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

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Sponsor:
Information provided by (Responsible Party):
Bolton Medical
ClinicalTrials.gov Identifier:
NCT01327742
First received: March 31, 2011
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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

Study Type: Expanded Access     What is 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bolton Medical:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327742

Locations
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
  More Information

No publications provided

Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT01327742     History of Changes
Other Study ID Numbers: IP-0004-06 rev I
Study First Received: March 31, 2011
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bolton Medical:
Relay
Thoracic
Aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Ulcer
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013