Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

NCT ID: NCT05442489

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.

Detailed Description

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Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP provided that its use is needed to treat a serious, but non-life-threatening condition. In the requesting physician's opinion, there must be no acceptable alternative treatment option. Patients are to be consented with an Emergency / Compassionate Use ICF template provided by Gore upon request for this type of device use. Sites will be required to fill out a packet justifying the rationale of use as well as their plan to conduct follow-up surveillance on the non-study subject. Upon performance of the case, the site will immediately notify Gore and provide supporting documentation to facilitate timely, compliant regulatory reporting.

Conditions

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Thoracoabdominal Aneurysm

Interventions

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GORE Excluder Thoracoabdominal Branch Endoprosthesis

TEVAR

Intervention Type DEVICE

Other Intervention Names

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TAMBE

Eligibility Criteria

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Inclusion Criteria

• 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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

Keck Medical Center of USC

Los Angeles, California, United States

Site Status

Kaiser Permanente San Francisco Medical Center

San Francisco, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

MedStar Health Research Institute - MedStar Washington Hospital

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

Site Status

University of Florida - Gainesville

Gainesville, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan - Cardiac Surgery

Ann Arbor, Michigan, United States

Site Status

Essentia Health

Duluth, Minnesota, United States

Site Status

Division of Vascular Surgery - Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Mount Sinai West

New York, New York, United States

Site Status

Weill Cornell Medical Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Sanger Heart & Vascular Institute

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

UPP Heart and Vascular Institute

Pittsburgh, Pennsylvania, United States

Site Status

University of Tennessee -University Vascular Surgeons

Knoxville, Tennessee, United States

Site Status

St. David's Healthcare

Austin, Texas, United States

Site Status

Baylor Heart & Vascular Hospital

Dallas, Texas, United States

Site Status

University of Texas Southwestern

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

The Methodist Hospital - Houston

Houston, Texas, United States

Site Status

University of Texas Health Science Center

Houston, Texas, United States

Site Status

Sentara Medical Group

Norfolk, Virginia, United States

Site Status

Carilion Clinic Hospitals

Roanoke, Virginia, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status

Aurora Health Care, Metro Inc.

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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AAA 17-01 Expanded Access

Identifier Type: -

Identifier Source: org_study_id

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