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

Peripheral Arterial Disease Clinical Trial

Official title:
Evaluation of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to Treat Peripheral Artery Disease

Clinical Trial 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.

Clinical Trial 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 (PAD) 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03635190
Study type Interventional
Source Cardio Flow, Inc.
Contact
Status Completed
Phase N/A
Start date December 17, 2018
Completion date October 13, 2021
View Details
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