CVI Drug Coated Balloon First In Human Trial

Inclusion Criteria: * Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery * De novo or restenotic lesion(s) \>70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation). * Target vessel reference diameter ≥3 mm and ≤7 mm (by visual estimation). * Rutherford classification of 2, 3 or 4 Exclusion Criteria: * Lesion length is \<3 cm or \>15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured. * Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure. * Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.