Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)

Exclusion Criteria

• •Female not using adequate contraception or is breastfeeding;
• •Rutherford class 0 1, and 6;
• •target lesion within a native graft,
• •in-stent restenosis,
• •≤ 50% occlusion, or chronic total occlusion;
• •history of vascular surgery or interventional procedure on index limb within 30 days prior to procedure, or planned procedure within 30 days after index procedure, lesion in contralateral limb requiring intervention during index procedure or within 30 days of index procedure;
• •known or suspected systemic infection;
• •unstable coronary disease; significant kidney disease requiring dialysis;
• •evidence of aneurysmal target vessel within past 2 months;
• •evidence of intracranial or GI bleeding, intracranial aneurysm, MI or stroke within 2 months of baseline evaluation;
• •history of heparin-induced thrombocytopenia;
• •contraindication to anti-platelet, anticoagulant, or thrombolytic therapy;
• •uncorrected bleeding disorders;
• •thrombolytic therapy within 2 weeks of index procedure;
• •life expectancy less than 12 months;
• •unwilling or unable to comply with follow-up requirements;
• •intraoperative complications due to the use of a marketed device prior to use of the atherectomy system;
• •currently participating in an investigational drug or other device study that has not completed primary endpoint;
• •unable to tolerate standard interventional procedures if the study device is not effective.