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

Not Applicable

Completed

• Conditions: and Penetrating Atherosclerotic Ulcers; Thoracic Aortic Aneurysms

• Registration Number: NCT00435942
• Lead Sponsor: Bolton Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-14
• Study First Submitted QC: 2007-02-14
• Study First Posted: 2007-02-16
• Primary Completion: 2011-04
• Results First Submitted: 2013-09-23
• Study Completion: 2017-05-15
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-03
• Results First Posted: 2017-09-05
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: Distribution of Major Adverse Events	1 year	The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure
Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects	1 year	The primary effectiveness endpoint was freedom from major device-related adverse events \[endoleak (Types I, III and IV), stent migration (\> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair\] at 1 year post-procedure.; The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.

Trial Locations

Locations (27)

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, 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

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