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, requiring Zone 2 proximal implantation of the device.
For Zone 2, there are two arms (Aneurysm arm, Non-aneurysm arm) and four cohorts, described as follows: Zone 2 Aneurysm, Zone 2 Dissection, Zone 2 Traumatic Transection, and Zone 2 Other Isolated Lesion. Continued access Subjects were enrolled in the Zone 2 Aneurysm arm. The Zone 2 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 2 Subjects enrolled for analysis were from the United States only.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Endovascular repair with the TBE Device
Proportion of Participants With Primary Endpoint Success for Zone 2
Primary Endpoint was composite of the following events: device technical success and absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device/procedure/withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Time frame: 12 Months
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Keck Medical Center of USC
Los Angeles, California, United States
Cedar-Sinai Medical Center
Los Angeles, California, United States
Leland Stanford Junior University
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
University of Florida - Gainesville
Gainesville, Florida, United States
Univeristy of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, United States
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