This study is a continuation of the pivotal trial studying the safety and efficacy of theRelay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is beingevaluated by the device-related adverse event rate of endovascular repair (via the Relaythoracic stent-graft) through 1 year. Safety is being evaluated by comparing majoradverse events through 1 year in subjects treated with the Relay thoracic stent-graft tothose who underwent surgical repair.
Device: Relay Thoracic Stent-Graft
Device implant
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
Arizona Heart Hospital
Phoenix, Arizona, United States
Washington Hospital Center
Washington, District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Indiana Heart Hospital
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of North Carolina
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
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Sentara Heart Hospital
Norfolk, Virginia, United States
University Washington
Seattle, Washington, United States