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

This is an interventional treatment trial for Peripheral Artery Disease Read More

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