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

Interventions: Procedure: Open Repair
Device: Relay Thoracic Stent-Graft

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

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

Arm && Interventions

Group	Intervention	Description
2	Open Repair	Surgical Control, underwent open repair
1	Relay Thoracic Stent-Graft	Endovascular Treatment arm to be implanted with Relay device

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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (27): Emory University
🇺🇸
Atlanta, Georgia, United States
Albany Medical Center
🇺🇸
Albany, New York, United States
East Carolina University
🇺🇸
Greenville, North Carolina, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
Rockford Memorial Hospital
🇺🇸
Rockford, Illinois, United States
The Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
University of North Carolina at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
New York Presbyterian Hospital --Columbia/Cornell University
🇺🇸
New York, New York, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania/Penn Presbyterian
🇺🇸
Philadelphia, Pennsylvania, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
INOVA Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
Sentara Heart Hospital
🇺🇸
Norfolk, Virginia, United States
Aurora St. Luke's Hospital
🇺🇸
Milwaukee, Wisconsin, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
University of Arizona
🇺🇸
Tucson, Arizona, United States
Arizona Heart Hospital
🇺🇸
Phoenix, Arizona, United States
University of California-San Francisco
🇺🇸
San Francisco, California, United States
University of Miami
🇺🇸
Miami, Florida, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Baptist Cardiac and Vascular Institute
🇺🇸
Miami, Florida, United States
Clarian Cardiovascular
🇺🇸
Indianapolis, Indiana, United States
Indiana Heart Hospial
🇺🇸
Indianapolis, Indiana, United States
Methodist Hospital
🇺🇸
Houston, Texas, United States
University of Washington
🇺🇸
Seattle, Washington, United States
University of Florida
🇺🇸
Gainesville, Florida, United States