August 17, 2018. Cardio Flow announced the start of its FAST II trial to evaluate the safety and effectiveness of its FreedomFlow™ Orbital Circumferential Atherectomy System for atherosclerotic plaque removal in subjects diagnosed with peripheral arterial disease of the lower extremities. Cardio Flow will begin enrolling patients for this study in late 2018.
Study Objective: To evaluate the safety and effectiveness of the FreedomFlow system for atherosclerotic plaque removal and vessel modification in de novo target lesions in the peripheral vasculature of the lower extremities.
Investigational Product: Cardio Flow FreedomFlow Orbital Atherectomy System
- CM1001 – Control Module and Tubing Set
- H4001 – User Handle
Study Design: Prospective, multi-center, non-randomized single-arm study.
Enrollment Size and Number of Sites: Up to 112 participants at 10 locations in the United States.
Primary Outcome Measures:
Technical success, as defined as the ability of the Cardio Flow FreedomFlow Orbital Circumferential Atherectomy System to achieve a residual diameter stenosis ≤ 50% without adjunctive therapy, as assessed by an independent Angiographic Core Laboratory.
Primary safety endpoint is freedom from a composite of new onset major adverse events (MAE) at 30 day follow-up as adjudicated by an Independent Clinical Events Committee.
Study Duration: Enrollment will begin in December, 2018, and estimated to continue through late 2020.
Device indications for use: The FreedomFlow™ Orbital Circumferential Atherectomy System is applied as therapy to remove atherosclerotic plaque within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.
CAUTION: Investigational device. Limited by United States law to investigational use.