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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorW.L.Gore & Associates

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure

Treatment groups

350 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators