GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

Launched by W.L.GORE & ASSOCIATES · Aug 27, 2024

Keywords

ClinConnect Summary

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 follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.

Gender

ALL

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).