Aneurysm Aortic, Dissection of Aorta, Frozen Elephant Trunk
Conditions
Keywords
frozen elephant trunk, aortic aneurysm, Aortic Dissection
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
Detailed description
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 and to assess the safety and performance of the Conformable GORE® TAG® Thoracic Endoprosthesis deployed antegrade as part of a FET procedure. This will be evaluated using real-world data and Computed Tomography (CT) imaging abstracted through retrospective chart review.
Interventions
DEVICEAntegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAE freedom within one year (365 days) post-implant | From date of index procedure through 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from imaging outcomes within the 12-Month analysis window | From the date of the index procedure through end of 12 months analysis window unless otherwise specified | 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 |
Contacts
CONTACTHarrison Lead Clinical Study Manager
Outcome results
None listed