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Active Not Recruiting
NCT06578741
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Conditions: Abdominal Aortic Aneurysm, Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 310
Sponsor: W.L.Gore & Associates
Location: Stanford Hospital Stanford California
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 of the TAMBE Device training program.
Eligibility Criteria
Inclusion Criteria:
The subject is / has:
1. 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.
2. Age ≥18 years at the time of informed consent signature.
3. An Informed Consent Form signed by subject or legal representative.
Exclusion Criteria:
The subject is / has:
1. Any contraindications for the TAMBE Device according to the IFU.
2. Planned parallel grafting with the TAMBE Aortic Component.
3. Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).
Source: ClinicalTrials.gov (NCT06578741). StuddyBuddy aggregates publicly available trial information.
