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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01327742
Expanded Access Status : Approved for marketing
First Posted : April 4, 2011
Last Update Posted : November 19, 2012
Information provided by (Responsible Party):
Bolton Medical

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
Thoracic Aortic Aneurysm Penetrating Ulcers Device: Relay Thoracic Stent-Graft

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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

Intervention Details:
  • Device: Relay Thoracic Stent-Graft
    Device implant

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01327742

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United States, Arizona
Arizona Heart Hospital
Phoenix, Arizona, United States, 85006
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
United States, Indiana
Indiana Heart Hospital
Indianapolis, Indiana, United States, 46250
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
Sentara Heart Hospital
Norfolk, Virginia, United States, 23510
United States, Washington
University Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Bolton Medical
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Responsible Party: Bolton Medical Identifier: NCT01327742    
Other Study ID Numbers: IP-0004-06 rev I
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: November 19, 2012
Last Verified: November 2012
Keywords provided by Bolton Medical:
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases