Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
DeviceAntegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
NCT Number: NCT07742592
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
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
Time frame: From date of index procedure through 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:
Time frame: From the date of the index procedure through end of 12 months analysis window unless otherwise specified
The secondary endpoints will be measured as freedom from each of the following imaging outcomes within the 12-Month analysis window unless specified:
Contact information is provided by the study sponsor or research team.
W.L.Gore & Associates
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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