Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD) — FAST  

Peripheral Arterial Disease Clinical Trial

Official title: Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease

Status Completed

Clinical Trial Summary

This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites. Patients will be followed at 30 days and 6 months to evaluate vessel patency following treatment. Safety will be assessed by monitoring adverse events throughout the study. Safety and Efficacy will be evaluated by comparing study results to established performance criteria,

Clinical Trial Description

Feasibility Clinical Trial of the Cardio Flow FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST Trial) is a prospective non-randomized single arm study that will enroll up to 10 patients at 1 - 2 sites. The study will evaluate the safety and effectiveness of the Cardio Flow atherectomy device for plaque removal in de novo target lesions in the peripheral vasculature of the lower extremities. The primary safety endpoint is defined as freedom from a composite of new onset major adverse events through the 30-day follow-up as adjudicated by an independent Clinical Events physician. The primary effectiveness endpoint is defined as the ability of the Cardio Flow Device to achieve a residual diameter stenosis ≤ 50% without adjunctive therapy, determined by Angiographic core lab evaluation. ;

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

• NCT number: NCT03365154
• Study type: Interventional
• Source: Cardio Flow, Inc.
• Status: Completed
• Phase: N/A
• Start date: January 25, 2018
• Completion date: November 6, 2018