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

• Conditions: Penetrating Ulcers; Thoracic Aortic Aneurysm

• Registration Number: NCT01327742
• Lead Sponsor: Bolton Medical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-04
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (15)

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

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