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

Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in Abdominal Position

Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.

Study Overview

• Status: Completed
• Conditions: Abdominal Aorta Aneurysm
• Intervention / Treatment: Device: Intergard Synergy Graft

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHRU
  • Besançon, France
    • CHU Jean Minjoz
  • Limoges, France
    • CHU Dupuytren
  • Lyon, France
    • Hopital Edouard Herriot
  • Nantes, France
    • Hopital G. Et R. Laennec
  • Paris, France
    • Hôpital Pompidou
  • Poitiers, France
    • CHU La Miletrie
• Germany
  • Frankfurt, Germany
    • Krankenhaus Nordwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intergard Synergy Graft	Device: Intergard Synergy Graft

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoint - assessment of AEs	Follow-up timeframes - 1, 6, 12, 24, and 36 months	Up to 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoint - levels of silver and triclosan	Serum levels prior to surgery, 1 day post-implant, discharge and 30 days	Up to 30 days

Collaborators and Investigators

• Sponsor: Maquet Cardiovascular
• Investigators: Principal Investigator: Jean-Baptiste Ricco, MD, CHU La Miletrie

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (Estimate): October 19, 2012

Study Record Updates

• Last Update Posted (Estimate): November 26, 2013
• Last Update Submitted That Met QC Criteria: November 24, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: HR07-001