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

February 16, 2026 updated by: W.L.Gore & Associates

Evaluation of the GORE® EXCLUDER® Thoracoabdominal BranchTreatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

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

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
    • California
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC
      • San Francisco, California, United States, 94118
        • Kaiser Permanente San Francisco Medical Center
      • Stanford, California, United States, 94305
        • Stanford University
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Health Research Institute - MedStar Washington Hospital
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida - Gainesville
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46226
        • Indiana University
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan - Cardiac Surgery
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health
      • Minneapolis, Minnesota, United States, 55407
        • Division of Vascular Surgery - Minneapolis Heart Institute
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10019
        • Mount Sinai West
      • New York, New York, United States, 10065
        • Weill Cornell Medical Center
      • Rochester, New York, United States, 14627
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Sanger Heart & Vascular Institute
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPP Heart and Vascular Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee -University Vascular Surgeons
    • Texas
      • Austin, Texas, United States, 78705
        • St. David's Healthcare
      • Dallas, Texas, United States, 75226
        • Baylor Heart & Vascular Hospital
      • Dallas, Texas, United States, 75352
        • University of Texas Southwestern
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center
      • Houston, Texas, United States, 77030
        • The Methodist Hospital - Houston
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Medical Group
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic Hospitals
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin - Madison
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Health Care, Metro Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

• 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAA 17-01 Expanded Access

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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