Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
Conditions: Peripheral Vascular Diseases
Sponsor: W.L.Gore & Associates

 Post-Market Registry of the GORE® VIABAHN® VBX Balloon 
Expandable Endoprosthesis Implanted in Peripheral Vessels  
NCT03720704
08 Jun 2020

 
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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® VIABAHN® VBX Balloon Expandable Endoprosthesis 
 
Title: 
 
 
   Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable  
 
 
   Endoprosthesis Implanted in Peripheral Vessels 
 
Short Title: 
 
   EXPAND Registry 
 
Protocol Number: 
   VBX 17-04 
Protocol Date:   
   08 Jun 2020 
Original Protocol:     10 May 2018 
 
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: __________________  
 
 

 
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Nothing herein is to be disclosed in any way without the prior  
express written permission of W. L. Gore & Associates, Inc. 
 
 
 
 
 
 
 
 
Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable  
Endoprosthesis Implanted in Peripheral Vessels 
 
 
 
 
 
 
Protocol number:    VBX 17-04 
Protocol date:       08 JUN 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 
 
 

 
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PROTOCOL SUMMARY 
Registry Title 
Post-Market Registry of the GORE® VIABAHN® VBX Balloon 
Expandable Endoprosthesis Implanted in Peripheral Vessels 
Short Title 
EXPAND Registry 
Protocol Number 
VBX 17-04 
Sponsor 
W. L. Gore & Associates, Inc. 
Medical Products Division 
Telephone: 800-437-8181 
Local Representative 
Gore Authorized Representative 
W. L. Gore & Associates B.V. 
Ringbaan Oost 152A, 5013CE Tilburg, 
The Netherlands 
Registry Design 
Prospective, multicenter, observational registry 
Registry Objective 
The primary objective of the VBX 17-04 registry is to collect 
post-market safety and performance data of the GORE® 
VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX 
Stent Graft) in peripheral vessels in patients who require 
interventional treatment 
Primary Endpoint  
A composite of any of the following events through 30 days 
post treatment. 
• 
Procedural Success 
• 
Freedom from VBX Stent Graft-related Serious 
Adverse Event (SAE) 
Secondary Endpoints  
• 
VBX Stent Graft-related death within 30 days post-
treatment 
• 
Procedural-related death within 30 days post-
treatment 
• 
Procedural-related SAE within 30 days post-treatment 
• 
VBX Stent Graft patency (primary, primary assisted, 
secondary) through 30 days post-treatment 
• 
VBX Stent Graft patency (primary, primary assisted, 
secondary) through five years post-treatment 
• 
VBX Stent Graft-related SAE through five years post-
treatment 
• 
VBX Stent Graft-related death through five years post-
treatment 
• 
Loss of VBX Stent Graft integrity through five years 
post-treatment 
• 
Limb salvage through five years post-treatment  
Patient Population 
Patients with peripheral lesions or needing preservation of 
peripheral vessels that are amenable with VBX Stent Graft 
treatment. 

 
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Number of Patients 
Two hundred eighty (280) implanted patients with the VBX 
Stent Graft. No one site can contribute more than 35% of 
the registry’s population (98 patients). 
Number of Sites 
A maximum of 20 sites located in Europe 
Coordination PI 
Key Inclusion Criteria 
• 
Age ≥ 18 years. 
• 
Signed informed consent form. 
• 
Intend for no other stents to be placed in the same 
peripheral vessel(s) targeted for VBX Stent Graft 
placement  
Key Exclusion Criteria 
• 
Known hypersensitivity to heparin or a previous incident 
of Heparin-Induced Thrombocytopenia (HIT) type II. 
• 
Life expectancy < 12 months due to comorbidities. 
• 
Treatment would be for de novo iliac occlusive disease 
• 
Use of the VBX Stent Graft is for the treatment of aortic 
coarctations 
• 
Use of the VBX Stent Graft in the coronary, pulmonary, 
carotid, vertebral, isolated infrarenal aortic or vena cava 
vessels 
Expected Time to 
Complete 
Enrollment  
28 Months 
Expected time of each 
study patient to 
complete the 
study 
60 Months 
Total expected 
duration of the 
study 
88 Months 
Schedule of Events 
All registry events will be performed per standard medical 
practice at each participating site. 
Vendor 
 
 

 
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LIST OF ABBREVIATIONS 
AE 
ADE 
Adverse Event 
Adverse Device Effect 
AIOD 
Aortoiliac Occlusive Disease 
AV 
Arteriovenous 
CBES 
Covered Balloon Expandable Stent 
CDMS 
Clinical Data Management System 
CE 
CEC 
Conformité Européenne 
Clinical Event Committee 
CERAB 
Covered Endovascular Reconstruction of Aortic Bifurcation 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CTA 
Computed Tomographic Angiography 
EC 
Ethics Committee 
EDC 
Electronic Data Capture system 
eCRF 
Electronic Case Report Form 
GCP 
Good Clinical Practice 
HIT 
Heparin-Induced Thrombocytopenia 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IFU 
Instructions for Use 
mm 
Millimeters 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
U.S. 
USADE 
United States 
Unanticipated Serious Adverse Device Effect 
VBX Stent Graft 
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DEFINITIONS 
Adverse Event: Any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including an abnormal laboratory finding) in patients, users, or other persons, whether or not 
related to the investigational medical device. 
Adverse Device Effect: Adverse event related to the use of an investigational medical device. 
Clinical Investigation Plan: A set of documents that describes the rationale, objectives, design and 
proposed analysis, methodology, monitoring, and the plan for the conduct of a 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, safety, or performance. Device deficiencies include malfunctions, use errors, and inadequate 
labeling. 
Enrollment: A patient is considered enrolled into the study once informed consent has been signed and 
dated. 
Serious Adverse Event: An adverse event that led to death, serious deterioration in the health of the 
patient or led to fetal distress, fetal death, or a congenital abnormality 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 Effects: Serious adverse device effect which by its nature, 
incidence, severity, or outcome has not been identified in the current version of the protocol, Investigator 
Brochure (IB) or Instructions for Use (IFU). 
 
 

 
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PROTOCOL SUMMARY ....................................................................................................................... iii 
LIST OF ABBREVIATIONS .................................................................................................................... v 
DEFINITIONS ...................................................................................................................................... vi 
1. Introduction ................................................................................................................................... 1 
1.1. Background ............................................................................................................................ 1 
1.2. Registry Rationale ................................................................................................................... 1 
2. Registry Objectives ........................................................................................................................ 2 
2.1. Primary Objective(s) ................................................................................................................ 2 
3. Registry Design ............................................................................................................................. 3 
3.1. Description of Registry Design................................................................................................... 3 
3.2. Registry Endpoint(s) ................................................................................................................ 3 
3.2.1. 
Definitions........................................................................................................... 3 
3.2.2. 
Primary Endpoint ................................................................................................. 4 
3.2.3. 
Secondary Endpoint(s) ......................................................................................... 5 
4. Study Population ........................................................................................................................... 5 
4.1. Description of Population .......................................................................................................... 5 
4.1.1. 
Treatment Population Characterization.................................................................... 6 
4.2. Inclusion Criteria ..................................................................................................................... 7 
4.3. Exclusion Criteria .................................................................................................................... 7 
5. Registry Procedures / Reporting ..................................................................................................... 7 
5.1. Registry Procedures and Evaluation Schema .............................................................................. 8 
5.2. Schedule of Events.................................................................................................................. 9 
5.3. Informed Consent Process........................................................................................................ 9 
5.4. Pre-Procedure ...................................................................................................................... 10 
5.5. Enrollment............................................................................................................................ 10 
5.6. Procedure ............................................................................................................................ 10 
5.6.1. 
Unsuccessful Procedure ..................................................................................... 10 
5.7. Reinterventions ..................................................................................................................... 10 
5.8. Follow Up............................................................................................................................. 11 
5.8.1. 
Follow-Up Visit Windows..................................................................................... 11 
5.9. Patient Withdrawal from the Registry ........................................................................................ 11 
5.10. Patient Lost to Follow Up ........................................................................................................ 12 
5.11. Registry Participant Completion ............................................................................................... 12 
5.12. Explant Procedures ............................................................................................................... 12 
6. Registry Administration................................................................................................................ 12 
6.1. Training ............................................................................................................................... 12 
6.2. Monitoring ............................................................................................................................ 13 
6.2.1. 
Site Initiation ..................................................................................................... 13 
6.2.2. 
Periodic Site Monitoring ...................................................................................... 13 
6.2.3. 
Device Accountability and Storage........................................................................ 13 
6.3. Protocol Deviations................................................................................................................ 14 
6.4. Protocol Amendments and ICF Revisions ................................................................................. 14 
6.5. Sponsor Representatives........................................................................................................ 14 
6.6. Access to Source Data / Documents ........................................................................................ 14 
6.7. Registry Records Retention .................................................................................................... 15 
6.8. Publication Plan .................................................................................................................... 15 
7. Data Collection and Submission ................................................................................................... 15 

 
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7.1. Data Collection Methods......................................................................................................... 15 
7.2. Data Clarification and Correction ............................................................................................. 16 
7.3. CRF Completion Schedule...................................................................................................... 16 
8. Risk Assessment ......................................................................................................................... 16 
8.1. Summary of Expected Benefits................................................................................................ 16 
8.2. Risk-to-Benefit Rationale ........................................................................................................ 16 
9. Adverse Events and Safety Monitoring .......................................................................................... 17 
9.1. Anticipated Adverse Events .................................................................................................... 17 
9.1.1. 
Adverse Event Relationship................................................................................. 17 
9.1.2. 
Adverse Event Classification................................................................................ 17 
9.1.3. 
Adverse Event Reporting and Coding.................................................................... 18 
9.1.4. 
Adverse event submission guidelines: ................................................................... 18 
9.1.5. 
Patient Death .................................................................................................... 18 
9.2. Unanticipated Serious Adverse Device Effects (USADE) ............................................................. 18 
9.3. Device Deficiency .................................................................................................................. 19 
9.4. Clinical Events Committee ...................................................................................................... 19 
10. Statistical Analysis....................................................................................................................... 20 
10.1. Statistical Approach ............................................................................................................... 20 
10.2. Sample Size Determination ..................................................................................................... 20 
10.3. Data Analysis........................................................................................................................ 20 
10.3.1. 
Timing of Analyses............................................................................................. 20 
10.3.2. 
Analysis Populations .......................................................................................... 20 
10.3.3. 
Pooling of Data .................................................................................................. 20 
10.3.4. 
Statistical Analysis of Primary Endpoint(s) ............................................................. 21 
10.3.5. 
Statistical Analysis of Secondary Endpoint(s) ......................................................... 21 
10.3.6. 
Analysis by Treatment Category........................................................................... 21 
10.3.7. 
Analysis of Individual Treatment Indications ........................................................... 21 
11. Ethical and Regulatory Considerations.......................................................................................... 21 
11.1. Statement of Compliance........................................................................................................ 21 
11.2. Compliance Responsibilities.................................................................................................... 22 
11.3. Informed Consent .................................................................................................................. 22 
11.4. Independent Ethical Review .................................................................................................... 22 
11.5. Conflict of Interest ................................................................................................................. 23 
11.6. Confidentiality ....................................................................................................................... 23 
11.7. Registry Discontinuation or Suspension .................................................................................... 23 
12. References .................................................................................................................................. 25 
APPENDIX A ...................................................................................................................................... 28 
APPENDIX B ...................................................................................................................................... 29 
 

 
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1. 
Introduction 
1.1. 
Background 
Seminal papers by Dotter1 and Parodi2 introduced the medical community to the ability to 
treat atherosclerotic lesions that were either circulation-restrictive or critically-dilated in a 
less invasive fashion. Since the introduction of these concepts, the equipment, techniques, 
and products used in interventional procedures have vastly improved due to the refinement 
of device design and advancements in technology. Multiple professional study treatment 
guidelines now advocate the use of stent-grafts as the preferred or primary method to treat 
certain patients3. 
In current application, covered balloon-expandable stents (CBES) are used in a multitude 
of applications either within the arterial or venous systems. One of the most prominent uses 
of a CBES is in aortoiliac occlusive disease (AIOD). The GORE® VIABAHN® VBX Balloon 
Expandable Endoprosthesis (VBX Stent Graft) underwent clinical investigation of de novo 
Iliac occlusive disease in the United States (U.S.) and New Zealand where the device 
performed well in all types of occlusive disease including lesions that are considered to be 
more severe in nature, TASC II C / D4, 5. The pivotal study reported 100% technical success 
with a nine-month primary patency rate of 96.7% (n=98 patients). Pivotal patients will be 
followed for three years post-procedure. There is a reasonable expectation that some 
institutions may report their experiences with the VBX Stent Graft in AIOD in the near future. 
Other clinical indications that may occur less frequent in the spectrum of treatment are 
visceral artery lesions, either iatrogenic or non-iatrogenic, that are in need for urgent, 
minimally invasive surgery 6, 7 8-10. In these cases, the stent-graft is the primary method of 
lesion exclusion. There are other techniques where a peripheral CBES is paired with a 
thoracic, thoracoabdominal, or abdominal stent-graft to exclude an aneurysm as part of a 
system. The CBES component may be used through a pre-designed portal / fenestration to 
connect with the aortic stent or placed in parallel to the other device, sometimes called a 
chimney or snorkel procedure, in order to maintain perfusion to covered branch vessels11, 
12. 
1.2. 
Registry Rationale 
Post-market observational registries are critical to identify, collect, and analyze medical 
devices outcomes. Peripheral stents see usage for a broad spectrum of applications and 
this registry offers an opportunity to understand breakdown of usage for the VBX Stent 
Graft. As the nature of these registries allows for the assessment of medical device 
performance in a real-world setting, data collected are useful for many purposes, such as 
limited surveillance of marketed products, fulfillment of post-market clinical follow-up data 
commitments for regulatory bodies, and differential assessment of device performance from 
a well-controlled, clinical trial environment to that of routine medical practice. 
The VBX Stent Graft leverages the stent graft design and clinical requirements of the 
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface. Clinical data 
collected from a wide range of clinical studies, registries and case studies has confirmed 
the long-term clinical performance of the VIABAHN® device itself13-26 The VBX 17-04 registry 
is designed to collect short-term procedural and clinical information, as well as safety events 
through five years. 

 
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Registry Device Description 
The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) is 
manufactured in Flagstaff, Arizona of the United States of America by W. L. Gore & 
Associates, Inc. (Gore). The device is Conformité Européenne (CE)-marked for use in 
peripheral vessels where an endovascular stent-graft may be warranted. The design, device 
sizes, and characteristics permit the use of the device in multiple pathologies. 
The VBX Stent Graft consists of a 316 L surgical grade stainless steel balloon expandable 
stent and a fluoropolymer graft (Figure 1). The CBAS Heparin Surface on the VBX Stent 
Graft consists of stable, covalent, end-point attached heparin of porcine origin. The 
endoprosthesis is pre-mounted on a delivery system equipped with a balloon. The delivery 
system has two radiopaque balloon markers embedded in the shaft (denoting the effective 
balloon length) to aid in the placement of the endoprosthesis (Figure 2). The delivery 
system is compatible with 0.035" (0.89 mm) guide wires. The delivery system can be used 
for initial stent placement and post stent dilatation. The pre-mounted stent system is 
available in a variety of endoprosthesis lengths from 15 to 79 mm and in a variety of 
diameters from 5 to 11 mm. The pre-mounted endoprosthesis system balloon catheter is 
also offered in two shaft lengths. This product is supplied sterile. 
 
 
Figure 1. GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 
 
 
 
Figure 2. GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 
Delivery System 
More detailed device information can be found in the Instructions for Use (IFU) and 
Investigators Brochure (IB). 
2. 
Registry Objectives 
2.1. 
Primary Objective(s) 
The primary objective of the VBX 17-04 registry is to collect post-market safety and 
performance data of the VBX Stent Graft in peripheral vessel in patients who require 
interventional treatment. This objective is based upon the need to incorporate post-approval 
data into the continuing evaluations of the VBX Stent Graft over its lifecycle. 

 
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3. 
Registry Design 
3.1. 
Description of Registry Design 
This registry utilizes a prospective, multicenter, non-randomized single-arm design to 
collect VBX Stent Graft clinical data in its use within the indicated peripheral vasculature 
but outside of de novo iliac occlusive disease. Data will be representative of real-world, 
clinical use. Real world clinical use data are integral for Gore combined with data from long-
term clinical investigations and reports from medical literature, to perform continuing 
assessments of device performance in addition to any long-term clinical investigations as 
well as reports in medical journals. To ensure that registry data are representative of real 
world use, the registry will employ broad inclusion / exclusion criteria to ensure its 
observational nature.  
A maximum of 20 clinical registry sites (referred to as “sites” in the remainder of this 
document) in Europe will participate in this observational registry. Gore will maintain an 
updated list of all principal investigators, site names, and addresses. This list shall be kept 
separately from this protocol. From all enrolled patients, the first 280 implanted patients will 
be evaluated for the registry.” No one site can contribute more than 35% of the total patient 
population (98 patients). There are no pathology-specific limitations at the registry or site 
level. The anticipated accrual rate is approximately 10 implanted patients per month for a 
total accrual period of approximately 28 months based upon the rapidity of site-start-up. 
Patients may be enrolled into the registry provided all inclusion and no exclusion criteria are 
met as specified in Section 4. Patients will be evaluated through hospital discharge with 
follow-up data collection up to 5 years post-treatment. Patients will be followed according 
to the regimen determined by their follow-up physician with entry into an Electronic Data 
Capture (EDC) system. Total estimated duration of the registry is 88 months. 
 
3.2. 
Registry Endpoint(s) 
3.2.1. Definitions 
The definitions in  
 
Table 1 are provided to facilitate consistent reporting across all registry sites.  
 
Table 1. Protocol Definitions 
Protocol Term 
Definition 
Procedural Success 
Technical Success (successful access, delivery, accurate 
deployment, and withdrawal of catheters) with patent VBX 
Stent Graft at end of procedure  
Patency27 
Primary - Uninterrupted patency with no procedures 
performed on or at the margins of the treated segment.  
Primary Assisted - Any procedure performed in the 
treated segment before thrombosis that might prevent 
eventual failure. 
Secondary - Any procedure that restores patency after 
thrombosis. 

 
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Limb Salvage 
Freedom from Major Tissue Loss—extending above 
transmetatarsal level; functional foot no longer 
salvageable28 
Loss of Device Integrity 
Defined as any of the following:  
• 
Device damage that compromises device 
functionality (stent fractures, graft tears, cuts, 
holes, delamination) 
• 
Transient (compression) or permanent stent-graft 
collapse (invagination) following complete device 
deployment, resulting in an overall reduction in the 
vessel luminal diameter 
Reintervention 
An additional unanticipated interventional or surgical 
procedure (including conversion to open surgery), related 
to the device (including withdrawal of the delivery system) 
or procedure. Anticipated or unanticipated status will be 
determined at the discretion of the investigator. 
• 
This includes reintervention to the VBX device 
used during the Index procedure and not in non-
VBX treatment areas 
Type I endoleak29 
A sealing failure at one of the attachment sites of the graft 
to the vessel wall providing arterial flow alongside the 
graft and into the perigraft space. 
• 
Type Ia- Proximal attachment site 
• 
Type Ib- Distal attachment site 
• 
Type Ic- Inadequate seal at distal landing zone of 
branch vessel device 
Type II endoleak 
Retrograde flow through collateral vessels into the 
aneurysmal sac. 
Type III endoleak 
• 
Type IIIa- Arterial flow from module disconnection 
• 
Type IIIb- Arterial flow from fabric disruption 
Type IV endoleak 
Arterial flow through porous fabric 
 
3.2.2. Primary Endpoint 
The primary endpoint of the VBX 17-04 registry is a composite of the following 
events reported within 30 days of treatment. 
• 
Procedural Success 
• 
Freedom from VBX Stent Graft-related Serious Adverse Event (SAE) 
The first component, procedural success, describes the technical function of the 
VBX Stent Graft at the time of implant. The other component event, freedom from 
VBX Stent Graft-related SAE, is a description of short-term device safety. Possible 
endpoint events will be identified from site reports and adjudicated by a Clinical 
Events Committee (CEC) for reporting eligibility.  
 
 
 

 
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3.2.3. Secondary Endpoint(s) 
Selected events that are illustrative of the device’s potential impact to a patient from 
a safety perspective, overall device function described as patency or device 
durability captured as device integrity are the registry’s secondary endpoints. 
Possible endpoint events will be identified from site reports with some secondary 
endpoints within scope of CEC adjudication.  
The secondary endpoints for the VBX 17-04 registry are the following:  
• 
VBX Stent Graft-related death within 30 days post-treatment 
• 
Procedural-related death within 30 days post-treatment 
• 
Procedural-related SAE within 30 days post-treatment 
• 
VBX Stent Graft patency (primary, primary assisted, secondary) through 30 
days post-treatment 
• 
VBX Stent Graft patency (primary, primary assisted, secondary) through five  
years post-treatment 
• 
VBX Stent Graft-related SAE through five years post-treatment 
• 
VBX Stent Graft-related death through five years post-treatment 
• 
Loss of device integrity through five years post-treatment 
• 
Limb salvage through five years post treatment  
 
4. 
Study Population 
4.1. 
Description of Population 
The registry has been designed with broad eligibility criteria to capture real-world VBX Stent 
Graft use, in multiple pathologies and in conditions needing preservation of peripheral 
vessels. It is anticipated that patients will generally benefit by the ability of the VBX Stent 
Graft to either exclude lesions from circulation or restore / ensure vessel patency to promote 
circulation to distal vessels or tissues. Only patients who meet all of the inclusion criteria 
and none of the exclusion criteria will be included in registry analyses. No vulnerable 
populations are included in this registry. The only exclusions to registry participation are in 
situations where the use of the VBX Stent Graft is contraindicated for safety, registry 
participation would infringe on patient rights, or that the collection of follow-up data would 
not have any utility.
 
 
 
 
 
 
 
 

 
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4.1.1. Treatment Population Characterization 
The performance characteristics and available sizes of the VBX Stent Graft may 
lend itself to treating multiple pathologies in varying regions of the body. To facilitate 
better distribution of treated pathologies as well as to prevent a homogenous registry 
patient population, Gore has developed maximum enrollment goals for specific 
indications of device use in the registry. Treatment indications utilizing similar device 
use mechanisms will be grouped together into Treatment Categories. Use of 
Treatment Category classification will simplify study reporting and permit a common, 
pathology-based review of device experience.  
 
Treatment Category Treatment Indication Example 
Max Enrollment per 
Treatment Category* 
Lesion-exclusion (Non-
iatrogenic in origin) 
Peripheral artery aneurysm 
90 
 
Pseudoaneurysm 
Endoleaks 
Lesion-exclusion 
(Iatrogenic in origin) 
Rupture 
Perforation 
Dissection 
Visceral Perfusion 
Snorkel / chimney technique with 
standard stent graft 
140 
Fenestrated / branched stent graft 
component  
Iliac-branched stent graft component 
Luminal Reconstruction 
Arteriovenous fistula 
50 
Arteriovenous graft  
Deep vein thrombosis 
Venous compression 
Occlusive Disease 
Artery occlusive 
50 
Aortoiliac reconstruction with 
CERAB**technique 
Iliac-in-stent restenosis 
* The total enrollment from all reporting categories is not meant to equal 280 patients. 
** CERAB is defined as the use of three combined stents to create a new aortic bifurcation. A kissing stent technique will not utilize a 
dedicated aortic component and is not within scope of the registry. 
 
 
These treatment categories may also be used to report statistical analyses performed in an ad 
hoc fashion at the time of registry analysis and where the available patient population makes 
such analyses feasible. 
 

 
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4.2. 
Inclusion Criteria 
For the purpose of registry enrollment and potential VBX Stent Graft implant, the following 
criteria should be evaluated at the time of Informed Consent Form (ICF) signature. 
The patient is / has: 
1. Age ≥ 18 years. 
2. Signed informed consent form. 
3. Endovascular indication for treatment based on treating physician’s best medical 
judgment.  
4. Intend for no other stents to be placed in the same peripheral vessel(s) targeted for VBX 
Stent Graft placement. 
5. Willingness of the patient to adhere to standard of care follow-up requirements. 
 
 
4.3. 
Exclusion Criteria 
Due to its observational nature, exclusion criteria for registry participation is associated with 
the safe use of the device and the likelihood for an enrolled patient to contribute to registry 
analyses. 
The patient is / has: 
1. Known hypersensitivity to heparin or a previous incident of Heparin-Induced 
Thrombocytopenia (HIT) type II. 
2. Participation in concurrent research study or registry which may confound registry 
results, unless approved by Gore. 
3. Pregnant or breast-feeding female at time of informed consent signature. 
4. Life expectancy < 12 months due to comorbidities. 
5. Use of the VBX Stent Graft is for the treatment of de novo iliac occlusive disease. 
6. Use of the VBX Stent Graft is for the treatment of aortic coarctations. 
7. Use of the VBX Stent Graft in the coronary, pulmonary, carotid, vertebral, isolated 
infrarenal aortic, or vena cava vessels. 
 
A rationale for each inclusion / exclusion criterion is located in Appendix A. 
 
5. 
Registry Procedures / Reporting 
The following sections provide information regarding registry expectations, in terms of its procedures, 
as well as the type of clinical data that may be captured as part of the clinical investigational plan. 
Due to its observational nature, the registry will not require the use of any procedure and / or test  and 
/ or medical device different from those required by routine clinical practice for treating the investigated 
pathologies. Each site will be responsible for using and maintaining the equipment and medical 
devices in accordance with the manufacturer’s directions and their institutional practices. 
The sponsor will not impose requirements that limit health care professionals from exercising their 
best medical judgment for treatment. Therefore, patient selection, diagnostic imaging, and treatment 
interventions will be determined by physicians based on clinical practice standards. 

 
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5.1. 
Registry Procedures and Evaluation Schema 
 
Figure 3. Registry Schema 
 

 
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5.2. 
Schedule of Events 
A Schedule of Events is provided in Table 2. The described events are consistent with the 
anticipated standard of care for a person receiving a vascular stent graft. The timing and 
content of an individual patient’s follow-up care regimen may differ from this expectation. 
Any device-related evaluations or the identification of an Adverse Event (AE) will need to 
be entered into the EDC system. Informed consent is required for all registry participants 
and is viewed as a protection measure in terms of patient’s rights and welfare. 
Table 2. Schedule of Events 
5.3. 
Informed Consent Process 
All patients must provide informed consent prior to any registry-related data collection being 
performed. In an emergency procedure where it is not possible for the patient to provide 
consent prior to the implant, consent may be obtained afterward, but it should occur prior to 
discharge. The registry will be explained in a manner that avoids any coercion or undue 
improper influence on, or inducement of, the patient to participate. Patients will not waive 
or appear to waive their legal rights and any document will use native non-technical 
language that is understandable to the patient. The informed consent form (ICF) will include 
emergency contact details for any concerns. The case history (i.e., source documents / 
patient chart) for each patient shall document that such informed consent was obtained. 
The Ethics Committee (EC)-approved consent form will be signed and personally dated by 
the patient and the person who conducted the informed consent discussion. The original 
signed ICF will be retained in the patient records. A copy of the ICF will be given to the 
patient for their records. 
No patients deemed to be of a vulnerable population may be enrolled. 

 
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5.4. 
Pre-Procedure 
In its management of the registry, Gore will not define the processes used to identify 
patients, conduct diagnostic imaging, or make medical decisions in the best interest of the 
patient. Physicians are encouraged to use their best medical judgment and to follow clinical 
practice standards in selecting patients for treatment with the VBX Stent Graft.  
It is anticipated that most patients who will undergo an interventional procedure will have a 
physical exam with medical history, a review of their medications, and a laboratory 
evaluation of blood chemistries as part of standard procedure. 
5.5. 
Enrollment  
The patient is considered enrolled when informed consent is obtained. Enrolled patients 
who do not undergo implantation with the VBX Stent Graft will be a screen failure. The 
principal reason for a screen failure will be recorded in the patient screening and enrollment 
log. Supporting documentation for all enrolled patients will be retained in site registry files. 
5.6. 
Procedure 
The VBX Stent Graft implant procedure will be performed according to standard practice of 
the enrolling institution. As stated in the IFU, implanting investigators are advised to 
evaluate their patient for concomitant anticoagulation and / or antiplatelet medication 
therapy prior to and after the procedure. The necessity and choice of antiplatelet therapy 
can be individualize according to patient history as well as the pathology treated.  
Any used VBX Stent Graft devices (implanted or opened but not implanted) will be recorded 
on the device accountability electronic Case Report Form (eCRF). It is recommended that 
a post-deployment angiogram is performed at the end of the procedure to assess device 
condition and efficacy of treatment provided that the patient’s renal function is not 
prohibitive. 
Procedural complications arising after enrollment of an eligible patient will be treated per 
investigator’s best medical judgment as well as recorded in the EDC. 
5.6.1. Unsuccessful Procedure 
Patients who undergo the VBX Stent Graft implant procedure but are not successful 
either by access failure or need for an open conversion are asked to be entered in 
the EDC system. EDC entry may include a description of any observed procedure 
or VBX Stent Graft-related AEs as well as any device deficiencies. 
Investigators are advised to collect follow-up information from one clinical visit 
following hospital discharge to ensure that the description of any AEs associated 
with the device or procedure are complete. 
5.7. 
Reinterventions 
Investigators are asked to record any additional treatments of the original pathology or 
interventions on the previously-implanted stent-graft(s). Clinically significant progression of 
the treated disease will be noted as an AE with any reintervention on the disease or device 
noted as treatment in its respective eCRF form. 
 

 
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5.8. 
Follow Up 
It is expected that implanted patients will be followed according to the standard practice of 
the enrolling physician. Accordingly, the registry will facilitate the collection of data 
obtained from physical examinations, medication use, and imaging assessments for 
multiple types of imaging modalities (e.g., CTA or ultrasound). For the purpose of registry 
reporting and eCRF organization, it is expected that most implanted patients will have a 
clinical follow-up visit within 1-3 months of the procedure with the next follow-up or device 
evaluation at approximately 9-12 months post-procedure. Thereafter follow-up will 
continue annually until 5 years post-procedure. The frequency of implanted patient 
evaluations and the imaging modality used to investigate treatment and device status is 
up to the discretion of the follow-up physician. In some cases (i.e. patient unable to reach 
the hospital) a phone follow-up can be acceptable as a visit. 
 
5.8.1. Follow-Up Visit Windows 
To aid in registry reporting, collected data will be organized and categorized into six 
visits. Table 3 describes the range of days where collected data will be assigned to 
either visit type. Any evaluation of the VBX Stent Graft outside of the general 
reporting windows can be entered in the EDC system as an unscheduled visit. 
 
5.9. 
Patient Withdrawal from the Registry 
An implanted patient may withdraw from the registry at any time and should notify their 
follow-up physician in this circumstance. The investigator may also withdraw the patient 
from the registry at any time based on his / her medical judgment. When withdrawing the 
participation of a patient for any reason, the site investigator or sub-investigator records the 
date of discontinuation, the reason for discontinuation, and the patient’s condition at the 
time of discontinuation on the eCRF. Patients may be considered withdrawn for any of the 
following: 
• 
The VBX Stent Graft is explanted 
• 
Death 
• 
Voluntary withdrawal 
• 
Investigator withdrawal 

 
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• 
Any other medical condition where evaluation of the VBX Stent Graft is not feasible 
(e.g., bypassed VBX Stent Graft) 
If the discontinuation is caused by the development or worsening of AEs, information on the 
AEs must also be recorded on the appropriate eCRF. All data generated prior to patient 
withdrawal will be maintained, and study data will be used as appropriate. If such withdrawal 
is due to problems related to the registry device safety or performance, the investigator shall 
ask for the patient's permission to follow his / her status / condition outside the registry 
If possible, an additional evaluation of the VBX Stent Graft(s) is recommended prior to their 
withdrawal from the registry. 
Sites are advised to provide patients with a recommendation on the long-term care and 
follow-up necessary for a device used in their specific pathology. 
5.10. 
Patient Lost to Follow Up 
A patient will be considered lost to follow up and withdrawn from the registry once they have 
missed three consecutive follow-up visits or phone follow-up. Three documented attempts 
should be made by the investigator or designee to contact the patient or next of kin. One of 
the three documented attempts must include a certified letter. 
5.11. 
Registry Participant Completion 
An implanted patient has completed the registry once an element of the last requested 
follow-up visit has been performed or the collection of follow-up information would be 
outside of the visit windows. An implanted patient that does not complete these 
requirements due to voluntary withdrawal, physician withdrawal, death, or any other reason 
will be considered a withdrawal. Regular follow-up after registry completion is suggested to 
be conducted in accordance with the discretion of the site investigator or sub-investigator(s) 
and standard of care. 
Patients will not be provided with any medical care by Gore after registry completion or 
withdrawal. 
5.12. 
Explant Procedures 
 
6. 
Registry Administration 
6.1. 
Training 
All investigators were selected for their education, medical background, and proficiency with 
endovascular techniques as determined by the sponsor during the qualification process. 

 
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Prior to the start of enrollment, Gore will provide appropriate training to the investigator and 
their pertinent delegated staff members. Registry training will include: 
• 
Registry protocol 
• 
EDC system 
Registry device is already marketed; therefore, specific device training for investigator and 
site staff will not be required. 
6.2. 
Monitoring 
Site monitoring for this protocol will be provided by a Contract Research Organization 
(CRO). Monitoring oversight will be provided by the sponsor. Sites must provide adequate 
access to all source data for the sponsor or representatives. 
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 registry protocol. In addition, they 
may assist in resolution of any problems that may arise during the conduct of the registry. 
6.2.1. Site Initiation 
Site initiation will be performed to verify that each investigator and his / her staff 
understands the protocol, applicable regulations, human patient protection 
requirements, and the investigator’s obligations. This visit will confirm that required 
documentation with the appropriate approval is in place prior to patient enrollment. 
The clinical investigation shall not begin until the sponsor has confirmed the required 
approval / favorable opinion from the EC or regulatory authority has been obtained. 
6.2.2. Periodic Site Monitoring 
Periodic site monitoring will occur as necessary to verify continuing adequacy of 
facilities and adherence to the registry protocol, Good Clinical Practices (GCPs), 
and applicable regulations and laws that pertain to the conduct of the registry. These 
activities will also review the eCRFs 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. A close out visit will be conducted 
at each site to confirm that all documentation is complete. 
Monitoring procedures and requirements will be documented 
in a clinical monitoring plan developed and maintained by Gore.  
6.2.3. Device Accountability and Storage  

 
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Information on Gore accessory devices used during the procedure may be collected. 
This may include additional non-VBX Stent Graft devices, balloon catheters, and 
sheaths.   
6.3. 
Protocol Deviations 
A protocol deviation is defined as any change, divergence, or departure from the registry 
design or procedures of a protocol. The investigator is responsible for promptly recording 
and reporting protocol deviations to Gore and the reviewing EC per their policy. 
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 patient. 
For the purpose of this registry, as implant procedures and follow-up visits will be performed 
according to participating sites’ standard practice, protocol deviations would only affect the 
informed consent signature process, verification of inclusion / exclusion criteria and data 
entry as specified in Section 7.3. 
Gore will determine the impact of the protocol deviation on patient safety and determine if 
additional reports or actions are required. Additional action may include site retraining and 
/ or site termination. 
6.4. 
Protocol Amendments and ICF Revisions 
The protocol and ICF may be amended by Gore throughout the life of the registry, as a 
result of new findings or business interests or needs. Investigators will obtain EC approval 
on all amendments in a timely manner. Gore will confirm proper training of investigators and 
site staff on all protocol amendments. 
6.5. 
Sponsor Representatives 
Gore representatives may be present during implant procedures to provide technical 
assistance to the investigator in the use of the device. The activities of the Gore 
representatives will be supervised by the investigator. Representatives may also assist in 
film reading, case planning, or training of site staff. 
6.6. 
Access to Source Data / Documents 
Source data are defined as all information necessary for the reconstruction and evaluation 
of the registry. 
The investigator will keep all study records, source data, and registry devices available for 
inspection by Gore, its monitors, representatives of the EC, or regulatory authorities as 
required by local regulations. The investigator should maintain adequate and accurate 
source documents and registry records that include all pertinent observations on each 
registry patient. Source data should be attributable, legible, contemporaneous, original, 
accurate, and complete. When a copy is used to replace an original document, the copy 
should fulfill the requirements for certified copies. 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). 
 
 

 
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6.7. 
Registry Records Retention 
The investigator will maintain complete  accurate  and current study records as required by 
applicable regulatory requirements. 
 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 patient’s case history and exposure to the device. Case histories 
include the CRFs worksheets 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. 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 authorities require 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. 
6.8. 
Publication Plan  
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a trials-registration policy as a condition for publication. This policy requires that all 
clinical trials be registered in a public trials registry. Gore will register the study and post 
results as required by this policy and applicable regional laws and regulations. 
It is the intent of Gore that the multicenter results of this registry will be submitted for 
publication (in a peer reviewed journal). 
Individual sites should coordinate requests for publication through the 
publications committee or Gore. 
7. 
Data Collection and Submission 
The Clinical Data Management System (CDMS) for this registry will be provided by Medidata Solutions 
Worldwide, Inc. Gore keeps a separate Clinical Data Management Plan 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. 
7.1. 
Data Collection Methods  
This registry will report clinical data using the Medidata Rave® CDMS web-based 
application. The CDMS will be the database of record for the protocol and patients 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. 

 
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Patient data will be collected using protocol-specific eCRFs. Site staff will enter data directly 
into the eCRF for transmission to the sponsor. The sites will be notified of any significant 
amendments to the eCRFs. 
7.2. 
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. Gore will 
perform periodic data reviews throughout the term of the registry. Procedures and 
documentation for regular and ongoing data review are described in the Clinical Data 
Management Plan. 
7.3. 
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. All registry data are targeted to be entered 
into the appropriate eCRF within 14 days of collection, however, data outside this window 
will not be considered a protocol deviation. 
8. 
Risk Assessment  
A complete listing of the known risks associated with the VBX Stent Graft can be found in both the IB 
and IFU. Investigators are advised to review both documents to familiarize themselves with these risks 
and correlate this information with the patient’s presenting pathology and prior medical history. 
8.1. 
Summary of Expected Benefits 
The VBX Stent Graft is a CE-marked device indicated for the endovascular grafting of 
peripheral vessels. Registry participants are expected to be suffering from a medical ailment 
where treatment with the VBX Stent Graft may alleviate patient symptoms, maintain vessel 
patency, or prevent a medical event associated with significant morbidity or mortality.  
Participation in this observational registry is not expected to provide any direct benefits to 
participating patients, other than those related to the treatment of their pathology. However, 
the data collected during the registry will foster a better understanding of the performance 
of the registry devices in real world, daily application. 
Moreover, as the registry 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 patients will not be exposed to additional risks as compared to routine 
clinical practice. 
8.2. 
Risk-to-Benefit Rationale 
The registry will not require the use of any procedure and / or test and / or device different 
from those required by routine clinical practice, enrolled patients will not be exposed to 
additional risks when compared to routine clinical practice. 
The only additional known risk is the possible loss of confidentiality. Controls have been put 
in place to prevent loss of confidentiality. 

 
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9. 
Adverse Events and Safety Monitoring 
Clinical AEs are defined as any untoward medical occurrence in a patient, whether device-related 
or not. Pre-existing conditions will not be considered AEs unless there is worsening of the condition 
after enrollment. All AEs will be documented in the patient’s permanent medical record, recorded 
on the appropriate eCRF, and reported in accordance with applicable national regulations. 
Emergency contact information for AE reporting can be found on the site’s ICF. 
9.1. 
Anticipated Adverse Events 
Anticipated adverse events are medical complications that are known to be associated with 
patients undergoing endovascular stent grafting of peripheral vessels. See Section 8, Risk 
Assessment. 
9.1.1. Adverse Event Relationship 
Each reported AE will be assessed by the investigator for its primary suspected 
relationship to the device, procedure, or disease, as further described below: 
• 
VBX Stent Graft-related  
o The functioning or characteristics of the device caused or contributed 
to the AE. 
• 
Registry Procedure-related  
o The procedure (and not the device) caused or significantly 
contributed to the AE. 
• 
Gore Accessory Use-related 
o Any additional Gore devices that were used during the index 
procedure and / or reintervention caused or contributed to the AE. 
• 
Unrelated to VBX Stent Graft or procedure 
o An AE which cannot be attributed to the device, procedure, access. 
Only one primary relationship will be assigned to each reported AE. 
9.1.2. Adverse Event Classification 
Each AE will be assessed by the investigator to determine if it is serious or non-
serious, according to ISO 14155:2011. An SAE is defined as satisfying any of the 
following:  
Serious Adverse Event30 
A serious adverse event is an adverse event that 
• 
Led to death 
• 
Led to serious deterioration in the health of the patient that either resulted in: 
o A life-threatening illness or injury, or 
o A permanent impairment of a body structure or a body function, or 
o In-patient or prolonged hospitalization, or 
o Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function 
• 
Led to fetal distress, fetal death, or congenital abnormality or birth defect. 
NOTE: Emergency room visits and 23-hour observations may not constitute 
hospitalization.  
Non-Serious Adverse Events: Any AE not meeting the above definition of serious. 

 
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9.1.3. Adverse Event Reporting and Coding 
AEs will be reported on the appropriate eCRF and documented in the patient’s 
permanent medical record. AE reporting will start from enrollment (when informed 
consent is obtained). . 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) 
• 
Treatment 
• 
Outcome 
• 
Resolution date 
AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). 
9.1.4. Adverse event submission guidelines: 
• 
AE reporting begins once the patient is enrolled in the registry. All AEs should 
be reported from enrollment through registry completion / discontinuation. 
• 
Provide a diagnosis if possible. If unable to provide a diagnosis, report the 
symptoms as separate events. AEs should be reported using the full name 
without abbreviations or narratives. 
• 
AEs with an outcome status of “ongoing” should be assessed at each follow-up 
evaluation to determine if the event has resolved. AEs ongoing at study 
completion / discontinuation should be left as “ongoing” on the AE case report 
form. 
The site principal investigator or designee must report SAEs to the registry sponsor 
as soon as possible after onset, observation, or first reporting of the occurrence, and 
in accordance with applicable national regulations. It is the responsibility of each 
investigator to report all SAEs to the reviewing EC, according to national regulations 
and EC requirements. A copy of the EC report will be forwarded to the sponsor. 
Source documents must be submitted upon request (e.g., histopathology findings, 
catheter lab reports, etc.). All source documents must be blinded using only the 
patient's unique study identifier and forwarded to the sponsor. 
9.1.5. Patient Death 
In this clinical investigation, death is not considered an AE, but rather the outcome 
of an AE. Any ongoing / unresolved AEs will be considered as ongoing at the time 
of death or registry withdrawal. An effort must be made to collect source 
documentation or death certificate in the case of death. 
9.2. 
Unanticipated Serious Adverse Device Effects (USADE) 
An Unanticipated Serious Adverse Device Effect (USADE) is defined in ISO 14155 as any 
serious adverse effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem, or death was not previously identified 
in nature, severity, or degree of incidence in the current version of the protocol, IB or IFU. 
If a complication occurs that the investigator believes may be a potential USADE, the site 

 
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should immediately contact the sponsor to determine reporting requirements. In addition, 
when there is a reason to believe a device may have malfunctioned, causing potential harm 
to a patient, the site should immediately notify the sponsor. 
All USADEs must be documented by the investigator including the date of onset, a complete 
description of the event, possible reason(s) for the event, severity, duration, actions taken, 
and outcome.  
9.3. 
Device Deficiency 
A device deficiency is defined as an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety, or performance of the study device. Device 
deficiencies include damages, malfunctions, use errors, or inadequate labeling whether 
such a condition is experienced in the stage of design, supply, storage, or use. Device 
deficiency may not be associated with an AE suffered by a registry patient but will need to 
be reported to Gore immediately upon identification by the site. 
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 patient AE information (if applicable) 
Device deficiency information on Gore accessory devices used during the procedure may 
be collected. This may include additional non-VBX Stent Graft devices, balloon catheters, 
and sheaths.   
9.4. 
Clinical Events Committee 
An independent Clinical Events Committee (CEC) will review safety-related, clinical events 
during the registry to ensure the consistency of endpoints reported by the site. The VBX 17-
04 CEC will be comprised of an interdisciplinary team of three members with pertinent 
expertise who are not directly involved in the conduct of the registry. 
The scope of the CEC activity includes the following: 
General review and adjudication of SAE’s to include: 
a. Adjudication on the serious adverse event (SAE) designation 
b. Adjudication on the relationship of the SAE to the study device, procedure, or 
unrelated 
This committee will operate under pre-specified procedures as outlined in the CEC Charter. 
The frequency of data review and other roles and responsibilities of the CEC will be 
specified in the CEC Charter. 
 
 
 

 
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10. Statistical Analysis 
10.1. 
Statistical Approach 
No formal hypothesis will be tested for this registry. 
10.2. 
Sample Size Determination 
Two hundred eighty (280) patients will be implanted with the VBX Stent Graft across 
multiple pathologies. The sample size of 280 patients was considered adequate to estimate 
study outcomes with reasonable precision and to have sufficient patients enrolled within 
each indication.  The sample size was determined by Gore to characterize broad device 
use across device indications. In combination with strategic selection of participating 
registry sites, this number should be sufficient to describe the study endpoints with less than 
6% margin of error. 
10.3. 
Data Analysis 
10.3.1. Timing of Analyses 
There are no planned interim analyses or guidelines for early termination / registry 
stoppage due to the commercial nature of the VBX Stent Graft.  
10.3.2. Analysis Populations 
All enrolled patients meeting the inclusion / exclusion criteria and treated with the 
VBX Stent Graft will be included in the primary and secondary endpoint analyses. 
10.3.3. Pooling of Data 
It is expected that the VBX Stent Graft may be used in treatments that may differ by 
type of treatment (elective vs. emergent), patient risk (high vs. low / moderate) or 
role in treatment (primary repair vs. combinatorial repair). In each of these 
indications, the mechanism of introduction and device delivery will remain the same 
along with intended device function (lesion exclusion / vessel patency). The use of 
balloon-expandable stent grafts is a well-known and practiced endovascular therapy 
that is not expected to differ between selected registry sites. As such, there is no 
concern in regards to pooling data from different European countries or sites 
together for analysis. 
Gore may perform analyses to detect differences in device experience according to 
gender, age, or pathology treated. 
 

 
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10.3.4. Statistical Analysis of Primary Endpoint(s) 
Tables of the primary endpoints procedural success and freedom from VBX Stent 
Graft-related SAEs at 30 days will be reported. Data will be presented descriptively 
with confidence intervals. 
Missing data at the time of analysis will not be included in the denominator. 
10.3.5. Statistical Analysis of Secondary Endpoint(s) 
Tables of the secondary endpoints—device related death at 30 days, procedural 
related death at 30 days, procedural related SAE at 30 days, device patency at 30 
days and on yearly basis, device-related SAEs, device-related death, loss of device 
integrity and limb salvage at yearly basis will be reported. Data will be presented 
descriptively with confidence intervals, where appropriate. 
Missing data at the time of analysis will not be included in the denominator. 
10.3.6. Analysis by Treatment Category 
Individual device treatment indications will be categorized into larger groups 
“Treatment Categories” based upon either similar device function or purpose. 
Combining treatment indications into larger groups will permit the analysis of general 
treatment concepts where an analysis based upon on an individual indication would 
not be feasible.
  
10.3.7. Analysis of Individual Treatment Indications 
At the conclusion of enrollment, an evaluation of the distribution of device use across 
individual pathologies will be performed. If feasible, device experience by indication 
will be tabulated for descriptive analysis. 
 
11. Ethical and Regulatory Considerations 
11.1. 
Statement of Compliance 
The requirements of Clinical Investigation of Medical Devices for Human Patients Good 
Clinical Practice (ISO14155:2011), 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: 
ICH-GCP E6 
International Conference on Harmonization 
Regulations Guideline For Good Clinical Practice 
Medical Device Directive (93/42/EEC) 
Article 15 Annex X 
Council Directive 93 / 42 / EEC of 14 June 1992 
Amendment to the MDD (2007/47/EC) 
Article 15 Annex X 
Directive 2007 / 47 / EC of the European Parliament 
and of the Council of 5 September 2007 
ISO 14155:2011 (E) 
Clinical investigation of medical devices for human 
patients – Good clinical practice 

 
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11.2. 
Compliance Responsibilities 
Gore will conduct the registry in accordance with all applicable regulations and laws. Gore 
will be responsible for documenting that investigators have the necessary skills, training, 
and information to properly participate in the registry. Gore will confirm proper monitoring of 
the registry and verify that the site has obtained Ethics Committee (EC) approval prior to 
enrollment. Gore will provide information to the investigators and the reviewing ECs 
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 patients under their care. The 
investigator is also responsible for ensuring that informed consent is properly obtained. 
The registry shall be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki. 
11.3. 
Informed Consent 
The investigator shall verify that all potential patients 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 patient, using the EC-approved consent form must be obtained 
prior to a patient’s entry in the registry. 
 
The consent form will be signed 
and personally dated by the patient and the person who conducted the informed consent 
discussion. The original signed informed consent form will be retained in the patient records. 
A copy of the informed consent document will be given to the patient for his or her records. 
Any significant, new information which emerges while the registry is in progress that may 
influence a patient’s willingness to continue to take part in the registry will be provided to 
the patient. 
The investigator shall verify that documentation of the acquisition of informed consent is 
recorded in each patient’s records in accordance with applicable regulations. 
Emergency contact details for reporting SAEs and serious adverse device effects will be 
listed in the EC-approved ICF. 
11.4. 
Independent Ethical Review 
The investigator shall not enroll any patients prior to obtaining approval for the registry from 
a properly constituted independent EC. 
The sponsor and / or designee will be responsible for submission of the IFU, protocol, draft 
ICF, eCRF (data requirements), and any other document required by the local EC for EC’s 
written approval. 

 
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11.5. 
Conflict of Interest 
All investigators will follow applicable laws and regulations as well as the conflict of interest 
policies of their site and the reviewing EC. 
11.6. 
Confidentiality 
All patient 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. The 
investigator will inform the patients that their records will be reviewed. 
11.7. 
Registry Discontinuation or Suspension 
The entire registry may be suspended or prematurely terminated by Gore in the following 
cases: 
• 
If new data become available which raises concern about the safety of the registry 
device, so that continuation of the registry might cause unacceptable risks to the 
patients. 
• 
On recommendation by the CEC for any perceived safety concern based on clinical 
judgment, including, but not limited to, a higher than anticipated rate for any component 
of the safety endpoint, device failures resulting in AEs or unexpected SAEs. 
• 
. 
Registry participation of an individual registry site or an individual member of a registry site 
may be suspended or prematurely terminated by Gore in the following cases: 
• 
If a principal investigator or EC responsible for the registry has withdrawn approval for 
any reason. 
• 
If Gore monitoring or auditing identifies serious or repeated deviations on the part of the 
registry site or an individual investigator. 
• 
If a site does not enroll any patients. 
Procedures for suspension or premature termination of this registry are: 
• 
If Gore or EC prematurely terminates the registry, all enrolled patients shall continue to 
be followed and treated as per standard of care at each site. Gore may request that 
patients are contacted or complete an office visit prior to registry termination.  
• 
The investigator of each site or authorized designee shall promptly inform the enrolled 
patients. 
• 
If the investigator receives notice that the EC approval has been withdrawn for any 
reason, the investigator shall notify Gore as soon as possible and preferably within 24 
hours. Registry enrollment must immediately cease until such approval is reinstated. 
• 
If Gore suspends or prematurely discontinues the registry, Gore 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. 

 
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• 
If the investigator terminates or suspends a registry without prior agreement of the 
sponsor, the investigator should inform their 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. 
The procedures of premature study termination of an individual patient (voluntary 
withdrawal or withdrawal of the patient by the investigator) are detailed in Section 5.9 of 
the registry protocol.  
Procedure for resuming the clinical investigation after temporary suspension: 
• 
When Gore concludes an analysis of the reason(s) for the suspension, implements the 
necessary corrective actions, and decides to lift the temporary suspension, Gore shall 
obtain concurrence from the ECs and, where appropriate, the regulatory authority by 
providing the rationale and relevant data supporting this decision before registry 
enrollment resumes. 
• 
When concurrence from ECs and, where appropriate, other regulatory authorities is 
obtained, Gore shall inform the investigators to resume the registry enrollment. 
• 
If patients have been informed of the suspension, the principal investigator or authorized 
designee shall inform them of the reasons for resumption. 
In addition, a final report to all reviewing ECs will be submitted within six months of 
completion, termination, or discontinuation. Sites that have enrolled a patient and have 
completed all patient follow-up requirements are asked to keep the clinical investigation 
active in order to receive the final study report.  
 
 

 
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12. References 
1.    
Dotter CT, Judkins MP. Transluminal treatment of arteriosclerotic obstruction. Description 
of a      new technic and a preliminary report of its application. Circulation. 1964;30:654-
70. 
2 
Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for 
abdominal aortic aneurysms. Annals of vascular surgery. 1991;5(6):491-9. 
3. 
Chaikof EL, Brewster DC, Dalman RL, Makaroun MS, Illig KA, Sicard GA, et al. The care 
of patients with an abdominal aortic aneurysm: the Society for Vascular Surgery practice 
guidelines. J Vasc Surg. 2009;50(4 Suppl):S2-49. 
4. 
Bismuth J, Gray BH, Holden A, Metzger C, Panneton J. Pivotal Study of a Next-
Generation Balloon-Expandable Stent-Graft for Treatment of Iliac Occlusive Disease. J 
Endovasc Ther. 2017:1526602817720463. 
5. 
Holden A, Merrilees S, Buckley B, Connor B, Colgan F, Hill A. First-in-Human Experience 
With the Gore Balloon-Expandable Covered Endoprosthesis in Iliac Artery Occlusive 
Disease. J Endovasc Ther. 2017;24(1):11-8. 
6. 
Goltz JP, Basturk P, Hoppe H, Triller J, Kickuth R. Emergency and elective implantation of 
covered stent systems in iatrogenic arterial injuries. Rofo. 2011;183(7):618-30. 
7. 
Stampfl U, Sommer CM, Bellemann N, Weitz J, Bockler D, Richter GM, et al. The use of 
balloon-expandable stent grafts for the management of acute arterial bleeding. J Vasc 
Interv Radiol. 2012;23(3):331-7. 
8. 
Bellemann N, Sommer CM, Mokry T, Kortes N, Gnutzmann D, Gockner T, et al. Hepatic 
artery stent-grafts for the emergency treatment of acute bleeding. Eur J Radiol. 
2014;83(10):1799-803. 
9. 
Chiriano J, Teruya TH, Zhang WW, Abou-Zamzam AM, Bianchi C. Treatment of superior 
mesenteric artery portal vein fistula with balloon-expandable stent graft. Annals of 
vascular surgery. 2009;23(1):99-102. 
10. 
Rossi M, Rebonato A, Greco L, Citone M, David V. Endovascular exclusion of visceral 
artery aneurysms with stent-grafts: technique and long-term follow-up. Cardiovasc 
Intervent Radiol. 2008;31(1):36-42. 
11. 
Donas KP, Lee JT, Lachat M, Torsello G, Veith FJ. Collected world experience about the 
performance of the snorkel/chimney endovascular technique in the treatment of complex 
aortic pathologies: the PERICLES registry. Ann Surg. 2015;262(3):546-53; discussion 52-
3. 
12. 
Mastracci TM, Greenberg RK, Eagleton MJ, Hernandez AV. Durability of branches in 
branched and fenestrated endografts. J Vasc Surg. 2013;57(4):926-33; discussion 33. 
13. 
Saxon, R.R., et al. Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in 
the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn 
Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral 
Artery Obstructive Disease) trial. Journal of Vascular and Interventional Radiology, 2013. 
24(2): p. 165-173. 
14. 
Laird, J.R., et al. Excimer laser with adjunctive balloon angioplasty and heparin‐coated 
self‐expanding stent grafts for the treatment of femoropopliteal artery in‐stent restenosis. 
Catheterization and Cardiovascular Interventions, 2012. 80(5): p. 852-859. 
15. 
Lammer, J., et al. Heparin-bonded covered stents versus bare-metal stents for complex 
femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis 
with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long 
lesions in superficial femoral artery occlusive disease). Journal of the American College of 
Cardiology, 2013. 62(15): p. 1320-1327. 

 
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16. 
Lammer, J., et al. Sustained benefit at 2 years for covered stents versus bare-metal stents 
in long SFA lesions: the VIASTAR trial. Cardiovascular and interventional radiology, 2015. 
38(1): p. 25-32. 
17. 
Bosiers, M., et al. Superiority of Stent-Grafts for In-Stent Restenosis in the Superficial 
Femoral Artery Twelve-Month Results From a Multicenter Randomized Trial. Journal of 
Endovascular Therapy, 2015. 22(1): p. 1-10. 
18. 
Zeller, T., et al. Heparin-bonded stent-graft for the treatment of TASC II C and D 
femoropopliteal lesions: the Viabahn-25 cm trial. Journal of Endovascular Therapy, 2014. 
21(6): p. 765-774.   
19. 
Donas, K. P., Lee, J. T., Lachat, M., Torsello, G., & Veith, F. J. (2015). Collected world 
experience about the performance of the snorkel/chimney endovascular technique in the 
treatment of complex aortic pathologies: the PERICLES registry. Annals of Surgery, 
262(3), 546-553; discussion 552-543.  
20. 
Donas, K. P., Telve, D., Torsello, G., Pitoulias, G., Schwindt, A., & Austermann, M. 
(2015). Use of parallel grafts to save failed prior endovascular aortic aneurysm repair and 
type Ia endoleaks. Journal of Vascular Surgery. 
21 
 Donas, K. P., Torsello, G. B., Piccoli, G., Pitoulias, G. A., Torsello, G. F., Bisdas, T., . . . 
Gasparini, D. (2015). The PROTAGORAS study to evaluate the performance of the 
Endurant stent graft for patients with pararenal pathologic processes treated by the 
chimney/snorkel endovascular technique. Journal of Vascular Surgery. 
22. 
Ferrer, C., Cao, P., De Rango, P., Tshomba, Y., Verzini, F., Melissano, G., Chiesa, R. 
(2015). A propensity-matched comparison for endovascular and open repair of 
thoracoabdominal aortic aneurysms. Journal of Vascular Surgery.  
23. 
Panuccio, G., Bisdas, T., Berekoven, B., Torsello, G., & Austermann, M. (2015). 
Performance of Bridging Stent Grafts in Fenestrated and Branched Aortic Endografting. 
European Journal of Vascular and Endovascular Surgery, 50(1), 60-70. 
24. 
Reilly, L. M., Rapp, J. H., Grenon, S. M., Hiramoto, J. S., Sobel, J., & Chuter, T. A. (2012). 
Efficacy and durability of endovascular thoracoabdominal aortic aneurysm repair using the 
caudally directed cuff technique. Journal of Vascular Surgery, 56(1), 53-63; discussion 63-
54.  
25. 
Sugimoto, M., Panuccio, G., Bisdas, T., Berekoven, B., Torsello, G., & Austermann, M. 
(2015). Tortuosity is the Significant Predictive Factor for Renal Branch Occlusion after 
Branched Endovascular Aortic Aneurysm Repair. European Journal of Vascular and 
Endovascular Surgery. 
26. 
Tran, K., Ullery, B. W., & Lee, J. T. (2016). Snorkel/Chimney Stent Morphology Predicts 
Renal Dysfunction after Complex Endovascular Aneurysm Repair. Annals of Vascular 
Surgery, 30, 1-11.e11. 
27. 
Sacks D, Marinelli DL, Martin LG, Spies JB. Reporting standards for clinical evaluation of 
new peripheral arterial revascularization devices. Technology Assessment Committee. J 
Vasc Interv Radiol. 1997;8(1 Pt 1):137-49. 
28.  
Creager MA, Belkin M, Bluth EI, et al. 2012 ACCF/AHA/ACR/ 
SCAI/SIR/STS/SVM/SVN/SVS key data elements and definitions for peripheral 
atherosclerotic vascular disease: a report of the American College of Cardiology 
Foundation/American Heart Association Task Force on Clinical Data Standards (Writing 
Committee to develop Clinical Data Standards for Peripheral Atherosclerotic Vascular 
Disease). Circulation. 2012;125:395–467. 
 
 

 
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29. 
Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM, et al. 
Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 
2002;35(5):1048-60. 
30. 
ISO. Clinical investigation of medical devices for human patients- Good clinical practice 
(ISO 14155:2011). 2011. 
 
 
 

 
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APPENDIX A 
The development of registry inclusion and exclusion criteria, as described in Table 4, was performed in a 
manner to permit physicians to treat patients in a relatively free manner while also preserving basic 
safety and ensuring the protection of patients’ rights. 
Table 4. Inclusion / Exclusion Criteria Justification 
Number 
Text 
Rationale 
Inclusion #1 
Age ≥ 18 years 
Age of legal consent for adults 
Inclusion #2 
Signed informed consent form 
An assurance that registry participant 
is a willing volunteer and aware of the 
risks / benefits of participation. 
Inclusion #3 
Endovascular indication for treatment based on 
treating physician’s best medical judgment 
Exposure to any endovascular 
procedure must be clinically warranted 
Inclusion #4 
Intend for no other stents to be placed in the same 
peripheral vessel(s) targeted for VBX Stent Graft 
placement 
Consistent with purpose of registry 
Inclusion #5 
Willingness, in the opinion of the treating physician, 
to adhere to standard of care follow-up requirements 
Registry participation needs to be of 
value in terms of follow-up data 
collection  
Exclusion #1 
Known hypersensitivity to heparin or a previous 
incident of Heparin-Induced Thrombocytopenia (HIT) 
type II 
Contraindication to the VBX Stent 
Graft 
Exclusion #2 
Participation in concurrent research study or registry 
which may confound registry results, unless 
approved by Gore 
To promote the ability to generate 
meaningful data on which statistical 
analyses can be made 
Exclusion #3 
Pregnant or breast-feeding female at time of 
informed consent signature 
The use of the VBX Stent Graft in this 
population has not been tested and 
could present unnecessary risk to a 
fetus 
Exclusion #4 
Life expectancy < 12 months due to comorbidities 
Consistent with the need for 12 month 
data as part of endpoint analysis  
Exclusion #5 
Use of the VBX Stent Graft is for the treatment of de 
novo iliac occlusive disease 
Treatment of this particular pathology 
is not within scope and objective of 
this registry 
Exclusion #6 
Use of the VBX Stent Graft is for the treatment of 
aortic coarctations 
Outside of the indicated use 
Exclusion #7 
Use of the VBX Stent Graft in the coronary, 
pulmonary, carotid, vertebral, isolated infrarenal 
aortic, or vena cava vessels 
Outside of the indicated use 
 
 
 
 
 
 
 

 
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APPENDIX B 
PROTOCOL MODIFICATION SUMMARY 
List of changes to VBX 17-04 Revision 6: 
 
• 
Minor typographical and punctuation errors have been corrected throughout the protocol.  
• In addition, the following changes have been made to the protocol: 
Section 
Changes to Protocol 
Rationale 
Protocol - All sections  
Extension of follow-up through five 
years. Corresponding sections, 
including flow chart and visit 
windows have been updated.  
 
List of changes to VBX 17-04 Revision 5: 
• 
Minor typographical and punctuation errors have been corrected throughout the protocol.  
• In addition, the following changes have been made to the protocol: 
Section 
Changes to Protocol 
Rationale 
 Protocol summary  
Updated contact name for the Local 
representative  
  
 
List of changes to VBX 17-04 Revision 4: 
 
• 
Minor typographical and punctuation errors have been corrected throughout the protocol.  
• In addition, the following changes have been made to the protocol: 
Section 
Changes to Protocol 
Rationale 
Protocol - All sections  
Total registry patient population 
increased to 280 patients. 
Corresponding sections, including 
Treatment Category caps, have 
been updated 
 
3.2.3. and protocol 
summary  
Added “limb salvage” as secondary 
endpoint 
4.1.1. Table 
Edited occlusive disease treatment 
indication example to  “artery 
occlusive”  

 
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5.3. 
 Edited language for clarity around 
consent after procedure  
9.1.  
AE reporting will start from 
enrollment  
 
Table 1 
Added definition of limb salvage  
 
 
 
List of changes to VBX 17-04 Revision 3: 
 
• 
Minor typographical and punctuation errors have been corrected throughout the protocol.  
• In addition, the following changes have been made to the protocol: 
Section 
Changes to Protocol 
Rationale 
 Protocol summary  
Changed name and address 
of Local representative  
Protocol summary  
Changed name and address 
of CRO 
 
 
List of changes in VBX 17-04 Revision 2: 
 
• 
Revision 1 of the protocol was not distributed to sites 
• 
Minor typographical and punctuation errors have been corrected throughout the protocol.  
 
In addition, the following changes have been made to the protocol: 
Section 
Changes to Protocol 
Rationale 
 4.2 Inclusion Criteria #3 
Changed word Surgical with 
Endovascular 
APPENDIX A Inclusion 
Criteria #3 Text 
Changed word Surgical with 
Endovascular 
 
APPENDIX A Inclusion 
Criteria #3 Rationale 
Changed word Surgical with 
Endovascular 
Section 9.1.1.  Adverse 
Event Relationship 
Added category:  Gore 
Accessory Use-related 
Any additional Gore devices 
that were used during the 
index procedure and / or 
reintervention caused or 
contributed to the AE