Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
1 other identifier
expanded_access
N/A
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2011
CompletedFirst Posted
Study publicly available on registry
April 4, 2011
CompletedNovember 19, 2012
November 1, 2012
March 31, 2011
November 16, 2012
Conditions
Keywords
Interventions
Device implant
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bolton Medicallead
Study Sites (15)
Arizona Heart Hospital
Phoenix, Arizona, 85006, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida
Gainesville, Florida, 32610, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176, United States
Indiana Heart Hospital
Indianapolis, Indiana, 46250, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Sentara Heart Hospital
Norfolk, Virginia, 23510, United States
University Washington
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2011
First Posted
April 4, 2011
Last Updated
November 19, 2012
Record last verified: 2012-11