Evaluation of FUSION™ Vascular Graft for Above Knee Targets (PERFECTION)

Maquet

Status

Terminated

Conditions

Peripheral Arterial Occlusive Disease (PAOD)

Treatments

Device: FUSION Vascular Graft

Study type

Interventional

Funder types

Industry

Identifiers

NCT01601496

VR7000856

Details and patient eligibility

About

The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft.

Full description

This study was a prospective, single-arm, multicenter study conducted in Germany and Austria to evaluate the FUSION Vascular Graft in patients with peripheral arterial occlusive disease undergoing above-the-knee bypass. Follow-up visits were performed at 30 days, 6 months, 12 months and included patency and post operative complications not associated with bypass patency.

Enrollment

117 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

No known malignant disease
Patient was willing and able to have follow-up visits and examinations
Peripheral arterial occlusive disease (PAOD) requiring treatment of the femoral artery; Fontaine stage IIb, III and IV with dry peripheral gangrene, and suitable for surgery
Patient was not participating in other clinical trials that would conflict with this protocol
Patient agreed to the study provisions and provided written informed consent

Exclusion criteria

Urgent or emergent surgery of any kind
Documented acute or suspected systemic infection
Life expectancy of less than one year
Patients who had a minor or major stroke within 6 weeks of the procedure or who had evidence of prior massive stroke
Patients who had experienced a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris
Severe chronic renal insufficiency or undergoing hemodialysis
Patients treated with coumadin (warfarin) that had not been stopped within 72 before enrollment
Medical conditions requiring oral anticoagulation
Antiplatelet therapy with clopidogrel or dual antiplatelet as well as any other antithrombotic medication within 7 days prior to scheduled bypass surgery except unfractionated heparin or aspirin
International normalized ratio (INR) > 2.0
Known hypersensitivity to heparin
Patient not tolerating aspirin
Previous history of bypass surgery in the target limb
Patient with category 6 ischemia (tissue loss)
Acute limb ischemia of any grade (0-3)
Patient with no outflow beyond the popliteal artery
Pregnant or may become pregnant during the course of the study
Uncontrolled arterial hypertension (BP > 200 mmHg) at 2 successive readings
Anaemia (hemoglobin < 8 g/ml)
Thrombocytopenia < 50 g/L
Active bleeding according to clinical judgment
Infected wet gangrene of any size and location at the target limb
Compromised arterial flow
Patient unwilling or unable to comply with follow-up requirements