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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 31, 2011
Last Updated Date	November 16, 2012
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01327742 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Official Title ^ICMJE	Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Expanded Access
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Thoracic Aortic Aneurysm Penetrating Ulcers
Intervention ^ICMJE	Device: Relay Thoracic Stent-Graft Device implant
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Approved for marketing
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01327742
Other Study ID Numbers ^ICMJE	IP-0004-06 rev I
Has Data Monitoring Committee	Not Provided
Responsible Party	Bolton Medical
Study Sponsor ^ICMJE	Bolton Medical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bolton Medical
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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