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

Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease

This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites. Patients will be followed at 30 days and 6 months to evaluate vessel patency following treatment. Safety will be assessed by monitoring adverse events throughout the study. Safety and Efficacy will be evaluated by comparing study results to established performance criteria,

Feasibility Clinical Trial of the Cardio Flow FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST Trial) is a prospective non-randomized single arm study that will enroll up to 10 patients at 1 - 2 sites. The study will evaluate the safety and effectiveness of the Cardio Flow atherectomy device for plaque removal in de novo target lesions in the peripheral vasculature of the lower extremities. The primary safety endpoint is defined as freedom from a composite of new onset major adverse events through the 30-day follow-up as adjudicated by an independent Clinical Events physician. The primary effectiveness endpoint is defined as the ability of the Cardio Flow Device to achieve a residual diameter stenosis ≤ 50% without adjunctive therapy, determined by Angiographic core lab evaluation.

Inclusion Criteria:

• Candidate for percutaneous endovascular intervention in the lower extremity;
• Disease is located in peripheral arteries between 2mm and 5mm diameter;
• Ankle brachial index ≤ 0.90;
• Rutherford classification 2,3,4 or 5;
• De novo target lesion has ≥ 50% stenosis;
• Target lesion length ≤ 200 cm;
• At least 1 patent tibial vessel runoff;
• Written, signed informed consent.

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.