Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

Completed · Not applicable

Conditions studied: Thoracic Aortic Aneurysms, and Penetrating Atherosclerotic Ulcers

In brief

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.

Key facts

Study ID

NCT00435942

Run by

Bolton Medical

People needed

180

Starts

2007-01-01

Expected to finish

2017-05-15

Last updated by the study team

2018-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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