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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Bolton Medical.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Bolton Medical Identifier:
First received: February 14, 2007
Last updated: November 16, 2012
Last verified: November 2012
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.

Condition Intervention Phase
Thoracic Aortic Aneurysms
and Penetrating Atherosclerotic Ulcers
Device: Relay Thoracic Stent-Graft
Phase 2

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Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

Further study details as provided by Bolton Medical:

Primary Outcome Measures:
  • Major device-related adverse events and major morbidity & mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical utility, lesion size increases, vascular complications [ Time Frame: 1, 6, 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2007
Estimated Study Completion Date: May 2015
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Endovascular Treatment arm
Device: Relay Thoracic Stent-Graft
Active Comparator: 2
Surgical Control
Device: Relay Thoracic Stent-Graft


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00435942

  Show 27 Study Locations
Sponsors and Collaborators
Bolton Medical
Principal Investigator: Mark Farber, MD University of North Carolina
  More Information

Responsible Party: Bolton Medical Identifier: NCT00435942     History of Changes
Obsolete Identifiers: NCT00998491
Other Study ID Numbers: IP-0004-06 
Study First Received: February 14, 2007
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on May 22, 2016