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

Thoracic Aortic Aneurysms Clinical Trial

Official title:

Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435942
• Other study ID #: IP-0004-06
• Status: Completed
• Phase: N/A
• First received: February 14, 2007
• Last updated: December 18, 2017
• Start date: January 2007
• Est. completion date: May 15, 2017

Study information

• Verified date: August 2017
• Source: Bolton Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00998491

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 15, 2017
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• and Penetrating Atherosclerotic Ulcers
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Thoracic Aortic Aneurysms

Intervention

Device:
• Relay Thoracic Stent-Graft
implant

Procedure:
• Open Repair
Open surgery

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bolton Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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