RecruitingNot ApplicableNCT06492733

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).

Sponsor

Versono Medical Ltd

Enrollment

65 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Total Occlusion of Artery of the Extremities

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)

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called FastWire System - Peripheral for people with chronic total occlusion of artery of the extremities. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFastWire System - Peripheral

The Investigator can use the FastWire System during the procedure to cross CTO Caps and/or to cross multiple lesions.

Locations(6)

EndoVascular Consultants

Wilmington, Delaware, United States

Vascular & Embolization Specialists

Cocoa, Florida, United States

Vascular Institute of the Midwest

Davenport, Iowa, United States

Cardiovascular Institute of the South-ASC

Gray, Louisiana, United States

Dearborn Cardiology

Dearborn, Michigan, United States

Vascular Institute of Chattanooga

Chattanooga, Tennessee, United States

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NCT06492733

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