Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
CHRU
Angers, France
CHU Jean Minjoz
Besançon, France
CHU Dupuytren
Limoges, France
Hôpital Edouard Herriot
Lyon, France
Primary Graft Patency
Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months
Time frame: Up to 36 months
Secondary endpoint - assessment of AEs
Follow-up timeframes - 1, 6, 12, 24, and 36 months
Time frame: Up to 36 months
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Hôpital G. et R. Laennec
Nantes, France
Hôpital Pompidou
Paris, France
CHU La Milétrie
Poitiers, France
Krankenhaus Nordwest
Frankfurt, Germany