Evaluation of FUSION™ Vascular Graft for Above Knee Targets

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

Detailed Description
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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.

Official Title
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Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)

Conditions
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Peripheral Arterial Occlusive Disease (PAOD)

Intervention / Treatment
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* Device: FUSION Vascular Graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients treated with the FUSION Vascular Graft
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FUSION Vascular Graft<br>All subjects who received a FUSION Vascular Graft at the baseline implant procedure. | Device: FUSION Vascular Graft<br>* All subjects who received the FUSION Vascular Graft at the baseline implant procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Primary Graft Patency at 12 Months | Subjects were assessed to have had primary graft patency at 12 months. A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no interventions. Patency was assessed by duplex ultrasound imaging. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Secondary Graft Patency at 12 Months | Subjects were assessed to have had secondary graft patency at 12 months. Secondary graft patency was defined as a graft patency established by another intervention to remediate occlusion within 12 months after surgery. | 12 Months | 
| Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months | Ankle-brachial index at 30 days, 6 months, and 12 months. The ankle-brachial index is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm. | 30 days, 6 months, 12 months | 
| Rutherford Category at 30 Days, 6 Months and 12 Months | Rutherford category at 30 days, 6 months and 12 months. Rutherford classification is a staging system to describe lower extremity ischemia, and is assigned by the Investigator. Higher grades represent more severe disease, ranging from asymptomatic (category 0) to major tissue loss (category 6). | 30 days, 6 months, 12 months | 
| Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death | Major Adverse Limb Events (MALE) were defined as major amputation (any amputation that resulted in limb shortening) or major graft reintervention (including placement of a new bypass graft at the same anatomic site, a jump/interposition graft, graft thrombectomy, graft excision (explant), or graft thrombolysis). Periprocedural Death (POD) was defined as death within 30 days of the index procedure or within 30 days of any remedial procedure performed at the same anatomical site or as a result of the initial procedure. | 12 Months |