To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
Symptomatic peripheral vascular occlusive disease (Rutherford-Becker Clinical Category 2-4)
Patient with life expectancy >36 months
Females of childbearing potential must have negative pregnancy test
Patient is able to provide informed consent
Hemoglobin <9.0 g/dL
WBC <3,000 cells/mm3
Platelet count <80,000 cells/mm3 or >700,000 cells/mm3
Acute or chronic renal dysfunction with creatinine >2.5 mg/dl (176 µmol/L)
Single group
Efemoral Vascular Scaffold System (EVSS)
DeviceBalloon-expandable, bioresorbable vascular scaffolds coated with sirolimus
Major Adverse Event (MAE)
Freedom from Binary Restenosis
Device Success
Achievement of successful delivery and deployment of the study device(s) at the intended target lesion
Primary patency rate
Binary restenosis rate
Target lesion revascularization (TLR)
Target lesion percent mean diameter stenosis
Target lesion percent maximum diameter stenosis
Target lesion late lumen loss
Ischemia-driven target lesion revascularization (IDTLR)
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