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

NCT05442489 | Unknown

• 1 other identifier: AAA 17-01 Expanded Access
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 41

Brief Summary

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

Conditions

Thoracoabdominal Aneurysm

Interventions

GORE Excluder Thoracoabdominal Branch Endoprosthesis DEVICE

TEVAR

Also known as: TAMBE

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

• 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (41)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Kaiser Permanente San Francisco Medical Center

San Francisco, California, 94118, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

MedStar Health Research Institute - MedStar Washington Hospital

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

Location

University of Florida - Gainesville

Gainesville, Florida, 32610, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46226, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan - Cardiac Surgery

Ann Arbor, Michigan, 48109, United States

Location

Essentia Health

Duluth, Minnesota, 55805, United States

Location

Division of Vascular Surgery - Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Sanger Heart & Vascular Institute

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UPP Heart and Vascular Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Tennessee -University Vascular Surgeons

Knoxville, Tennessee, 37920, United States

Location

St. David's Healthcare

Austin, Texas, 78705, United States

Location

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

University of Texas Southwestern

Dallas, Texas, 75352, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The Methodist Hospital - Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

Carilion Clinic Hospitals

Roanoke, Virginia, 24014, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Aurora Health Care, Metro Inc.

Milwaukee, Wisconsin, 53215, United States

Location

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: July 5, 2022
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (41)