Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2018 |
| Start Date: | January 2007 |
| End Date: | May 15, 2017 |
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
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 event rate of endovascular repair (via Relay Thoracic Stent-Graft)
through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in
subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair.
Long term follow-up is conducted through 5 years.
stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the
device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft)
through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in
subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair.
Long term follow-up is conducted through 5 years.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
27
sites
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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University of Miami A private research university with more than 15,000 students from around the...
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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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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166 Fort Washington Avenue
New York, New York 10032
New York, New York 10032
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3400 Spruce Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
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University of Arizona The University of Arizona is a premier, public research university. Established in...
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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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