Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries
Conditions: Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
Sponsor: W.L.Gore & Associates

“Real-World Data Collection of the GORE® 
 when used as a Bridging 
Stent with Branched and Fenestrated Endografts in the 
Treatment of Aortic Aneurysms involving the Renal-Mesenteric 
Arteries” 
05 Oct 2022 
 NCT05143138

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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 registry contact. Retain a copy with the protocol at the registry site in 
the regulatory binder. 
 
Device: 
 
 
Title: 
“Real-World Data Collection of the 
 when used as a Bridging Stent with Branched and Fenestrated Endografts in 
the Treatment of Aortic Aneurysms involving the Renal-Mesenteric Arteries” 
 
Protocol Number: 
 
21-04  
Protocol Date: 
 
05 Oct 2022 
 
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 registry. 
 
 
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. 
 
 
 
Real-World Data Collection of the 
 when 
used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic 
Aneurysms involving the Renal-Mesenteric Arteries 
 
 
 
Protocol number: 
21-04 
 
Protocol date: 05 Oct 2022 
 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 

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PROTOCOL SUMMARY 
Registry Title 
Real-World Data Collection of the 
when used as a Bridging Stent with Branched 
and Fenestrated Endografts in the Treatment of Aortic Aneurysms involving 
the Renal-Mesenteric Arteries 
Protocol Number 
 21-04  
Registry Device 
Sponsor 
W. L. Gore & Associates, Inc. 
Registry Design 
Multicenter, single-arm retrospective and prospective registry 
Local Representative 
Gore Authorized Representative 
W. L. Gore & Associates B.V. 
 
Registry Objective 
The primary objective is to confirm the clinical performance of the 
when used as a 
Bridging Stent with Branched and Fenestrated Endografts in the Treatment 
of Aortic Aneurysms involving the Renal-Mesenteric Arteries. 
The secondary objective is to confirm safety of the 
 when used as a Bridging Stent with 
Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms 
involving the Renal-Mesenteric Arteries. 
Registry Endpoint(s) 
Target vessel patency (patient level) at 12 months 
Subject Population 
Patients treated with the 
 as a Bridging Stent in conjunction with a 
branched/fenestrated stent-graft to allow endovascular aneurysm repair 
Inclusion Criteria 
1. Patients treated with the 
as a Bridging Stent in conjunction with a 
branched/fenestrated stent-graft to facilitate endovascular aneurysm 
repair from 31 December 2021 until 01 January 2017  
2. Age ≥18 years at the time of implant  

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3. An Informed Consent Form (ICF) signed by subject or next of 
kin/legal representative (for deceased patients at registry entry, 
unless a waiver was granted), according to local regulations. 
Exclusion Criteria 
1. Patient treated for ruptured aneurysm or who were 
otherwise hemodynamically unstable at the time of the procedure  
2. Patient treated for acute or subacute dissection, <90 days from onset 
of symptoms  
3. Patient treated using physician-modified endovascular grafts 
4. Patient intended to be treated with chimney, periscope, octopus, 
sandwich technique per the pre treatment case plan. 
5. At the time of treatment, patient had known coagulation disorders 
including hypercoagulability that were not amenable to treatment  
6. Patient was pregnant at the time of treatment.  
7. Participation in another drug or device investigational study within 
one year of device implant, that can confound the registry endpoints.  
8. Patient had known or suspected systemic infection (including 
treatment for mycotic aneurysm) at the time of implant. 
 
Number of Subjects 
Subject Cohort 
Number patients 
Caps per site 
(patient) 
Fenestrated repair (FEVAR) 
100 
First cap 10% (10 
patients) 
Second and max Cap 
30% (30 patients) 
Branched repair (BEVAR) 
120 
First cap 10% (12 
patients) 
Second and max Cap 
30% (36 patients) 
Fenestrated-branched repair 
Up to 40  
N.A. 
Number of Sites 
Up to 15 sites in Europe 
Coordinating PI 
  
Contact details and professional position are kept separately from this protocol  
Registry Duration  
Time to complete enrollment: 8 months, all subjects are enrolled 
retrospectively  
Follow-up time: FU data collection up to 5 years. Part of the FU will be 
prospective. 
Total registry duration:  5.5 years 

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Additional Information 
Contract Research Organization (CRO):  
 
Electronic Data Capture System:  
 
Core Lab: 
 
Imaging Transfer:  
 
 
 

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LIST OF ABBREVIATIONS 
AE 
ADE 
Adverse Event 
Adverse Device Effect 
ASA 
BEVAR 
American Society of Anesthesiologists 
Branched endovascular aneurysm repair  
CAAA 
Complex abdominal aortic aneurysms 
CABG 
Coronary Artery Bypass Graft 
CAD 
Coronary Artery Disease 
CBC 
Complete Blood Count 
CDMS 
Clinical Data Management System 
CE 
Conformité Européenne 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigation Plan 
cm 
Centimeters 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CT 
Computed Tomography 
CTA 
Computed Tomographic Angiography 
DTA 
Descending Thoracic Aortic  
EC 
Ethics Committee 
EDC 
Electronic Data Capture 
eCRF 
Electronic Case Report Form 
ePTFE 
Expanded Polytetrafluoroethylene 
ESVS 
European Society for Vascular Surgery 
EU 
FEVAR 
European Union 
Fenestrated endovascular aneurysm repair  
FDA 
Food and Drug Administration (United States) 
Fr 
French (sizing) 
GCP 
Good Clinical Practice 
GIS 
Gore Imaging Sciences  
HE 
Health Economics 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 

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IFU 
Instructions for Use 
LAR 
Legal Authorized Representative  
LSA  
Left Subclavian Artery  
MDD 
Medical Devices Directive 
MDR 
Medical Devices Regulation 
MI 
Myocardial Infarction 
mm 
Millimeters 
MRI 
Magnetic Resonance Imaging 
OMA 
Office of Medical Affairs (W. L. Gore & Associates, Inc.) 
PG 
Performance Goal 
PHI 
Protected Health Information 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SVS 
Society of Vascular Surgery 
TAAA 
Thoraco-Abdominal Aortic Aneurysms 
TIA 
Transient Ischemic Attack 
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  whether anticipated or unanticipated. This definition includes events 
related to the investigational medical device and events related to the procedures 
involved 
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: 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. 
Enrollment: A patient is considered enrolled into the registry once informed 
consent has been signed and dated or consent is 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:  
(a) death 
(b) serious deterioration in the health of the subject, users, or other persons as 
defined by one or more of the following:  
(i) life-threatening illness or injury, 
(ii) permanent impairment of a body structure or a body function including 
chronic diseases,  
(iii) in-patient or prolonged hospitalization,  
(iv) medical or surgical intervention to prevent life-threatening illness or injury 
or permanent impairment to a body structure or a body function 
 (c) fetal distress, fetal death, or a congenital abnormality, or birth defect including 
physical or mental impairment  
 Defined in more detail in section 9.1.2. 
Serious Adverse Device Effect: An adverse device effect that has resulted in any 
of the consequences characteristic of a serious adverse event 
Serious Health Threat: Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration in the health in 
subjects, users or other persons, and that requires prompt remedial action for 
other subjects, users or other persons. 
Unanticipated Adverse Device Effect: 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 or incidence in the investigational plan or application (including 

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a supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects. 
Unanticipated Serious Adverse Device Effect: Serious adverse device effect 
which by its nature, incidence, severity, or outcome has not been identified in the 
current version of the protocol and IFU.  
 
 
 

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Table of Contents 
PROTOCOL SUMMARY ........................................................................................................................ ii 
LIST OF ABBREVIATIONS .................................................................................................................... v 
DEFINITIONS ..................................................................................................................................... vii 
1. Introduction ................................................................................................................................... 1 
1.1. 
Disease............................................................................................................................... 1 
1.2. 
Historical Treatments ............................................................................................................ 1 
1.3. 
Registry Device Description ................................................................................................... 2 
1.4. 
Pre-clinical Data ................................................................................................................... 3 
1.5. 
Clinical Data ........................................................................................................................ 3 
2. Registry Objectives ........................................................................................................................ 3 
2.1. 
Primary Objective(s).............................................................................................................. 3 
2.2. 
Secondary Objective(s) ......................................................................................................... 4 
2.3. 
Health Economic Data Analysis .............................................................................................. 4 
3. Registry Design ............................................................................................................................. 4 
3.1. 
Registry Design Schema ....................................................................................................... 4 
3.2. 
Description of Registry Design ................................................................................................ 5 
3.3. 
Management of potential confounding factors / bias ................................................................... 5 
3.4. 
Registry Endpoint(s).............................................................................................................. 6 
3.4.1. 
Definitions .............................................................................................................. 6 
3.4.2. 
Primary Endpoints ................................................................................................... 8 
3.4.3. 
Secondary Endpoints ............................................................................................... 8 
4. Registry Population........................................................................................................................ 9 
4.1. 
Description of Population ....................................................................................................... 9 
4.2. 
Inclusion Criteria................................................................................................................. 10 
4.3. 
Exclusion Criteria................................................................................................................ 10 
5. Registry Procedures / Evaluations ................................................................................................ 10 
5.1. 
Registry Procedures and Evaluation Schema.......................................................................... 11 
5.2. 
Schedule of Events ............................................................................................................. 12 
5.3. 
Informed Consent Process ................................................................................................... 12 
5.3.1. 
Remote Collection of the Informed Consent Form ....................................................... 13 
5.3.2. 
Vulnerable Populations........................................................................................... 13 
5.3.3. 
Emergent Cases.................................................................................................... 13 
5.4. 
Pre-Screening .................................................................................................................... 13 
5.5. 
Enrollment ......................................................................................................................... 14 
5.6. 
Screening .......................................................................................................................... 14 
5.7. 
Screen Failure.................................................................................................................... 14 
5.8. 
Randomization and or Blinding ............................................................................................. 15 
5.9. 
Procedure ......................................................................................................................... 15 
5.10. 
Repeat Interventions ........................................................................................................... 15 
5.11. 
Follow Up .......................................................................................................................... 15 

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5.12. 
Subject Withdrawal from the Registry .................................................................................... 15 
5.13. 
Subject Lost to Follow Up .................................................................................................... 16 
5.14. 
Subject Registry Completion ................................................................................................ 16 
5.15. 
Explant Procedures............................................................................................................. 16 
6. Registry Administration................................................................................................................ 16 
6.1. 
Training............................................................................................................................. 16 
6.2. 
Monitoring ......................................................................................................................... 18 
6.3. 
Site Initiation ...................................................................................................................... 18 
6.4. 
Periodic Site Monitoring ....................................................................................................... 18 
6.5. 
Device Accountability and Storage ........................................................................................ 18 
6.6. 
Core Lab ........................................................................................................................... 18 
6.7. 
Protocol Deviations ............................................................................................................. 19 
6.8. 
Protocol Amendments ......................................................................................................... 20 
6.9. 
Access to Source Data / Documents...................................................................................... 20 
6.10. 
Registry Records Retention.................................................................................................. 20 
6.11. 
Publication Plan ................................................................................................................. 21 
6.12. 
Health Economics............................................................................................................... 21 
7. Data Collection and Submission ................................................................................................... 21 
7.1. 
Data Collection Methods ...................................................................................................... 22 
7.2. 
Data Clarification and Correction........................................................................................... 22 
7.3. 
CRF Completion Schedule ................................................................................................... 22 
8. Risk Assessment ......................................................................................................................... 22 
8.1. 
Potential Risks ................................................................................................................... 22 
8.2. 
Minimization of Risks........................................................................................................... 23 
8.3. 
Summary of Expected Benefits ............................................................................................. 23 
8.4. 
Risk-to-Benefit Rationale ..................................................................................................... 23 
9. Adverse Events and Safety Monitoring .......................................................................................... 24 
9.1. 
Anticipated Adverse Events.................................................................................................. 24 
9.1.1. 
Adverse Event Relationship .................................................................................... 24 
9.1.2. 
Adverse Event Classification ................................................................................... 25 
9.1.3. 
Adverse Event Reporting and Coding ....................................................................... 25 
9.1.4. 
Subject Death ....................................................................................................... 26 
9.2. 
Unanticipated Serious Adverse Device Effects (USADE) .......................................................... 26 
9.3. 
Device Deficiency ............................................................................................................... 26 
9.4. 
Clinical Event Committee ..................................................................................................... 27 
10. Statistical Analysis....................................................................................................................... 27 
10.1. 
Registry Hypotheses ........................................................................................................... 27 
10.2. 
Sample Size Assumptions.................................................................................................... 27 
10.3. 
Sample Size Determination .................................................................................................. 28 
10.4. 
Data Analysis ..................................................................................................................... 28 
10.4.1. Timing of Analyses ................................................................................................ 28 
10.4.2. Analysis Populations .............................................................................................. 28 

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10.4.3. Registry Deviations ................................................................................................ 28 
10.4.4. Pooling of Data...................................................................................................... 29 
10.4.5. Statistical Analysis of Primary Endpoint(s) ................................................................. 29 
10.4.6. Statistical Analysis of Secondary Endpoint(s) ............................................................. 29 
11. Ethical and Regulatory Considerations.......................................................................................... 29 
11.1. 
Statement of Compliance ..................................................................................................... 29 
11.2. 
Compliance Responsibilities ................................................................................................. 29 
11.3. 
Informed Consent ............................................................................................................... 30 
11.4. 
Regulatory Review.............................................................................................................. 30 
11.5. 
Conflict of Interest............................................................................................................... 31 
11.6. 
Confidentiality .................................................................................................................... 31 
11.7. 
Registry Discontinuation or Suspension ................................................................................. 31 
12. References .................................................................................................................................. 33 
 
Table of Tables 
Table 1. TAAA Classification per ESVS Treatment Guidelines ............................................................... 1 
Table 2: Core Lab specifications .......................................................................................................... 19 
 
Table of Figure 
Figure 1: 
 Device sizes............................. 2 
Figure 2: 
................................................ 3 
Figure 3: 
....................... 3 
Figure 4 Zones of Attachment.............................................................................................................. 35 
 
Table of Appendices  
Appendix A: Eligibility Criteria with Justification / Rationale................................................................... 34 
Appendix B: Zones of Attachment........................................................................................................ 35 
 
 

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1. 
Introduction 
1.1. Disease 
Complex abdominal aortic aneurysms (CAAA) and thoraco-abdominal (TAAA) are those 
that affect the visceral aortic branch vessels (including the renal, the celiac trunk and the 
superior and inferior mesenteric arteries).1 CAAA (including short-necked infrarenal 
juxtarenal, paravisceral and suprarenal aneurysms) are defined as aneurysms that involve 
the renal or mesenteric arteries and extend up to the level of the celiac axis or 
diaphragmatic hiatus but do not extend into the thoracic aorta.2 Aneurysms extending 
proximal to the renal arteries which involve variable extent of the thoracic aorta are 
referred to as TAAA which were classified by Crawford-Safi based on the extent of 
surgical repair required. ESVS guidelines3 provide anatomic descriptions which are 
included in Table 1. 
Table 1. TAAA Classification per ESVS Treatment Guidelines 
TAAA Type 
Definition3 
Type I 
Start at the level of the left subclavian artery, or at least proximal to the level of 
the sixth vertebra (T6) and affect the entire DTA, involve the visceral arteries 
and end at the renal arteries. The aneurysm can involve the origin of the LSA or 
even involve the distal aortic arch. 
Type II 
Start at the same level as a type I, but involve the DTA and the entire abdominal 
aorta 
Type III 
Start more distal than type II aneurysms, usually at the level of T6, and extend 
distally as in a type II. 
Type IV 
Start at the level of the diaphragm and involve the entire abdominal aorta, with 
or without extension to the iliac arteries. 
1.2. Historical Treatments  
 CAAA and TAAA involving the visceral segment may be treated by open surgical repair 
specific to the type of aneurysms or a variety of endovascular techniques. The purpose of 
this registry is to assess the utility of the 
as a bridging stent when used in conjunction with a branched or 
fenestrated stent graft. Therefore, this review will focus on the devices that are used in 
this application.  
In early experience with fenestrated grafts, bare metal stents were commonly employed 
primarily to maintain alignment of the fenestration with the target vessel. As an example, 
the Cook Zenith® fenestrated graft study reported a mixed usage of bare metal and 
covered stents in the bridging application.4 In this report, loss of patency was higher in 
vessels treated with bare metal stents, although this was not statistically significant. Over 
time, balloon expandable covered stents have become the preferred option for FEVAR.  
More recently, Farivar and colleagues published results with a variety of devices and 
conclude that the choice of balloon expandable covered stent has no effect on branch 
durability in FEVAR procedures.5  

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In BEVAR procedures, a covered bridging stent is generally selected given the need to 
exclude the aneurysm from circulation while still maintaining perfusion of the target vessel.  
Mastracci and colleagues6 performed an analysis of outcomes in branched aortic repair 
and were unable to demonstrate any difference in occlusion or reintervention between 
balloon-expandable and self-expandable covered stents.  
The successful usage of the 
 
has been reported in several publications involving FEVAR and BEVAR procedures7-11, 
which suggests that this device may offer a reasonable option as a bridging stent in these 
applications.  
1.3. Registry Device Description 
The design, device sizes, and characteristics 
permit the use of the device in multiple pathologies. 
 

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1.4. Pre-clinical Data 
Gore has performed the following pre-clinical testing on the 
1.5. Clinical Data 
 
More detailed device information can be found in the Instructions for Use (IFU) 
2. 
Registry Objectives 
2.1. Primary Objective(s) 
The primary objective is to confirm the clinical performance of the 
 
 when used as a Bridging Stent with Branched 
and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-
Mesenteric Arteries. 
 
 

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2.2. Secondary Objective(s) 
The secondary objective is to confirm safety of the 
 when used as a Bridging Stent with Branched and 
Fenestrated Endografts in the Treatment of Aortic Aneurysms involving the Renal-
Mesenteric Arteries. 
2.3. 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. 
3. 
Registry Design 
3.1. Registry Design Schema 
 
 
 

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3.2. Description of Registry Design 
This multicenter, single-arm retrospective and prospective registry is being conducted to 
confirm the clinical performance and safety of 
 when used as a Bridging Stent with Branched and 
Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-
Mesenteric Arteries.  
A single arm design was chosen as the clinical application does not readily lend to 
randomization due to involvement of multiple vessels and variability with respect to the 
main body design.   
A retrospective and prospective registry was determined to be suitable observational 
study design to reliably answer the research question, based on consistency of device 
design, procedures, clinical results available and operative techniques. 
Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had 
treatment with 
 when used 
as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic 
Aneurysms Involving the Renal-Mesenteric Arteries. 
Each site cannot contribute to more than 10% of the total patient for each cohort without 
sponsor approval, with a maximum of 30% 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. 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 and prospectively for up to 5 years of follow-up from the index 
procedure.  
3.3. 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 to ensure that no selection bias is applied by the site during 
patient screening, please see section 5.5 for more details.  
The registry is meant to retrospectively and prospectively collect data for reporting as well 
as evaluate “real world” experience of clinical practice and patient outcomes during 
treatment and throughout follow-up extending up to 5 years. Patient selection, diagnostic 
imaging and treatment interventions will be determined by physicians based on this 
protocol and clinical practice standards. 

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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, signed by next of kin/legal 
representative, according to local regulations.  
Refer to section 5.3.1 regarding the waived process. 
3.4. Registry Endpoint(s) 
3.4.1. 
Definitions 
Outcome 
Definition per SVS reporting Standards 
Technical Success Related Outcomes 
Target Vessel Technical Success  
Successful catheterization and 
 
placement in all intended target vessels. 
 
For this registry, technical success will be reported for 
the overall procedure and specifically for the vessels 
targeted for treatment with the 
 
Primary Technical Success (Total 
Endovascular Procedure) 
 
A modified technical success definition, requiring the 
following: 
1. Successful side branch catheterization and 
placement of bridging stents with restoration 
and maintenance of flow in all intended target 
vessels 
2. Patency of all aortic modular stent graft 
components and intended side branch 
components 
3. Absence of type I or type III endoleaks at 
completion angiography that extends beyond 30 
days by confirmatory imaging (CTA, magnetic 
resonance angiography [MRA], or duplex 
ultrasound) 
 
Vessel Patency Related Outcomes 
Primary Patency  
(Primary Endpoint) 
Uninterrupted patency with no occlusion or procedure 
performed to maintain patency on the 
t 
or native target vessel. Interventions intended to treat 
endoleak or stent disconnection do not count as loss of 
primary patency. 
 
Primary Assisted Patency 
Endovascular intervention performed to maintain 
patency in the presence of a stenosis before occlusion 

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Secondary Patency 
Endovascular restoration of patency after occlusion of 
the side branch, stent, or stent graft has already 
occurred. Conversion to bypass or inability to treat by 
endovascular means defines loss of secondary patency 
Occlusion 
Objective documentation by angiography, computed 
tomography, or ultrasound of complete stent occlusion 
with or without minimal flow into a targeted vessel 
Stenosis  
Objective documentation by angiography, computed 
tomography, or ultrasound of stenosis intra-stent or into 
a targeted vessel 
Kink  
Objective documentation by angiography, computed 
tomography, or ultrasound of kink in the stented or 
native segment of a targeted vessel 
Other Outcomes 
Intraprocedural complications 
Any vessel perforation, dissection, or occlusion during 
target vessel stenting 
Reintervention 
Any repeated vascular or nonvascular procedure related 
to the index procedure  
 
Reintervention will be adjudicated as major or minor 
based on the following  
Major:  
deployment of proximal or distal aortic or iliac 
extensions, removal of the device, use of thrombectomy 
or thrombolysis, and any major open surgical procedure. 
 
Minor: 
endovascular procedures (percutaneous transluminal 
angioplasty, atherectomy, stenting) without 
thrombectomy or thrombolysis, interventions to treat 
branch vessel stenosis, interventions to treat type II 
endoleak or branch-related endoleaks, and minor 
surgical revisions (patch angioplasty) of the access 
vessels. 
 
Each reintervention will be adjudicated as related to a 
-treated branch vessel component, related to a non-
-treated branch vessel component, or related to 
main body component(s), if possible.  
Target vessel instability 
Death or rupture related to side branch complication 
(e.g., endoleak) or reintervention to treat a branch-
related complication, including endoleak, disconnection, 
kink, stenosis, occlusion, or rupture 
 

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Aneurysm-related mortality 
Any death that occurs within the first 30 days or any 
death that results from aneurysm rupture, aorta-related 
complications (eg, infection, occlusion, dissection, 
hematoma), or a complication of a secondary 
intervention 
Major Adverse Events (MAEs) 
All-cause mortality  
Myocardial infarction (MI): MI resulting in severe 
hemodynamic dysfunction necessitating resuscitation, 
cardiac arrest, or fatal outcome. 
Respiratory failure requiring prolonged (>24 hours from 
anticipated) mechanical ventilation or reintubation  
Any renal function deterioration according to the RIFLE 
classification system.  
Bowel ischemia requiring surgical resection or not 
resolving with medical therapy  
Permanent paraplegia (any grade 3 A-C spinal cord 
injury) in a patient who is no ambulatory. 
Any major stroke defined according to National Institutes 
of Health Stroke Scale (NIHSS) or equivalent. 
3.4.2. 
Primary Endpoints 
• 
Primary Performance Outcome: Target vessel patency (patient level) at 12 
months  
3.4.3. 
Secondary Endpoints 
Secondary performance outcomes 
o Reintervention (total and reintervention that can be attributed to branches 
originally treated with the 
) at 12 months and annually 
through 5 years post-implant
o Target Vessel Technical Success 
o Primary Technical Success (Total Endovascular Procedure) 
o Target vessel instability at 12 months and annually through 5 years post-
implant 
o Target vessel patency, patient level, annually from 2-5 years post-implant 
(extended primary endpoint)  
o Target vessel patency, vessel level analysis, annually from procedure to 5 
years post-implant  
Secondary safety outcomes  
o Aneurysm-related mortality at 12 months and annually through 5 years 
post-implant 
o MAEs at 30 days 
 
 

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4. 
Registry Population 
4.1. Description of Population 
The registry population will consist of patients that have had treatment with 
 and that meet the registry eligibility 
criteria.
Subject 
Cohort 
Treatment 
period 
FU period after 
index 
procedure* 
(years) 
Number patients 
Caps per site** 
(patient) 
Fenestrated 
repair (FEVAR) 
From July 2021 
to Jan 2017 
5 
100 
First cap 10% (10 
patients) 
Second and max 
cap 30% (30 
patients) 
Branched 
repair (BEVAR) 
From July 2021 
to Jan 2017 
5 
120 
First cap 10% (12 
patients) 
Second and max 
cap 30% (36 
patients) 
Fenestrated-
branched 
repair*** 
From July 2021 
to Jan 2017 
5 
Up to 40  
N.A. 
* Subject who died before the end of FU period will be not excluded from the registry.  
** for FEVAR and BEVAR cohorts an enrollment cap is fixed at 10% of the total patients without sponsor 
approval. With sponsor approval, a single site may enroll a maximum of 30% of total patients. 
***Hypothesis testing will be performed on the FEVAR and BEVAR cohort only.  
 
Target for hypothesis testing is to have 220 subjects among FEVAR and BEVAR only 
subjects. The registry also accounts for mixed cases that can be enrolled according to 
consecutive screening procedure, as described in section 5.5  
Site’s registry staff will review patients’ medical records to identify eligible patients for this 
retrospective and prospective data collection. The registry has been designed with 
standard eligibility criteria to enroll subjects for which the registry device has been 
intended to treat. Only patients who meet all of the inclusion criteria and none of the 
exclusion criteria will be included in the registry.  
Considering the nature of the patient’s disease, elderly patients (≥ 65 years old) can 
represent the majority of subjects enrolled in this registry. This population can include 
patients with cognitive disorder or severe dementia.  
According to EU regulation, elderly patients are considered vulnerable population. 
However, considering the retrospective nature of the registry, the patients have already 
been treated at the time of the inclusion, therefore there are not additional risks for this 
vulnerable population (please see risk assessment at (section 9) to be included in this 
registry. 
 
 

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4.2. 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. 
1. Patients treated with the 
 as 
a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow 
endovascular aneurysm repair from 31 December 2021 until 01 January 2017  
2. Age ≥18 years at the time of implant  
3. Provision of informed consent by the patient or next of kin/legal representative (for 
deceased patients at registry entry, unless a waiver was granted), according to local 
regulations. 
4.3. Exclusion Criteria 
1. Patient treated for ruptured aneurysm or who were 
otherwise hemodynamically unstable at the time of the procedure  
2. Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms 
3. Patient treated using physician-modified endovascular grafts 
4. Patient intended to be treated with chimney, periscope, octopus, sandwich technique 
per the pre-treatment case plan  
5. At the time of treatment, patient had known coagulation disorders including 
hypercoagulability that were not amenable to treatment  
6. Patient was pregnant at the time of treatment.  
7. Participation in another drug or device investigational study within one year of device 
implant, that can confound the registry endpoints.  
8. Patient had known or suspected systemic infection (including treatment for mycotic 
aneurysm) at the time of implant. 
5. 
Registry Procedures / Evaluations 
No product or procedure-related training is required, the registry is designed to retrospectively 
collect pseudo-anonymized data on demographic (including medical history), procedure, clinical 
follow-up, and device characteristic from the patient’s medical record.   
Similarly, for follow-up data that will be collected prospectively, 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 following up 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, follow-up modalities will be determined by 
physicians based on clinical practice standards. 
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 3.3 
regarding minimization of bias. 
 
 

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5.1. Registry Procedures and Evaluation Schema 
 

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5.2. Schedule of Events 
1 Available information used in case planning (e.g. diagrams, imaging) will be requested as part of registry documentation  
2 Available imaging performed per the site standard of care for complex EVAR procedures and follow-up. This may include angiography, 
echocardiography, X-Ray, computed tomography and /or magnetic resonance. Any available imaging performed (fully anonymized) can 
be requested as part of registry documentation. 
3 Medication collected: Antiplatelet and anticoagulant therapy  
4 The start of the prospective phase may change from subject to subject depending on the treatment date. 
5 collection of any possible re-intervention data
  
6 Lab result will be collected if available, and can include, RBC, WBC, platelet, Creatinine, eGFR 
 
5.3. 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 Ethics Committee approved 
Informed Consent Form (ICF) before enrolment in the registry.  
As this registry is retrospective and considering the nature of patient’s disease, some 
patients may 
. 
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. 

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To protect patient privacy, patient-identifiable information (e.g., name, initials, complete 
birth date, and race) will not be collected in the registry clinical data management system.  
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, 
The EC approved consent form will be signed and personally dated by the subject or next 
of kin/legal representative (for deceased patients at registry entry, unless a waiver was 
granted), according to local regulations 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.  
5.3.1. 
Considering the low risk (see section 8, Risk Assessment) of this retrospective 
registry and the absence of registry-specific procedures for the patient, t
 Specific procedures to 
ensure adequate documentation of 
 informed consent process, in 
accordance with regulation and best clinical practice, will be provided to the 
investigators in a separate document.  
5.3.2. 
Vulnerable Populations 
Vulnerable population is described in section 4.1 
In case the patient is unable to make the decision to participate in this registry, 
Informed consent should be signed by next of kin/legal representative (LAR), 
according to local regulations. In such cases, the subject shall also be informed 
about the registry within his/her ability to understand and the subject should sign 
and personally date the written informed consent if capable. 
5.3.3. 
Emergent Cases 
Not applicable due to retrospective nature of the registry  
5.4. Pre-Screening 
Site are expected to perform a search of patients treated with 
 as a Bridging Stent in conjunction with a 
branched/fenestrated stent-graft within the hospital database following the site initiation 
performed by Gore. Upon site activation, 

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Screening will be divided in two phases: 
The research results will be recorded in the Pre-screening list based on patient’s date of 
index procedure in reverse chronological order (from newest to oldest patient treated). 
The pre-screening list produced during phase one and two 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 sent to Gore/other external individuals (CRO) but is available at the site 
in the registry binder for audit/inspection purposes. 
5.5. Enrollment  
Patient enrollment should be consecutive,and will occur according to paragraph 5.4 .  
From the pre-screening list (sorted by treatment date), the site should review patients 
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 
 
(LAR), according to local regulations
In order to minimize selection bias and to prove that patients have been screened in 
consecutive fashion, all patients, present in the pre-screening list, who will undergo 
inclusion/exclusion criteria assessment, 
 until the site reaches the max cap of enrolled patients planned for this 
registry or until the cohort is completed.  
If patient identified in the pre-screening list will not be enrolled, 
no personal information is recorded. The investigators will identify additional subjects to 
be screened.  
During the on-site monitoring visit, the monitor should review Subject Screening and 
Enrollment log against the subjects recorded in the EDC, in order to prove the enrolment 
occurred sequentially. 
5.6. 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.  
5.7. Screen Failure 
For clarity, this registry defines screening failure as subjects from the pre-screening list who: 
- do not meet Inclusion/Exclusion criteria.  
- declined consent. 
However, if after the collection of the consent, the subjects do not meet eligibility criteria, 
the primary reason for screen failure 
. 
The subject will be excluded from the registry and a replacement subject may be enrolled 
in agreement with sponsor and investigator.  

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5.8. Randomization and or Blinding 
No randomization or blinding is to be performed due to the confirmatory nature of the 
registry design. 
5.9. Procedure 
The registry procedures consist of two phases, retrospective phase and prospective phase.  
The retrospective phase consists only of the collection of retrospective data (baseline, 
treatment and FU data) from the source documents available at the site from the time of the 
treatment until the enrollment date (ICF signature). It is expected that sites will provide pre 
and post treatment as well as treatment images for Core Lab review.  
The prospective phase consists in collection of follow-up visits from the enrollment up to 5 
years. The FU data collected prospectively can change from subject to subject depending 
on the index procedure date. Diagnostic imaging, treatment interventions, and follow up will 
be determined by physicians based on clinical practice standards. 
5.10. Repeat Interventions 
Reinterventions may be performed at the discretion of the principal investigator / sub-
investigator to treat AEs. Any reinterventions performed will be documented on the CRF 
form. The components used as part of the reintervention, the date of the reintervention 
and the AEs leading to reintervention will also be documented on the CRF form.  
5.11. Follow Up 
All follow-up performed from the index procedure to the ICF signature will be collected 
retrospectively. FU data will be collected from the information already present in the 
medical chart.  
From the date of the enrollment, all FU visits including any imaging, performed according 
to hospital standard of care, will be collected up to 5 years post index procedure.  
In addition to in person visits, remote phone follow-up is also acceptable and clinical 
information obtained via phone can be collected.  
For testing done at institutions different than the registry site, or in case no follow-up data 
are available, investigators should make any efforts to retrieve documentation from the 
patient or from other records/sources (e.g. hospital databases, family doctor, family 
members).  
Subjects will continue to be followed by the site’s standard of care after completion of the 
registry. 
5.12. Subject Withdrawal from the Registry 
A subject may withdraw from the registry at any time and should notify the investigator in 
this event. The investigator may also withdraw the subject from the registry at any time 
based on his / her medical judgment. The sponsor may retain and continue to use any 
data collected before the withdrawal of consent, if not explicitly requested otherwise by the 
subject. 
If such withdrawal is due to problems related to the device safety or performance, the 
investigator shall ask for the subject's permission to follow his / her status / condition 
outside the registry. 

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During the prospective phase, patients may be considered withdrawn for any of the 
following: 
• 
Death 
• 
Voluntary withdrawal 
• 
Investigator withdrawal 
• 
Any other medical condition where evaluation of the 
 is not feasible 
(e.g., bypassed 
, explant of the device)
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 registry data will be used as appropriate.  
If possible, an additional evaluation of the 
(s) is recommended prior to their 
withdrawal from the registry. 
5.13. Subject Lost to Follow Up 
Due to the observational nature of this Registry and the variability of real - world follow-up 
frequency, patients will be declared lost to follow-up according to site’s standard 
modalities or at the end of the 5 years FU windows. Attempt to contact the subject or next 
of kin will be documented in the subject files. 
5.14. Subject Registry Completion 
A subject has completed the registry when he/she has reached the 5 years post treatment 
(+/- 1 month) and the visit has been 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. 
After subject registry completion the site standard of care will be continued. 
5.15. Explant Procedures 
The 
 may be explanted 
during a surgical procedure or as part of an autopsy. If this occur during the prospective 
phase of the registry sites are requested to return explanted devices to the sponsor for 
gross and histological evaluation. Prior to planned or potential device retrieval, contact the 
Gore Associate managing the registry to communicate that a specimen is being retrieved 
from a registry subject. A specimen shipping kit will be immediately sent to the site. The 
specimen kit provides specific packaging and handling instructions for the specimen and 
contains a shipping container. 
In complex aortic procedures it is expected that more than one 
can be 
implanted in the same subject, if the explanted device is the only one used in the subject 
then the subject will be discontinued, if other 
 remain implanted the 
subject will continue in the registry.  
6. 
Registry Administration 
6.1. Training 

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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. 
 
 

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6.2. Monitoring 
Site monitoring for this protocol will be provided by 
who are independent from the 
investigational site(s). Monitoring oversight will be provided by the sponsor. The Principal 
Investigator will be accessible to the monitor and respond to questions during monitoring 
visits. 
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 registry. 
6.3. Site Initiation 
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. 
The registry 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. 
6.4. 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 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 on-site or remotely contacted at close-
out to confirm that all documentation is complete.  
The registry will employ a risk-based monitoring approach where data are centrally 
reviewed for logical context, completeness, and obvious outliers. Only specific critical data 
variables will be source verified during on-site visits. Informed consent documentation or 
documentation that 
, will be reviewed for all patients to verify that all 
patients agreed to registry participation or are amenable for waiver. Monitoring procedures 
and requirements will be documented in a clinical monitoring plan developed and 
maintained by Gore. 
6.5. Device Accountability and Storage 
Due to the 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. 
6.6. Core Lab 
Core Lab services for this registry will be provided by 
 as 
referenced in Table 2. 

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Table 2: Core Lab specifications 
Core Lab 
Name 
Core Lab Location 
Type of Imaging 
Reviewed 
Main 
Assessments 
Timepoint 
 
 
Pre-procedure,  
Post-procedure 
and annually 
The Core Lab will perform assessments of imaging modalities according to objective 
process and standard procedures completed by trained and qualified personnel. 
Medical imagery will be transmitted to the Core Lab using the secure, web portal 
functionality of the 
. Imaging submitted through the 
portal will be stripped of personal health information and replaced with appropriate registry 
subject identifiers in automated, systemic fashion. Recipients will process received 
imaging according to their standard operating procedures or registry-specific processes. 
 
Additional imaging modalities, such as magnetic resonance, may be performed during the 
course of the registry as part of standard practice or in response to a clinical event. Gore 
may request these films to be submitted to aid in the understanding of an event or to 
support the conduct of an independent review committee such as a Clinical Events 
Committee (CEC). 
The site needs to upload the required imaging using 
, making sure that all PHI is 
redacted. 
6.7. Protocol Deviations 
The investigator/ sub-investigator must follow the protocol, except in the event of an 
immediate hazard(s) to a subject. The investigator must report those deviations and 
explanation 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 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, 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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The investigator will determine the cause and implement appropriate corrective and 
preventive actions to address significant noncompliance to the protocol. 
6.8. 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. 
6.9. Access to Source Data / Documents 
Source data are defined as all information necessary for the reconstruction and evaluation 
of the clinical investigation. 
The investigator and site staff should maintain adequate and accurate source documents 
and registry records that include all pertinent observations on each registry subject 
including documentation of the type and location of source documents. 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 registry team with a statement that it is a true 
reproduction of the original source.  
The investigator or designee will clearly mark subject clinical records to indicate the 
subject is enrolled in this registry. 
The investigator will keep all registry records and source data, available for inspection by 
the sponsor, sponsor’s monitors, EC, and regulatory authorities. 
6.10. 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 15 years after the latter of the date on which the registry is terminated or 
completed, where completion is intended as the last follow-up visit of the last treated 
subject. 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. 

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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. 
o A record of the exposure of each subject to the 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 require to be maintained by regulation or by 
specific requirement for a category of investigations or a particular investigation. 
• 
A signed Investigator Agreement, if applicable 
• 
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 6.7. 
• 
Other: Any other reports as reasonably requested by the sponsor or required by 
regulatory authority. 
• 
Withdrawal of EC approval: The investigator will report any withdrawal of approval 
within 5 working days after the investigator has been notified of the withdrawal” 
6.11. Publication Plan  
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a trials-registration policy as a condition for publication. This policy requires that 
all clinical trials be registered in a public trials registry. The sponsor will register the 
registry and post results as required by applicable regional laws and regulations. 
It is the intent of the sponsor that the multicenter results of this registry will be submitted 
for one or more publications (in a peer reviewed journal). A publications committee will be 
established to review the multicenter results and develop one or more publications at the 
completion of the registry. The timing of the multicenter publication may be dependent on 
regulatory submissions and approvals. Individual sites should coordinate requests for 
publication through the publications committee or the sponsor/Clinical Science Liaison. 
6.12.  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. With 
consent of the subject and approval of the supervising EC, billing information may be 
collected to aid in this evaluation. 
7. 
Data Collection and Submission 
The validated Clinical Data Management System (CDMS) for this registry will be provided by 
 The sponsor keeps a separate Clinical Data Management Plan (CMMP) describing the 
procedures for verification, validation, and security of the CDMS. The CDMP will describe and 
document procedures regarding data management processes for this registry. 
 
 

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7.1. Data Collection Methods  
This registry will report clinical data using the 
 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. 
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. 
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. 
7.3. CRF Completion Schedule 
All registry data are targeted to be entered into the appropriate eCRF within 10 days of 
enrollment for the retrospective phase and within 10 days of collection for the prospective 
phase, however, data outside this window will not be considered a protocol deviation. Pre-
Screening information will be recorded for all subjects and will only consist in inclusion 
/exclusion criteria evaluation, and enrollment information. All subsequent data entry will 
only occur after collection of inform consent to participate in the registry.  
8. 
Risk Assessment  
Given the registry design, subjects would have been already treated at the time of enrollment, 
therefore there is no potential for physical risks to subjects during the retrospective phase of the 
registry. T
There is a minimal risk of 
since subject information will be collected 
and analyzed for the proposed registry. However, appropriate measures will be taken to minimize 
the risk as much as possible. All information entered into the central registry database will be de-
identified. This registry will abide by all regulations related to protecting human subjects and 
protected health information (PHI). 
A complete listing of the known risks associated with the 
 can be found the IFU. 
8.1. Potential Risks 
Potential risks were listed in the IFU available at the time of the implant, given the 
retrospective treatment it is expected that majority of risk are no more applicable because 
related to the implant procedure. Nevertheless, some device related risks could potentially 
still occur in the long term i.e (see section Hazards and Adverse Events from IFU): 
• 
Side branch occlusion 
• 
Thrombosis  

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 
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• 
Infection  
8.2. Minimization of Risks 
• 
The sponsor has conducted risk management activities for the 
 according to ISO14971:2019. Risks 
remaining after the risk control measures have been implemented are acceptable and 
the effectiveness of these measures have been verified. The combined impact of the 
individual risks has been assessed and found to be acceptable. The benefit of the 
product has been assessed against the overall residual risk and determined that the 
medical benefit of the product outweighs the risk. The overall residual risk for this 
product is comparable to similar products. Therefore  overall residual risk has been 
evaluated for the 
 and 
has been deemed acceptable. All appropriate methods are in place to collect clinical 
information during the trial for the
All risks related to the design, manufacturing and usability of the 
medical device have been reduced as far as possible. 
• 
The sponsor has performed qualification testing on the device and device components 
and appropriate quality control measures have been implemented into production. 
Investigators will be selected who are knowledgeable and experienced in 
endovascular procedures. 
• 
The site investigator, sub-investigators, study coordinator(s) or designee at each site 
will be trained to the protocol and subject follow-up requirements. 
• 
Protocol inclusion / exclusion criteria and follow-up schedules are designed to select 
appropriate subjects and identify potential complications early.  
• 
Safety and efficacy findings during the registry will be shared with the site 
investigators to aid understanding of the device and potential complications 
associated with its use. 
• 
Possible interactions with concomitant medical treatments are not expected as such 
treatment will be consistent with best medical practices and institutional standards. 
The sponsor will promptly notify the investigator and regulatory authorities of findings 
that could affect the safety of subjects, impact the conduct of the registry, or alter the 
IRB / EC’s approval to continue the registry. 
8.3. Summary of Expected Benefits 
Participation in this observational registry is not expected to provide any direct benefits to 
participating patients. However, the data collected during the registry will foster a better 
understanding of the performance of the registry device. 
8.4. Risk-to-Benefit Rationale 
The registry will not require the use of any procedure/follow-up and / or test and / or 
device different from those required by routine clinical practice for the treated conditions, 
therefore enrolled patients will not be exposed to additional risks as compared to routine 
clinical practice. 
The clinical data supports an appropriate performance and safety profile and risk-benefit 
ratio, for the 
when used as 
intended, and the potential benefits offered by the 
outweigh the identified potential risks. 

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9. 
Adverse Events and Safety Monitoring 
9.1. Anticipated Adverse Events 
Anticipated adverse events are medical complications that are known to be associated 
with treatment of aortic aneurysms involving the renal-mesenteric arteries using GORE® 
 as a Bridging Stent with Branched 
and Fenestrated Endografts. 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, disease. 
Only one primary relationship will be assigned to each reported AE. 
-related 
The functioning or characteristics of the registry device caused or contributed to 
the adverse event. 
Procedure-related 
The procedure (and not the device) caused or significantly contributed to the 
adverse event (e.g., contrast induced renal failure, access vessel complication, 
etc.)* 
Procedure-related 
The procedure (and not the device) to implant 
 caused or 
significantly contributed to the adverse event. 
Device related (
and Gore accessory) 
The functioning or characteristics of the device, other than 
and 
Gore accessory, caused or contributed to the adverse event. 
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. 
Gore Accessory related  
The functioning or characteristics of the Gore accessory caused or contributed to 
the adverse event. 
Not-related 
An adverse event which cannot be attributed to the device, procedure, or disease. 
Unknown relationship 
The relationship of the adverse event to the device, procedure, or disease insert 
other categories as appropriate cannot be determined. 
*Events related to the specific part of the procedure where 
 is implanted are 
not included in this definition  
 
 

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9.1.2. 
Adverse Event Classification 
Each AE, regardless of the causal relationship with the device, will be assessed by 
the Investigator to determine if it is Serious or Non-serious, as defined below. The 
CEC will review this information and provide a final adjudicated classification. 
Clinical Affairs uses the ISO 14155 definition for classification of severity. 
Serious Adverse Event 
A serious adverse event is an adverse event that led to any of the following:  
(a) death 
(b) serious deterioration in the health of the subject, users, or other persons as 
defined by one or more of the following:  
(i) life-threatening illness or injury, or 
(ii) permanent impairment of a body structure or a body function including 
chronic diseases, or 
(iii) in-patient or prolonged hospitalization, or 
(iv) medical or surgical intervention to prevent life-threatening illness or injury 
or permanent impairment to a body structure or a body function 
(c) fetal distress, fetal death, or a congenital abnormality, or birth defect including 
physical or mental impairment  
NOTE: Emergency room visits and 23-hour observations may not constitute 
hospitalization. 
Serious Health Threat 
Signals from adverse events or device deficiencies are required to be evaluated by 
the Principal Investigator and reported to Gore immediately 
9.1.3. 
Adverse Event Reporting and Coding 
Adverse event reporting begins after enrolment, starting from index procedure 
date, and ends when the subject completes the 5 years visit. After enrollment all 
adverse events from the retrospective phase will be reported by the site in the 
EDC with the initial data entry. Adverse events that occur in the prospective phase 
will be reported as soon as possible. 
For any condition reported in the medical history and / or present at baseline or 
index procedure do not report as an adverse event unless it becomes serious or 
increase in intensity, or if a worsening of a baseline condition is reported.  
AEs will be reported on the appropriate CRF and documented in the subject’s 
permanent medical record. The investigator at each site is ultimately responsible 
for reporting AEs to the sponsor. 
The following information on each reported AE will be collected: 
• 
Adverse event name 
• 
Adverse event onset date 
• 
Relationship 
• 
Classification serious or non-serious 
• 
Treatment 

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• 
Outcome 
• 
Resolution date 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA). 
Adverse event submission guidelines: 
• 
Adverse event reporting begins once the patient is enrolled in the registry. All 
adverse events 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. Adverse events should be reported using the 
full name without abbreviations or narratives. 
• 
Adverse events with an outcome status of “ongoing” should be assessed at 
each follow-up evaluation to determine if the event has resolved. Adverse 
events ongoing at registry completion / discontinuation should be left as 
“ongoing” on the AE case report form. 
9.1.4. 
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. 
Attempts will be made by the Site to obtain death certificate and autopsy reports, 
when possible. 
9.2. 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. 
9.3. 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, user or other persons 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. 
 
 

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9.4. Clinical Event Committee 
An independent Clinical Events Committee (CEC) will review endpoint related clinical 
events during the registry to ensure the consistency of endpoints reported by the site. The 
21-04 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. 
CEC will be managed by 
to ensure the independency of the members from the 
sponsor.  
Sponsor will not take part of any CEC activities and may only deliver initial training to the 
CEC members on the protocol and registry device. 
After review, the CEC will inform 
whether or not additional data is required to 
evaluate any specific event, whether or not clarifications are needed.  
Site may need to send anonymized source documentation to CRO related to the events 
that need to be adjudicated by CEC.  
This committee will operate under pre-specified procedures as outlined in its charter. The 
frequency of data review and other roles and responsibilities of the committee will be 
specified in the registry specific CEC charter. 
10. Statistical Analysis 
10.1. Registry Hypotheses  
The registry is designed to statistically test the hypothesis that the Target Vessel Patency 
at 12 months (Primary Performance Endpoint) in both FEVAR and BEVAR populations of 
subjects is greater than 77%.  The hypothesis will be tested separately in the two cohorts 
(FEVAR and BEVAR), using the subjects with imaging results available for the 12 months 
visit. The binomial exact test will be used with a one-sided 2.5% level of significance to 
test the null hypothesis.  
The statistical hypothesis is specified as follows: 
H0: P < 77% 
HA: P ≥ 77% 
Alpha= 0.025 (one-sided) 
Whereas P is the probability of maintaining Target Vessel Patency at 12 months. 
The ITT population will be used to perform this test. 
A separate analysis in the subgroup with mixed placement of branched and fenestrated 
endografts as well as other clinical uses not described as only FEVAR or BEVAR will also 
be assessed with no formal hypothesis. 
10.2. Sample Size Assumptions  
The assumptions used for the calculation of sample size in the registry included the 
anticipated performance of the 
 for the FEVAR and BEVAR procedures, 
the acceptance criteria determined from the l
 The preliminary clinical evaluation suggested that the 
in the FEVAR and BEVAR cohorts respectively.  

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10.3. Sample Size Determination  
Using the above assumptions, the 
enrolled in the FEVAR and BEVAR cohorts respectively. 
10.4. Data Analysis  
10.4.1. Timing of Analyses  
The analysis to test the primary hypothesis will be conducted once all subjects 
have completed their 12 Month follow-up, data has been entered and cleaned in 
the EDC system.  Subjects with a visit within 90 days of the annual time frames will 
be considered for analysis of the annual outcomes. 
. The 
subject follow-up will continue for five years, and the final analysis will be done 
once all subjects have completed five-year follow-up. Separate analysis will be 
performed for FEVAR and BEVAR cohorts.  No interim analysis for the early 
termination of registry is planned due to the post marketing usage of the 
 and retrospective nature of the enrollment. In addition, once the 
primary analysis has been performed and hypothesis tested, further analyses may 
also be performed as needed for annual reports, presentations and publications 
based on interim data or at any other time at the discretion of Gore. 
10.4.2.  Analysis Populations  
Intent-to-Treat (ITT) dataset will consist of all enrolled patients meeting the 
inclusion / exclusion criteria and treated at least one vessel with the 
 ITT dataset will be used for the analysis of the primary and secondary 
endpoints. In addition, Per-Protocol dataset will also be created after excluding 
subjects not meeting inclusion/exclusion criteria or the vessels treated with the 
devices other than the 
.  Similarly, per vessel analysis will be 
performed with both datasets after identifying each vessel treated. Per vessel 
analysis will be further identified by type of main body portal and vessel treated 
e.g., BEVAR SMA, BEVAR Celiac, Fenestrated renal, BEVAR renal etc. and may 
include vessels from the cohort of subjects treated with mixed FEVAR/BEVAR 
procedures. 
10.4.3. Registry Deviations 
The registry protocol deviations will be assessed descriptively and their potential 
impact on the registry results will be evaluated considering the nature of such 
deviations. The sample size for the registry is increased by 10% to compensate for 
the missed visits to that extent and allow for the testing of the registry hypothesis 
without compromising the power. 
 

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10.4.4. Pooling of Data  
All sites in the registry will follow a common protocol and the data will be monitored 
to assure compliance. The data collection and handling procedures will be the 
same at all registry Sites. As such, there is no concern in pooling data from 
different sites together for analysis. Gore may perform analyses to explore 
differences in device performance by gender, age, or any other subgroup of 
interest. 
10.4.5. Statistical Analysis of Primary Endpoint(s)  
Analysis of the Primary Endpoint to test the hypothesis will be performed using 
. Missing data at the 
time of analysis will not be imputed.
10.4.6. Statistical Analysis of Secondary Endpoint(s)  
Tables of each secondary endpoint will be
 Missing data at the time of analysis will not be 
imputed.
11. Ethical and Regulatory Considerations 
11.1. 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), have been incorporated into applicable Clinical Quality 
System procedures. 
The following are applicable to this registry: 
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 
on medical devices,  
ISO 14155:2020(E) 
Clinical investigation of medical devices 
for human subjects – Good clinical 
practice 
11.2. 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, the 
reviewing EC concerning the progress of and any new material information about the 
registry. 

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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. The investigator is also responsible for ensuring that informed consent 
is properly obtained or a possible waiver documented as required. 
The investigator will determine the cause and implement appropriate corrective and 
preventive actions to address significant noncompliance. 
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 subjects still alive and reachable for this 
registry are provided with an EC approved consent form describing this registry and 
sufficient information to make an informed decision about their participation. In case of 
deceased patients, the next of kin/legal representative could sign the informed consent 
form unless a waiver has been granted by the EC. 
The formal consent of a subject, using the EC-approved consent form, must be obtained 
by the investigator or designee before that subject undergoes any registry-related follow-
up procedure. The consent form will be signed and personally dated by the subject and 
the person who conducted the informed consent discussion.   Next of kin/legal 
representative can sign on behalf of the subject if he/she is unable to make the decision to 
participate or if subject deceased at registry entry, (unless a waiver was granted), 
according to local regulations.  
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 or LAR. 
The investigator or designee 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. 
11.4. Regulatory Review 
The investigator/ sub-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/ sub-investigator shall not enroll any subjects prior to obtaining 
approval for the registry from a properly constituted independent EC. 
The investigator will submit the protocol, informed consent forms, other information to be 
provided to subjects such as survey instruments or questionnaires, and any proposed 
advertising / recruitment materials, to the EC for written approval. 

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11.5. Conflict of Interest 
All investigators/ sub-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 subject records will be kept confidential to the extent provided by applicable laws and 
regulations. The 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 or designee will inform the subjects that their records will be reviewed. 
11.7. Registry Discontinuation or Suspension 
The entire registry may be suspended or prematurely terminated by the sponsor in the 
following cases: 
• 
Serious adverse events as defined in section 9.1.2 attributable to the investigation.  
• 
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 
subjects. 
• 
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. 
• 
National regulatory authority withdrawal of registry approval. 
• 
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. 
• 
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 or regulatory authority 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, EC or regulatory authority suspends or prematurely terminates the 
registry, all implanted subjects shall continue to be followed and treated as per 
standard of care at each site. The sponsor may request that subjects are contacted or 
complete an office visit prior to registry termination.  
• 
The investigator of each site or authorized designee shall promptly inform the enrolled 
subjects. 

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• 
If the sponsor received notice that the EC and/or regulatory authority approval has 
been withdrawn for any reason, the sponsor shall notify the investigator as soon as 
possible and preferably within 24 hours. Enrollment must immediately cease until such 
approval is reinstated. 
• 
If the investigator receives notice that the EC and/or regulatory authority approval has 
been withdrawn for any reason, the investigator shall notify the sponsor as soon as 
possible and preferable within 24 hours. 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 EC s and the 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 as 
described in section 6.4 will be performed. 
• 
If the investigator terminates or suspends a trial 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. 
The procedures of premature registry termination of an individual subject (voluntary 
withdrawal or withdrawal of the subject by the investigator) are detailed in section 5.2 of 
the registry 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 regulatory authority by providing the rational and relevant data 
supporting this decision before the registry resumes. 
• 
When concurrence from ECs and, where appropriate, other regulatory 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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12. References 
1. 
Yaoguo Y, Zhong C, Lei K, Yaowen X. Treatment of complex aortic aneurysms with fenestrated 
endografts and chimney stent repair: Systematic review and meta-analysis. Vascular. 
2017;25(1):92-100. 
2. 
Oderich GS, Forbes TL, Chaer R, Davies MG, Lindsay TF, Mastracci T, Singh MJ, Timaran C, 
Woo EY; Writing Committee Group. Reporting standards for endovascular aortic repair of 
aneurysms involving the renal-mesenteric arteries. J Vasc Surg. 2021 Jan;73(1S):4S-52S. doi: 
10.1016/j.jvs.2020.06.011. Epub 2020 Jun 29. PMID: 32615285. 
3. 
Riambau V, Bockler D, Brunkwall J, et al. Editor's Choice - Management of Descending Thoracic 
Aorta Diseases: Clinical Practice Guidelines of the European Society for Vascular Surgery 
(ESVS). Eur J Vasc Endovasc Surg. 2017;53(1):4-52. 
4. 
Oderich GS, Greenberg RK, Farber M, et al. Results of the United States multicenter prospective 
study evaluating the Zenith fenestrated endovascular graft for treatment of juxtarenal abdominal 
aortic aneurysms. J Vasc Surg. 2014;60(6):1420-1428 e1421-1425. 
5. 
Farivar BS, Brier C, Kuramochi Y, Eagleton MJ. Impact of bridging stent design and configuration 
on branch vessel durability after fenestrated endovascular repair of complex aortic aneurysms. J 
Vasc Surg. 2021;73(3):819-825. 
6. 
Mastracci TM, Carrell T, Constantinou J, et al. Editor's Choice - Effect of Branch Stent Choice on 
Branch-related Outcomes in Complex Aortic Repair. Eur J Vasc Endovasc Surg. 2016;51(4):536-
542. 
7. 
Gallitto E, Faggioli G, Pini R, et al. First/Preliminary Experience of Gore Viabahn Balloon-
Expandable Endoprosthesis as Bridging Stent in Fenestrated and Branched Endovascular Aortic 
Repair. Ann Vasc Surg. 2019;61:299-309. 
8. 
Mafeld S, Annamalai G, Lindsay TF, et al. Initial Experience With Viabahn VBX as the Bridging 
Stent Graft for Branched and Fenestrated Endovascular Aneurysm Repair. Vasc Endovascular 
Surg. 2019;53(5):395-400. 
9. 
Motta F, Parodi FE, Knowles M, et al. Performance of Viabahn balloon-expandable stent 
compared with self-expandable covered stents for branched endovascular aortic repair. J Vasc 
Surg. 2021;73(2):410-416 e412. 
10. 
Tenorio ER, Karkkainen JM, Mendes BC, et al. Outcomes of directional branches using self-
expandable or balloon-expandable stent grafts during endovascular repair of thoracoabdominal 
aortic aneurysms. J Vasc Surg. 2020;71(5):1489-1502 e1486. 
11. 
Torsello GF, Beropoulis E, Munao R, Trimarchi S, Torsello GB, Austermann M. Outcomes of 
bridging stent grafts in fenestrated and branched endovascular aortic repair. J Vasc Surg. 
2020;72(3):859-865. 
 
 

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Registry-Specific Appendices 
Appendix A: Eligibility Criteria with Justification / Rationale 
 
 
Item 
Number 
Text of Criterion 
Rationale 
I1 
Patients treated with the 
as a 
Bridging Stent in conjunction with a 
branched/fenestrated main body stent graft to 
allow endovascular aneurysm repair from 31 
December 2021 until the 01 January 2017  
I2 
Age ≥18 years at the time of implant 
I3 
Provision of informed consent by the patient or 
next of kin/legal representative (for deceased 
patients at registry entry, unless a waiver was 
granted), according to local regulations. 
I
 
 
 
E1 
Patients treated for ruptured aneurysm or who 
were otherwise hemodynamically unstable at 
the time of the procedure 
E2 
Patient treated for dissection acute or sub-
acute, <90 days from presenting symptoms 
E3 
Patient treated using physician-modified 
endovascular grafts 
estrated and branched 
E4 
Patient intended to be treated with chimney, 
periscope octopus, sandwich technique per the 
pre treatment case plan. 
 
E5 
At the time of treatment, patient had known 
coagulation disorders including 
hypercoagulability that were not amenable to 
treatment 
E6 
Patient was pregnant at the time of treatment. 
E7 
Participation in another drug or device 
investigational drug or device study within one 
year of device implant, that can confound the 
registry endpoints. 
E8 
Patient had known or suspected systemic 
infection (including treatment for mycotic 
aneurysm) at the time of implant. 

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Appendix B: Zones of Attachment 
For reporting purposes, the location and extent of stent-graft coverage will utilize a system of numerically 
labeled zones according to Figure 4. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 4 Zones of Attachment  
 
 
 

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Protocol Modification Summary 
List of Changes in VBX 21-04 protocol version #2 
The following administrative changes have been made to the protocol: 
• 
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 
Potential impact on 
performance, 
effectiveness, 
safety or other 
endpoints 
Inclusion/Exclusion 
criteria  
Changed the wording of 
Inclusion criteria #1 to:  
Patients treated with the 
as a 
Bridging Stent in 
conjunction with a 
branched/fenestrated 
stent-graft to facilitate 
endovascular aneurysm 
repair from 
Changed the worlding of 
Exclusion criteria #4 to: 
Patient intended to be 
treated with chimney, 
periscope, octopus, 
sandwich technique per 
the pre treatment case 
plan. 
 
Updated to extend 
screening and 
enrollment windows 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clarification of intent  
 
 
 
 
 
 
 
 
 
 
 
This addition only 
provides clarification 
and will not affect 
study endpoints  
Section 4.1 – 
description of the 
population 
Maximum cap per site 
increased from 20 to 30 
percent  
Ward enrollment 
progression and meet 
powered simple size 
requirements   
No impact  
Section 5.5 – Pre-
Screening  
Added information about 
how phase one and 
Adding details to clarify 
screening and 
No impact 

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CONFIDENTIAL INFORMATION 
MD133246 Protocol Template 
 
Page 37 of 37 
Revision#: 7  
Doc Type: GC 
phase two of the 
screening will occur 
enrollment timeframe 
extension  
Section 10.4.1 – Timing 
of the analysis 
Added information on 
visit windows that will be 
considered for analysis  
Providing clarification  
No impact