NCT02021812

Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of Proximal Descending Thoracic Aortic Aneurysms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA)

Detailed description

The GORE® TAG® Thoracic Endoprosthesis (TAG® Device) received premarket approval (PMA) for use in endovascular aneurysm repair of the descending thoracic aorta (DTA) on 23-Mar-2005 under P040043, and design changes that resulted in the conformable GORE® TAG® Thoracic Endoprosthesis (CTAG Device) received premarket approval for the treatment of aneurysms of the DTA on 23-Aug-2011 (P040043/S039). The TAG® Device and CTAG Device are intended to exclude an aneurysm from the blood circulation in patients diagnosed with DTA aneurysms. However, endovascular-only treatment options for patients with aneurysms approaching the aortic arch are limited as current stent graft technology would require coverage of the left subclavian artery (LSA) which may result in the need for a surgical revascularization procedure. This prompted the creation of the GORE® TAG® Thoracic Branch Endoprosthesis (previously known as Branched TAG® Device), which was evaluated in this study under IDE G130120 for Zone 2 aneurysms of the DTA.

Conditions

• Aortic Aneurysm, Thoracic

Interventions

Type	Name	Description
DEVICE	GORE® TAG® Thoracic Branch Endoprosthesis

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-08-01
• Completion: 2022-03-01
• First posted: 2013-12-27
• Last updated: 2022-09-09
• Results posted: 2017-08-02

Locations

6 sites across 1 country: United States