Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position

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Abdominal aortic aneurysm
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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