Status:
ENROLLING_BY_INVITATION
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Abdominal Aortic Aneurysm
Pararenal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy o...
Detailed Description
A maximum of 300 adult subjects will be enrolled at up to 60 U.S. centers, with a minimum of 70 subjects enrolled at study centers with no prior experience using the TAMBE Device. Subjects will have f...
Eligibility Criteria
Inclusion
- The subject is / has:
- Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels.
- Age ≥18 years at the time of informed consent signature.
- An Informed Consent Form signed by subject or legal representative.
Exclusion
- The subject is / has:
- Any contraindications for the TAMBE Device according to the IFU.
- Planned parallel grafting with the TAMBE Aortic Component.
- Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).
Key Trial Info
Start Date :
November 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2037
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06578741
Start Date
November 25 2024
End Date
March 1 2037
Last Update
December 11 2024
Active Locations (1)
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1
Stanford Hospital
Stanford, California, United States, 94305