Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
1 other identifier
interventional
180
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 14, 2007
CompletedFirst Posted
Study publicly available on registry
February 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2017
CompletedResults Posted
Study results publicly available
September 5, 2017
CompletedJanuary 16, 2018
August 1, 2017
4.2 years
February 14, 2007
September 23, 2013
December 18, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects
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.
1 year
Primary Safety Endpoint: Distribution of Major Adverse Events
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
1 year
Study Arms (2)
1
EXPERIMENTALEndovascular Treatment arm to be implanted with Relay device
2
ACTIVE COMPARATORSurgical Control, underwent open repair
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bolton Medicallead
Study Sites (27)
Arizona Heart Hospital
Phoenix, Arizona, 85006, United States
University of Arizona
Tucson, Arizona, 85724, United States
University of California-San Francisco
San Francisco, California, 94143, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010-2975, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami
Miami, Florida, 33136, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176, United States
Emory University
Atlanta, Georgia, 30322, United States
Rockford Memorial Hospital
Rockford, Illinois, 61103, United States
Clarian Cardiovascular
Indianapolis, Indiana, 46202, United States
Indiana Heart Hospial
Indianapolis, Indiana, 46250, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
The Mayo Clinic
Rochester, Minnesota, 55905, United States
Albany Medical Center
Albany, New York, 12208, United States
New York Presbyterian Hospital --Columbia/Cornell University
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
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
Hospital of the University of Pennsylvania/Penn Presbyterian
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Methodist Hospital
Houston, Texas, 77030, United States
INOVA Fairfax Hospital
Falls Church, Virginia, 22042, United States
Sentara Heart Hospital
Norfolk, Virginia, 23510, United States
University of Washington
Seattle, Washington, 98105, United States
Aurora St. Luke's Hospital
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Many subjects experienced more than one type of event.
Results Point of Contact
- Title
- Annie Weiller
- Organization
- Bolton Medical, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Farber, MD
University of North Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 14, 2007
First Posted
February 16, 2007
Study Start
January 1, 2007
Primary Completion
April 1, 2011
Study Completion
May 15, 2017
Last Updated
January 16, 2018
Results First Posted
September 5, 2017
Record last verified: 2017-08