NCT07147569

TAMBE Japan Post-Marketing Surveillance

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Marketing Surveillance

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.

Conditions

• Thoracoabdominal Aortic Aneurysm
• Pararenal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis	The target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used.

Timeline

• Start date: 2026-03-01
• Primary completion: 2034-02-28
• Completion: 2034-02-28
• First posted: 2025-08-29
• Last updated: 2026-02-18

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated device study