This trial is active, not recruiting.

Conditions aortic aneurysm, abdominal, occlusive disease of artery of lower extremity
Treatment intergard synergy vascular graft
Sponsor Maquet Cardiovascular
Start date October 2012
End date October 2013
Trial size 50 participants
Trial identifier NCT01698671, MCV00010173


The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
intergard synergy vascular graft

Primary Outcomes

Graft Patency and Complications
time frame: 6 months

Secondary Outcomes

Mortality rate
time frame: 6 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients requiring an InterGard Synergy Vascular Graft Exclusion Criteria: - Patients with contra-indications per InterGard Synergy Vascular Graft - Patients with current graft infection - Patients with a known allergy to collagen, triclosan or silver acetate - Patients who require urgent or emergent surgery

Additional Information

Official title InterGard Synergy Post-Marketing Surveillance Study
Principal investigator Max Zegelman, MD
Description Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Maquet Cardiovascular.