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 range18 Years – 85 Years

SexALL

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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).
✕. Myocardial infarction or stroke in two months prior to the index procedure.
✕. Known, unstable coronary artery disease or other, uncontrolled comorbidity.
✕. Any known haemorrhagic or coagulation deficiency.
✕. Evidence of active infection, including but not limited to the target limb.
✕. Current use of cocaine or other substance of abuse.
✕. Patients who have received any thrombolytic therapy in the last two weeks.

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