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

Abdominal Aorta Aneurysm Clinical Trial

— SYNERGY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710878
• Other study ID #: HR07-001
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: November 24, 2013
• Start date: February 2008
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Maquet Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Aorta Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Intergard Synergy Graft

Locations

Country	Name	City	State
France	CHRU	Angers
France	CHU Jean Minjoz	Besançon
France	CHU Dupuytren	Limoges
France	Hôpital Edouard Herriot	Lyon
France	Hôpital G. et R. Laennec	Nantes
France	Hôpital Pompidou	Paris
France	CHU La Milétrie	Poitiers
Germany	Krankenhaus Nordwest	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Maquet Cardiovascular

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Secondary endpoint - levels of silver and triclosan	Serum levels prior to surgery, 1 day post-implant, discharge and 30 days	Up to 30 days	Yes
Primary	Primary Graft Patency	Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months	Up to 36 months	No
Secondary	Secondary endpoint - assessment of AEs	Follow-up timeframes - 1, 6, 12, 24, and 36 months	Up to 36 months	Yes