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)
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
31
Leland Stanford Junior University
Stanford, California, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
The Hitchcock Foundation (Dartmouth Hitchcock Medical Center)
Lebanon, New Hampshire, United States
Number of Participants With Successful Study Device Access
Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.
Time frame: During treatment procedure (day 0)
Number of Participants With Successful Study Device Deployment
Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.
Time frame: During treatment procedure (day 0)
Number of Participants With Primary Procedural Side Branch Patency as Assessed by Angiography
The presence of forward flow through the implanted Side Branch Component into the target branch vessel.
Time frame: At conclusion of the treatment procedure (day 0)
Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab
Time frame: 1 Month
Number of Participants Without 1 Month Device Related Endoleaks Assessed by an Independent Core Lab
Device-related endoelaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the adjacent tissue (endoleak type IA or IB) OR the junction between the Aortic Component and either the SB Component or the Aortic Extender (type III endoleak).
Time frame: 1 Month
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States