CompletedNot Applicable

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

Dominican Republic8 participantsStarted 2022-12-14

Plain-language 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)

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The patient, or the patient's legal guardian has signed and dated an Informed Consent Form.
. Aged between 18 years and 85 years (inclusive).
. Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD.
. Angiographic confirmation of a de novo, CTO, infrainguinal ligament including above the knee, below the knee, or below the ankle vessels.

Exclusion criteria

. Life expectancy of less than 12 months.
. Females who are pregnant or lactating (urine test for women of childbearing age).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Technical Success (On Procedure Day)

Timeframe: Day 1

Clinical success (On Procedure Day)

Timeframe: Day 1

Freedom from Serious Adverse Events related to the use of FastWire, at 30 days post procedure:

Timeframe: Up to Day 30

Trial details

NCT IDNCT05869435

SponsorVersono Medical Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-16

View on ClinicalTrials.gov More Chronic Total Occlusion of Arteries of the Extremities trials