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