NCT01710878

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Maquet Cardiovascular · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aorta Aneurysm

Interventions

Type	Name	Description
DEVICE	Intergard Synergy Graft

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-12-01
• Completion: 2012-12-01
• First posted: 2012-10-19
• Last updated: 2013-11-26

Locations

8 sites across 2 countries: France, Germany