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

NCT06492733 | Recruiting DMC FDA Device

• 1 other identifier: CIP002FREEFLOW PIVOTAL
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 6

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 Artery of the Extremities

Keywords

Chronic Total Occlusion; Peripheral; CTO; FastWire System; FastWire wire; intra-luminal; Active wire; Procedure; Device; peripheral vascular disease; critical limb ischemia; CLI; CLTI; critical limb threatening ischemia

Outcome Measures

Primary Outcomes (2)

• Clinical success (On Day of Procedure)

  Ability to facilitate treatment of the target lesion using the FastWire as a crossing device only and by allowing additional devices to cross the CTO as required. This will be angiographically confirmed.

  Day 1

• Freedom from Serious Adverse Events

  Freedom from Serious Adverse Events related to the use of the FastWire System, at 30 days post procedure: * Cardiovascular deaths. * Vessel dissection (Grade C or greater) requiring an intervention to resolve. * Unplanned index limb amputation. * Symptomatic distal embolization is defined as clinical signs or symptoms of distal emboli detected in the treated limb distal to the treated lesion after the index procedure or noted angiographically after the index procedure and requiring mechanical or pharmacologic means to improve flow.

  Up to Day 30

Secondary Outcomes (6)

• Technical success (On Day of Procedure)

  Day 1

• SADE (Up to Day 30)

  Up to Day 30

• Vessel dissection or bleeding (Within 24 Hours, Max 36 hrs)

  Within 24 Hours, Max 36 hrs

• Traverse the CTO (On Day of Procedure)

  Day 1

• Procedural success (On Day of Procedure)

  Day 1

Study Arms (1)

FastWire System - Peripheral

EXPERIMENTAL

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).

Device: FastWire System - Peripheral

Interventions

FastWire System - 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 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 at the time of the procedure of a de novo CTO below the origin of the superficial femoral artery (SFA) including above the knee or below the knee. (Note: Multilevel CTOs are included as long as the total length from the beginning of the most proximal total occlusion to the end of the most distal total occlusion is less than 40 cm.)
• % stenosis by a visual estimate of angiography at the time of procedure.
• For below-the-knee CTOs, the target limb shall have at least one patent (\<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at the time of the procedure.

You may not qualify if:

• Subjects who meet any of the following criteria are not eligible for this clinical investigation:
• 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.
• Known sensitivity to nickel, titanium, or their alloys.
• Evidence of active infection, including but not limited to the target limb.
• Current use of cocaine or other substances 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 previous attempt at time of index procedure.

Sponsors & Collaborators

• Versono Medical Ltd: lead

Study Sites (6)

EndoVascular Consultants

Wilmington, Delaware, 19805, United States

RECRUITING

Vascular & Embolization Specialists

Cocoa, Florida, 32926, United States

RECRUITING

Vascular Institute of the Midwest

Davenport, Iowa, 52807, United States

RECRUITING

Cardiovascular Institute of the South-ASC

Gray, Louisiana, 70359, United States

RECRUITING

Dearborn Cardiology

Dearborn, Michigan, 48126, United States

RECRUITING

Vascular Institute of Chattanooga

Chattanooga, Tennessee, 37421, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Hugh O'Donoghue Chief Technology Officer

CONTACT

212-252-2059; hugh.odonoghue@versono.life

Lea Doyle Head of Clinical & Regulatory Affairs

CONTACT

352-362-1021; lea.doyle@versono.life

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: July 1, 2024
• First Posted: July 9, 2024
• Study Start: November 5, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)