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

This treatment has been approved for sale to the public.
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

March 31, 2011
November 16, 2012
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Complete list of historical versions of study NCT01327742 on ClinicalTrials.gov Archive Site
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Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

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.

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Expanded Access
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  • Thoracic Aortic Aneurysm
  • Penetrating Ulcers
Device: Relay Thoracic Stent-Graft
Device implant
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Approved for marketing
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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
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01327742
IP-0004-06 rev I
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Bolton Medical
Bolton Medical
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Bolton Medical
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP