Status:
COMPLETED
Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Lead Sponsor:
Bolton Medical
Conditions:
Thoracic Aortic Aneurysms
and Penetrating Atherosclerotic Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse e...
Eligibility Criteria
Inclusion
- Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers
- Subjects who are at least 18 years of age
- Subjects whose anatomy can accommodate the Relay device
- Subjects who consent to participate
- Subjects who agree to comply with follow-up schedule
Exclusion
- Subjects with non-aneurysm lesions
- Subjects with less than 1 year life expectancy
- Subjects who are pregnant
- Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.)
- Subjects participating in another investigational study
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2017
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00435942
Start Date
January 1 2007
End Date
May 15 2017
Last Update
January 16 2018
Active Locations (27)
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1
Arizona Heart Hospital
Phoenix, Arizona, United States, 85006
2
University of Arizona
Tucson, Arizona, United States, 85724
3
University of California-San Francisco
San Francisco, California, United States, 94143
4
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010-2975