NCT05869435

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• 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

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.

Conditions

• Chronic Total Occlusion of Arteries of the Extremities

Interventions

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

Timeline

• Start date: 2022-12-14
• Primary completion: 2022-12-16
• Completion: 2023-01-17
• First posted: 2023-05-22
• Last updated: 2025-12-11

Locations

1 site across 1 country: Dominican Republic