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

NCT05869435 | Completed

• 1 other identifier: CIP001FREEFLOW
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Chronic Total Occlusion of Arteries of the Extremities

Keywords

Chronic Total Occlusion; Peripheral; CTO; FastWire System; FastWire Guidewire; intra-luminal; Active wire; Procedure; Device

Outcome Measures

Primary Outcomes (3)

• Technical Success (On Procedure Day)

  Ability of the FastWire to successfully cross angiographically confirmed chronic total occlusions and provide a platform for delivery of other treatment devices.

  Day 1

• Clinical success (On Procedure Day)

  Clinical success is assessed as the angiographically confirmed passage of the FastWire tip through the lesion and the successful delivery and retrieval of FastWire and the delivery of a treatment device to the target site.

  Day 1

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

  * Cardiovascular deaths. * Vessel dissection requiring an intervention to resolve. * Unplanned index limb amputation. * Symptomatic distal embolization.

  Up to Day 30

Secondary Outcomes (4)

• Freedom from Serious Adverse Device Effects (SADE) (Up to Day 30)

  Up to Day 30

• Freedom from Vessel dissection or bleeding (Within 24 Hours)

  Within 24 Hours

• Procedural success (On Procedure Day)

  Day 1

• Procedure related mortality (Up to Day 7 & Day 30)

  Up to Day 7 & Day 30

Study Arms (1)

FastWire System - Peripheral

OTHER

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). This is a First in Human study

Device: FastWire System Device - Peripheral

Interventions

FastWire System Device - Peripheral DEVICE

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

FastWire System - Peripheral

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of severe allergy or contraindication, to contrast medium or other medications used during or after endovascular therapy.
• Subject participating in another study involving an investigational drug or device
• Patient has surgery or vascular intervention planned within 30 days of the index procedure.
• Patient has had a previous peripheral bypass that includes the target vessel.
• Patient has had a previous intervention in the target CTO (angioplasty, stenting) including at time of index procedure.
• Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice.
• Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min.

Sponsors & Collaborators

• Versono Medical Ltd: lead

Study Sites (1)

INDEN

Santo Domingo, Dominican Republic

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: December 14, 2022
• Primary Completion: December 16, 2022
• Study Completion: January 17, 2023
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)