Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

February 2, 2026 updated by: W.L.Gore & Associates

Assessment of Long Term, Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The purpose of the Gore Together Aortic Registry is to collect real-world data (RWD) for Gore aortic endovascular devices. Due to the nature of the program, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions.

Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Perth, Australia
        • Recruiting
        • Royal Perth Hospital
        • Principal Investigator:
          • Nishath Altaf, M.D.
        • Contact:
      • Sydney, Australia
        • Not yet recruiting
        • Royal Prince Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Jack Loa, M.D.
    • New South Wales
      • New Lambton Heights, New South Wales, Australia
        • Not yet recruiting
        • John Hunter Hospital
        • Contact:
        • Principal Investigator:
          • Zoheb Williams, M.D.
    • Queensland
      • Southport, Queensland, Australia
        • Recruiting
        • Gold Coast Hospital and Health Services
        • Contact:
        • Principal Investigator:
          • Venu Bhamidi, M.D.
    • South Australia
      • Bedford Park, South Australia, Australia
        • Recruiting
        • Flinders Medical Centre (Vascular Unit)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chris Delaney, Professor
    • Victoria
      • Melbourne, Victoria, Australia
        • Recruiting
        • The Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Thodur Vasudevan, M.D.
  • Austria
      • Vienna, Austria
        • Recruiting
        • Medizinische Universität Wien
        • Principal Investigator:
          • Florian Wolf
        • Contact:
  • Finland
      • Helsinki, Finland
        • Recruiting
        • Helsinki University Hospital (HYKS III)
        • Contact:
        • Principal Investigator:
          • Pekka Aho
      • Tampere, Finland
        • Recruiting
        • Wellbeing Services County of Pirkanmaa
        • Contact:
        • Principal Investigator:
          • Velipekka Suominen, MD
      • Tampere, Finland
        • Recruiting
        • Wellbeing Services County of Pirkanmaa Tampere University Hospital
        • Contact:
        • Principal Investigator:
          • Velipekka Suominen, M.D.
  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Basheer Sheikh-Yousif, M.D.
  • Italy
      • Ancona, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona
        • Principal Investigator:
          • Emanuele Gatta
        • Contact:
      • Bari, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico di Bari
        • Contact:
        • Principal Investigator:
          • Domenico Angiletta, M.D.
      • Pavia, Italy
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Principal Investigator:
          • Antonio Bozzani
        • Contact:
      • Torino, Italy
        • Recruiting
        • AOU Città della Salute e della Scienza di Torino Ospedale S.Giovanni Battista- Molinette
        • Contact:
        • Principal Investigator:
          • Fabio Verzini
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
        • Principal Investigator:
          • Gian Franco Veraldi
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC Research BV
        • Principal Investigator:
          • Kak Khee Yeung
        • Contact:
      • Tilburg, Netherlands
        • Recruiting
        • Stichting Elisabeth-TweeSteden Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Jan Heyligers
      • Venlo, Netherlands
        • Recruiting
        • VieCuri Medical Center
        • Principal Investigator:
          • Jan-Willem Elshof
        • Contact:
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • Auckland District Health Board Charitable Trust
        • Contact:
        • Principal Investigator:
          • Anastasia Dean, M.D.
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand
        • Recruiting
        • Clinical Trials New Zealand Limited - Waikato Hospital
        • Principal Investigator:
          • Manar Khashram, M.D.
        • Contact:
  • Poland
      • Lublin, Poland
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
        • Contact:
        • Principal Investigator:
          • Piotr Terlecki, Professor
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
        • Principal Investigator:
          • Jaume Dilme
      • Seville, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • Lucas Fuentes, M.D.
  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital
        • Contact:
        • Principal Investigator:
          • Carl Magnus Wahlgren, M.D.
  • United Kingdom
      • Leicester, United Kingdom
        • Recruiting
        • University Hospitals of Leicester NHS Trust
        • Contact:
        • Principal Investigator:
          • Gregory McMahon
      • Liverpool, United Kingdom
        • Recruiting
        • Countess Of Chester Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Leith Williams, Mr.
      • London, United Kingdom
        • Recruiting
        • Imperial College Healthcare NHS Trust, St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Colin Bicknell
      • London, United Kingdom
        • Recruiting
        • St Thomas Hospital - Guys and St. Thomas' NHS
        • Contact:
        • Principal Investigator:
          • Said Abisi, M.D.
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Central Arkansas Veteran's Healthcare System
        • Contact:
        • Principal Investigator:
          • Lauren Story-Hefta, M.D.
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California - Irvine
        • Contact:
        • Principal Investigator:
          • Anthony Chau, M.D.
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Contact:
        • Principal Investigator:
          • Sukgu Han, M.D.
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University School of Medicine
        • Contact:
        • Principal Investigator:
          • Kenneth Tran, MD
      • Stanford, California, United States, 94304
        • Recruiting
        • Stanford University School of Medicine
        • Contact:
        • Principal Investigator:
          • Kenneth Tran, M.D.
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Vascular Institute
        • Contact:
        • Principal Investigator:
          • Michael Ayad, M.D.
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University Of South Florida
        • Contact:
        • Principal Investigator:
          • Dean Arnaoutakis, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30033
        • Recruiting
        • VA Medical Center- Atlanta
        • Contact:
        • Principal Investigator:
          • Olamide Alabi, M.D.
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
        • Principal Investigator:
          • James Chang, M.D.
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Medical Center
        • Contact:
        • Principal Investigator:
          • Gautam Agarwal, M.D.
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Atlanta VA Medical Center
        • Principal Investigator:
          • Olamide Alabi, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Hospital
        • Principal Investigator:
          • Trissa Babrowski, M.D.
        • Contact:
      • Evanston, Illinois, United States, 60026
        • Recruiting
        • Endeavor Health
        • Contact:
        • Principal Investigator:
          • CJ Lee, M.D.
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • St. Vincent Medical Group, Inc.
        • Principal Investigator:
          • Brent Marsden, M.D.
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Contact:
        • Principal Investigator:
          • Amit Dwivedi, M.D.
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake Regional Medical Center
        • Contact:
        • Principal Investigator:
          • P. Michael Davis, M.D.
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland - Baltimore
        • Contact:
        • Principal Investigator:
          • Shahab Toursavadhohi, M.D.
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Bay City, Michigan, United States, 48708
        • Recruiting
        • McLaren Heatlh Care Corporation
        • Principal Investigator:
          • Nicolas Mouawad, M.D.
        • Contact:
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Corewell Health Medical Group West
        • Contact:
        • Principal Investigator:
          • Eanas Yassa, M.D.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Contact:
        • Principal Investigator:
          • Elliot Stephenson, M.D.
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Jill Colglazier, M.D.
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri
        • Contact:
        • Principal Investigator:
          • Todd Vogel, M.D.
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Cox Health
        • Contact:
        • Principal Investigator:
          • Zachary Schmittling, M.D.
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Principal Investigator:
          • Bjoern Suckow, M.D.
        • Contact:
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo, Research Foundation
        • Contact:
        • Principal Investigator:
          • Linda Harris, M.D.
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Recruiting
        • Mission Hospital
        • Contact:
        • Principal Investigator:
          • John Henretta, MD
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • Mark Farber, M.D.
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Chandler Long, MD
        • Contact:
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Universtiy Medical Center
        • Principal Investigator:
          • Chandler Long, M.D.
        • Contact:
      • Winston-Salem, North Carolina, United States, 27103
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist
        • Contact:
        • Principal Investigator:
          • Matthew Goldman, M.D.
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals - Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Jae-Sung Cho, M.D.
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Portland VA Health Care System
        • Contact:
        • Principal Investigator:
          • Enjae Jung, M.D.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Principal Investigator:
          • Grace Wang, M.D.
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health-Upstate
        • Contact:
        • Principal Investigator:
          • Sagar Gandhi, M.D.
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Shadman Baig, M.D.
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott and White
        • Contact:
        • Principal Investigator:
          • Dennis Gable, M.D.
      • Plano, Texas, United States, 75075
        • Recruiting
        • HCA Healthcare Research Institute/Columbia Medical Center of Plano
        • Principal Investigator:
          • Edic Stephanian, M.D.
        • Contact:
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Health
        • Contact:
        • Principal Investigator:
          • Evan Brownie, M.D.
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Nathan Droz, M.D.
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Health Care Services
        • Contact:
        • Principal Investigator:
          • Kendal Endicott, M.D.
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Heart Hospital
        • Principal Investigator:
          • Animesh Rathore, M.D.
        • Contact:
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • CAMC Health and Education and Research Institute, Inc
        • Contact:
        • Principal Investigator:
          • Ali Aburahma, M.D.
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Peter Rossi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Registry participants are derived from patients presenting with vascular disease that may benefit from the placement of an endovascular stent graft. The target registry population is patients who are treated with either EXCC or IBE Device at participating sites. This includes initial procedures and reinterventions (regardless of original intervention). Only patients who meet all the inclusion and none of the exclusion criteria will be included in the registry.

The registry has been designed with broad eligibility criteria to optimize the visibility of overall registry device use. An integral requirement to the target subject population is that the decision to use a GORE® EXCLUDER® product has been made prior to considering the patient for possible registry participation.

Description

Inclusion Criteria:

  1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements
  2. Patient has been or is intended to be treated with an eligible registry device
  3. Patient is age ≥ 18 years at time of informed consent signature.

Exclusion Criteria:

  1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
  2. Patient with exclusion criteria required by local law.
  3. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device)
Patients treated with the EXCC Device
GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device)
Patients treated with the IBE Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deployment Technical Success
Time Frame: Time of Surgery
Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system.
Time of Surgery
Lesion-related Mortality
Time Frame: Day 30 through Year 10
Death related to the index endovascular procedure, secondary procedure associated with the index lesion or the registry device, or any death where the treated disease / index lesion or registry device caused or significantly contributed to the death
Day 30 through Year 10
Lesion Rupture
Time Frame: Time of Surgery through Year 10
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or Computed Tomographic Angiography (CTA) scan
Time of Surgery through Year 10
Lesion Enlargement
Time Frame: Time of Surgery through Year 10
An increase in maximum vessel (e.g., aorta or treated branch) diameter of > 5 mm in the region encompassed by the initial lesion as compared to baseline using orthogonal (i.e., perpendicular to the centerline) measurements on CTA scans
Time of Surgery through Year 10
Endoleaks
Time Frame: Time of Surgery through Year 10
Perfusion of a treated lesion identified through imaging analysis
Time of Surgery through Year 10
Device Migration
Time Frame: Time of Surgery through Year 10
Longitudinal movement of all or part of the device for a distance ≥ 10 mm, as confirmed by CTA scan, relative to anatomical landmarks and device positioning at the first post-operative CTA scan.
Time of Surgery through Year 10
Loss of aortic / branch patency
Time Frame: Time of Surgery through Year 10
No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.
Time of Surgery through Year 10
New onset renal failure
Time Frame: Time of Surgery through Day 30
New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for > 4 weeks
Time of Surgery through Day 30
Device integrity events
Time Frame: Time of Surgery through Year 10
wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis
Time of Surgery through Year 10
Reintervention
Time Frame: Time of Surgery through Year 10
Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure.
Time of Surgery through Year 10
Renal function deterioration
Time Frame: Time of Surgery through Year 10
New onset of a decrease in eGFR > 30% following treatment when compared to baseline eGFR.
Time of Surgery through Year 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of remote data collection to supplement follow-up activities
Time Frame: Time of Surgery through Year 10
An exploratory description intended to assign significance to an increasingly used method of participant engagement to assess utilization, frequency by time, outcomes, contribution to total follow-up, need for elevation of care
Time of Surgery through Year 10
New onset buttock claudication / erectile dysfunction
Time Frame: Time of Surgery through Year 1
Patient reported
Time of Surgery through Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Investigators

  • Principal Investigator: S. Han, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2024

Primary Completion (Estimated)

September 30, 2042

Study Completion (Estimated)

September 30, 2042

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGR 23-02AA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data to be shared will be pseudo-anonymized with subject names and birthdates removed, but information such as procedure date will not.

IPD Sharing Time Frame

Sharing of IPD will not routinely be performed and is contingent on an assessment of the researcher's proposal for novelty or value in advancing educational, quality or medical practice objectives in use of this data.

IPD Sharing Access Criteria

See above

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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