Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
- Conditions
- Thoracoabdominal Aneurysm
- Registration Number
- NCT05442489
- Lead Sponsor
- W.L.Gore & Associates
- Brief Summary
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective 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.
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
University of Texas Health Science Center
🇺🇸Houston, Texas, United States
St. David's Healthcare
🇺🇸Austin, Texas, United States
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
Sentara Medical Group
🇺🇸Norfolk, Virginia, 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
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
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