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Phase II 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: NCT00435942
Recruitment Status : Completed
First Posted : February 16, 2007
Results First Posted : September 5, 2017
Last Update Posted : January 16, 2018
Information provided by (Responsible Party):
Bolton Medical

Brief 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.

Condition or disease Intervention/treatment Phase
Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers Device: Relay Thoracic Stent-Graft Procedure: Open Repair Not Applicable

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: 1
Endovascular Treatment arm to be implanted with Relay device
Device: Relay Thoracic Stent-Graft

Active Comparator: 2
Surgical Control, underwent open repair
Procedure: Open Repair
Open surgery

Primary Outcome Measures :
  1. Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects [ Time Frame: 1 year ]

    The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure.

    The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.

  2. Primary Safety Endpoint: Distribution of Major Adverse Events [ Time Frame: 1 year ]
    The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure

Information from the National Library of Medicine

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

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): NCT00435942

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Sponsors and Collaborators
Bolton Medical
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Principal Investigator: Mark Farber, MD University of North Carolina
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Responsible Party: Bolton Medical Identifier: NCT00435942    
Obsolete Identifiers: NCT00998491
Other Study ID Numbers: IP-0004-06
First Posted: February 16, 2007    Key Record Dates
Results First Posted: September 5, 2017
Last Update Posted: January 16, 2018
Last Verified: August 2017
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases