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

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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
Indianapolis, Indiana 46250
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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8900 North Kendall Drive
Miami, Florida 33176
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Miami, FL
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Greenville, NC
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Norfolk, Virginia 23510
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Norfolk, VA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Phoenix, Arizona 85006
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Seattle, Washington 98105
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Seattle, WA
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110 Irving St NW
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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Washington,
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