Clinical trial NCT01327742: Phase II Clinical 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: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Thoracic Aortic Aneurysm
Penetrating Ulcers
Keywords: Relay
Thoracic
Aneurysm
Lead sponsor: Bolton Medical
Sponsor class: INDUSTRY
First posted: 2011-04-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.


Eligibility criteria: Inclusion Criteria:

* Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer
* Subjects whose anatomy can accommodate the Relay device
* Subjects who consent to participate
* Subjects who agree to a follow-up schedule

Exclusion Criteria:

* Subjects with lesions other than thoracic aneurysm and penetrating ulcer
* Subjects with less than 1 year life expectancy
* Subjects who are pregnant
* Subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
* Subjects participating in another investigational study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Hospital
state: Arizona
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: Baptist Cardiac and Vascular Institute
state: Florida
city: Indianapolis
country: United States
facility: Indiana Heart Hospital
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: Chapel Hill
country: United States
facility: University of North Carolina
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: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
city: Seattle
country: United States
facility: University Washington
state: Washington
Study officials:
References: