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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

Conditions: Dissection of Aorta, Aneurysm Aortic, Frozen Elephant Trunk

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 350
Sponsor: W.L.Gore & Associates

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

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07742592). StuddyBuddy aggregates publicly available trial information.