First-in-Human Clinical Trial
Feasibility Clinical Trial of the Cardio Flow FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST Trial)
Cardio Flow received a Investigational Device Exemption (IDE) approval for its FreedomFlow Orbital Atherectomy System First-in-Human (FIH) clinical trial from the FDA in November, 2017. Cardio Flow will soon begin enrolling patients for this First-in-Human FAST Trial.
Study Objective: To evaluate first-in-human safety and effectiveness of the Cardio Flow FreedomFlow Orbital Atherectomy System for atherosclerotic plaque removal in de novo native target lesions in the peripheral vasculature of the lower extremities.
Investigational Product: Cardio Flow FreedomFlow™ Orbital Atherectomy System
Study Design: Prospective, 2 centers, non-randomized single-arm study
Enrollment Size and Number of Sites: Up to 10 subjects at up to 2 sites in the United States.
Primary Effectiveness: Technical success, defined as the ability of the Cardio Flow FreedomFlow Orbital Atherectomy System to achieve a residual diameter stenosis ≤50% post treatment with or without adjunctive therapy, as assessed by an independent Angiographic Core Laboratory
Study Duration: Enrollment is expected to take approximately 2 months, with observation periods at time of procedure, pre-discharge, 30 days, and 6 months post-procedure follow-up
CAUTION: Investigational device. Limited by United States law to investigational use.
Protocol Number and Version Number: 010-031, Version 2.0 – May 31, 2017