TAMBE Device for Thoracoabdominal Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: W.L.Gore & Associates

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for adults over 18 with various types of aortic aneurysms, specifically those involving the visceral vessels. Participants must have been treated with the GORE® EXCLUDER® TAMBE Aortic Component and signed an informed consent form.

Inclusion Criteria

I have signed the Informed Consent Form.

I am 18 years old or older.

I have been treated with the GORE® EXCLUDER® device for aortic disease.

Participant Groups

The study evaluates real-world use of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in patients with aortic aneurysms to confirm its ongoing safety and effectiveness, as well as assessing training adequacy.

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Treatment with GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)