Evaluation of the FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease

Brief description of study

To evaluate the safety and effectiveness of the Cardio Flow FreedomFlow Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities.

Detailed Study Description

The FAST II study is a prospective, multi-center, non-randomized single-arm trial designed to evaluate the safety and effectiveness of the FreedomFlow Orbital Circumferential Atherectomy System in subjects diagnosed with peripheral arterial disease of the lower extremities.

The FreedomFlow Orbital Circumferential Atherectomy System is a minimally invasive, catheter-based system designed for improving luminal diameter and modifying vessel wall compliance in patients with PAD.

The FreedomFlow Orbital Circumferential Atherectomy System is indicated to remove atherosclerotic plaque and modifying vessel wall compliance within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The objective of the study is to evaluate the safety and effectiveness of the FreedomFlow Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel modification in de novo target lesions in the peripheral vasculature of the lower extremities.

Clinical Study Identifier: NCT03635190

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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