Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE) (THRIVE)
Thoracic Aortic Aneurysms
About this trial
This is an interventional treatment trial for Thoracic Aortic Aneurysms focused on measuring thoracic aneurysm, thoracic aortic aneurysms, Thoracic Endovascular Aneurysm Repair (TEVAR), Talent Thoracic Stent Graft
Eligibility Criteria
Inclusion Criteria: appropriate anatomy for elective repair of the descending thoracic aortic aneurysm
- iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and or accessories
- non-aneurysmal aortic diameter in the range of 18-42mm; and
- non-aneurysmal aortic proximal and distal neck lengths equal to or greater than 20mm
- subject has a Descending Fusiform Thoracic Aneurysm = to or greater than 5cm in diameter OR is = to or greater than 2 times the diameter of the non-aneurysmal thoracic aorta and/or saccular aneurysms/penetrating ulcers
- Signed patient informed consent
Exclusion Criteria:
- Less than 18 yrs old
- pregnant
- unable to comply w/follow-up
- participating in other drug or device trials;
- Subject has a co-morbidity causing expected survival to be less than 1 year
Sites / Locations
- Cedars Sinai Medical Center
- Harbor-UCLA
- Washington Hospital D.C.
- U Florida at Shands Hospital
- Osceola Regional Med Ctr
- Emory University
- Northwestern MH
- Southern Illinois University
- St. Vincent Heart Center
- Brigham & Women's Hospital
- Albany Medical Center
- Northwell Health Inc
- Duke University Medical Center
- Riverside Methodist Hospital
- University of Toledo Med Ctr
- UPMC Presbyterian Hospital
- Pinnacle Health
- Memorial Hospital
- Baptist Memorial Hospital
- Tennova Physicians Regional Medical Center
- Baylor College of Medicine
- The Methodist Hospital
- The Heart Hospital/Baylor Plano
- Sentara Norfolk General Vascular & Transplant Specialists
- University of Washington
- Providence Sacred Heart
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
DeNovo
Valor
Prospectively enrolled subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
Historical control arm, consisting of 195 subjects from the VALOR Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol. The data from these subjects will be combined with the data from the subjects implanted after commercial release (DeNovo) to comprise the final analysis cohort for the THRIVE Study