NCT02777528

Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Detailed description

For Zone 0/1, there are two arms (Aneurysm arm, Non-aneurysm arm) and three cohorts, described as follows: Zone 0/1 Aneurysm, Zone 0/1 Dissection, and Zone 0/1 Other Isolated Lesion. The Zone 0/1 Aneurysm cohort was the only cohort analyzed with a hypothesis test, however data was collected similarly for all cohorts and for continued access Subjects. Zone 0/1 Subjects enrolled for analysis were from the United States and Japan.

Conditions

• Aortic Aneurysm, Thoracic
• Aorta, Lesion

Interventions

Type	Name	Description
DEVICE	GORE® TAG® Thoracic Branch Endoprosthesis	Endovascular repair with the TBE Device
PROCEDURE	Revascularization Procedure	Revascularization procedure of the great vessel

Timeline

• Start date: 2016-08-01
• Primary completion: 2024-03-01
• Completion: 2028-03-01
• First posted: 2016-05-19
• Last updated: 2025-06-25
• Results posted: 2025-06-25

Locations

39 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated device study