NCT06578741

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Abdominal Aortic Aneurysm
• Pararenal Aortic Aneurysm
• Thoracoabdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)	Treatment with the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in patients with Pararenal Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms

Timeline

• Start date: 2024-11-25
• Primary completion: 2027-06-01
• Completion: 2036-06-01
• First posted: 2024-08-29
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study