Breakthrough Stent-Graft approved for deadly aortic aneurysms

NCT ID NCT05442489

APPROVED_FOR_MARKETING Disease control Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

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.

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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

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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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