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Breakthrough Stent-Graft approved for deadly aortic aneurysms

NCT ID NCT05442489

Disease control 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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study provides expanded access to a new device called the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis for people with thoracoabdominal or pararenal aortic aneurysms. These are bulges in the main artery that involve branches to vital organs. The device is a stent-graft that repairs the aneurysm from inside the blood vessel, avoiding open surgery. Participants must have an aneurysm at least 5 cm wide, a saccular aneurysm, or one growing rapidly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (a stent-graft device)
What this could lead to
If successful, this device could provide a safe, minimally invasive way to repair complex aortic aneurysms, reducing the need for open surgery.
What could go wrong
This is an expanded access study, not a randomized trial, so results may be less definitive. Risks include device-related complications like leakage, migration, or blood vessel damage.

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.

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.

Ages

19 years and older

Sex

Anyone

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.

• Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following: Fusiform aneurysm diameter ≥ 5 cm Saccular aneurysm (no diameter requirement) Rapid aneurysm growth (≥ 5 mm in one year) * An Informed Consent Form signed by Subject or legal representative * Appropriate aortic anatomy to receive the TAMBE Device d

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Conditions

The condition(s) this trial relates to.

aortic aneurysm thoracic aortic aneurysm

As listed by the trial registrant

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

Thoracoabdominal aneurysm

Contacts and locations

Locations

  • Aurora Health Care, Metro Inc.

    Milwaukee, Wisconsin, 53215, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Baylor Heart & Vascular Hospital

    Dallas, Texas, 75226, United States

  • Carilion Clinic Hospitals

    Roanoke, Virginia, 24014, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Division of Vascular Surgery - Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Essentia Health

    Duluth, Minnesota, 55805, United States

  • Indiana University

    Indianapolis, Indiana, 46226, United States

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California, 94118, United States

  • Keck Medical Center of USC

    Los Angeles, California, 90033, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259, United States

  • MedStar Health Research Institute - MedStar Washington Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Mount Sinai West

    New York, New York, 10019, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Sanger Heart & Vascular Institute

    Charlotte, North Carolina, 28203, United States

  • Sentara Medical Group

    Norfolk, Virginia, 23507, United States

  • St. David's Healthcare

    Austin, Texas, 78705, United States

  • Stanford University

    Stanford, California, 94305, United States

  • The Methodist Hospital - Houston

    Houston, Texas, 77030, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • UPP Heart and Vascular Institute

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Florida - Gainesville

    Gainesville, Florida, 32610, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan - Cardiac Surgery

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester

    Rochester, New York, 14627, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Tennessee -University Vascular Surgeons

    Knoxville, Tennessee, 37920, United States

  • University of Texas Health Science Center

    Houston, Texas, 77030, United States

  • University of Texas Southwestern

    Dallas, Texas, 75352, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical Center

    New York, New York, 10065, United States

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