Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure and to assess the safety and performance of the Conformable GORE® TAG® Thoracic Endoprosthesis deployed antegrade as part of a FET procedure. This will be evaluated using real-world data and Computed Tomography (CT) imaging abstracted through retrospective chart review.
Study Type
OBSERVATIONAL
Enrollment
350
Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
MAE freedom within one year (365 days) post-implant
The primary endpoint will be measured as freedom from the composite of the following major adverse events (MAE) occurring within one year (365 days) post-implant: * Permanent Stroke * Permanent Paraplegia/ Paraparesis * Mortality * Reoperation
Time frame: From date of index procedure through 365 days post implant
Freedom from imaging outcomes within the 12-Month analysis window
The secondary endpoints will be measured as freedom from each of the following imaging outcomes within the 12-Month analysis window unless specified: * Failed Patency (within one year (365 days) post-implant) * Pseudoaneurysm (within one year (365 days) post-implant) * Increase in Aortic Diameter * Device Integrity * Device Migration * Type IA Endoleak * Type IB Endoleak * Type III Endoleak * Thrombosis of Index Pathology
Time frame: From the date of the index procedure through end of 12 months analysis window unless otherwise specified
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