Official Title
Evaluation of the GORE® EXCLUDER® Thoracoabdominal BranchTreatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
Brief Summary

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

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.

Approved for marketing
Individual Patients
Thoracoabdominal Aneurysm

Device: GORE Excluder Thoracoabdominal Branch Endoprosthesis

TEVAR
Other Name: TAMBE

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 19 Years ~ Maximum: N/A
Countries
United States
Locations

University of Alabama at Birmingham
Birmingham, Alabama, United States

Mayo Clinic Arizona
Scottsdale, Arizona, United States

Keck Medical Center of USC
Los Angeles, California, United States

Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States

Stanford University
Stanford, California, United States

MedStar Health Research Institute - MedStar Washington Hospital
Washington, District of Columbia, United States

University of Florida - Gainesville
Gainesville, Florida, United States

University of South Florida
Tampa, Florida, United States

Emory University Hospital
Atlanta, Georgia, United States

Northwestern University
Chicago, Illinois, United States

Indiana University
Indianapolis, Indiana, United States

University of Maryland Medical Center
Baltimore, Maryland, United States

Massachusetts General Hospital
Boston, Massachusetts, United States

University of Michigan - Cardiac Surgery
Ann Arbor, Michigan, United States

Essentia Health
Duluth, Minnesota, United States

Division of Vascular Surgery - Minneapolis Heart Institute
Minneapolis, Minnesota, United States

Mayo Clinic - Rochester
Rochester, Minnesota, United States

Washington University School of Medicine
Saint Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States

Mount Sinai West
New York, New York, United States

Weill Cornell Medical Center
New York, New York, United States

University of Rochester
Rochester, New York, United States

University of North Carolina
Chapel Hill, North Carolina, United States

Sanger Heart & Vascular Institute
Charlotte, North Carolina, United States

Duke University Medical Center
Durham, North Carolina, United States

Cleveland Clinic
Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center
Columbus, Ohio, United States

University of Pennsylvania
Philadelphia, Pennsylvania, United States

UPP Heart and Vascular Institute
Pittsburgh, Pennsylvania, United States

University of Tennessee -University Vascular Surgeons
Knoxville, Tennessee, United States

Cardiothoracic and Vascular Surgeons, PA (CTVS)
Austin, Texas, United States

Baylor Heart & Vascular Hospital
Dallas, Texas, United States

University of Texas Southwestern
Dallas, Texas, United States

Baylor College of Medicine
Houston, Texas, United States

The Methodist Hospital - Houston
Houston, Texas, United States

University of Texas Health Science Center
Houston, Texas, United States

Sentara Medical Group
Norfolk, Virginia, United States

Carilion Clinic Hospitals
Roanoke, Virginia, United States

University of Washington
Seattle, Washington, United States

University of Wisconsin - Madison
Madison, Wisconsin, United States

Aurora Health Care, Metro Inc.
Milwaukee, Wisconsin, United States

W.L.Gore & Associates
NCT Number
MeSH Terms
Aneurysm
Aortic Aneurysm