Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
| Status: | Available |
|---|---|
| Conditions: | Cardiology, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Contact: | Julie H Byerly |
| Email: | jbyerly@boltonmedical.com |
| Phone: | 954-838-9699 |
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
This study is a continuation of the pivotal trial studying the safety and efficacy of the
Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being
evaluated by the device-related adverse event rate of endovascular repair (via the Relay
thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse
events through 1 year in subjects treated with the Relay thoracic stent-graft to those who
underwent surgical repair.
Inclusion Criteria:
- Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer
- Subjects whose anatomy can accommodate the Relay device
- Subjects who consent to participate
- Subjects who agree to a follow-up schedule
Exclusion Criteria:
- Subjects with lesions other than thoracic aneurysm and penetrating ulcer
- Subjects with less than 1 year life expectancy
- Subjects who are pregnant
- Subjects with medical conditions that wold complicate the endovascular procedure or
confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery
disease)
- Subjects participating in another investigational study
We found this trial at
15
sites
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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