NCT02264977

Early Feasibility of the Branched TAG® Device in the Treatment of Aortic Arch Aneurysms

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (Branched TAG® Device) in the Treatment of Aortic Arch Aneurysms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (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 early feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the aortic arch

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) received premarket approval for the treatment of aneurysms of the DTA on 23-Aug-2011 (P040043/S039). The TAG® Device and CTAG are intended to exclude an aneurysm from the blood circulation in patients diagnosed with DTA aneurysms. However, endovascular treatment options for patients with aortic arch aneurysms are limited as current stent graft technology would require coverage of aortic arch vessels. This prompted the creation of the GORE® TAG® Thoracic Branch Endoprosthesis (previously known as Branched TAG® Device), which was being evaluated under IDE G130120 for Zone 2 aneurysms when this clinical investigation was initiated to evaluate the GORE® TAG® Thoracic Branch Endoprosthesis for the treatment of Zone 0 and Zone 1 aneurysms of the aortic arch.

Conditions

• Aneurysm of Aortic Arch

Interventions

Type	Name	Description
DEVICE	GORE® TAG® Thoracic Branch Endoprosthesis

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-07-01
• Completion: 2022-03-01
• First posted: 2014-10-15
• Last updated: 2022-09-14
• Results posted: 2017-08-02

Locations

6 sites across 1 country: United States