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10-Year watch on aneurysm repair devices begins

NCT ID NCT06218875

Knowledge-focused Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 2000 people who have or will receive a GORE EXCLUDER stent-graft to repair an abdominal aortic aneurysm (AAA). Researchers will track device safety and performance over 10 years, checking for complications like leaks, movement, or kidney problems. The goal is to learn how well these devices work in everyday medical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Sep 2042

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm Aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aaa - abdominal aortic aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    90 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Città della Salute e della Scienza di Torino Ospedale S.Giovanni Battista- Molinette

    RECRUITING

    Torino, Italy

  • Amsterdam UMC Research BV

    RECRUITING

    Amsterdam, Netherlands

  • Atlanta VA Medical Center

    RECRUITING

    Decatur, Georgia, 30033, United States

  • Auckland District Health Board Charitable Trust

    RECRUITING

    Auckland, New Zealand

  • Augusta University Medical Center

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera Universitaria Integrata Verona

    RECRUITING

    Verona, Italy

  • Azienda Ospedaliero Universitaria Policlinico di Bari

    RECRUITING

    Bari, Italy

  • Azienda Ospedaliero Universitaria Policlinico di Bari

    RECRUITING

    Bari, Italy

  • Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona

    RECRUITING

    Ancona, Italy

  • Baylor Scott and White

    RECRUITING

    Plano, Texas, 75093, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • CAMC Health and Education and Research Institute, Inc

    RECRUITING

    Charleston, West Virginia, 25304, United States

  • Central Arkansas Veteran's Healthcare System

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Clinical Trials New Zealand Limited - Waikato Hospital

    RECRUITING

    Hamilton, Waikato Region, New Zealand

  • Corewell Health Medical Group West

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Countess of Chester Hospital NHS Foundation Trust

    RECRUITING

    Liverpool, United Kingdom

  • Countess of Chester Hospital NHS Foundation Trust

    RECRUITING

    Liverpool, United Kingdom

  • Cox Health

    RECRUITING

    Springfield, Missouri, 65807, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Duke Universtiy Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory Saint Joseph's Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Endeavor Health

    RECRUITING

    Evanston, Illinois, 60026, United States

  • Flinders Medical Centre (Vascular Unit)

    RECRUITING

    Bedford Park, South Australia, Australia

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, Italy

  • Forsyth Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Gold Coast Hospital and Health Services

    RECRUITING

    Southport, Queensland, Australia

  • HCA Healthcare Research Institute/Columbia Medical Center of Plano

    RECRUITING

    Plano, Texas, 75075, United States

  • Helsinki University Hospital (HYKS III)

    RECRUITING

    Helsinki, Finland

  • Helsinki University Hospital (HYKS III)

    RECRUITING

    Helsinki, Finland

  • Hospital De La Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, Spain

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Imperial College Healthcare NHS Trust, St. Mary's Hospital

    RECRUITING

    London, United Kingdom

  • Inova Health Care Services

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Intermountain Health

    RECRUITING

    Murray, Utah, 84107, United States

  • Intermountain Health

    RECRUITING

    Murray, Utah, 84107, United States

  • John Hunter Hospital

    NOT_YET_RECRUITING

    New Lambton Heights, New South Wales, Australia

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Sweden

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Sweden

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • McLaren Heatlh Care Corporation

    RECRUITING

    Bay City, Michigan, 48708, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medizinische Universitat Wien

    RECRUITING

    Vienna, Austria

  • Minneapolis Heart Institute Foundation

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Mission Hospital

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • Mount Sinai Vascular Institute

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • Our Lady of the Lake Regional Medical Center

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

  • Portland VA Health Care System

    RECRUITING

    Portland, Oregon, 97239, United States

  • Portland VA Health Care System

    RECRUITING

    Portland, Oregon, 97239, United States

  • Prisma Health-Upstate

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Prisma Health-Upstate

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Royal Perth Hospital

    RECRUITING

    Perth, Australia

  • Royal Prince Alfred Hospital

    NOT_YET_RECRUITING

    Sydney, Australia

  • Sentara Heart Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Sentara Heart Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • St Thomas Hospital - Guys and St. Thomas' NHS

    RECRUITING

    London, United Kingdom

  • St Thomas Hospital - Guys and St. Thomas' NHS

    RECRUITING

    London, United Kingdom

  • St. Vincent Medical Group, Inc.

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Stanford University School of Medicine

    RECRUITING

    Palo Alto, California, 94304, United States

  • Stanford University School of Medicine

    RECRUITING

    Stanford, California, 94304, United States

  • Stichting Elisabeth-Tweesteden Ziekenhuis

    RECRUITING

    Tilburg, Netherlands

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, Israel

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, Australia

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University Hospitals - Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University Hospitals of Leicester NHS Trust

    RECRUITING

    Leicester, United Kingdom

  • University at Buffalo, Research Foundation

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of California - Irvine

    RECRUITING

    Irvine, California, 92697, United States

  • University of Chicago Hospital

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Maryland - Baltimore

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Missouri

    RECRUITING

    Columbia, Missouri, 65212, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Uniwersytecki Szpital Kliniczny NR 1 W Lublinie

    NOT_YET_RECRUITING

    Lublin, Poland

  • VA Medical Center- Atlanta

    RECRUITING

    Atlanta, Georgia, 30033, United States

  • VieCuri Medical Center

    RECRUITING

    Venlo, Netherlands

  • Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Wellbeing Services County of Pirkanmaa

    RECRUITING

    Tampere, Finland

  • Wellbeing Services County of Pirkanmaa Tampere University Hospital

    RECRUITING

    Tampere, Finland

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