FAST I Clinical Trial
Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST Trial)
Cardio Flow received an 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 began enrolling patients in January 2018 and completed the study in November 2018.
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
- CM1001 – Control Module and Tubing Set
- H4001 – User Handle
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 time was approximately 2 months, with observation periods at time of procedure, pre-discharge, 30 days, and 6 months post-procedure follow-up.