GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

Running, not enrolling · Not applicable

Conditions studied: Abdominal Aortic Aneurysm, Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm

In brief

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.

Key facts

Study ID

NCT06578741

Run by

W.L.Gore & Associates

People needed

310

Starts

2024-11-25

Expected to finish

2036-06-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Stanford Hospital — Stanford, California, United States

Full record on ClinicalTrials.gov

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