Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

W.L. Gore & Associates

Status

Conditions: Thoracoabdominal Aneurysm

Treatments: Device: GORE Excluder Thoracoabdominal Branch Endoprosthesis

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05442489

AAA 17-01 Expanded Access

Details and patient eligibility

About

Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.

Full description

Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP provided that its use is needed to treat a serious, but non-life-threatening condition. In the requesting physician's opinion, there must be no acceptable alternative treatment option. Patients are to be consented with an Emergency / Compassionate Use ICF template provided by Gore upon request for this type of device use. Sites will be required to fill out a packet justifying the rationale of use as well as their plan to conduct follow-up surveillance on the non-study subject. Upon performance of the case, the site will immediately notify Gore and provide supporting documentation to facilitate timely, compliant regulatory reporting.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following: Fusiform aneurysm diameter ≥ 5 cm Saccular aneurysm (no diameter requirement) Rapid aneurysm growth (≥ 5 mm in one year)

• An Informed Consent Form signed by Subject or legal representative
• Appropriate aortic anatomy to receive the TAMBE Device d