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

  • STATUS
    Recruiting
  • participants needed
    112
  • sponsor
    Cardio Flow, Inc.
Updated on 7 October 2022
arteriopathy
stenosis
endovascular intervention
rest pain
intermittent claudication
atherectomy
peripheral arterial diseases
transluminal angioplasty

Summary

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.

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.

Details
Condition Peripheral vascular disease, Circulation Disorders, Peripheral vascular disease, peripheral arterial disease, Peripheral Arterial Disease (PAD), Circulation Disorders, Peripheral Arterial Disease (PAD), peripheral arterial diseases, peripheral artery disease
Treatment Orbital Circumferential Atherectomy
Clinical Study IdentifierNCT03635190
SponsorCardio Flow, Inc.
Last Modified on7 October 2022

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