FREERIDE STUDY, Freeway Paclitaxel Coated Balloon Catheter to Treat Peripheral Artery Disease

Inclusion Criteria: * Male or non-pregnant female (\> 18 years of age) with symptomatic ischemia, requiring treatment of SFA or PI segment ( 2-5 of Rutherford classification) * Single and/or multiple de novo occluded, stenotic or reoccluded, restenotic lesion(s) of \> 70% , ≤ 15 cm in total length and vessel diameter ≥ 4mm and ≤ 7mm (by visual estimation). * Patient provides a signed informed consent and complies with the follow up visits * Successful wire crossing of lesion * At least one patent (less than 50% stenosis) tibioperoneal run-off vessel Exclusion Criteria: * Gastrointestinal bleeding or coagulopathy contraindicating use of anti-platelet therapy * Known intolerance contraindications to study medications and contrast agents, non-controllable with medication. * Patient actively participating in another device or drug study * History of hemorrhagic stroke within 3 months * Previous or planned surgical or intervention procedure within 30 days of index procedure * Significant untreated inflow disease or no normal arterial segment proximal of lesion in which duplex ultrasound velocity ratios can be measured * Acute or sub-acute thrombus in target vessel * Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon) * Patients with in-stent restenosis or prior surgery of the target lesion * Patients with abdominal aortic, iliaca or popliteal aneurysm (AAA) with ≥ 4cm diameter