The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery

Inclusion Criteria: * 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 * Patient agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site. * Patient must be able to take antiplatelet and/or anticoagulant agents as prescribed * Single de novo native disease segment of the superficial femoral artery (SFA) or P1 popliteal segment * Reference vessel diameter ≥5.5 mm and ≤6.5 mm * Target lesion length ≤90 mm * Target lesion with ≥50% DS * Inflow artery and popliteal artery free from flow-limiting lesion (DS \<50%) Exclusion Criteria: * 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) * Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of SGOT or SGPT * A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannot be adequately pre-medicated * Patient requires a planned procedure that would necessitate discontinuation of antiplatelet therapy * Patient is unable to walk * Patient has undergone a percutaneous vascular intervention \<30 days prior …