By InvitationNot Applicable

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

United States300 participantsStarted 2024-11-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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).

What they're measuring

Co-Primary Endpoint #1: Technical Success

Timeframe: Time of index procedure

Co-Primary Endpoint #2: Clinical Success

Timeframe: Index procedure through 12 months

Trial details

NCT IDNCT06578741

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-01

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm trials