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

Study Overview
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Brief Summary
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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)

Detailed Description
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A first-in-human, single-arm, single-center, feasibility study to assess the efficacy and safety of the FastWire System in patients who have a chronic total occlusion in their peripheral vasculature causing an ischemic limb. The enrollment will consist of up to 10 patients meeting the inclusion/exclusion criteria.

Official Title
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A First-in-human, Single-arm, Single-center, Feasibility Study to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities, (For LOWer Limbs) (FREEFLOW)

Conditions
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Chronic Total Occlusion of Arteries of the Extremities

Intervention / Treatment
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* Device: FastWire System Device - Peripheral


Participation Criteria
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Eligibility Criteria
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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. 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. Platelet count < 50,000.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FastWire System - Peripheral<br>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<br>* The Investigator can use the FastWire System during the procedure to cross CTO Caps and/or to cross multiple lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Serious Adverse Device Effects (SADE). | Freedom from Serious Adverse Device Effects (SADE). | Up to Day 30 | 
| Freedom from Vessel dissection or bleeding | Freedom from Vessel dissection or bleeding within 24 hours (16-36 hours) of index procedure. | Within 24 Hours | 
| Procedural success | Procedural success, defined as achievement of technical success together with post procedure patency (less than 50% residual diameter stenosis of target vessel patent as assessed by angiographic imaging post device retrieval. | Day 1 | 
| Procedure related mortality | All procedure related mortality at day 7 post procedure, and all-cause mortality at 30 days post procedure. | Up to Day 7 & Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Total Occlusion, Peripheral, CTO, FastWire System, FastWire Guidewire, intra-luminal, Active wire, Procedure, Device