NCT07166133

GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.

Detailed description

Minimum of 125 total subjects with a TBE Device implantation procedure initiated in up to 50 Sites in the United States. Subjects will have follow-up at 1 Month, 6 Month, 1 Year, and annually thereafter for a minimum of 5-years and up to a maximum of 10 years.

Conditions

• Aortic Arch Dissection
• Aortic Arch Aneurysm

Interventions

Type	Name	Description
DEVICE	GORE® TAG® Thoracic Branch Endoprosthesis	Lesions in aortic arch in Zone 0 or Zone 1

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-07-01
• Completion: 2036-03-01
• First posted: 2025-09-10
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study