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

APPROVED_FOR_MARKETING

Conditions studied: Thoracic Aortic Aneurysm, Penetrating Ulcers

In brief

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.

Key facts

Study ID

NCT01327742

Run by

Bolton Medical

Last updated by the study team

2012-11-19

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Heart Hospital — Phoenix, Arizona, United States
• Washington Hospital Center — Washington D.C., 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

Full record on ClinicalTrials.gov

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