Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
NCT ID: NCT00435942
Last Updated: 2018-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2007-01-31
2017-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Endovascular Treatment arm to be implanted with Relay device
Relay Thoracic Stent-Graft
implant
2
Surgical Control, underwent open repair
Open Repair
Open surgery
Interventions
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Relay Thoracic Stent-Graft
implant
Open Repair
Open surgery
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bolton Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Farber, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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Arizona Heart Hospital
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
University of California-San Francisco
San Francisco, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Rockford Memorial Hospital
Rockford, Illinois, United States
Clarian Cardiovascular
Indianapolis, Indiana, United States
Indiana Heart Hospial
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
The Mayo Clinic
Rochester, Minnesota, United States
Albany Medical Center
Albany, New York, United States
New York Presbyterian Hospital --Columbia/Cornell University
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania/Penn Presbyterian
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Methodist Hospital
Houston, Texas, United States
INOVA Fairfax Hospital
Falls Church, Virginia, United States
Sentara Heart Hospital
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
Aurora St. Luke's Hospital
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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IP-0004-06
Identifier Type: -
Identifier Source: org_study_id
NCT00998491
Identifier Type: -
Identifier Source: nct_alias
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