Cardio Flow completes enrollment within its FAST II Clinical Trial of the FreedomFlow Orbital Atherectomy System
February 2, 2021—Cardio Flow, Inc., announces completion of the enrollment phase of its FreedomFlow® Orbital…
August 17, 2018—Cardio Flow, Inc., announced today the start of its FAST II trial to evaluate the safety and effectiveness of its FreedomFlow® Orbital 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
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:
Study Duration: Enrollment will begin in December, 2018, and estimated to continue through early 2021.
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.