480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions

Study Overview
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Brief Summary
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This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral artery lesions.

Official Title
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A Safety Assessment of the 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo SFA Lesions

Conditions
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Superficial Femoral Artery Lesions, Atherosclerosis of Femoral Artery

Intervention / Treatment
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* Device: 480 Biomedical Bioresorbable Scaffold System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/= 18 years De novo stenotic lesion(s) in the superficial femoral artery located at least 1cm distal to the femoral bifurcation and > 3 cm above the knee joint Lifestyle-limiting claudication defined as symptomatic subjects with Rutherford Becker Category 2-3 Target lesion native reference vessel diameter 4.6 - 6.0 mm by on-line QVA; target lesion native reference vessel diameter less than 5.0 mm only if lesion residual stenosis is ≤ 25% Lesion length: up to a maximum that can be covered by one 100mm scaffold Target lesion > 50% stenosis or total occlusion Undisturbed flow to the foot via at least 2 patent infrapopliteal vessel on the treated side with one vessel free from > 50% stenosis to the ankle joint Patent common and external iliac; TASC A & B lesions may be successfully treated (<30% residual stenosis) at the time of the index procedure The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Human Research Ethics Committee (HREC) of the respective clinical site The study patient agrees to comply with all required post-procedure follow-up visits Exclusion Criteria: Previously implanted stent(s) or stent graft(s) in the target lesion Previous endovascular treatment of the target lesion Femoral access in the target limb within 30 days of study procedure Target lesion residual stenosis > 30% after pre-dilatation with nominally sized balloon Severely calcified lesions as determined by a balloon deformity during dilatation with a nominally sized balloon inflated at nominal pressure. Acute embolic complication at the trifurcation following pre-dilatation not resolved by aspiration Target vessel contains acute thrombus Aneurysm in target vessel Critical limb ischemia defined as Rutherford-Becker Category 4-6 Intolerance, or allergies which cannot be adequately pre-medicated, to the following: aspirin, clopidogrel or ticlopidine, heparin, any scaffold components, contrast agents Life expectancy of less than 12 months Pregnancy or breast feeding (negative pregnancy test within 7 days required in females of child bearing potential) Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease) Renal insufficiency (serum creatinine level > 220 µmol/L, or subject is on dialysis) Immunocompromised Active systemic infection or lower limb infection of any nature WBC < 3,000 cells/mm3 Myocardial infarction within the past 1 month Stroke within 3 months Un-controlled Atrial-Fibrillation Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scaffold Treatment<br> | Device: 480 Biomedical Bioresorbable Scaffold System<br>* 480 Biomedical Bioresorbable Scaffold System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events at 6 months post procedure |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events at 1 month post procedure |  | 1 Month | 
| Major adverse events at 3, 12 months and 24 months post procedure |  | 3, 12 & 24 Months | 
| Patency in the treated vessel at 1, 3, 6, 12 and 24 months post procedure |  | 1, 3, 6, 12, 24 Months | 
| Change in Rutherford Becker Category at 1, 3, 6,12 and 24 months post procedure |  | 1, 3, 6, 12, 24 Months | 
| Walking Impairment Questionnaire |  | 1, 3, 6, 12, 24 Months | 
| Ankle-Brachial Index (ABI) at 1, 3, 6, 12, and 24 months post procedure |  | 1, 3, 6, 12, 24 Months | 
| Clinically driven TLR at 3, 12 and 24 months post procedure |  | 3,12, 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial femoral artery, Peripheral arterial disease, Atherosclerosis, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases