Clinical trial NCT00435942: Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Official title: Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Aortic Aneurysms
and Penetrating Atherosclerotic Ulcers
Lead sponsor: Bolton Medical
Sponsor class: INDUSTRY
First posted: 2007-02-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects
timeFrame: 1 year
measure: Primary Safety Endpoint: Distribution of Major Adverse Events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Hospital
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: San Francisco
country: United States
facility: University of California-San Francisco
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Rockford
country: United States
facility: Rockford Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Clarian Cardiovascular
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Heart Hospial
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: The Mayo Clinic
state: Minnesota
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital --Columbia/Cornell University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania/Penn Presbyterian
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Falls Church
country: United States
facility: INOVA Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Hospital
state: Wisconsin
Study officials:
affiliation: University of North Carolina
name: Mark Farber, MD
role: PRINCIPAL_INVESTIGATOR
References: