| Registry | NCT07742592 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 350 (Estimated) |
| Sponsor | W.L.Gore & Associates (Industry) |
| Conditions | Dissection of Aorta, Aneurysm Aortic, Frozen Elephant Trunk |
| Interventions | Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure (Device) |
| Dates | start 2026-09-01 (estimated), primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-08-03, last updated 2026-08-03 |
Related Papers Related Patents Related Grants Related Experts
All trials for Dissection of Aorta All trials for Aneurysm Aortic All trials of Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk 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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Chronic/Subacute Dissections and Aneurysms | Device: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure | Chronic/Subacute Dissections and Aneurysms | |
| Acute/Hyperacute Dissections | Device: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure | Acute/Hyperacute Dissections |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Treated for aneurysm or dissection using antegrade deployed Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device at least 12 months prior to date of enrollment. 2. Age ≥ 18 years at the time of the index procedure. 3. Proximal extent of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device is sutured to the aorta and/or distal aspect of the surgical graft. 4. Informed Consent Form (ICF) is signed by the subject or a legally authorized representative, or a waiver of consent is granted by the IRB of record and appropriately documented by the enrolling site. Exclusion Criteria: 1. Any modification performed on the CTAG Device, excluding suturing. 2. Procedure performed in the setting of infection requiring treatment with parenteral anti-infective medication. 3. Pregnant at the time of the index procedure. 4. Aneurysm or Subacute / Chronic Dissection cases (onset of symptoms ≥15 days prior to the date of the procedure) with documented aortic rupture at the time of the index procedure.