An observational study in Dissection of Aorta, Aneurysm Aortic and Frozen Elephant Trunk, sponsored by W.L.Gore & Associates. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by W.L.Gore & Associates · 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
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.
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 350 is above the median of 150 across 117 observational studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Compared within Aortic Aneurysm, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aortic Dissection. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The patient pool from which sites will screen for enrollment is comprised of patients with history of thoracic aortic disease that required surgical repair using a FET procedure. For qualifying patients with dissections, they will be enrolled into either of the following cohorts:
Those patients who meet all inclusion and no exclusion criteria, will be eligible for enrollment in this retrospective study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic/Subacute Dissections and Aneurysms
Device: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
Acute/Hyperacute Dissections
Device: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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