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
Related Research Topics
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Trial Locations
- Locations (41)
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
Scroll for more (31 remaining)St. David's Healthcare🇺🇸Austin, Texas, United States