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
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.
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.
The patient pool from which sites will screen for enrollment is comprised of patients with history of thoracic aortic disease that required surgical repair using a FET procedure. For qualifying patients with dissections, they will be enrolled into either of the following cohorts: * Hyperacute: onset of symptoms must be documented to be \<24 hours prior to the date of the procedure. * Acute: onset of symptoms must be documented to be 1-14 days prior to the date of the procedure. * Subacute: onset of symptoms must be documented to be 15-90 days prior to the date of the procedure. * Chronic: onset of symptoms must be documented to be more than 90 days prior to the date of the procedure. Those patients who meet all inclusion and no exclusion criteria, will be eligible for enrollment in this retrospective study.
Cohort
Retrospective
Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
DeviceAntegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
MAE freedom within one year (365 days) post-implant
The primary endpoint will be measured as freedom from the composite of the following major adverse events (MAE) occurring within one year (365 days) post-implant: * Permanent Stroke * Permanent Paraplegia/ Paraparesis * Mortality * Reoperation
Freedom from imaging outcomes within the 12-Month analysis window
The secondary endpoints will be measured as freedom from each of the following imaging outcomes within the 12-Month analysis window unless specified: * Failed Patency (within one year (365 days) post-implant) * Pseudoaneurysm (within one year (365 days) post-implant) * Increase in Aortic Diameter * Device Integrity * Device Migration * Type IA Endoleak * Type IB Endoleak * Type III Endoleak * Thrombosis of Index Pathology
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