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

NCT ID: NCT01327742

Last Updated: 2012-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracic Aortic Aneurysm Penetrating Ulcers

Keywords

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Relay Thoracic Aneurysm

Interventions

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Relay Thoracic Stent-Graft

Device implant

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bolton Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Heart Hospital

Phoenix, Arizona, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Site Status

Indiana Heart Hospital

Indianapolis, Indiana, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Sentara Heart Hospital

Norfolk, Virginia, United States

Site Status

University Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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IP-0004-06 rev I

Identifier Type: -

Identifier Source: org_study_id