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NCT01327742 Clinical Trial

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

Thoracic Aortic Aneurysm 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: Approved for marketing

Administrative data
NCT number NCT01327742
Other study ID # IP-0004-06 rev I
Secondary ID
Status Approved for marketing
Phase N/A
First received March 31, 2011
Last updated November 16, 2012

Study information
Verified date November 2012
Source Bolton Medical
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Device:
• Relay Thoracic Stent-Graft
Device implant

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Massachusetts General Hospital Boston Massachusetts
United States University of North Carolina Chapel Hill North Carolina
United States Cleveland Clinic Foundation Cleveland Ohio
United States Ohio State University Columbus Ohio
United States University of Florida Gainesville Florida
United States East Carolina University Greenville North Carolina
United States Indiana Heart Hospital Indianapolis Indiana
United States Baptist Cardiac and Vascular Institute Miami Florida
United States Sentara Heart Hospital Norfolk Virginia
United States University of Pennsylvania Philadelphia Pennsylvania
United States Arizona Heart Hospital Phoenix Arizona
United States University of Pittsburgh Pittsburgh Pennsylvania
United States University Washington Seattle Washington
United States Washington Hospital Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Bolton Medical

Country where clinical trial is conducted

United States, 

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