CompletedNot Applicable

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

United States180 participantsStarted 2007-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects

Timeframe: 1 year

Primary Safety Endpoint: Distribution of Major Adverse Events

Timeframe: 1 year

Trial details

NCT IDNCT00435942

SponsorBolton Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-04

Results submitted2013-09-23

View on ClinicalTrials.gov More Thoracic Aortic Aneurysms trials