InterGard Synergy Post-Marketing Surveillance Study

Maquet

Status: Unknown

Conditions: Occlusive Disease of Artery of Lower Extremity; Aortic Aneurysm, Abdominal

Treatments: Device: InterGard Synergy Vascular Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT01698671

MCV00010173

Details and patient eligibility

About

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

Full description

Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

InterGard Synergy Vascular Graft

Other group

Treatment:

Device: InterGard Synergy Vascular Graft