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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bolton Medical
ClinicalTrials.gov Identifier:
NCT00435942
First received: February 14, 2007
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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

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

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:

U.S. FDA Resources

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
implant
Active Comparator: 2
Surgical Control
 Device: Relay Thoracic Stent-Graft
implant

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435942

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

No publications provided

Responsible Party: Bolton Medical
ClinicalTrials.gov 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:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on June 13, 2013