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

Sponsor

Bolton Medical (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT01327742

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Aortic Aneurysm Penetrating Ulcers	Device: Relay Thoracic Stent-Graft

Study Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Heart Hospital	Phoenix	Arizona	United States	85006
2	Washington Hospital Center	Washington	District of Columbia	United States	20010
3	University of Florida	Gainesville	Florida	United States	32610
4	Baptist Cardiac and Vascular Institute	Miami	Florida	United States	33176
5	Indiana Heart Hospital	Indianapolis	Indiana	United States	46250
6	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
7	University of Michigan	Ann Arbor	Michigan	United States	48109
8	University of North Carolina	Chapel Hill	North Carolina	United States	27599
9	East Carolina University	Greenville	North Carolina	United States	27834
10	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
11	Ohio State University	Columbus	Ohio	United States	43210
12	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
13	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
14	Sentara Heart Hospital	Norfolk	Virginia	United States	23510
15	University Washington	Seattle	Washington	United States	98105