dated consent forms and medical records, including, for 
example, progress notes of the physician, the  individual’s hospital chart(s), and 
the nurses’ notes.  Such records shall include: 
 
Documents evidencing informed consent and, for any use of a device 
without informed consent, any written concurrence of a licensed 
physician and a brief description of the circumstances justifying the 
failure to obtain the informed consent.  The case history for each 
individual shall document that informed consent was obtained prior to 
participation in the study.   
 
All relevant observations, including records concerning adverse device 
effects (anticipated and unanticipated), the information and date and 
condition of each Subject upon entering, and information about relevant 
previous medical history and the results of all diagnostic tests. 
 
A record of the exposure of each Subject to the Study Device, including 
the date and time of each use, and any other therapy. 

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 
The protocol, any amendments, and documentation of any deviations from the 
protocol, including the dates and the reasons for such deviations. 
 
Any other records that Regulatory Authority requires to be maintained by 
regulation or by specific requirement for a category of investigations or a 
particular investigation. 
 
A certification stating that the IRB/EC is in compliance with Regulatory Authority 
regulations. 
 
Any other records as required by the Regulatory Authority, the IRB/EC and the 
Sponsor. 
 
The Investigator will prepare and submit the following reports:  
 
Withdrawal of IRB/EC approval: The Investigator will report any withdrawal of 
approval within 5 working days after the Investigator has been notified of the 
withdrawal. 
 
Progress reports: Progress reports documenting the procedure, AEs and follow-
up data concerning individual Subjects will be submitted to the Sponsor on 
standardized CRFs.  The Investigator may also be required to submit progress 
reports and final reports to the IRB/EC and to the Sponsor summarizing the 
Investigator’s experience during the study.  
 
Protocol Deviations shall be reported as described in Section 6. 
 
Other: Any other reports as reasonably requested by the Sponsor or required by 
Regulatory Authority. 
 
6.10. Publication Plan  
The International Committee of Medical Journal Editors (ICMJE) member journals 
have adopted a trials-registration policy as a condition for publication.  This policy 
requires that all clinical trials be registered in a public trials registry.  The Sponsor will 
register the study and post results as required by this policy and applicable U.S. laws 
and regulations.  
  
7. 
Data Collection and Submission 
The Clinical Data Management System (CDMS) for this study will be provided by: 
 
Medidata Solutions Worldwide 
379 Thornall Street, 15th Floor 
Edison, New Jersey 08837 
 
7.1. Data Collection Methods  
This study will report clinical data using the Medidata Rave® CDMS web-based 
application. The CDMS will be the database of record for the protocol and subject to 
regulatory inspections. All users will be trained to use the CDMS and will comply with 
study specific guidelines/instructions as well as applicable regulatory requirements. 
 
Subject data will be collected using protocol-specific case report forms (CRF).  Site 
staff will enter data directly into the CRF for transmission to the Sponsor. The Sites 
will be notified of any significant amendments to the CRFs. 
 
 

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7.2. Data Clarification and Correction  
Once entered, data will be evaluated to ensure that it is complete, consistent and 
logically sound.  If changes to the data in the CDMS are required, all changes, 
reasons for changes, and persons making the changes will be captured in the 
CDMS's audit trail. 
 
7.3. CRF Completion Schedule 
Case Report Forms will be completed as soon as reasonably possible during or 
following each Subject visit. 
 
8. 
Risk Assessment  
8.1. Potential Risks  
The risks associated with the GORE® VIABAHN® Endoprosthesis for use in in-stent 
restenosis are expected to be similar to the risks associated with the use of PTA or 
other endovascular procedures in the superficial femoral artery.   
 
Such risks associated with these devices, including the GORE® VIABAHN® 
Endoprosthesis include, but are not limited to:  
 
Hematoma 
 
Stenosis 
 
Thrombosis or occlusion 
 
Distal embolism  
 
Side branch occlusion 
 
Vessel wall trauma and/or rupture 
 
False aneurysm 
 
Infection  
 
Inflammation 
 
Fever and/or pain in the absence of infection 
 
Deployment failure 
 
Malposition 
 
Malapposition 
 
Device migration 
 
Device failure 
 
Risks associated with endovascular procedures include, but are not limited to:  
 
access site infection 
 
entry site bleeding and/or hematoma 
 
vessel thrombosis 
 
occlusion 
 
psuedoaneurysm 
 
trauma to the vessel wall including perforation, rupture, or dissection 
 
distal embolization 
 
arteriovenous fistula formation 
 
transient or permanent contrast induced renal failure 
 
renal toxicity 
 
sepsis or shock 
 
radiation injury 

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 
myocardial infarction 
 
fever 
 
pain 
 
inflammation 
 
death 
 
The GORE® VIABAHN® Endoprosthesis should not be used in patients with known 
hypersensitivity to heparin, including those patients who have had a previous incidence 
of Heparin-Induced Thrombocytopenia (HIT) type II. 
 
8.2. Minimization of Risks 
Potential risks associated with the use of the Study Device may be minimized by the 
following activities: 
 
The Study Device has been FDA approved for the application being evaluated in 
this study protocol and for other uses.  The Study Device has been CE-marked 
for the application being evaluated in the study protocol and for other uses. 
 
The Sponsor has performed qualification testing on the device and device 
components and appropriate quality control measures have been implemented 
into production.   
 
Investigators will be selected who are knowledgeable and experienced in 
peripheral endovascular procedures.  
 
Comprehensive Site Investigator and staff training will be conducted to share 
information regarding design and proper use of the Study Device. 
 
The Site Investigator, Sub-Investigators, Study Coordinator(s) or designee at 
each Site will be trained to the protocol and Subject follow-up requirements.  
 
Protocol inclusion/exclusion criteria and follow-up schedules are designed to 
select appropriate Subjects and identify potential complications early. Subjects 
will be assessed post-procedure and subsequently on a regular basis to collect 
information on the Subject’s status and any reportable Adverse Events. 
 
Data completed by the Sites will be monitored to evaluate protocol compliance 
and the data for accuracy and Subject safety. 
 
The Instructions for Use will be provided with the Study Device. 
 
8.3. Summary of Expected Benefits 
Subjects may receive no benefit from taking part in this study.  The Study Device is 
expected to improve blood flow in patients with symptomatic peripheral artery disease 
in the superficial femoral artery. 
 
9. 
Adverse Events and Safety Monitoring  
Adverse Events (AEs) are defined as any untoward medical occurrences in a Subject 
whether device-related or not. 
 
9.1. Anticipated Adverse Events  
Anticipated Adverse Events are complications that are known to be associated with 
PAD patients undergoing endovascular procedure.  See Section 8, Risk Assessment.  
 
 
 

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9.1.1. 
Adverse Event Relationship 
Each reported AE will be assessed by the Investigator for its primary 
suspected relationship to the study device, procedure, or disease.  Only one 
primary relationship will be assigned to each reported AE. 
 
Study Device-related  
If functioning or characteristics of the study device caused or contributed 
significantly to the Adverse Event, the AE would be classified as primarily 
related to the study device.   
 
Study Procedure-related 
If the procedure (and not the device) caused or significantly contributed to 
the Adverse Event, the AE would be classified as primarily related to the 
index procedure.   
 
Disease-related   
If the Adverse Event was a result of the underlying disease progression for 
which the study procedure is being performed, and not the device or 
procedure, the AE would be classified as primarily related to the disease.   
 
Not-related  
If an Adverse Event which cannot be attributed to the study device, 
procedure, or disease, it will be reported as “Not related”.   
 
Unknown relationship  
If the relationship of the Adverse Event to the device, procedure, or disease 
cannot be determined, it will be reported as “Unknown”.  
 
9.1.2. 
Adverse Event Classification 
The severity of each AE will be categorized by the Investigator as either 
serious or non-serious, as defined below:  
 
Serious Adverse Event (ISO 14155 Definition) 
A Serious Adverse Event is an Adverse Event that 
 
led to death 
 
led to serious deterioration in the health of the Subject that either 
resulted in 
 
a life threatening illness or injury, or 
 
a permanent impairment of a body structure or body function, 
or  
 
inpatient or prolonged hospitalization, or  
 
medical or surgical intervention to prevent life threatening 
illness or injury or permanent impairment to a body structure 
or a body function 
 
led to fetal distress, fetal death or a congenital abnormality or birth 
defect.  
 

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Non-Serious Adverse Events:  generally uncomplicated, resolving without 
intervention, extension of ongoing medical therapy, or consequence to the 
Subject. 
 
9.1.3. 
Adverse Event Reporting and Coding 
AEs will be reported on the appropriate case report form (CRF) and 
documented in the Subject’s permanent medical record.  The Investigator at 
each Site is ultimately responsible for reporting AEs to the Sponsor.  
 
The following information on each reported Adverse Event will be collected:  
 
Adverse Event Name 
 
Adverse Event Onset Date 
 
Relationship 
 
Classification Serious or Non-Serious 
 
Treatment 
 
Outcome 
 
Resolution Date 
 
Adverse Events will be coded using the Medical Dictionary for Regulatory 
Activities (MedDRA).  The Sponsor is responsible for the MedDRA 
classification, along with AE reporting and ongoing safety evaluation of the 
study in accordance with national regulatory requirements 
 
Adverse Event submission guidelines: 
 
Adverse Event reporting begins once the patient is enrolled in the study 
following the final assessment of angiographic eligibility requirements 
during the study procedure. All Adverse Events should be reported from 
enrollment through study completion/discontinuation. 
 
Clinical conditions present pre-procedure are not adverse events unless 
the severity of the condition worsens during the course of the Subject’s 
participation in the study.  
 
Provide a diagnosis if possible. If unable to provide a diagnosis, report 
the symptoms as separate events. Adverse Events should be reported 
using the full name without abbreviations or narratives. 
 
Adverse Events with an outcome status of “Ongoing” should be 
assessed at each follow-up evaluation to determine if the event has 
resolved.  Adverse Events ongoing at study completion/discontinuation 
should be left as “Ongoing” on the AE case report form.   
 
9.1.4. 
Subject Death 
Death is not an AE but instead an outcome of an AE.  In rare cases the 
known cause of death or one AE may not be able to be declared as the 
major contributor to death, however when possible death should be reported 
as an outcome.   
Any ongoing or unresolved AEs at the time of death will be indicated as 
“ongoing” on the CRF. 
Attempts will be made by the Investigative site to obtain death certificates, 
autopsy reports, and device explants when at all possible. 

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9.2. Clinical Events Committee 
An independent Clinical Event Committee(CEC) will be established to review all 
safety-related and clinical events during the study. The committee will be composed 
of three members representing Interventional Radiology, Interventional Cardiology 
and/or Vascular Surgery.  
 
The scope of the CEC is as follows: 
1. General review and adjudication of Adverse Events to include: 
a. Agreement on the Serious Adverse Event designation as coded by 
Site 
b. Agreement of the relationship of the AE to the study device, index  
procedure, or disease 
c. Review of MedDRA coding for consistency between similar events 
2. Death summary review and agreement of relationship of the death to the 
study device or index procedure as reported by the Site 
3. Protocol Deviation review (as appropriate) 
4. General study consultation (as appropriate) 
 
The CEC meetings will be scheduled approximately 3 times per year depending on 
the rate of enrollment. At minimum, safety data will be reviewed by the committee 
prior to each 6-month and/or annual due date for a FDA interim report.  
 
10. Statistical Analysis 
10.1. Primary Endpoint Analysis 
10.1.1. Primary Effectiveness  
The primary effectiveness endpoint is Primary Patency at 12 months post-
procedure.  Primary patency will be estimated through 365 days along with a 
95% confidence interval using Kaplan-Meier analysis.  Equivalent analysis 
will be performed with regards to the primary patency partitioning the data by 
lesion length (< 230 mm and ≥ 230mm).  All results will be compared to that 
obtained in the RELINE study. 
    
10.1.2. Primary Safety 
The primary safety endpoint is procedure or device-related Serious Adverse 
Events within 30 days of the index procedure. The total number of events as 
well as the number of Subjects experiencing them will be tabulated along 
with a 95% confidence interval.  
    
10.2. Secondary Endpoint Analysis 
10.2.1. Acute Procedural Success 
Acute Procedural Success is defined as successful delivery of the study 
device and complete coverage of the target lesion without a procedure or 
device-related Serious Adverse Event prior to hospital discharge.  This will 
be tabulated omitting all Subjects with unknown status.      
    
 
 
 

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10.2.2. Primary Patency 
Primary patency is defined as patent blood flow through the study device, 
which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by 
the Core Lab, without repeat intervention.  Primary patency will be estimated 
at 30 days, 12, 24 and 36 months along with a 95% confidence interval using 
Kaplan-Meier analysis.         
 
10.2.3. Primary Assisted Patency 
Primary assisted patency is defined as blood flow through the study device 
regardless of repeat interventions to maintain patency prior to occlusion. 
Blood flow will require confirmation by the study core lab.  Primary assisted 
patency will be estimated at 30 days, 12, 24 and 36 months along with a 
95% confidence interval using Kaplan-Meier analysis.        
  
10.2.4. Secondary Patency 
Secondary patency is defined as blood flow through the study device 
regardless of repeat interventions to restore patency after occlusion.   Blood 
flow will require confirmation by the study core lab.  Secondary patency will 
be estimated at 30 days, 12, 24 and 36 months along with a 95% confidence 
interval using Kaplan-Meier analysis.       
   
10.2.5. Freedom from Target Lesion Revascularization (TLR) 
Target Lesion Revascularization is defined as a repeat intervention within 
the study device and 5 mm proximal or distal to the edge of the study device 
to maintain or re-establish patency.  Freedom from TLR will be estimated at 
30 days, 12, 24 and 36 months along with a 95% confidence interval using 
Kaplan-Meier analysis.  
        
10.2.6. Freedom from Major Amputation 
Major Amputation is defined as removal of the study limb above the 
metatarsals, resulting from a vascular event.  Freedom from major 
amputation will be estimated at 30 days, 12, 24 and 36 months along with a 
95% confidence interval using Kaplan-Meier analysis.  
            
10.2.7. Change in Ankle-Brachial Index (ABI) 
Ankle Brachial Index is defined as the ankle systolic pressure in the study 
limb divided by the highest brachial systolic pressure in either arm.  The 
minimum, maximum, median, mean and standard error will be reported for 
the change in ABI relative to that measured pre-procedure at 30 days, 12, 24 
and 36 months.  All values measured within the defined window will be used 
in calculation.   
 
10.2.8. Change in Rutherford Category  
The change in Rutherford Category, measured relative to that obtained pre-
procedure, will be assessed at 30 days, 12, 24 and 36 months.  The 
minimum, maximum, median, mean and standard error will be reported as 
well as the counts for each outcome.  All values measured within the defined 
window will be used in calculation.   
       

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10.2.9. Stent Fracture 
Device stent fractures will be assessed by the study core lab through x-ray 
images.  A table of all stent fractures, which are clearly distinguishable from 
previously implanted stents, will be reported at 12, 24 and 36 months.  All 
values measured within the defined window will be used in tabulation.  
        
10.3. Additional Analysis 
A Health Economic analysis will be performed using clinical study data. The objective of 
the Health Economic analysis is to understand the value of the treatment(s) studied during 
the period of the clinical investigation.  
 
10.4. Sample Size  
A sample size of 108 Subjects is expected to provide an evaluable sample size of 86 
Subjects at 1-year after 20% lost to follow-up.   
 
10.5. Blinding Scheme  
Due to the fact that there is only one study treatment, neither the Subjects nor 
Investigators will be blinded to the study treatment. 
 
10.6. Data Analysis 
10.6.1. Timing of Analyses 
Reports will be prepared when follow-up is complete for endpoints of the 
study (e.g. 1-year, 2-year, and 3-year).  Additional interim analyses and 
reports will be done in order to comply with regulatory reporting 
requirements. This will consist of, at a minimum, the physical characteristics 
of enrolled Subjects as well as tabulations of all interventions and adverse 
events.  In addition, listings of all interventions and adverse events will be 
prepared.  Once all Subjects have either completed 36 months of follow-up 
or been withdrawn from the study, a formal statistical analysis will be 
performed to evaluate all study endpoints.   
 
10.6.2. Analysis Populations 
Both of the following populations will be used for analyses of primary and 
secondary endpoints.   
(1) Intent to treat – All patients assigned to the study treatment, regardless 
of whether or not they received it or have any protocol violations.      
(2) Per protocol – A subset of the ITT population consisting of Subjects 
receiving the study device which meet all inclusion and exclusion criteria 
and without any major protocol violations. 
 
10.6.3. Pooling of Data 
Data from all study sites will be pooled on a clinical basis, i.e., the study sites 
will follow a common protocol, the study will be monitored to assure 
compliance with the protocol and applicable government regulations, and the 
data collection and handling procedures will be the same at all study sites.   
 
 
 

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11. Ethical and Regulatory Considerations 
11.1. Statement of Compliance  
The study will be conducted in compliance with this protocol, International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP), and applicable 
regulatory requirements.   
 
The following are applicable to this study:   
 
21 CFR Part 11 
 
Electronic Records; Electronic 
Signatures 
21 CFR Part 50 
 
Protection of Human Subjects 
21 CFR Part 56 
 
Institutional Review Boards 
ICH-GCP E6 
International Conference on 
Harmonisation Regulations 
Guideline For Good Clinical 
Practice 
 
11.2. Compliance Responsibilities 
The Sponsor will conduct the study in accordance with all applicable regulations and 
laws.  The Sponsor will be responsible for documenting that Investigators have the 
necessary skills, training and information to properly conduct the study.  The Sponsor 
will ensure proper monitoring of the study and ensure the Site has obtained IRB/EC 
approval prior to enrollment.  The Sponsor will provide information to the 
Investigators, the reviewing IRB/EC and the Food and Drug Administration 
concerning the progress of and any new material information about the study.   
 
The Investigator will conduct the study in accordance with all applicable regulations 
and laws, any relevant agreements, the study protocol, and all approval conditions of 
the reviewing IRB/EC and the Food and Drug Administration.  The Investigator will 
ensure IRB/EC approval is obtained prior to enrollment, maintained throughout the 
course of the study, and that all IRB/EC reporting requirements are met.  The 
Investigator is responsible for protecting the rights, safety, and welfare of Subjects 
under the Investigator’s care and for the control of devices under investigation.  The 
Investigator is also responsible for ensuring that informed consent is properly 
obtained.  
 
11.3. Informed Consent 
The Investigator shall ensure that all potential Subjects for this study are provided 
with a consent form describing this study and sufficient information to make an 
informed decision about their participation.   
 

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The formal consent of a Subject, using the IRB/EC-approved consent form, must be 
obtained by the Investigator before that Subject undergoes any study-related 
procedure.  The consent form will be signed and personally dated by the Subject and 
the person who conducted the informed consent discussion.  The original signed 
informed consent form will be retained in the Subject records.  A copy of the informed 
consent document will be given to the Subject for his or her records.   Any significant, 
new information which emerges while the study is in progress that may influence a 
Subject’s willingness to continue to take part in the study will be provided to the 
Subject. 
 
The Investigator shall ensure that documentation of the acquisition of informed 
consent is recorded in each Subject’s records in accordance with applicable 
regulations. 
 
11.4. Independent Ethical Review  
The Investigator shall not enroll any Subjects prior to obtaining approval for the study 
from a properly constituted independent IRB/EC. 
  
The Investigator will submit the protocol, informed consent forms, and other 
information to be provided to Subjects such as survey instruments or questionnaires, 
and any proposed advertising/recruitment materials, to the IRB/EC for written 
approval. 
 
11.5. Conflict of Interest 
All Investigators will follow applicable laws and regulations as well as the conflict of 
interest policies of their Site and the reviewing IRB/EC. 
 
 
11.6. Confidentiality 
All Subject records will be kept confidential to the extent provided by applicable laws 
and regulations.  The study monitors and other authorized representatives of the 
Sponsor may inspect all documents and records required to be maintained by the 
Investigator, including but not limited to medical records.   
 
Such records may also be reviewed by the Site’s IRB/EC and other regulatory bodies 
(e.g., FDA). 
 
The Investigator will inform the Subjects that their records will be reviewed.  
 
11.7. Study Discontinuation or Suspension  
If the Sponsor prematurely discontinues the study, all enrolled patients will be 
followed per the standard of care at each institution.  The Sponsor may request that 
Subjects are telephoned or come in for an office visit prior to study termination.   
 
 
 
 

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12. References 
1. Tzoulaki I and Fowkes FGR, Epidemiology of Peripheral Arterial Disease., in 
Peripheral Arterial Disease, E.R. Mohler III and M.R. Jaff, Editors. 2008, 
American College of Physicians: Philadelphia. p. 1-20. 
 
2. Lumsden AB, Davies MG, and Peden EK. Medical and Endovascular 
Management of Critical Limb Ischemia. Journal of Endovascular Therapy, 
2009: 16[Suppl II]: II31-II62. 
 
3. Allaqaband S, Kirvaitis R, Jan F, and Bajwa T. Endovascular Treatment of 
Peripheral Vascular Disease. Current Problems in Cardiology, 2009: 34(9): 
359-476. 
 
4. Capek P et al., Femoropopliteal Angioplasty: Factors Influencing Long-Term 
Success. Circulation, 1991: 83[Suppl I]: I-70-I-80. 
 
5. Laird J et al., Nitinol Stent Implantation versus Balloon Angioplasty for Lesions 
in the Superficial Femoral Artery and Proximal Popliteal Artery:  Twelve-Month 
Results from the RESILIENT Randomized Trial.  Circulation:  Cardiovascular 
Interventions, 2010: 3: 267-276. 
 
6. Schillinger M et al., Balloon Angioplasty versus Implantation of Nitinol Stents in 
the Superficial Femoral Artery. New England Journal of Medicine, 2006: 
354(18): 1879-1888. 
 
7. Bennet M R, In-Stent Stenosis: Pathology and Implications for the 
Development of Drug Eluting Stents. Heart, 2003: 89: 218-224. 
 
8. Mehran R et al., Angiographic Patterns of In-Stent Restenosis Classification 
and Implications for Long-Term Outcome. Circulation, 1999: 100: 1872-1878. 
 
9. Laird J et al., Outcomes Following Treatment of Femoropopliteal In-Stent 
Restenosis: A Single Center Experience. Catheterizations and Cardiovascular 
Interventions, 2011: 78: 604-608. 
 
10. Saxon R et al., Long-term Patency and Clinical Outcome of the Viabahn Stent-
Graft for Femoropopliteal Artery Obstructions. Journal of Vascular 
Interventional Radiology, 2007: 18: 1341-1350. 
 
11. Laird J et al., Excimer Laser with Adjunctive Balloon Angioplasty and Heparin-
Coated Self-Expanding Stent Grafts for the Treatment of Femoropopliteal 
Artery In-Stent Restenosis: Twelve-Month Results From the SALVAGE Study.  
Catheterizations and Cardiovascular Interventions, 2012: 80: 852-859. 
 
12. Kazemi S et al., VIABAHN Stent-Graft for Treatment of In-Stent Restenosis in 
Femoropopliteal Vascular Occlusive Disease, Procedural Outcome and One-
Year Follow Up. TCT 2006, Washington, DC. 
 

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13. Ansel G et al., A 2007 Update on Treating Nitinol Stent Restenosis: Using 
VIABAHN covered stents to treat restenosis in the superficial femoral artery. 
Endovascular Today, 2007: 80-82. 
 
14. Al Shammeri O et al., VIABAHN for Femoropopliteal In-Stent Restenosis.  Ann 
Saudi Med 2012; 32(6): 575-582. 
 
15. Monahan TS et al., Effective Treatment of Femoropopliteal In-Stent Restenosis 
with Stent Grafts.  Abstracts Journal of Vascular Surgery, 2011; 54(3): 917-
918.