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

Not Applicable

Completed

• Conditions: Abdominal Aorta Aneurysm
• Interventions: Device: Intergard Synergy Graft

• Registration Number: NCT01710878
• Lead Sponsor: Maquet Cardiovascular

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 Timeline

• Study Start: 2008-02
• Primary Completion: 2010-12
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-17
• Study First Posted: 2012-10-19
• Study Completion: 2012-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-24
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intergard Synergy Graft	Intergard Synergy Graft	-

Primary Outcome Measures

Name	Time	Method
Primary Graft Patency	Up to 36 months	Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint - assessment of AEs	Up to 36 months	Follow-up timeframes - 1, 6, 12, 24, and 36 months

Trial Locations

Locations (8)

Hôpital Pompidou; 🇫🇷 Paris, France

Hôpital G. et R. Laennec; 🇫🇷 Nantes, France

CHRU; 🇫🇷 Angers, France

CHU Jean Minjoz; 🇫🇷 Besançon, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

CHU Dupuytren; 🇫🇷 Limoges, France

CHU La Milétrie; 🇫🇷 Poitiers, France

Krankenhaus Nordwest; 🇩🇪 Frankfurt, Germany