Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:22 AM
Study NCT ID:
NCT02021812
Status:
COMPLETED
Last Update Posted:
2022-09-09
First Post:
2013-12-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms
Sponsor:
W.L.Gore & Associates
Organization:
Study Overview
Official Title:
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of Proximal Descending Thoracic Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: