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

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