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

• Sponsor: Maquet Cardiovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01710878
• Collaborator: (none)
• Enrollment: 60
• Locations: 8
• Arm: 1
• Duration (Months): 58
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aorta Aneurysm	Device: Intergard Synergy Graft	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in Abdominal Position
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Secondary endpoint - assessment of AEs [Up to 36 months]

   Follow-up timeframes - 1, 6, 12, 24, and 36 months

Other Outcome Measures

1. Secondary endpoint - levels of silver and triclosan [Up to 30 days]

   Serum levels prior to surgery, 1 day post-implant, discharge and 30 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU	Angers		France
2	CHU Jean Minjoz	Besançon		France
3	CHU Dupuytren	Limoges		France
4	Hôpital Edouard Herriot	Lyon		France
5	Hôpital G. et R. Laennec	Nantes		France
6	Hôpital Pompidou	Paris		France
7	CHU La Milétrie	Poitiers		France
8	Krankenhaus Nordwest	Frankfurt		Germany

Sponsors and Collaborators

• Maquet Cardiovascular

Investigators

• Principal Investigator: Jean-Baptiste Ricco, MD, CHU La Milétrie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maquet Cardiovascular
• ClinicalTrials.gov Identifier: NCT01710878
• Other Study ID Numbers: HR07-001
• First Posted: Oct 19, 2012
• Last Update Posted: Nov 26, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Study Results

No Results Posted as of Nov 26, 2013