Not yet recruiting NCT07742592

Retrospective Real-World Data Collection of the Conformable GORE® TAG® Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for Treatment of Aortic Aneurysms and Dissections

— Observational Dissection of Aorta Aneurysm Aortic Frozen Elephant Trunk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure.
Who it may be relevant to: Registry conditions: Dissection of Aorta, Aneurysm Aortic, Frozen Elephant Trunk. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Detailed description

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.

Interventions

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

Primary outcome measures

MAE freedom within one year (365 days) post-implant [Time frame: From date of index procedure through 365 days post implant]

Secondary outcome measures (1)

Freedom from imaging outcomes within the 12-Month analysis window [Time frame: From the date of the index procedure through end of 12 months analysis window unless otherwise specified]

Eligibility criteria

Inclusion criteria

Treated for aneurysm or dissection using antegrade deployed Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device at least 12 months prior to date of enrollment.
Age ≥ 18 years at the time of the index procedure.
Proximal extent of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device is sutured to the aorta and/or distal aspect of the surgical graft.
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

Any modification performed on the CTAG Device, excluding suturing.
Procedure performed in the setting of infection requiring treatment with parenteral anti-infective medication.
Pregnant at the time of the index procedure.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07742592 · TAG 25-09

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗