NCT06492733

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

A Pivotal, Single-arm, Multi-centre, Prospective Clinical Investigation to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities, (For LOWer Limbs) (FREEFLOW).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Versono Medical Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Single-arm, multi-center, pivotal 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 65 patients meeting the inclusion/exclusion criteria.

Conditions

• Chronic Total Occlusion of Artery of the Extremities

Interventions

Type	Name	Description
DEVICE	FastWire System - Peripheral	The Investigator can use the FastWire System during the procedure to cross CTO Caps and/or to cross multiple lesions.

Timeline

• Start date: 2024-11-05
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2024-07-09
• Last updated: 2025-12-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study