Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access
Conditions: PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm, End-Stage Renal Disease
Sponsor: W.L.Gore & Associates

COVER PAGE 
 
 
Study Title:  Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and 
GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms and Dialysis Access. 
 
 
 
Protocol Date:  16 June 2021 
 
 
NCT number: NCT05124184 

GORE-TEX® Vascular Graft, GORE-TEX® Stretch Vascular Graft, GORE® INTERING® 
Vascular Graft and GORE® PROPATEN® Vascular Graft  
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PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
Principal Investigator: Please complete the information below. If instructed by W. L. Gore & Associates, 
Inc., (Gore), please sign and date the bottom of the page and return the original 
to the Gore study contact. Retain a copy with the protocol at the study site in the 
regulatory binder. 
 
Device: 
 GORE-TEX® Vascular Graft, GORE-TEX® Stretch Vascular Graft, GORE® INTERING® 
Vascular Graft and GORE® PROPATEN® Vascular Graft  
 
Title: 
Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and 
GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, aortic aneurysms, and 
dialysis access.  
 
Protocol Number: 
VGP 21-01  
Protocol Date:  
16 June 2021 
 
I, the undersigned, have read and understood the specified protocol and agree with the contents. 
The protocol and any additional information provided by the sponsor will serve as a basis for 
conduct of the study. 
 
 
Name and Title (print):  
 
 
 
Address:  
 
 
 
 
 
 
 
 
 
 
 
 
 
Phone: 
 
 
 
 
 
 
Signature:  
 
Date: ___________________  
 
 
 
 
 
 
 
 

GORE-TEX® Vascular Graft, GORE-TEX® Stretch Vascular Graft, GORE® INTERING® 
Vascular Graft and GORE® PROPATEN® Vascular Graft  
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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. 
 
 
 
 
Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® 
PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms and Dialysis Access.  
 
 
 
Protocol number: 
VGP 21-01 
 
Protocol date 16 June 2021  
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 

GORE-TEX® Vascular Graft, GORE-TEX® Stretch Vascular Graft, GORE® INTERING® 
Vascular Graft and GORE® PROPATEN® Vascular Graft  
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PROTOCOL SUMMARY 
Study Title 
Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® 
Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral 
Artery Disease, Aortic Aneurysms and Dialysis Access. 
Protocol Number 
VGP 21-01 
Sponsor 
W. L. Gore & Associates, Inc. 
Medical Products Division 
1505 N. Fourth Street.  
Flagstaff, Arizona. 86004 USA 
Telephone: 800-437-8181 
Local 
Representative 
Gore Authorized Representative 
W. L. Gore & Associates B.V. 
Ringbaan Oost 152A, 5013CE Tilburg, 
The Netherlands 
Coordination PI 
Prof. Roberto Chiesa 
I.R.C.C.S Ospedale San Raffaele 
Via Olgettina n. 60, 20132 Milano 
Objective 
The primary objective is to confirm the clinical performance and safety of 
GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft 
throughout the device functional lifetime for each indication for use. 
Study Design 
Multicenter, single-arm retrospective study  
Study Devices 
GORE-TEX® Vascular Graft, GORE-TEX® Stretch Vascular Graft, 
GORE® INTERING® Vascular Graft, and GORE® PROPATEN® Vascular 
Graft 
Subject Population 
Patients that have had treatment with GORE-TEX® Vascular Grafts or 
GORE® PROPATEN® Vascular Grafts for peripheral artery disease 
(PAD), aortic aneurysms, or dialysis access. 
General Inclusion 
Criteria 
1. Patient is willing and able to provide written informed consent or 
consent is waived. 
2. Patient was at least 18 years of age at the time of implant. 
General Exclusion 
Criteria 
1. Patient was not available for follow up (on-site or remotely) at the 
clinical site, with the exception of death (e.g., patient lost to follow-up 
immediately after treatment, patient who lives far away from the 
treatment site and not available to share follow-up data performed 
locally).  
2. At the time of treatment, patient had known coagulation disorders, 
including hypercoagulability, that were not amenable to treatment. 
3. Patient was pregnant at the time of treatment. 
4. Patient had known or suspected systemic infection or infection at the 
site of graft implantation at the time of implant. 
5. Patient had a separate major interventional or surgical vascular 
procedure within 30 days prior to treatment. CVC catheter placement 
would be permitted. 
6. Patient is already enrolled in this registry under a different cohort. 
Peripheral Artery 
Disease Cohort 
Clinical 
Outcomes 
Primary Safety Outcome: Device-related seroma or 
infection at 5 years 
Primary Performance Outcome: Secondary patency 
(revascularization) through 5 years 

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Secondary Outcomes:  
• Limb Salvage through 1 year 
• Amputation Free survival through 1 year 
• Device-related Adverse Events through 1 year 
• Device-related infection requiring reoperation 
through 5 years 
• Primary Patency through 1 year 
Follow-Up 
5 Years 
Sample Size 
72 Patients with any GORE-TEX® Vascular Graft 
72 Patients with any GORE® PROPATEN® Vascular 
Graft 
PAD Cohort 
Inclusion 
 Criteria 
Patient was treated for peripheral arterial disease or 
peripheral arterial aneurysm requiring bypass with 
GORE-TEX® Vascular Graft, GORE® INTERING® 
Vascular Graft, GORE-TEX® Stretch Vascular Graft, 
or GORE® PROPATEN® Vascular Graft at least 5 
years before site initiation. 
PAD Cohort 
Exclusion 
Criteria 
At the time of treatment, the patient must not have 
met any of the following criteria: 
1. Patient had percutaneous transluminal angioplasty 
(PTA) or stenting of the target artery at the 
anticipated site of the proximal or distal 
anastomosis within 30 days prior to the index 
procedure. Use of PTA or stenting during the 
index procedure is permitted. 
2. Patient had a stroke or myocardial infarction (MI) 
within 6 weeks prior to the index procedure. 
3. Patient has previous instance of Heparin-induced 
Thrombocytopenia type 2 or has known 
hypersensitivity to heparin. 
4. Patient required composite bypass for index 
procedure (graft + significant length of autologous 
vessel). Autologous “cuffs” or patches are 
allowed. 
Aortic Aneurysm 
Cohort 
Clinical 
Outcomes 
Primary Safety Outcome: Survival at 5 years 
Primary Performance Outcome: Primary patency at 5 
years 
Follow-Up 
5 Years 
Sample Size 
65 Patients with GORE-TEX® Vascular Graft 
Aortic Aneurysm 
Cohort Inclusion 
Criteria 
Underwent simultaneous or staged aortic aneurysm 
repair (open surgical AAA or TAAA) involving a 
GORE-TEX® Vascular Graft, GORE® INTERING® 
Vascular Graft, or GORE-TEX® Stretch Vascular Graft 
at least 5 years before site initiation. Research device 
could have been used to replace or bypass either a 
diseased visceral branch or the aorta itself. 
Aortic Aneurysm 
Cohort 
Patients required emergency surgery at the time of 
implant due to aneurysm rupture. 

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Exclusion 
Criteria 
Dialysis Access 
Cohort 
Clinical 
Outcomes 
Primary Safety Outcome: Device-related infection 
through 2 years  
Primary Performance Outcome: Useable access 
circuit (reported as secondary patency) through 2 
years 
Secondary Outcomes: 
• Primary patency through 1 year 
• Device-related adverse events through 1 year 
Follow-Up 
2 years 
Sample Size 
72 patients implanted with any GORE-TEX® Vascular 
Graft 
72 Patients implanted with any GORE® PROPATEN® 
Vascular Graft 
Dialysis Access 
Cohort Inclusion 
Criteria 
Patient required the creation of a vascular access 
graft for hemodialysis secondary to a diagnosis of 
End-Stage Renal Disease using a GORE-TEX® 
Vascular Graft, GORE® INTERING® Vascular Graft, 
GORE-TEX® Stretch Vascular Graft, or GORE® 
PROPATEN® Vascular Graft at least 2 years before 
site initiation with the intent to cannulate the registry 
device. 
Dialysis Access 
Cohort 
Exclusion 
Criteria 
At the time of treatment, the patient must not have 
met the following criteria: 
1. The patient had a previous documented (via 
imaging technique) and unsuccessfully treated 
ipsilateral central venous stenosis. 
2. The patient was taking maintenance 
immunosuppressant medication at the time of 
implant such as rapamycin, mycophenolate or 
mycophenolic acid, prednisone (> 10 mg), 
cyclosporine, tacrolimus, or cyclophosphamide. 
3. The patient has had a previous instance of 
Heparin-Induced Thrombocytopenia type 2 (HIT-
2) or has known sensitivity to heparin. 
Number of Sites 
Up to 9 sites in Europe  
Schedule of Events 
Pre-enrollment: Patients will be retrospectively identified and enrolled if 
treated with GORE-TEX® Vascular Grafts or GORE® PROPATEN® 
Vascular Grafts and deemed suitable for inclusion.  
Procedure: Patient procedural and adverse event information will be 
retrospectively collected.  
Follow-up: Patient records will be collected for 2-5 years post-procedure 
by cohort. 
Additional 
Information 
Contract Research Organization: 
ICON Clinical Research Limited 
South County Business Park, Leopardstown 
Dublin 18, Ireland 

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LIST OF ABBREVIATIONS 
AAA 
Abdominal Aortic Aneurysms 
AE 
Adverse Event 
ACC/AHA 
American College of Cardiology/American Heart Association 
ADE 
Adverse Device Effect 
ALI 
Acute Limb Ischemia 
AVF 
Arteriovenous Fistulae 
AVG 
Arteriovenous Grafts 
CDMS 
Clinical Data Management System 
CE 
Conformité Européenne 
CIP 
Clinical Investigation Plan 
CKD 
Chronic Kidney Disease 
CLI 
Critical Limb Ischemia 
CLTI 
Chronic Limb-Threatening Ischemia 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CVC 
Central Venous Catheters 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
ePTFE 
Expanded Polytetrafluoroethylene 
ESRD 
End Stage Renal Disease 
ESVS 
European Society of Vascular Surgery 
EU 
European Union 
EVAR 
Endovascular Aneurysm Repair 
FDA 
Food and Drug Administration (United States) 
FP 
Femoropopliteal Occlusions 
FEP 
Fluorinated Ethylene Propylene 
Fr 
French (sizing) 
GCP 
Good Clinical Practice 
GFR 
Glomerular Filtration Rate 
Gore 
W. L. Gore & Associates, Inc. 
HE 
Health Economics 
IB 
Investigators Brochure 

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ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
PAD 
Peripheral Artery Disease 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PTA 
Percutaneous Transluminal Angioplasty 
RRT 
Renal Replacement Therapy 
SAE 
Serious Adverse Event 
SFA 
Superficial Femoral Artery 
SAA 
Splenic Artery Aneurysms 
SVS 
Society of Vascular Surgery 
TAAA 
Acute Thoracoabdominal Aortic Aneurysm 
US 
United States 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 

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DEFINITIONS 
Adverse Event: Untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including an abnormal laboratory finding) in subjects, 
users, or other persons, whether or not related to the investigational medical 
device and whether anticipated or unanticipated. 
Adverse Device Effect: Adverse event related to the use of an investigational 
medical device 
Clinical Investigation Plan: Documents that describes the rationale, objectives, 
design and pre-specified analysis, methodology, organization, monitoring, conduct 
and record-keeping of clinical investigation. These documents may include the 
protocol, monitoring plans, and statistical analysis plans. 
Device Deficiency: Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety or performance. 
Enrollment: A patient is considered enrolled into the registry once informed 
consent has been signed and dated or consent if waived. 
Registry Device: The medical device being assessed for safety or performance in 
this registry. May also be referred to as registry device. This includes medical 
devices already on the market that are being evaluated for new intended uses, 
new populations, new materials, or design changes. 
Serious Adverse Event: Any adverse event that led to any of the following: death; 
serious deterioration in the health of the subject, users, or other persons as 
defined by one or more of the following: life-threatening illness or injury, permanent 
impairment of a body structure or a body function, hospitalization or prolonged of 
patient hospitalization, medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure or a body function, 
chronic disease; or fetal distress, fetal death, or a congenital physical or mental 
impairment or birth defect. Defined in more detail in section 9. 
Serious Adverse Device Effect: An adverse device effect that has resulted in any 
of the consequences characteristic of a serious adverse event. 
Unanticipated Serious Adverse Device Effect: Serious adverse device effect 
which by its nature, incidence, severity, or outcome has not been identified in the 
current risk assessment.  
 
 
 
 

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TABLE OF CONTENTS 
PROTOCOL SUMMARY ..................................................................................................................................... ii 
DEFINITIONS .................................................................................................................................................... vii 
 Introduction.................................................................................................................................................. 1 
 
Disease ............................................................................................................................................. 1 
 
Occlusive or Aneurysmal Disease ......................................................................................... 1 
 Peripheral Artery Disease ......................................................................................... 1 
 Aneurysmal Disease ................................................................................................ 3 
 
Hemodialysis Access ............................................................................................................ 6 
 
Historical Treatments ........................................................................................................................ 6 
 
Occlusive or Aneurysmal Diseases ....................................................................................... 6 
 Summary of Treatment Options for Occlusive Disease ............................................. 6 
 Summary of Treatment Options for Aneurysmal Disease .......................................... 7 
 
Hemodialysis Access ............................................................................................................ 9 
 
Registry Device Description ............................................................................................................... 9 
 
GORE-TEX® Vascular Grafts ................................................................................................ 9 
 
GORE® PROPATEN® Vascular Graft .................................................................................. 10 
 
Pre-clinical Data .............................................................................................................................. 11 
 
Clinical Data .................................................................................................................................... 11 
 Registry Objectives ................................................................................................................................... 11 
 
Primary Objective(s) ........................................................................................................................ 11 
 
Health Economic Data Analysis ....................................................................................................... 12 
 Registry Design ......................................................................................................................................... 12 
 
Registry Design Schema ................................................................................................................. 12 
 
Description of Registry Design ......................................................................................................... 13 
 
Management of potential confounding factors / bias ............................................................ 13 
 
Registry Endpoint(s) ........................................................................................................................ 14 
 
Definitions........................................................................................................................... 14 
 
Primary Endpoints .............................................................................................................. 15 
 Peripheral Artery Disease Cohort ........................................................................... 15 
 Aortic Aneurysm Cohort ......................................................................................... 15 
 Dialysis Access Cohort ........................................................................................... 15 
 
Secondary Endpoints .......................................................................................................... 15 
 Peripheral Artery Disease Cohort ........................................................................... 15 
 Dialysis Access Cohort ........................................................................................... 15 
 Study Population ....................................................................................................................................... 16 
 
Description of Population ................................................................................................................. 16 
 
Inclusion Criteria ............................................................................................................................. 16 
 
General Inclusion Criteria .................................................................................................... 16 
 
PAD Cohort Inclusion Criteria ............................................................................................. 17 
 
Aortic Aneurysm Cohort Inclusion Criteria ........................................................................... 17 

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Dialysis Access Cohort Inclusion Criteria ............................................................................ 17 
 
Exclusion Criteria ............................................................................................................................ 17 
 
General Exclusion Criteria .................................................................................................. 17 
 
PAD Cohort Exclusion Criteria ............................................................................................ 17 
 
Aortic Aneurysm Cohort Exclusion Criteria .......................................................................... 18 
 
Dialysis Access Cohort Exclusion Criteria ........................................................................... 18 
 Registry Procedures / Evaluations ........................................................................................................... 18 
 
Schedule of Events ......................................................................................................................... 18 
 
Informed Consent Process .............................................................................................................. 18 
 
Remote Collection of the Informed Consent Form ............................................................... 19 
 
Vulnerable Populations ....................................................................................................... 19 
 
Emergent Cases ................................................................................................................. 19 
 
Pre-Screening ................................................................................................................................. 19 
 
Enrollment ....................................................................................................................................... 20 
 
Screening ........................................................................................................................................ 21 
 
Screen Failure ................................................................................................................................. 21 
 
Randomization and or Blinding ........................................................................................................ 21 
 
Procedure ....................................................................................................................................... 21 
 
Subject Chart Review ......................................................................................................... 21 
 
Data Elements .................................................................................................................... 22 
 
Repeat Interventions ....................................................................................................................... 22 
 
Follow Up ........................................................................................................................................ 22 
 
Subject Withdrawal from the Registry .............................................................................................. 23 
 
Subject Lost to Follow Up ................................................................................................................ 23 
 
Subject Registry Completion ........................................................................................................... 23 
 Subject Discontinuation....................................................................................................... 23 
 
Explant Procedures ......................................................................................................................... 23 
 Registry Administration ............................................................................................................................ 23 
 
Training ........................................................................................................................................... 23 
 
Monitoring ....................................................................................................................................... 23 
 
Site Initiation ....................................................................................................................... 23 
 
Periodic Site Monitoring ...................................................................................................... 24 
 
Device Accountability and Storage .................................................................................................. 24 
 
Core Lab ......................................................................................................................................... 24 
 
Protocol Deviations ......................................................................................................................... 24 
 
Protocol Amendments ..................................................................................................................... 25 
 
Access to Source Data / Documents................................................................................................ 25 
 
Registry Records Retention ............................................................................................................. 25 
 
Publication Plan .............................................................................................................................. 26 
 
Health Economics ........................................................................................................................... 26 
 Data Collection and Submission ............................................................................................................... 26 
 
Data Collection Methods ................................................................................................................. 27 

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Data Clarification and Correction ..................................................................................................... 27 
 
CRF Completion Schedule .............................................................................................................. 27 
 Risk Assessment ....................................................................................................................................... 27 
 
Summary of Expected Benefits ........................................................................................................ 27 
 
Risk-to-Benefit Rationale ................................................................................................................. 28 
 Adverse Events and Safety Monitoring .................................................................................................... 28 
 
Anticipated Adverse Events ............................................................................................................. 28 
 
Adverse Event Relationship ................................................................................................ 28 
 
Adverse Event Classification ............................................................................................... 29 
 
Adverse Event Reporting and Coding ................................................................................. 29 
 
Subject Death ..................................................................................................................... 30 
 
Unanticipated Serious Adverse Device Effects (USADE) ................................................................. 30 
 
Device Deficiency ............................................................................................................................ 30 
 Statistical Analysis .................................................................................................................................... 30 
 
Registry Hypotheses ....................................................................................................................... 30 
 
Sample Size Assumptions ............................................................................................................... 31 
 
Sample Size Determination ............................................................................................................. 31 
 
Randomization Scheme .................................................................................................................. 31 
 
Blinding Scheme ............................................................................................................................. 31 
 
Data Analysis .................................................................................................................................. 31 
 Timing of Analyses ............................................................................................................. 31 
 Analysis Populations ........................................................................................................... 31 
 Pooling of Data ................................................................................................................... 32 
 Statistical Analysis of Primary Endpoint(s)........................................................................... 32 
 Statistical Analysis of Secondary Endpoint(s) ...................................................................... 32 
 Ethical and Regulatory Considerations .................................................................................................... 32 
 
Statement of Compliance ................................................................................................................ 32 
 
Compliance Responsibilities ............................................................................................................ 33 
 
Informed Consent ............................................................................................................................ 33 
 
Regulatory Review .......................................................................................................................... 33 
 
Conflict of Interest ........................................................................................................................... 34 
 
Confidentiality ................................................................................................................................. 34 
 
Registry Discontinuation or Suspension ........................................................................................... 34 
 References ................................................................................................................................................. 36 
 
TABLE OF TABLES 
Table 1: Classification of Chronic Kidney Disease Based on Glomerular Filtration Rate .......................... 6 
 
TABLE OF FIGURES 
Figure 1: Peripheral Arterial Disease4 ...................................................................................................... 2 
Figure 2: Classification of Abdominal Aortic Aneurysms10 ........................................................................ 4 
Figure 3: Characteristics of the FEP Ringed GORE-TEX® Vascular Graft . Error! Bookmark not defined. 

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Figure 4: Characteristics of the GORE® INTERING® Vascular Graft ...................................................... 10 
Figure 5: Bifurcated GORE-TEX® Vascular Graft ................................................................................... 10 
Figure 6: Axillobifemoral GORE-TEX® Vascular Graft ............................................................................ 10 
Figure 7: Longitudinal View of the GORE® PROPATEN® Vascular Graft ............................................... 10 
Figure 8: Characteristics of the GORE® PROPATEN® Vascular Graft  (Non-integrated Ring 
Configurations) ...................................................................................................................................... 11 
Figure 9: Characteristics of the GORE® PROPATEN® Axillobifemoral Vascular Graft ............................ 11 
 
TABLE OF APPENDICES 
Appendix A: Eligibility Criteria with Justification / Rationale .................................................................... 38 
 

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Introduction 
 
Disease 
The GORE-TEX® Vascular Graft, GORE-TEX® Stretch Vascular Graft, GORE® 
INTERING® Vascular Graft, and GORE® PROPATEN® Vascular Grafts are clinically 
indicated in the treatment of applicable cardiovascular conditions, including occlusive or 
aneurysmal diseases, hemodialysis access, pediatric heart disease, and trauma. This 
retrospective registry is designed to investigate specific applications, including occlusive 
or aneurysmal disease and hemodialysis access in adults. Review of each condition is 
provided below. A separate protocol will investigate the use of the devices in pediatric 
heart disease. 
 Occlusive or Aneurysmal Disease 
 
Peripheral Artery Disease 
Atherosclerosis is a systemic disease of the large and medium-sized 
arteries causing vessel narrowing (focal or diffuse), a phenomenon 
which results from accumulation of immune cells, lipids, and fibrous 
material between the intimal and medial layers of the vessel.1,2 The 
subintimal accumulation of lipid and fibrous material can narrow the 
vessel lumen causing arterial stenosis or occlusion, or the plaque can 
rupture causing embolism or thrombosis. Multiple factors contribute to 
the pathogenesis of atherosclerosis, including endothelial dysfunction, 
dyslipidemia, inflammatory and immunologic factors, plaque rupture, 
and tobacco use. Atherosclerosis is the dominant etiology restricting 
arterial blood flow in the extremities, in comparison with diseases such 
as inflammation and thrombosis. Lower limb vessels are more 
frequently impacted than vessels in the upper extremities. 
Peripheral artery disease (PAD) principally arises as a result of 
atherosclerotic occlusion, a narrowing of the arteries in the lower 
extremities, impeding blood flow to the limbs.3 The most common 
location is femoropopliteal arteries, the loci in approximately 50% of 
retrospective review, with the exception of patients with early-onset 
PAD, for whom the aortoiliac segment is evidently the most prevalent 
location. Atherosclerosis in the lower extremities is a multisegmented 
disease in approximately two-thirds of symptomatic patients.  
The clinical manifestations of PAD depend upon the location and 
severity of arterial stenosis or occlusion and range from mild extremity 
pain with activity (i.e. claudication) to limb-threatening tissue necrosis. 
Acute limb ischemia of the lower extremity, one of the most common 
vascular emergencies, occurs with mortality and limb amputation rates 
as high as 20% to 40%. Other symptoms include rest pain, ulceration, 
and gangrene. Atherosclerosis in the aorta can also be associated with 
aneurysm. The pathology of aneurysmal disease is felt to be distinct 
from that of atherosclerosis; however, the clinical manifestations may 
overlap.  

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Figure 1: Peripheral Arterial Disease4 
Single-level disease (i.e. aortoiliac arteries, superficial femoral artery 
[SFA]) often manifests initially as claudication. Multilevel disease can 
manifest as claudication, when collateral circulation is adequate, but 
often manifests as ischemic rest pain or lower extremity ulceration 
when a well-developed collateral circulation is absent. Severe 
manifestations can occur without an intervening history of claudication, 
particularly in older patients with diabetes or chronic kidney disease. 
Symptoms of PAD (e.g. pain, pallor, pulselessness, poikilothermia, 
paresthesia, paralysis, etc.) for less than two weeks or less is 
considered acute limb ischemia (ALI).5 If these symptoms persist past 2 
weeks or nonhealing wound/ulcers, or gangrene is evident in 1 or both 
legs, the disease has progressed to chronic limb-threatening ischemia 
(CLTI, also referred to as critical limb ischemia [CLI]).5 
The overall prevalence of lower extremity PAD varies widely depending 
upon the population studied but is estimated to be approximately 10% 
of adults in the United States older than 55 years. Data from the 2010 
United States census suggested that the overall burden of PAD among 
adults in the United States is greater for women compared with men, 
with prevalence in women increasing further in women aged 70 years 
and older versus men of comparable age. Peripheral artery disease is 
more prevalent in African-Americans compared to the non-Hispanic 
white population, a distinction that is evidently only partly due to 
disparities in risk factors for atherosclerosis, with prevalence in women 
increasing further in women aged 70 years and older versus men of 
that age. African-Americans and Hispanic-Americans experience higher 
incidence of diabetes and hypertension in comparison with the white 
population in the United States.  
In Europe and North America, an estimated 27 million individuals are 
affected with approximately 413,000 inpatient admissions annually 

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attributed to PAD. The majority of individuals with PAD (70%) live in 
low/middle income regions of the world, including 55 million individuals 
in Southeast Asia and 46 million in the western pacific region. The 
number of individuals with PAD increased by 29 percent in low to 
middle income regions and 13 percent in high-income regions from 
2000 to 2010 compared with the preceding decade.  
The American College of Cardiology/American Heart Association 
(ACC/AHA) guidelines on PAD indicates that all adults over the age 
of 65 are at increased risk for PAD5. Adults between the ages of 50 and 
64 are at increased risk of PAD if they have one or more traditional risk 
factor for atherosclerosis or a family history of PAD.5 Any adult with 
diabetes mellitus and one or more concomitant risk factors for 
atherosclerosis is at increased risk for developing PAD.5 Traditional risk 
factors of atherosclerosis include hypertension, diabetes mellitus, 
history of smoking, hyperlipidemia.5 Individuals with established, 
clinically significant coronary artery disease or evidence of 
atherosclerosis in another vascular bed (e.g. coronary, carotid, 
subclavian, renal, mesenteric artery stenosis, or AAA) are also at 
increased risk for developing PAD.5 
 
Aneurysmal Disease 
An aneurysm is a segmental full thickness dilation of a blood vessel to 
150% or greater of the basal vessel diameter.6 True aneurysm involves 
distention of all 3 layers of the arterial wall such that the vessel adopts 
a dilated or balloon-like morphology in one or more section.7 This 
dilation typically occurs progressively, weakening the vessel wall and 
applying pressure to the perivascular tissue.8 Most aneurysms are 
asymptomatic and are discovered accidently during an unrelated 
exam.8 As they progress, however, the distension of the vessel can 
cause pain and  hemodynamic impairment which may be observed 
upon instrumentation of the vessel.7 At some point the weakened 
vessel may rupture which may, depending on the nature (contained or 
free), cause immediate cardiovascular compromise.7 Alternatively, the 
atherosclerotic lesion causing the aneurysm may rupture or dislodge, 
causing embolism in a distal vessel. If rupture results in bleeding into 
the retroperitoneal space, the symptoms may be confused with 
something else.  
The etiological mechanisms underpinning aneurysmal disease are 
thought to vary and are not fully understood.2,7 Aneurysms are thought 
to result from a pro-inflammatory vascular milieu coupled with local 
smooth muscle cell apoptosis and extracellular matrix degradation.9 
Atherosclerotic stenosis can activate the remodeling of the vascular 
wall which predisposes the artery to aneurysm. However, only a subset 
of aneurysms are attributed to atherosclerosis; others are driven by 
other processes such as vascular infection, embryological 
development, or hemodynamic stress.9  

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Aneurysms can form in any large vessel. Patients with a known 
aneurysm in one vessel (e.g. iliac, femoral, popliteal, aortic) are likely to 
develop or already have an aneurysm in another location.9 An 
estimated 85% of patients who present with a femoral artery aneurysm 
have concomitant abdominal aortic aneurysm (AAA).9 Additionally, up 
to 25% of patients that present with an abdominal aortic aneurysm 
present with a thoracic aortic aneurysm.9 
The abdominal aorta is defined as aneurysmal when a localized dilation 
is more than 50 percent larger than the normal aortic diameter. From a 
practical standpoint, an infrarenal aortic diameter greater than 3.0 cm 
(measured outer wall-to-outer wall) is considered aneurysmal for most 
individuals.10 AAAs are commonly described based on the relationship 
to the renal arteries as infrarenal, juxtarenal, pararenal, and suprarenal 
(Figure 2).10 
 
Figure 2: Classification of Abdominal Aortic Aneurysms10 
AAAs most often occur in the segment of aorta between the renal 
arteries and the bifurcation of the aorta.10 Only 5 percent of aortic 
aneurysms involve the renal or visceral arteries.10 Up to 40 percent of 
AAAs are associated with iliac artery aneurysm(s). The presence of 
iliac artery aneurysm may necessitate placement of a bifurcated graft. 
The extent of the aneurysm also affects the surgical approach.10 
Acute thoracoabdominal aortic aneurysm (TAAA) is a rare condition 
with exceptionally high mortality and morbidity.8 Thoracoabdominal 
aortic aneurysm accounts for approximately one third of aortic 
aneurysm admission; while incidence of aortic AAA appears to be 
decreasing, the incidence of TAAA is evidently on the rise.8  
The majority of patients who present with TAAA display no symptoms; 
TAAAs that do manifest symptoms are, on average, particularly large 
and at enhanced risk for rupture, thus accompanied by higher mortality 
rates than asymptomatic aneurysms.8 Symptoms include chest or 
upper back pain or symptoms consistent with compression of 
surrounding structures, such as hoarseness and diaphragm paralysis, 

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causing lack of nerve function or arterial compression resulting in 
ischemia or thromboembolism.8 Additional symptoms may be caused 
by aortic regurgitation or thromboembolism to almost any vascular bed, 
including coronary, cerebral, renal, mesenteric, lower extremity, and, in 
rare cases, spinal cord.8 Aortic dissection and rupture are the most 
serious potential complications. Symptoms of rupture are severe pain 
as well as hypotension or shock.8 
For a TAAA to be categorized as a true aneurysm, the diameter of the 
blood vessel must increase by at least 50% in relation to expected 
normal diameter and must affect all three layers of the arterial wall, 
intima, media and adventitia.8 “Thoracic aortic aneurysms are classified 
by location within the aorta, extent of aortic involvement, and 
morphology…[and] can be classified into four general anatomic 
categories; however, some aneurysms involve more than one segment: 
• 
Ascending aortic aneurysms arise anywhere from the aortic valve to 
the innominate artery (60 percent) 
• 
Aortic arch aneurysms include any thoracic aneurysm that involves 
the brachiocephalic vessels (10 percent) 
• 
Descending aortic aneurysms are those distal to the left subclavian 
artery (40 percent) 
• 
Thoracoabdominal aneurysms (10 percent)8  
• 
Complications of abdominal and thoracic aortic aneurysmal disease 
are a leading cause of death in the United States, especially in the 
population > 55 years of age.8 Risk factors of TAAAs are as follows: 
• 
Risk factors for atherosclerosis (e.g., smoking, hypertension, 
hypercholesterolemia). 
• 
Known aneurysm in the thoracic aorta or at other sites (e.g., 
abdominal aortic aneurysm). 
• 
Prior aortic dissection. 
• 
High-risk conditions – Marfan syndrome, Loeys-Dietz syndrome, 
vascular Ehlers-Danlos syndrome, Turner syndrome, or other 
connective tissue disease. Patients with these conditions may have 
a known mutation in genes known to predispose to TAAA (FBN1, 
TGFBR1, TGFBR2, ACTA2, and MYH11). 
• 
Known aortic valve disease (e.g., bicuspid aortic valve, aortic valve 
replacement, or aortic stenosis). 
• 
Family history of aortic dissection or thoracic aortic aneurysm. 
• 
Cerebral aneurysm.8 
Peripheral aneurysm resulting from arterial degenerative disease are 
rare, with a reported incidence of 0.1% to 2%.11 Examples include 
hepatic, celiac, renal, splenic, superior and inferior mesenteric artery 
aneurysms, and splenic artery aneurysms (SAAs). Among peripheral 
aneurysms, SAAs are the most prevalent aneurysms and are the third 

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most prevalent abdominal aneurysms after aortic and iliac artery 
aneurysms.3 Family history and smoking increase the risk of developing 
peripheral aneurysms; comorbidity of an existing peripheral aneurysm 
exacerbates the risk of developing another peripheral aneurysm in an 
additional location. 
 Hemodialysis Access 
Chronic kidney disease (CKD) is an international health problem that affects 
millions of people. Several common risk factors can impact CKD, including 
diabetes, obesity, and hypertension. Chronic kidney disease is classified into 5 
stages (Table 1); but renal insufficiency is limited to stages 3 to 5, with a 
glomerular filtration rate (GFR) below 60 ml/min per 1.73 m2 for 3 months or 
more.12 End Stage Renal Disease (ESRD), Stage 5, is the most severe, and is 
characterized by a GFR below 15 ml/min per 1.73 m2.12 End Stage Renal Disease 
has 2 phases: 1) Conservative treatment without dialysis and 2) Renal 
Replacement Therapy (RRT), in the form of either dialysis or kidney 
transplantation. The number of patients per year starting RRT has shown an 
exponential rise, with incidence (per million population) increasing between 2002 
and 2006 from 333 to 360 in the United States (US), from 262 to 275 in Japan, and 
from 94 to 115 in Australia. The incidence in Europe, unlike other reported regions, 
has held constant during the time frame with incidence of 129 per million.12 The 
prevalence of patients undergoing RRT is also rising, likely due to the increase in 
the number of patients who start RRT each year and/or due to the increased 
survival of patients with ESRD. Registries of ESRD patients undergoing RRT can 
be used to identify patient demographics and treatment modality, with 70% of RRT 
patients in the US being treated by dialysis and 30% receiving a kidney transplant. 
Diabetes causes 44% of new ESRD cases in the US and hypertension accounts 
for 27.9% of cases. The elderly population recently accounted for 25-30% of 
ESRD population requiring RRT.12  
Table 1: Classification of Chronic Kidney Disease Based on Glomerular Filtration Rate 
Stage 
Description 
GFR mL/min/1.73 m2 
1 
Kidney damage with normal or elevated GFR 
90+ 
2 
Kidney damage with mildly decreased GFR 
60-89 
3 
Moderately decreased GFR 
30-59 
4 
Severely decreased GFR 
15-29 
5 
End Stage Renal Disease (ESRD) 
< 15 or on dialysis 
 
Historical Treatments  
 Occlusive or Aneurysmal Diseases 
 
Summary of Treatment Options for Occlusive Disease 
Several treatments and procedures are employed in the treatment PAD 
and conditions such lower limb ischemia and femoropopliteal (FP) 
occlusions. Interventions include open surgical repair, endarterectomy, 
endovascular treatment, balloon angioplasty and stents (drug coated, 

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drug eluting, non-drug coated, covered, bare metal). According to 
Farber et al.,13 little scientific data is available to identify the optimal 
revascularization strategy, hence the variability and equipoise in the 
treatment. Open vascular surgery and endovascular therapy play key 
roles in the treatment of this disease. 13  
Recommended medical therapy involves reducing risk factors for 
atherosclerosis.14 These recommendations include smoking cessation, 
healthy diet and physical activity, statin therapy to control lipid levels. 14 
It is recommended that patients with diabetes should maintain strict 
glycemic control. 14 Those with hypertension should control blood 
pressure (to less than 140/90 mmHg) using angiotensin-converting 
enzyme inhibitor and angiotensin-receptor blockers as a first-line 
therapy. 14 
Treatments for PAD include lifestyle interventions (e.g. exercise), 
pharmacological interventions, percutaneous or endovascular 
interventions or open surgical interventions.3 These interventions can 
be used individually to treat disease or in combination.3 
Pharmacological treatments are primarily intended to mitigate risk 
factors of atherosclerosis to stop the progression of disease and to 
provide symptom relief.3 Noninterventional treatments can significantly 
slow the progression of the disease and allow patients to maintain a 
high quality of life.3 However, in a significant minority of patients (20% 
to 30%) disease progression will cause a significant reduction in 
function and quality of life, warranting intervention.3 The American 
College of Cardiology (ACC) and American Heart Association (AHA) 
indicate that surgical intervention is reasonable when guideline-directed 
management and therapy lose efficacy and the sequelae becomes life 
limiting.5  
The Clinical guidelines addressing treatment of PAD offer guidance on 
what patient and disease conditions are preferentially treated with 
either endovascular or open surgery.  
Generally, the clinical guidelines recommend endovascular procedures 
over open procedures for small and localized occlusive disease. 
However, open interventions are appropriate and recommended in 
several clinical scenarios. Several factors should be considered when 
choosing whether to proceed with surgical revascularization or an 
endovascular approach for treating CLTI. These factors include the 
position of the lesions, the severity of disease, and the presence of 
comorbidities which may increase the risk of surgery. 
 
Summary of Treatment Options for Aneurysmal Disease 
Professional medical societies publish consensus statements and 
guidelines that contribute supportive information regarding the 
treatment of aortic aneurysms, using the available literature and their 

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practical expertise to craft documents that are based on the best 
judgement of subject matter experts.  
Non-Surgical Treatment Options 
Patients with asymptomatic aortic aneurysms are presented with 
several preventative and interventional treatment options before 
surgical consideration. Smoking cessation, a level 1 recommendation 
from the Society of Vascular Surgeons (SVS) and a class I 
recommendation from the European Society of Vascular Surgery 
(ESVS), has been shown to reduce the risk of aortic aneurysms and 
has been recommended for patients with aortic aneurysms or patients 
with a family history of aortic aneurysms.15, 16 Similarly, a general 
reduction in risk factors may benefit patients with aortic aneurysms; 
treatment of hypertension, hyperlipidemia, diabetes, and atherosclerotic 
disease reduce mortality rates.15 Lifestyle changes such as improved 
diet and regular exercise should also be considered.16 Patients also 
have the option of pharmacological intervention with blood pressure 
medications, statins, doxycycline, roxithromycin, ACE inhibitors, 
angiotensin receptor blockers, and antiplatelet therapies; however, 
these are not recommended for the primary purpose of reducing 
aneurysm size. 15,16  
Surgical Treatment Options 
Before the introduction of endovascular aneurysm repair (EVAR) in 
1991, open surgical repair was the only option for aortic aneurysm 
intervention; currently, open repair is largely reserved for patients that 
do not meet the anatomic requirements for EVAR.15, 16 During 
endovascular repair, a stent graft is percutaneously inserted into the 
aorta through the femoral artery. It is then expanded at the aneurysm 
site so that the blood flow is excluded from the aneurysm sac. EVAR 
uses local anesthetic, which makes it a better treatment option for 
patients contraindicated for general anesthesia.15 Although EVAR is 
associated with a higher rate of reintervention than open surgery, 
EVAR is better than no intervention as it improves the survival rate for 
patients with aortic aneurysms that have been considered unfit for 
surgery. 15,16 The SVS and ESVS acknowledge the decrease in annual 
deaths caused by aneurysm rupture since the introduction of EVAR 
while similarly praising the increase in elective repair. 15,16 
Grading of Recommendations Assessment, Development, and 
Evaluation (GRADE) evidence based recommendations suggest that 
either open repair or EVAR may be used to treat unruptured aneurysm 
and the final choice should be dependent on surgical risk, aortic 
anatomy, age, and personal preference.17 
Clinical guidelines addressing surgical treatment of AAA and aorto-iliac 
aneurysms offer guidance on what patient and disease conditions are 
preferentially treated with either endovascular or open surgery. 

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 Hemodialysis Access 
Patients who have ESRD will ultimately require hemodialysis, which is a critical 
treatment for survival. In order to provide adequate dialysis, implantation of a 
vascular conduit is required. Vascular access can be one of the most challenging 
aspects of RRT; and if the vascular access is malfunctioning, hemodialysis may 
not be possible. Three modalities of vascular access used for hemodialysis are 
central venous catheters (CVC), arteriovenous grafts (AVG), and autologous 
arteriovenous fistulae (AVF).18  
An AVF is a surgically created anastomosis between a vein and an artery, with the 
vein serving as the accessible conduit. The vein portion of the fistula will grow in 
diameter and the wall will begin to thicken as it matures, allowing cannulation with 
hemodialysis needles, also allowing for sufficient blood flow for hemodialysis. 
United States guidelines recommend the most distal region in the upper 
extremities be utilized first for vascular access (e.g. wrist [radiocephalic], elbow 
[brachiocephalic] and transposed brachial basilic vein).19 An AVG is similar to an 
AVF; in AVG, however, a surgically implanted vascular graft connects the artery to 
the vein. The third option for vascular access is a CVC, a catheter inserted into a 
large vein, generally either in the neck or chest. Hemodialysis catheters frequently 
require a cuff to be placed under the skin to aid in holding the catheter in place. 
 
Registry Device Description 
 GORE-TEX® Vascular Grafts  
The GORE-TEX® Vascular Graft, GORE-TEX® Stretch Vascular Graft, and GORE® 
INTERING® Vascular Graft devices, manufactured by W. L. Gore & Associates, 
Inc., (Gore), collectively referred to as the GORE-TEX® Vascular Graft, is a 
synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a 
reinforcing film for radial strength. Certain configurations of the GORE-TEX® 
Vascular Graft contain removable or nonremovable fluorinated ethylene propylene 
(FEP) rings for additional compression resistance. GORE-TEX® Vascular Grafts 
are intended for use as vascular prostheses for replacement or bypass of diseased 
peripheral vessels in patients suffering occlusive or aneurysmal diseases, in 
trauma patients requiring vascular replacement, for patients with ESRD requiring 
dialysis, or for pediatric heart disease. They can be used to improve blood flow to 
tissue or organs that are supplied by damaged vessels, provide vascular access 
for hemodialysis, or to create a shunt for palliative care of patients with cyanotic 
congenital heart disease.  
Certain configurations of the GORE-TEX® Vascular Graft contain FEP rings for 
additional compression resistance (Error! Reference source not found.). Such 
grafts are configured with either fixed (non-removable) rings or removable rings. 
Grafts with removable rings possess an additional layer of ePTFE film applied 
longitudinally to the graft between the radial reinforcing film and the FEP rings. 
 
 

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1 Expanded PTFE base tube 
2 Expanded PTFE thin film 
3 Longitudinal film (*removable ring versions only) 
4 FEP ring or removable ring versions 
 
1 Expanded PTFE base tube 
2 Expanded PTFE thin film 
3 Integrated rings 
4 Total graft length 
5 The standard ring length configuration 
Figure 3: Characteristics of the GORE® INTERING® Vascular Graft 
Bifurcated vascular grafts are characterized by a primary vessel that branches into 
two smaller vessels. Although the basic structure of bifurcated vascular grafts is 
similar to other ePTFE vascular grafts, these grafts possess a trunk and two legs 
(Figure 4).  
 
Figure 4: Bifurcated GORE-TEX® Vascular Graft 
Axillobifemoral vascular grafts are characterized by a primary ePTFE graft to 
which another ePTFE graft is attached with an end-to-side anastomosis (Figure 5). 
Currently, all axillobifemoral vascular grafts are configured only as standard wall 
thickness and with removable rings.  
 
Figure 5 : Axillobifemoral GORE-TEX® Vascular Graft 
More detailed device information can be found in the Instructions for Use (IFU) and 
Investigator’s Brochure (IB). 
 GORE® PROPATEN® Vascular Graft  
The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an ePTFE 
tube with a reinforcing film for radial strength. GORE® PROPATEN® Vascular 
Grafts have the feature of being extensible in the longitudinal direction. The 
luminal surface of the vascular graft is coated with the CBAS® Heparin Surface, as 
illustrated in Figure 6. 
 
Figure 6: Longitudinal View of the GORE® PROPATEN® Vascular Graft 
The GORE® PROPATEN® Vascular Graft features the CBAS® Heparin Surface, a 
coating technology incorporating stable, covalent, end-point attached heparin of 
porcine origin. This technology consists of CBAS-heparin covalently attached to a 
polymeric base matrix consisting of polyethyleneimine (CBAS-polymin) and 
dextran sulfate. The CBAS® Heparin Surface uses a proprietary covalent end-point 
bond that preserves the active site of the heparin molecule, thus retaining 

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heparin’s anticoagulant activity. CBAS-heparin, the active constituent of the 
CBAS® Heparin Surface, imparts thromboresistant properties to the device. 
Certain configurations of the GORE® PROPATEN® Vascular Graft contain FEP 
rings for additional compression resistance (Figure 7). Such grafts are configured 
with either fixed (non-removable) rings or removable rings.  
 
1 Expanded PTFE base rube 
2 Expanded PTFE thin film 
3 Longitudinal film (*removable ring versions only) 
4 FEP ring or removable ring versions 
5 CBAS® Heparin Surface 
Figure 7: Characteristics of the GORE® PROPATEN® Vascular Graft  
(Non-integrated Ring Configurations) 
The GORE® PROPATEN® Axillobifemoral Vascular Graft is characterized by a 
primary ePTFE graft to which another ePTFE graft is attached with an end-to-side 
anastomosis (Figure 8). Currently, all axillobifemoral vascular grafts are configured 
only as standard wall thickness and with removable rings. The luminal surface of 
the vascular graft is coated with the CBAS® Heparin Surface. 
  
1 Graft described in Figure 8– removable ring configuration 
2 ePTFE sutures  
3 Medical grade silicone 
Note: The angle shown will be 90°. 
Figure 8: Characteristics of the GORE® PROPATEN® Axillobifemoral Vascular Graft 
More detailed device information can be found in the Instructions for Use (IFU) and 
Investigator’s Brochure (IB). 
 
Pre-clinical Data 
Gore has performed the following pre-clinical testing on GORE-TEX® Vascular Grafts and 
GORE® PROPATEN® Vascular Grafts: 
1. in vitro testing;  
2. biocompatibility testing per ISO 10993-1; 
3. in vivo animal studies. 
 
Clinical Data 
Both GORE® PROPATEN® Vascular Grafts and Thin Walled GORE-TEX® STRETCH 
Vascular Grafts were previously studied in the GORE-TEX PROPATEN Vascular Graft 
Study, which completed enrollment in 2006. PPT 01-04 was an Investigational Device 
Exemption (IDE) conducted in the United States (reference #G020203). More information 
can be found on Clinicaltrials.gov. 
 
Registry Objectives 
 
Primary Objective(s) 

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The primary objective is to confirm the clinical performance and safety of GORE-TEX® 
Vascular Grafts and GORE® PROPATEN® Vascular Grafts throughout the device 
functional lifetime for each indication area; peripheral artery disease (PAD), aortic 
aneurysms, and dialysis access. 
Cohorts including PAD, aortic aneurysm, and dialysis access represent applicable patient 
populations for these disease states. Appropriate sample sizes were calculated per cohort 
based on safety and performance acceptance criteria as part of the clinical evaluation 
process under European Medical Device Regulation (MDR). Statistical justifications were 
based on anticipated outcomes, and sample sizes were planned to estimate the same 
outcomes with determined level of accuracy. 
 
Health Economic Data Analysis 
A Health Economic analysis will be performed using clinical registry data. The objective of 
the Health Economic analysis is to understand the value of the treatment(s) studied during 
the period of the registry. 
 
Registry Design 
 
Registry Design Schema 
--REDACTED-- 
 
 

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Description of Registry Design 
This multicenter, single-arm retrospective registry (chart review) is being conducted to 
confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® 
PROPATEN® Vascular Graft throughout the device functional lifetime for each indication 
area. A single arm design was chosen as the registry is intended only to add to existing 
data and literature on the study populations and devices. A retrospective registry was 
determined to be an appropriate design for post-market clinical data collection based on 
consistency of device design, procedures, clinical results available in literature and 
operative techniques. 
Up to 9 sites in Europe will be required to enroll 353 patients that have had treatment with 
GORE-TEX® Vascular Grafts or GORE® PROPATEN® Vascular Grafts in the following 
indication areas: 
• 
144 patients in PAD Cohort 
o 72 Patients with any GORE-TEX® Vascular Graft 
o 72 Patients with GORE® PROPATEN® 
• 
65 patients in Aortic Aneurysm Cohort with GORE-TEX® Vascular Graft 
• 
144 patients in Dialysis Access Cohort 
o 72 patients implanted with any GORE-TEX® Vascular Graft 
o 72 Patients implanted with Patients with GORE® PROPATEN® 
Each site cannot contribute to more than 25% of the total patient for each cohort without 
sponsor approval, with a maximum of 50% of total enrollment for a single site. See section 
4.1 for more details. 
The Sponsor or designee will maintain an updated list of all principal investigators, site 
names, and addresses. This list shall be kept separately from this protocol. 
Subjects may be enrolled when all inclusion and no exclusion criteria are met as specified 
in section 4.2 for each indication for use. Patients are enrolled into the registry when they 
provide consent or consent is waived and meet all inclusion and exclusion criteria. 
Subjects’ medical records will be reviewed by the investigator and specific data will be 
collected retrospectively for up to 5 years of follow-up from the index procedure for 
subjects in the PAD and aortic aneurysm cohorts and up to 2 years for subjects in the 
dialysis access cohort.  
 Management of potential confounding factors / bias 
Bias will be controlled by strict adherence to the registry protocol. Sites will be 
monitored for compliance with registry protocol, including subject eligibility criteria, 
as allowed by EC regulations. In order to minimize selection bias, it is mandatory 
that the enrollment of patients will be consecutive in nature based on the date of 
the index procedure. Gore has put in place quality control in order to ensure that 
no selection bias is applied by the site during patient screening, please see section 
5.4 for more details. 

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The registry is meant to retrospectively collect data for descriptive reporting as well 
as evaluate “real world” experience of clinical practice and patient outcomes during 
treatment and throughout follow-up extending up to 2-5 years, by cohort. Patient 
selection, diagnostic imaging and treatment interventions will be determined by 
physicians based on this protocol and clinical practice standards. 
It is well known that excluding treated patients who are deceased or not reachable 
at the time of the inclusion due lack of informed consent can generate an important 
selection bias in retrospective study and is likely to seriously prevent the 
achievement of the research objectives. Therefore, for patients, who are deceased 
or not reachable at the time of the inclusion, the consent can be waived, according 
to national and local regulation. Refer to section 5.2 regarding the waived process. 
 
Registry Endpoint(s) 
 Definitions 
Outcome 
Definition 
Primary Patency 
 
Aortic Aneurysm / 
PAD Cohort 
Patency of the study graft without additional or secondary 
surgical or endovascular procedures to maintain or restore 
flow to the graft. The only exceptions that do not disqualify 
the graft for primary patency are procedures performed for 
disease beyond the graft and its two anastomoses. 
Dialysis Access 
Cohort  
Interval following intervention until the next access 
thrombosis or repeated intervention. 
Secondary Patency 
 
Aortic Aneurysm / 
PAD Cohort 
Patency of the study graft with additional or secondary 
surgical or endovascular procedures to restore flow to the 
graft after occlusion or stenosis of the graft or its 
anastomoses  
The only exceptions that do not disqualify the graft for 
secondary patency are procedures performed for disease 
beyond the graft and its two anastomoses 
Dialysis Access 
Cohort 
Patency of the study graft from the time of access creation 
or placement until access abandonment 
Limb Salvage 
Freedom from an amputation above the level of the ankle of 
the index limb 
Amputation Free survival 
Freedom from an amputation above the level of the ankle of 
the index limb or all cause death 
Device-related seroma 
or infection 
PAD Cohort 
Clinical evidence of an infectious process in the direct 
vicinity of the access site or distal to the treated vascular 
site or seroma classified by the registry investigator as 
primarily related to the registry device 

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Device-related infection 
requiring reoperation 
PAD Cohort 
Clinical evidence of an infectious process in the direct 
vicinity of the access site or distal to the treated vascular 
site classified by the registry investigator as primarily related 
to the registry device and required surgical intervention 
Device-related infection  
Dialysis Access Cohort 
Clinical evidence of an infectious process in the direct 
vicinity of the access site classified by the study investigator 
as primarily related to the study device 
Survival 
All Cause survival 
Device-related Adverse 
Events 
Any untoward medical occurrence classified by the registry 
investigator as primarily related to the registry device 
 Primary Endpoints 
 
Peripheral Artery Disease Cohort 
• 
Primary Safety Outcome: Device-related seroma or infection 
through 5 years 
• 
Primary Performance Outcome: Secondary patency 
(revascularization) through 5 years 
 
Aortic Aneurysm Cohort 
• 
Primary Safety Outcome: Survival through 5 years 
• 
Primary Performance Outcome: Primary patency through 5 years 
 
Dialysis Access Cohort 
• 
Primary Safety Outcome: Device-related infection through 2 years  
• 
Primary Performance Outcome: Useable access circuit (reported as 
secondary patency) through 2 years 
 Secondary Endpoints 
 
Peripheral Artery Disease Cohort 
• 
Limb Salvage through 1 year 
• 
Amputation-free survival through 1 year 
• 
Device-related Adverse Events through 1 year 
• 
Device-related infection requiring reoperation through 5 years 
• 
Primary Patency through 1 year 
 
Dialysis Access Cohort 
• 
Primary patency through 1 year 
• 
Device-related adverse events through 1 year 
No secondary endpoints have been identified for the Aortic Aneurysm 
Cohort. 
 
 

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Study Population 
 
Description of Population 
The study population will consist of three cohorts. Patients that have had treatment with 
GORE-TEX® Vascular Grafts or GORE® PROPATEN® Vascular Graft for PAD, aortic 
aneurysms, or dialysis access are eligible for consideration for enrollment in the registry.   
 
Cohort 
Treatment 
period 
FU period after 
index procedure 
(years) 
Number patients 
Cap per site** 
(patient) 
PAD 
at least 5 years 
before site 
initiation 
5* 
72 Patients with any 
GORE-TEX® Vascular 
Graft 
18 (25%)  
36 (50%) 
72 Patients with 
GORE® PROPATEN® 
18 (25%)  
36 (50%) 
Aortic 
Aneurysms 
at least 5 years 
before site 
initiation  
5* 
65 with GORE-TEX® 
Vascular Graft 
16 (25%) 
33 (50%) 
Dialysis Access 
at least 2 years 
before site 
initiation 
2* 
72 Patients with any 
GORE-TEX® Vascular 
Graft 
18 (25%)  
36 (50%) 
72 Patients with 
GORE® PROPATEN® 
18 (25%)  
36 (50%) 
* Subject who died before the end of FU period will be not excluded from the registry.  
** Site cannot enroll more than 25% of the total patients in each indication without sponsor 
approval. With sponsor approval, a single site may enroll a maximum of 50% of total patients. 
Study staff will review patients’ medical records to identify eligible patients for this 
retrospective data collection. The registry has been designed with standard eligibility 
criteria to enroll subjects for which the registry device has been intended to treat. Two sets 
of inclusion and exclusion criteria have been identified: general and cohort-specific 
criteria. Only patients who meet all of the inclusion criteria and none of the exclusion 
criteria (general and cohort-specific) will be included in the registry. A subject cannot be 
included in more than one cohort. 
No vulnerable populations are included in this registry. 
 
Inclusion Criteria 
The Inclusion Criteria reflects the potential broad application of the device as evaluated by 
the medical judgement of the implanting physician. Inclusion Criteria will be evaluated at 
the time of initial identification as part of the retrospective device-use search using the 
patient health status at the time of the index procedure. 
 General Inclusion Criteria 
1. Patient is willing and able to provide written informed consent or consent is 
waived, according to national and local regulations. 
2. Patient was at least 18 years of age at the time of implant. 
 
 

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 PAD Cohort Inclusion Criteria 
1. Patient was treated for peripheral arterial disease or peripheral arterial 
aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® 
INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® 
PROPATEN® Vascular Graft at least 5 years before site initiation. 
 Aortic Aneurysm Cohort Inclusion Criteria  
1. Patient underwent simultaneous or staged aortic aneurysm repair (open 
surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® 
INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft at least 5 
years before site initiation. Research device could have been used to replace 
or bypass either a diseased visceral branch or the aorta itself. 
 Dialysis Access Cohort Inclusion Criteria 
1. Patient required the creation of a vascular access graft for hemodialysis 
secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® 
Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch 
Vascular Graft or GORE® PROPATEN® Vascular Graft at least 2 years before 
site initiation with the intent to cannulate the registry device. 
 
Exclusion Criteria 
 General Exclusion Criteria 
1. Patient was not available for follow up (on-site or remotely) at the clinical site, 
with the exception of death (e.g., patient lost to follow-up immediately after 
treatment, patients who live far away from the clinical site and are not available 
to share follow-up data performed locally). 
2. At the time of treatment, patient had known coagulation disorders, including 
hypercoagulability, that were not amenable to treatment. 
3. Patient was pregnant at the time of treatment. 
4. Patient had known or suspected systemic infection or infection at the site of 
graft implantation at the time of implant. 
5. Patient had a separate major interventional or surgical vascular procedure 
within 30 days prior to treatment. CVC catheter placement would be permitted. 
6. Patient is already enrolled in this registry under a different cohort. 
 PAD Cohort Exclusion Criteria 
At the time of treatment, the patient must not have met any of the following criteria: 
1. Patient had percutaneous transluminal angioplasty (PTA) or stenting of the 
target artery at the anticipated site of the proximal or distal anastomosis within 
30 days prior to the index procedure. Use of PTA or stenting during the index 
procedure is permitted. 
2. Patient had a stroke or myocardial infarction (MI) within 6 weeks prior to the 
index procedure. 
3. Patient has previous instance of Heparin-induced Thrombocytopenia type 2 or 
has known hypersensitivity to heparin. 
4. Patient required composite bypass for index procedure (graft + significant 
length of autologous vessel). Autologous “cuffs” or patches are allowed. 

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 Aortic Aneurysm Cohort Exclusion Criteria 
At the time of treatment, the patient must not have met any of the following criteria: 
1. Patient required emergency surgery due to aneurysm rupture. 
 Dialysis Access Cohort Exclusion Criteria 
At the time of treatment, the patient must not have met any of the following criteria: 
1. The patient had a previous documented and unsuccessfully treated ipsilateral 
central venous stenosis via imaging technique. 
2. The patient was taking maintenance immunosuppressant medication at the 
time of implant such as rapamycin, mycophenolate or mycophenolic acid, 
prednisone (> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide. 
3. The patient has had a previous instance of Heparin-Induced 
Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. 
A rationale for each inclusion / exclusion criterion is located in Appendix A. 
 
Registry Procedures / Evaluations 
No product- or procedure-related training is required, as the registry is designed to collect 
pseudo-anonymized clinical follow-up, procedure, demographic (including medical history), and 
device characteristic data from the patient’s medical record.  
Subjects were followed per clinical routine practices and this retrospective approach does not 
impact the future routine clinical treatment at the site. For this registry it is expected that the sites 
will follow this protocol to ensure scientifically sound evaluation of outcomes. There are no 
additional, known or foreseeable factors that may compromise the outcome of the registry or the 
interpretation of results; please refer to section 3.2.1 regarding minimization of bias. 
 
Schedule of Events 
Retrospective data collection only. Refer to section 5.8 for more details. 
 
Informed Consent Process 
For the inclusion of patients in the registry, the investigator should review all 
inclusion/exclusion criteria and, in the case of including patients who are alive and 
reachable at the site, the patient will be required to sign the Informed Consent Form (ICF) 
before enrolment in the registry. 
As this study is retrospective and considering the nature of patient’s disease, some 
patients may have died by the time they are included. The investigator is expected to 
make reasonable efforts to contact the potential patient, such as checking whether they 
are still alive, browsing through their clinical records, contacting available telephone 
numbers, or obtaining contact information from population and/or health care registers. If, 
after reasonable effort, the patients are found to be deceased or not reachable, the 
request for informed consent can be waived in accordance with national and local 
legislation.  
If, during the course of the registry, patients who were not previously reachable come 
back to the clinical site for a visit, the investigator is expected to collect informed consent 
from those patients. 
To protect patient privacy, patient-identifiable information (e.g., name, initials, complete 
birth date, and race) will not be collected.  

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The informed consent form will include emergency contact details for any concerns. The 
case history (i.e., source documents / subject chart) for each subject shall document that 
such informed consent was obtained, if this was obtained remotely or if the consent was 
waived. In case the consent was waived, the reason must be clearly described in the 
source document.  
The 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 signed informed 
consent document will be given to the subject for their records.  
For France only. According to Méthodologie de référence MR-004, applicable for this 
retrospective registry, the investigator has to inform all pre-identified patients (all patients 
present in the pre-screening log) about this registry, and in particular their right to oppose 
the processing of their data for the scope of this registry. Regarding the processing of data 
of deceased persons, investigator has to make sure that the patient had not objected to it 
during his lifetime in writing. If not, the personal data concerning him will be collected for 
the scope of this registry. In this context, an Information and Non-opposition letter is 
prepared and sent to all patients present in the pre-screening log. The data collection will 
not begin until one month after the investigator sent out the non-opposition letter, to give 
time to the patient to read and, eventually oppose in writing his/her participation in this 
registry.  
 Remote Collection of the Informed Consent Form 
Considering the low risk (see section 8, Risk Assessment) of this retrospective 
registry and the absence of registry-specific procedure for the patient, the remote 
collection of the informed consent will not adversely affect the rights and welfare of 
the patients. 
In case the patient is unable to come to the hospital (e.g., COVID-19 pandemic, 
moved to another area, logistics, etc.), the discussion and collection of the consent 
may take place by a means other than a face to face (e.g., mailing consent 
documents to potential participants and discussing the registry and consent 
document via phone) per local regulations. 
Specific procedures to ensure adequate documentation of prospective informed 
consent process, in accordance with regulation and best clinical practice, will be 
provided to the investigators in a separate document. 
 Vulnerable Populations 
No patients deemed to be of a vulnerable population may be enrolled. 
 Emergent Cases 
Not applicable due to retrospective nature of the registry. 
 
Pre-Screening 
Sites are expected to perform a search of patients treated with the registry devices within 
the hospital database following the site initiation performed by Gore. Upon site activation, 
the site staff will search in the hospital database patients who were treated with registry 
devices for each indication, representing patients meeting Inclusion #1 for each cohort. 
This search is based on the information already present in the patient medical record. 

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The research results will be recorded in the Pre-screening log and ordered based on 
patient’s date of index procedure. 
The pre-screening log produced with this research must be maintained at the site in order 
to document the reasons for exclusion for any patient preventing bias of the data. This list 
cannot be shared with Gore/other external individuals (CRO), but are only available at the 
site in the study binder for audit/inspection purposes.  
 
  
  
 
Enrollment  
Patient enrollment should be consecutive and beginning with patients with most recent 
treatment date and working towards earlier patients. The site should review batches of 15 
consecutive patients at a time until site or study cap is reached.  From the pre-screening 
log (sorted by most recent treatment date), the site should review the patients charts 
against inclusion and exclusion criteria, then check whether the patients are still alive and 
reachable in order to obtain consent. The patient is considered enrolled when informed 
consent is obtained or consent if waived.  

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Only patients enrolled in the study will be recorded in the EDC until the site reaches the 
max cap of enrolled patients planned for this study or until the cohort is completed. 
If a patient identified in the pre-screening list will not be enrolled, only the principal reason 
will be recorded in the patient screening and enrollment log. 
During the on-site monitoring visit, the CRA should review the Pre-screening log and 
Subject Screening and Enrollment log against the subjects recorded in the EDC, in order 
to prove the enrolment occurred sequentially, with the purpose of minimizing selection 
bias. 
Patients cannot be enrolled in more than one cohort. Before enrolling a patient, sites 
should review the patient chart to confirm the patient is not eligible for more than one arm. 
If the patient is eligible for more than one arm (i.e. AAA & PAD), sites should enroll 
patients into the arm with the earliest treatment date. 
 
Screening 
Formal screening will not be performed due to retrospective nature of this registry.  
No screening procedures are performed, with exception of reviewing of the inclusion and 
exclusion criteria based on the information already present in the patient’s medical record. 
 
Screen Failure 
For clarity, this registry defines screening failure as subjects from the pre-screening log who 
do not meet Inclusion/Exclusion criteria or declined consent. 
However, if after the collection of the consent, the subjects do not meet eligibility criteria, 
the primary reason for screen failure will be documented and retained in registry records. 
The subject will be excluded from the registry and a replacement subject may be enrolled. 
Screening failure subject after obtaining ICF signature will be recorded in the EDC. 
 
Randomization and or Blinding 
No randomization or blinding is to be performed due to the confirmatory nature of the 
registry design. 
 
Procedure 
The registry procedures consist only of the collection of retrospective data from the source 
documents available at the site. Diagnostic imaging, treatment interventions, and follow up 
will be determined by physicians based on clinical practice standards. 
 Subject Chart Review 
The chart reviews will be conducted by the investigator or a trained study coordinator at 
each site. Records from all patients who underwent treatment with GORE-TEX® Vascular 
Grafts or GORE® PROPATEN® Vascular Grafts for PAD, aortic aneurysms, or dialysis 
access will be identified for further screening according the inclusion and exclusion 
criteria.  
Those subjects meeting all of the inclusion criteria and none of the exclusion criteria will 
be considered for data collection. 
 
 

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 Data Elements 
The following clinical routine data will be recorded in the registry database from the 
existing medical records of enrolled subjects. 
• 
Subject information and Demographics (Age and sex) 
• 
Medical History 
• 
Index procedure information 
• 
Discharge information 
• 
Follow-up data, including (antiplatelet and anticoagulant therapy) and imaging 
reports (no imaging will be collected) 
• 
Adverse events  
• 
Device Deficiency 
• 
Repeat Intervention 
• 
Death or discontinuation 
 
Repeat Interventions 
Reinterventions may have been performed at the discretion of the investigator to treat AEs 
or maintain device performance. Any reinterventions performed will be documented on the 
CRF form. The components used as part of the reintervention, the date of the 
reintervention, procedural data and any AEs leading to reintervention will also be 
documented on the CRF form.  
 Follow Up 
No on-site follow-up is required after the subject is included in the registry, as the registry 
consists of retrospective data collection only. 
Follow-up data will be collected from the information already present in the medical chart 
at least to 5 years from the index procedure for the PAD and aortic aneurysm cohort and 
at least to 2 years for the dialysis access cohort. This data should include any adverse 
events, repeat interventions, and records of office, telephone, or imaging visits. No 
imaging will be collected for this registry. 
In case the site recognized that the enrolled subject does not have data available 
regarding the last FU visit specified in the protocol, site should enter the next follow up 
data available (i.e. if a patient did not come in at year 5, but came in at year 6, year 6 data 
should be entered). If no follow up visit data is available, site staff should collect and 
document any past safety data (SAE, re-intervention, hospitalization, death, etc.) through 
the end of the follow up period specified for the cohort.  If consent is waived, the site 
should contact relatives or general practitioner by phone to collect this data. 
 
 

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 Subject Withdrawal from the Registry 
Subjects who are alive at the time of their enrollment in the registry can withdraw from the 
registry without indicating any reasons at any time. No additional data will be collected 
and reported into the registry database after consent withdrawal. The sponsor may retain 
and continue to use any data collected before the withdrawal of consent, if not explicitly 
requested otherwise by the subject. 
A replacement subject may be enrolled in rare event that a subject decides to withdraw 
from the registry before all follow-up visits have been recorded in the EDC. 
 Subject Lost to Follow Up 
No subject lost to follow up are expected in this registry. According to General Exclusion 
criterion #1, subjects with no follow-up after treatment should not be included in the 
registry. All subjects that complete at least one follow-up after treatment will be enrolled. 
 Subject Registry Completion 
A subject has completed the registry when the all expected follow-up visits have been 
completed and properly recorded in the EDC. Any subject who does not complete these 
requirements due to voluntary withdrawal, physician withdrawal, death, or any other 
reason will be considered a withdrawal.   
 Subject Discontinuation 
Subjects will be discontinued from the registry in case of the explant of the device 
or renal transplantation for subjects enrolled in the AV access cohort.  
 Explant Procedures 
Not applicable due to the retrospective data collection. 
 
Registry Administration 
 
Training 
All Investigators involved in this registry must be trained on the protocol, EDC and Good 
Document Practice by Sponsor associates, designees, or another appropriately trained 
physician at the registry Site. 
 
Monitoring 
Site monitoring for this protocol will be provided by Contract Research Organization 
(CRO). Monitoring oversight will be provided by the sponsor. 
The site monitors are qualified by training and experience to oversee the progress of the 
registry at the site and will verify that the investigators and their staff understand and 
adhere to both the applicable regulatory requirements and the protocol. In addition, they 
may assist in resolution of any problems that may arise during the registry. 
 Site Initiation 
The start of this registry corresponds with the first site initiation perform at the first 
site. Site initiation will be performed to verify that each investigator and his / her 
staff understands the protocol, applicable regulations, human subject protection 
requirements, and the investigator’s obligations. This visit will confirm that required 
documentation with the appropriate approval is in place prior to subject enrollment. 

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The clinical investigation shall not begin until the sponsor has confirmed the 
required approval / favorable opinion from the EC or regulatory authority have 
been obtained. Site Initiation can be performed remotely (web-conference) if on-
site visit is not possible. 
 Periodic Site Monitoring 
Periodic site monitoring will occur as necessary to verify continuing adequacy of 
facilities and adherence to the protocol, Good Clinical Practices (GCPs), and 
applicable regulations and laws that pertain to the conduct of the registry. These 
activities will also review the Case Report Forms (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 confirm that all documentation is complete. 
The registry will employ a risk-based monitoring approach where data are 
reviewed remotely and centrally for logical context, completeness, and obvious 
outliers. Only specific critical data variables will be source verified during on-site 
visits. Informed consent documentation for all patients will be reviewed to verify 
that all patients agreed to registry participation. Monitoring procedures and 
requirements will be documented in a clinical monitoring plan developed and 
maintained by Gore. 
 
Device Accountability and Storage 
Due to the retrospective nature of this registry, participating sites will have utilized their 
commercial contractual agreement with the Sponsor or designee for device shipping, 
storage, use and return. Implanted device part numbers will be collected on CRFs, if 
available. 
 
Core Lab 
Not applicable. This registry will not utilize a Core Lab for evaluation of imaging. 
 
Protocol Deviations 
The investigator must follow the protocol, except in the event of an immediate hazard(s) to 
a subject. The investigator must report those deviations immediately to the sponsor. The 
investigator will report the protocol deviation in accordance with the applicable regulations. 
A protocol deviation is defined as any change, divergence, or departure from the registry 
design or procedures of a research protocol. The investigator is responsible for promptly 
recording and reporting protocol deviations to the sponsor and the reviewing Ethic 
Committee (EC) per EC policy. The sponsor will determine the effect of the protocol 
deviation on the scientific soundness of the registry 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 EC, except in the 
event of an immediate hazard(s) to a subject. The investigator will document and report 
the protocol deviation in accordance with the applicable regulations. Protocol deviations 
will be analyzed by the sponsor and reported to regulatory authorities in accordance with 
applicable regulations. 

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Considering the retrospective nature of this registry, protocol deviations would only affect 
the informed consent signature process and verification of inclusion / exclusion criteria. 
 
Protocol Amendments 
The protocol may be amended by the sponsor throughout the life of the registry, as result 
of new findings or advisement from the applicable regulatory body or advisory committee. 
The investigator will obtain EC approval on all amendments in a timely manner. The 
sponsor will confirm proper training of Investigator and site staff on all protocol 
amendments. 
 
Access to Source Data / Documents 
Source data are defined as all information necessary for the reconstruction and evaluation 
of the clinical investigation. 
The investigator should maintain adequate and accurate source documents and registry 
records that include all pertinent observations on each registry subject. Source data 
should be attributable, legible, contemporaneous, original, accurate, and complete. 
Changes to source data should be traceable, should not obscure the original entry and 
should be explained if necessary (e.g., via an audit trail). 
Where copies of the original source documents or printouts are retained, these need to be 
signed and dated by a member of the study team with a statement that it is a true 
reproduction of the original source.   
The investigator will keep all study records, source data, and investigational devices 
available for inspection by the sponsor, sponsor’s monitors, EC, and regulatory 
authorities. 
 
Registry Records Retention 
The investigator will maintain complete, accurate, and current registry records as required 
by applicable regulatory requirements. Records will be maintained during the registry and 
for a minimum of fifteen years after the latter of the date on which the registry is 
terminated or completed. In any event, registry 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 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: 
o Documents evidencing informed consent. In case the consent is waived, 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 or waived prior to participation in the registry. 
o 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. 

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o A record of the exposure of each subject to the investigational device, including 
the date and time of each use, and any other therapy. 
• 
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 signed Investigator Agreement. 
• 
Any other records as required by the regulatory authority, the EC, and the sponsor. 
The investigator will prepare and submit the following reports:  
• 
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. 
 
Publication Plan  
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a trials-registration policy as a condition for publication. According to ISO14155, 
this registry will be recorded in a public trials registry.  
It is the intent of the sponsor that the multicenter results of this registry will be submitted 
for publications (in a peer reviewed journal). A publications committee will be established 
to review the multicenter results, data request, and develop a publication strategy. The 
timing of the multicenter publications may be dependent on regulatory submissions and 
approvals. Individual sites should coordinate requests for either single center or multi-
center data through the publications committee. 
 Health Economics 
The sponsor may use registry data to develop a better understanding of the impact that 
the device may have on clinical practice in order to meet anticipated business needs. 
 
Data Collection and Submission 
The validated Clinical Data Management System (CDMS) for this registry will be provided by 
Viedoc (Stationsgatan 23, Uppsala Sweden). The sponsor keeps a separate Clinical Data 
Management Plan (CDMP) describing the procedures for verification, validation, and security of 
the CDMS. The Clinical Data Management Plan will describe and document procedures 
regarding data management processes for this investigation. 
Patient data will be retrospectively collected from the medical records and other source 
documentation already existing in patient files at the sites. 
 
 

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Data Collection Methods  
This registry will report clinical data using the Viedoc CDMS web-based application. The 
CDMS will be the database of record for the protocol and subject to regulatory inspections 
and quality assurance review. All users will be trained to use the CDMS and will comply 
with registry 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. 
A source document is defined as original documents, data, and records (e.g., hospital 
records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or 
evaluation checklists, recorded data from automated instruments, copies or transcriptions 
certified after verification as being accurate copies, x-rays, subject files, and records kept 
at the pharmacy, at the laboratories and at medico-technical departments involved in the 
clinical trial). 
 
Data Clarification and Correction 
Once entered, data will be evaluated to confirm 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. 
Sponsor will perform periodic data reviews throughout the entire registry. Procedures and 
documentation for regular and ongoing data review are described in the Clinical Data 
Management Plan. 
 
CRF Completion Schedule 
Entry of patient data into the EDC system cannot occur prior to the collection of the 
patient’s informed consent to participate in the registry or after investigator documents that 
the informed consent can be waived.  
 
Risk Assessment  
A complete listing of the known risks associated with GORE-TEX® Vascular Grafts, GORE-TEX® 
Stretch Vascular Grafts, GORE® INTERING® Vascular Grafts, and GORE® PROPATEN® 
Vascular Grafts can be found in the applicable product IFUs. Investigators are advised to review 
the IFU document to familiarize themselves with these risks and correlate this information with the 
subject’s presenting pathology and prior medical history.  
 
Summary of Expected Benefits 
GORE® Vascular Grafts are a commercially-marketed devices indicated for replacement 
or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in 
trauma patients requiring vascular replacement and for dialysis access. Patients suffering 
from a medical ailment described here who were treated with a GORE® Vascular Grafts 
would likely experience the benefit of restored patency/flow in the target lesion and relief 
from symptoms. The duration of this  benefit would likely be appreciated by the patient 
throughout their lifetime as the ePTFE  component of these devices is intended to be a 
permanent repair; however, the ability of the device to achieve its intended function may 
be affected by the subject’s underlying condition or subsequent medical course. 
Participation in this study is not expected to provide any direct benefits to participating 
subjects. However, the data collected during the study will foster a better understanding of 

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GORE® Vascular Grafts. As the study will not require the use of any procedure and / or 
test and / or device different from those required by routine clinical practice for the 
investigated conditions, enrolled subjects will not be exposed to additional risks as 
compared to routine clinical practice.  
 
Risk-to-Benefit Rationale 
As this is a retrospective study, there is no potential for physical risks to subjects. There is 
a minimal risk of breaches of confidentiality since subject information will be collected and 
analyzed for the proposed study. However, appropriate measures will be taken to 
minimize the risk as much as possible. All information entered into the central database 
will be de-identified. This study will abide by all regulations related to protecting human 
subjects and protected health information (PHI). 
The study does not use any clinical procedures, tests, devices from those required by 
routine clinical practice, enrolled subjects will not be exposed to additional risks when 
compared to routine clinical practice. 
 
Adverse Events and Safety Monitoring 
 
Anticipated Adverse Events 
Anticipated adverse events are medical complications that are known to be associated 
with PAD, artery aneurysm and dialysis access patients undergoing surgical procedure 
with treatment with GORE-TEX® Vascular Grafts or GORE® PROPATEN® Vascular Graft. 
See section 8, Risk Assessment. 
 Adverse Event Relationship 
Each reported AE will be assessed by the investigator for its primary suspected 
relationship to the device, procedure or disease. 
Only one primary relationship will be assigned to each reported AE. 
Registry Device-related 
The functioning or characteristics of the device caused or contributed to the 
adverse event. 
Registry Procedure-related 
The registry procedure (and not the device or other adjunctive procedure) caused 
or significantly contributed to the adverse event. 
Registry Disease-related 
The adverse event was a result of the underlying disease progression for which 
the registry procedure is being performed, and not the device or procedure. Within 
the dialysis cohort, adverse events attributed to a cannulation procedure should be 
classified as registry disease-related. 
Not-related 
An adverse event which cannot be attributed to the device, procedure, or disease. 
 
 

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Unknown relationship 
The relationship of the adverse event to the device, procedure, or disease cannot 
be determined. 
 Adverse Event Classification 
Each AE will be assessed by the Investigator to determine if it is Serious or Non-
serious, as defined below, per ISO14155.  
Serious Adverse Event 
A serious adverse event is an adverse event that 
• 
Led to death 
• 
Led to serious deterioration in the health of the subject that resulted in: 
o A life-threatening illness or injury,  
o A permanent impairment of a body structure or a body function,  
o Hospitalization or prolongation of patient hospitalization, or 
o Medical or surgical intervention to prevent life-threatening illness or injury 
or permanent impairment to a body structure or a body function 
o Chronic disease 
• 
Led to fetal distress, fetal death, or congenital physical or mental impairment or 
birth defect. 
Any AE that does not meet the definition of a SAE will be considered Non-serious. 
Planned hospitalization for elective procedure without serious deterioration in 
health is not considered serious. 
NOTE: Emergency room visits and 23-hour observations may not constitute 
hospitalization. 
 Adverse Event Reporting and Coding 
Considering the retrospective nature of the registry only AEs already documented 
in the subject’s medial record will be reported on the appropriate CRF.  
No follow-up related to the open adverse event in order to obtain new information 
is required for this registry. 
The investigator at each site is ultimately responsible for reporting AEs to the 
sponsor. 
The following information on each reported AE will be collected: 
• 
Adverse event name 
• 
Adverse event onset date 
• 
Relationship 
• 
Classification serious or non-serious 
• 
Outcome 
• 
Resolution date 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA). 
 
 

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Adverse event submission guidelines: 
• 
Adverse event reporting begins once the patient is enrolled in the registry (ICF 
signed or waived). All adverse events should be reported from index procedure 
through registry completion / discontinuation. 
• 
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 ongoing at registry completion / discontinuation should be left 
as “ongoing” on the AE case report form. 
• 
Medical condition and adverse event observed at the time of treatment will be 
part in the medical history of the patients. Adverse events will be reported in 
the EDC only if they become serious or increase in intensity, or if a worsening 
of a baseline condition.  
 Subject Death 
In this registry, death is not considered an AE, but rather the outcome of an AE.  
An ongoing AE at the time of death or registry withdrawal will remain categorized 
as ongoing. 
 
Unanticipated Serious Adverse Device Effects (USADE) 
The sponsor is required to notify the appropriate regulatory agencies per local 
requirements of any USADE. Therefore, if a complication occurs that the investigator 
believes may be a potential USADE, the site should immediately contact the sponsor and 
EC to determine reporting requirements.  
 
Device Deficiency 
Device deficiencies are defined as any inadequacy in the identity, quality, durability, 
reliability, safety, or performance of an investigational device, including malfunction, use 
errors, or inadequacy in information supplied by the manufacturer. 
All device deficiencies – even those that could have led to a SAE should be reported to 
the Sponsor immediately.  
The following information on each reported deficiency will be collected: 
• 
Description of deficiency 
• 
Date of occurrence 
• 
Batch code and lot number of the affected device 
• 
Related subject AE information (if applicable) 
Due to the retrospective approach, any device deficiency may have already been reported 
as part of the hospital’s routine via Product Surveillance Group procedures. To close any 
potential gaps, sites are asked to report all device deficiency in the EDC. 
 
Statistical Analysis 
 Registry Hypotheses 
No formal statistical hypothesis is planned for testing in the study. Separate primary and 
secondary outcomes will be measured along with 95% confidence intervals for each 
cohort using Exact Binomial method. The analysis of the primary endpoint will be 
descriptive in nature.  

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 Sample Size Assumptions 
The sample size for the study is estimated using the desired width of the 95% confidence 
interval. It is assumed that for PAD and Dialysis cohorts, if the estimated percentage of 
the primary outcome is around 55%, the half-width of the confidence interval would be 
12%. Similarly, for the Aortic Aneurysms, considering the primary outcome to be around 
32%, the sample size of 65 subjects would allow the half-width of the confidence interval 
to be lower than 12%.  
 
Cohort 
Endpoint Used for Sample Size 
Calculation, Assumed Rate 
Sample Size 
PAD 
≥ 56% Secondary patency 
(revascularization) at 5 years 
 
72 Patients 
(per device) 
Aortic Aneurysm 
≥ 33% survival at 5 years 
65 Patients 
Dialysis Access 
≥ 55% secondary patency through 2 
years 
72 Patients 
(per device) 
 Sample Size Determination 
The sample is calculated assuming the Binomial Exact 95% confidence interval would be 
constructed for the primary outcomes using the above assumptions. The subjects for 
which the primary outcomes cannot be determined will be considered missing in the 
analysis. 
 Randomization Scheme  
The subjects will be enrolled in the study who had previously been treated with the 
GORE-TEX® Vascular Graft or GORE® PROPATEN® Vascular Graft devices and meet the 
I/E criteria for the study. As such this section does not apply to the study.  
 Blinding Scheme 
Since the study subjects have already been treated and the device type known, this 
section does not apply 
 Data Analysis 
 Timing of Analyses 
Separate analysis will be performed for each of the PAD, Aortic Aneurysms and 
Dialysis Access cohorts once all data has been entered and cleaned in the EDC. 
Analyses at any other time may be performed at the discretion of Gore.  
There are no planned interim analyses or guidelines for early termination due to 
the retrospective and exploratory nature of the study.  
 Analysis Populations 
This study consists of five different analyses populations, defined by 
indication/disease type and device used. Separate analysis will be performed for 
each patient population. 

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1. PAD patients treated with any GORE-TEX® Vascular Graft  
2. PAD patients treated with any GORE® PROPATEN® Vascular Graft 
3. Aortic Aneurysm patients treated with any GORE-TEX® Vascular Graft  
4. Dialysis Access patients treated with any GORE-TEX® Vascular Graft  
5. Dialysis Access patients treated with any GORE® PROPATEN® Vascular Graft 
All enrolled subjects meeting the inclusion / exclusion criteria will be included in the primary and 
secondary endpoint analyses.  
 Pooling of Data 
Clinical use is not expected to differ significantly between study sites. As such, 
there is no anticipated concern in pooling the data from different sites for 
analysis. However, separate analysis will be performed to show the consistency of 
safety and effectiveness by gender and age for the primary outcomes. 
 Statistical Analysis of Primary Endpoint(s) 
Analysis for the primary endpoints will be presented with confidence 
intervals. Missing data at the time of analysis will not be imputed.  
 Statistical Analysis of Secondary Endpoint(s) 
Analysis for the secondary endpoints will be presented with confidence 
intervals. Missing data at the time of analysis will not be imputed. 
 
Ethical and Regulatory Considerations 
 Statement of Compliance 
The requirements of Clinical Investigation of Medical Devices for Human Subjects Good 
Clinical Practice (ISO14155:2020), International Conference on Harmonization Good 
Clinical Practice (ICH E6 (R2)), and Food & Drug Administration (FDA) applicable 
regulations have been incorporated into applicable Clinical Quality System procedures. 
The following are applicable to this registry: 
21 CFR Part 11 
Electronic Records; Electronic Signatures 
21 CFR Part 50 
Protection of Human Subjects 
ICH-GCP E6 (R2) 
International Conference on 
Harmonization Regulations Guideline For 
Good Clinical Practice 
Regulation (EU) 2017/745 
Regulation (EU) 2017/745 of the European 
Parliament and of the Council of 5 April 
2017 on medical devices, amending 
Directive 2001/83/EC, Regulation (EC) No 
178/2002 and Regulation (EC) No 
1223/2009 and repealing Council 
Directives 90/385/EEC and 93/42/EEC 

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ISO 14155:2020 (E) 
Clinical investigation of medical devices 
for human subjects – Good clinical 
practice 
 Compliance Responsibilities 
The sponsor will conduct the registry 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 registry. The sponsor 
will confirm proper monitoring of the registry and verify that the site has obtained EC 
approval prior to enrollment. The sponsor will provide information to the investigators and 
the reviewing EC concerning the progress of, and any new material information about, the 
registry. 
The investigator will conduct the registry in accordance with all applicable regulations and 
laws, any relevant agreements, the registry protocol, and all approval conditions of the 
reviewing EC. Any additional requirements imposed by the EC shall be followed. The 
investigator will verify EC approval is obtained prior to enrollment, maintained throughout 
the course of the registry, and that all 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 or waived 
according to national and local regulation. 
The registry shall be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki. 
 Informed Consent 
The investigator shall verify that all potential subjects still alive and reachable for this 
registry are provided with a consent form describing this registry and sufficient information 
to make an informed decision about their participation. 
The formal consent of a subject, using the EC-approved consent form, must be obtained 
by the investigator before that subject undergoes any registry-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 registry is in progress that may influence a subject’s willingness to continue to 
take part in the registry will be provided to the subject. 
The investigator shall verify that documentation of the acquisition of informed consent is 
recorded in each subject’s records in accordance with applicable regulations. 
Emergency contact details for reporting serious adverse events and serious adverse 
device effects will be listed in the EC-approved Informed Consent Form. 
 Regulatory Review 
The investigator shall not enroll any subjects prior to obtaining approval from all required 
local authorities, including competent authorities and radiation committee. 
In addition, the investigator shall not enroll any subjects prior to obtaining approval for the 
registry from a properly constituted independent EC. 

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 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 EC. 
 Confidentiality 
All subject records will be kept confidential to the extent provided by applicable laws and 
regulations. The registry 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 EC and other regulatory bodies. 
 Registry Discontinuation or Suspension 
The entire registry may be suspended or prematurely terminated by the sponsor in the 
following cases: 
• 
If suspicion of an unacceptable risk to subjects arises during the registry, the sponsor 
may suspend the registry while the risk is assessed. The sponsor will terminate the 
registry if an unacceptable risk is confirmed. 
• 
Administrative decision by the sponsor. 
Registry participation of an individual registry site or an individual member of a registry 
site may be suspended or prematurely terminated by the sponsor in the following cases: 
• 
If a principal investigator, EC responsible for the registry has withdrawn approval for 
any reason. 
• 
If sponsor monitoring or auditing identifies serious or repeated deviations on the part 
of the registry site or an individual registry investigator. 
• 
If a site does not enroll any subjects. 
Procedures for suspension or premature termination of this registry are: 
• 
If the sponsor received notice that the EC has been withdrawn for any reason, the 
sponsor shall notify the investigator as soon as possible and preferably within 24 
hours. Registry enrollment must immediately cease until such approval is reinstated. 
• 
If the investigator receives notice that the EC has been withdrawn for any reason, the 
investigator shall notify the sponsor as soon as possible and preferable within 24 
hours. Registry enrollment must immediately cease until such approval is reinstated. 
• 
If the sponsor suspends or prematurely discontinues the registry the sponsor shall 
inform the investigators, the ECs and the competent authority of the rationale and 
provide them with the relevant data supporting this decision.  
• 
If the registry (or a registry site) is prematurely terminated a routine close out visit will 
be performed. 
• 
If the investigator terminates or suspends a registry without prior agreement of the 
sponsor, the investigator should inform the institution where applicable, and the 
investigator / institution should promptly inform the sponsor and the EC, and should 
provide the sponsor and the EC a detailed written explanation of the termination or 
suspension. 
 
 

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The procedures of premature registry termination of an individual subject (voluntary 
withdrawal or withdrawal of the subject by the investigator) are detailed in section 5.11 of 
the protocol.  
Procedure for resuming the registry after temporary suspension  
• 
When the sponsor concludes an analysis of the reason(s) for the suspension, 
implements the necessary corrective actions, and decides to lift the temporary 
suspension, the sponsor shall obtain concurrence from the ECs and, where 
appropriate, the competent authority by providing the rational and relevant data 
supporting this decision before the registry resumes.  
• 
When concurrence from ECs and, where appropriate, other competent authorities is 
obtained, the sponsor shall inform the investigators to resume the registry. 
• 
If subjects have been informed of the suspension, the principal investigator or 
authorized designee shall inform them of the reasons for resumption. 
 
 

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 References 
1. Berger JS, Davies MG. Overview of lower extremity peripheral artery disease In:October 7, 2019. 
2. Harris L, Dryjski M. Epidemiology, risk factors, pathogenesis, and natural history of abdominal 
aortic aneurysm - UpToDate.pdf. In:September 25, 2019. 
3. Conte MS, Pomposelli FB, Clair DG, et al. Society for Vascular Surgery practice guidelines for 
atherosclerotic occlusive disease of the lower extremities: Management of asymptomatic disease 
and claudication. Journal of Vascular Surgery. 2015;61(3):2S-41S.e41. 
4. Davis MG. Patient education - Peripheral artery disease and claudication (Beyond the Basics). 
In:2019. 
5. Gerhard-Herman Marie D, Gornik Heather L, Barrett C, et al. 2016 AHA/ACC Guideline on the 
Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the 
American College of Cardiology/American Heart Association Task Force on Clinical Practice 
Guidelines. Circulation. 2017;135(12):e726-e779. 
6. Barshes NR. Overview of upper extremity peripheral artery disease. In:June 4, 2019. 
7. Jim J, Thompson RW. Clinical features and diagnosis of abdominal aortic aneurysm. In:October 
15, 2019. 
8. Woo YJ, Greene CL. Clinical manifestations and diagnosis of thoracic aortic aneurysm. In:May 2, 
2019. 
9. Chung J. Epidemiology, risk factors, and natural history of lower extremity peripheral artery 
disease In:April 16, 2019. 
10. Eidt JF. Open surgical repair of abdominal aortic aneurysm. In:September 17, 2019. 
11. Hogendoorn W, Lavida A, Myriam Hunink MG, et al. Open repair, endovascular repair, and 
conservative management of true splenic artery aneurysms. Journal of Vascular Surgery. 
2014;60(6):1667-1676.e1661. 
12. Schmidli J, Widmer MK, Basile C, et al. Editor's Choice - Vascular Access: 2018 Clinical Practice 
Guidelines of the European Society for Vascular Surgery (ESVS). European Journal of Vascular 
and Endovascular Surgery. 2018;55(6):757-818. 
13. Farber A, Eberhardt RT. The Current State of Critical Limb Ischemia: A Systematic Review. 
JAMA surgery. 2016;151(11):1070-1077. 
14. Aboyans V, Ricco J-B, Bartelink M-LEL, et al. Editor's Choice - 2017 ESC Guidelines on the 
Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European 
Society for Vascular Surgery (ESVS). European Journal of Vascular and Endovascular Surgery. 
2018;55(3):305-368. 
15. Chaikof EL, Dalman RL, Eskandari MK, et al. The Society for Vascular Surgery practice 
guidelines on the care of patients with an abdominal aortic aneurysm. Journal of Vascular 
Surgery. 2018;67(1):2-77.e72. 
16. Wanhainen A, Verzini F, Van Herzeele I, et al. Editor's Choice - European Society for Vascular 
Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac 
Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019;57(1):8-93. 
17. Posso M, Quintana MJ, Bellmunt S, et al. GRADE-Based Recommendations for Surgical Repair 
of Nonruptured Abdominal Aortic Aneurysm. Angiology. 2019;70(8):701-710. 
18. Bylsma LC, Gage SM, Reichert H, Dahl SLM, Lawson JH. Arteriovenous Fistulae for 
Haemodialysis: A Systematic Review and Meta-analysis of Efficacy and Safety Outcomes. 

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European journal of vascular and endovascular surgery : the official journal of the European 
Society for Vascular Surgery. 2017;54(4):513-522. 
19. Clinical Practice Guidelines for Vascular Access. American Journal of Kidney Diseases. 
2006;48:S176-S247. 
 
 

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Registry-Specific Appendices 
Appendix A: Eligibility Criteria with Justification / Rationale 
 
General Inclusion & Exclusion Criteria 
 
 
Item 
Number 
Text of Criterion 
Rationale 
Inclusion 1 
Patient is willing and able to provide 
written informed consent or consent 
is waived. 
Required element of ISO 14155 and other 
regulatory guidelines 
Inclusion 2 
Patient was at least 18 years of 
age, at the time of implant. 
Patients younger than 18 would be considered a 
vulnerable population. 
Exclusion 1 
Patient was not available for follow 
up (on-site or remotely) at the 
clinical site, with the exception of 
death (e.g., patient lost to follow-up 
immediately after treatment, patient 
who lives far away from the 
treatment site and not available to 
share FU data performed locally).  
Ensures a reasonable expectation of follow up. 
 
Exclusion 2 
At the time of treatment, patient had 
known coagulation disorders, 
including hypercoagulability, that 
were not amenable to treatment, 
As device patency is under examination, 
coagulation disorders could confound data. It is 
expected that medications will change over the 
follow up period, patients have poor compliance & 
meds may not be documented well 
retrospectively. 
 
Exclusion 3 
Patient was pregnant at the time of 
treatment. 
Potential device effects on a pregnant woman or 
fetus have not been nor are desired to be 
evaluated. Study Subjects are expected to 
receive radiation as part of the index procedure 
and recommended follow-up procedures. 
Exclusion 4 
Patient had known or suspected 
systemic infection or infection at 
the site of graft implantation at the 
time of implant. 
Infections could lead to adverse events and 
confound the interpretation of study results.  
Exclusion 5 
Patient had a separate major 
interventional or surgical vascular 
procedure within 30 days prior to 
treatment. CVC catheter placement 
would be permitted. 
Additional procedures could confound endpoints. 
While scheduled post treatment procedures were 
initially included, team felt this would be hard to 
capture. This will be captured in the CRFs if 
available. 
Exclusion 6 
Patient is already enrolled in this 
registry under a different cohort 
 
Patients enrolled in multiple arms could confound 
the study results. 

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PAD Cohort Criteria 
 
 
 
 
Item Number Text of Criterion 
Rationale 
Inclusion 1 
Patient was treated for peripheral 
arterial disease or peripheral 
arterial aneurysm requiring 
bypass treated with GORE-TEX® 
Vascular Graft, GORE® 
INTERING® Vascular Graft, 
GORE-TEX® Stretch Vascular 
Graft or GORE® PROPATEN® 
Vascular Graft at least 5 years 
before site initiation. 
Target population with time for follow up. 
Pathologies, configurations, & anatomic location 
are intentionally as broad as possible to represent 
real world data. If appropriate, analysis will be 
weighted based on configurations & lengths. 
 
Patients are to be enrolled in reverse consecutive 
order with at least 5 years of FU from the time of 
SIV. 
 Exclusion 1 
Patient had percutaneous 
transluminal angioplasty (PTA) or 
stenting of the target artery at the 
anticipated site of the proximal or 
distal anastomosis within 30 days 
prior to the index procedure. Use 
of PTA or stenting during the 
index procedure is permitted. 
Use of additional devices could confound 
endpoints. 
 Exclusion 2 
Patient had a stroke or MI within 6 
weeks of the procedure. 
Recent myocardial infarction or stroke could 
confound the interpretation of registry results.   
Exclusion 3 
Patient has previous instance of 
Heparin-induced 
Thrombocytopenia type 2 or has 
known hypersensitivity to heparin. 
Heparin may be used in any vascular procedure. 
In addition, per the GORE® PROPATEN® 
Vascular Graft IFU, this is a contraindication. 
Team would prefer to leave In/Ex the same across 
devices. 
Exclusion 4 
Patient has previous Patient 
required composite bypass for 
index procedure (graft + 
significant length of autologous 
vessel). Autologous “cuffs” or 
patches are allowed. 
Use of composite bypass represent a more 
technically challenging procedure and population 
that are not representative of the larger intended 
group. 

GORE-TEX® Vascular Graft, GORE-TEX® Stretch Vascular Graft, GORE® INTERING® 
Vascular Graft and GORE® PROPATEN® Vascular Graft  
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CONFIDENTIAL INFORMATION 
MD133246 Protocol Template 
 
Page 40 of 43 
Revision#: 6  
Doc Type: GC 
AAA Cohort Criteria 
 
 
Hemodialysis Access Criteria 
 
 
Item 
Number 
Text of Criterion 
Rationale 
Inclusion 1 
Underwent simultaneous or staged 
aortic aneurysm repair (open 
surgical AAA or TAAA) involving a 
GORE-TEX® Vascular Graft, 
GORE® INTERING® Vascular 
Graft, GORE-TEX® Stretch 
Vascular Graft at least 5 years 
before site initiation. Research 
device could have been used to 
replace or bypass either a 
diseased visceral branch or the 
aorta itself. 
Target population. Leaving the indication broad. 
This would include the graft used as both Aortic 
replacement and as a visceral branch. Acceptance 
criteria was based on graft used for visceral 
branching and not aorta. If necessary, analysis will 
be stratified by configuration. 
 
Patients are to be enrolled in reverse consecutive 
order with at least 5 years of FU from the time of 
SIV. 
Item 
Number 
Text of Criterion 
Rationale 
Exclusion 
1 
Patients required emergency 
surgery at the time of implant due 
to aneurysm rupture. 
Represents a more severe patient population. 
Item 
Number 
Text of Criterion 
Rationale 
Inclusion 1 
Patient required the creation of a 
vascular access graft for 
hemodialysis secondary to a 
diagnosis of End-Stage Renal 
Disease using a GORE-TEX® 
Vascular Graft, GORE® 
INTERING® Vascular Graft, GORE-
TEX® Stretch Vascular Graft or 
GORE® PROPATEN® Vascular 
Graft at least 2 years before site 
initiation with the intent to 
cannulate the registry device. 
Target Population with opportunity for follow up.  
Patients are to be enrolled in reverse consecutive 
order with at least 5 years of FU from the time of 
SIV. Intention is for device to be used for dialysis. 

GORE-TEX® Vascular Graft, GORE-TEX® Stretch Vascular Graft, GORE® INTERING® 
Vascular Graft and GORE® PROPATEN® Vascular Graft  
                                                                                                                 MD182859 VGP 21-01 PROT Revision#: 1 Doc Type: SP 
 
CONFIDENTIAL INFORMATION 
MD133246 Protocol Template 
 
Page 41 of 43 
Revision#: 6  
Doc Type: GC 
 
Item 
Number 
Text of Criterion 
Rationale 
Exclusion 
1 
The patient had a previous 
documented and unsuccessfully 
treated ipsilateral central venous 
stenosis via imaging technique. 
 
Venous stenosis could confound endpoints. 
Exclusion 
2 
The patient was taking 
maintenance  
immunosuppressant medication at 
the time of implant such as 
rapamycin, mycophenolate or 
mycophenolic acid, prednisone (> 
10 mg), cyclosporine, tacrolimus, 
or cyclophosphamide. 
Population may have renal transplant or preparing 
for a transplant. This exclusion is not anticipated to 
limit enrollment.  
Exclusion 
3 
Patient has previous instance of 
Heparin induced 
Thrombocytopenia type 2 or has 
known hypersensitivity to heparin. 
Heparin may be used in any vascular procedure. In 
addition, per the GORE® PROPATEN® Vascular 
Graft IFU, this is a contraindication.