Brief Title
Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position
Official Title
Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in Abdominal Position
Brief Summary
Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.
Detailed Description
The purpose of this multi center, single arm study is to demonstrate the safety and performance of the Second Generation Anti-Microbial (InterGard Synergy) vascular graft in the treatment of aneurismal and occlusive diseases of the abdominal aorta. The primary endpoint is the assessment of primary and secondary graft patency. The secondary endpoints were the assessment of adverse events and the assessment of triclosan and silver contents in the serum over the time.
Study Type
Interventional
Primary Outcome
Primary Graft Patency
Secondary Outcome
Secondary endpoint - assessment of AEs
Condition
Abdominal Aorta Aneurysm
Intervention
Intergard Synergy Graft
Study Arms / Comparison Groups
Intergard Synergy Graft
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
60
Start Date
February 2008
Completion Date
December 2012
Primary Completion Date
December 2010
Eligibility Criteria
Inclusion Criteria: Patient aged 18-85 years Patient presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and eligible for a revascularization with a bifurcated graft Exclusion Criteria: Patient treated as an emergency Patient included in another investigation Patient pregnant or lactating or woman of childbearing potential Patient with a known allergy to the material device used (collagen, triclosan, silver) Patient with previous aorto-iliac bypass or replacement
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Jean-Baptiste Ricco, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01710878
Organization ID
HR07-001
Responsible Party
Sponsor
Study Sponsor
Maquet Cardiovascular
Study Sponsor
Jean-Baptiste Ricco, MD, Principal Investigator, CHU La Milétrie
Verification Date
November 2013