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Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft | Clinical Trials | Clareo Health

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

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

NCT00435942•Bolton Medical

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (27)

Arizona Heart Hospital

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

University of California-San Francisco

San Francisco, California, United States

Washington Hospital Center

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

University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Rockford Memorial Hospital

Rockford, Illinois, United States

Clarian Cardiovascular

Indianapolis, Indiana, United States

Key Dates

Start Date

January 1, 2007

Primary Completion Date

April 1, 2011

Completion Date

May 15, 2017

Last Updated

January 16, 2018

Enrollment

180

ACTUAL participants

Conditions

Thoracic Aortic Aneurysmsand Penetrating Atherosclerotic Ulcers

Interventions

Relay Thoracic Stent-Graft

DEVICE

Open Repair

PROCEDURE

Endovascular Treatment of Thoracic Aortic Disease

NCT00583817

Thoracic Aortic AneurysmsDissecting, Aneurysm+7 more

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COMPLETEDPHASE2/PHASE3

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NCT00604799

Thoracic Aortic Aneurysms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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