Retrospective Real-World Data Collection of the Conformable GORE® TAG® Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for... | NCT07742592

NCT07742592

Overview

NCT ID: NCT07742592
Lead Sponsor: W.L.Gore & AssociatesINDUSTRY
Official Title: 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
Brief Summary: 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
Conditions: Dissection of Aorta
Aneurysm Aortic
Frozen Elephant Trunk
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Central Contacts: Harrison Lead Clinical Study ManagerContact
hkelner@wlgore.com12068225653