Status:
TERMINATED
Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)
Lead Sponsor:
Medtronic Cardiovascular
Collaborating Sponsors:
Medtronic
Conditions:
Thoracic Aortic Aneurysms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market appr...
Detailed Description
A descending thoracic aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weake...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT00805948
Start Date
April 1 2009
End Date
August 1 2017
Last Update
September 27 2021
Active Locations (26)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
Harbor-UCLA
Torrance, California, United States, 90502
3
Washington Hospital D.C.
Washington D.C., District of Columbia, United States, 20010
4
U Florida at Shands Hospital
Gainesville, Florida, United States, 32610