FastWire REvascularisation of Extremities, (For LOWer Limbs) - Feasibility Study (FREEFLOW)

Chronic Total Occlusion of Arteries of the Extremities Clinical Trial

Official title: A First-in-human, Single-arm, Single-center, Feasibility Study to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities, (For LOWer Limbs) (FREEFLOW)

Status Completed

Clinical Trial Summary

This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)

Clinical Trial Description

A first-in-human, single-arm, single-center, feasibility study to assess the efficacy and safety of the FastWire System in patients who have a chronic total occlusion in their peripheral vasculature causing an ischemic limb. The enrollment will consist of up to 10 patients meeting the inclusion/exclusion criteria. ;

Related Conditions & MeSH terms

• Chronic Total Occlusion of Arteries of the Extremities

• NCT number: NCT05869435
• Study type: Interventional
• Source: Versono Medical Ltd
• Status: Completed
• Phase: N/A
• Start date: December 14, 2022
• Completion date: January 17, 2023