Using the FastWire System to treat blocked arteries in the legs

A Pivotal, Single-arm, Multi-centre, Prospective Clinical Investigation to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities, (For LOWer Limbs) (FREEFLOW).

This study is testing a new tool called the FastWire System to see if it can help people with blocked leg arteries improve their blood flow and overall health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Versono Medical Ltd (industry)
• Locations: 6 sites (Wilmington, Delaware and 5 other locations)
• Trial ID: NCT06492733 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the FastWire System for treating chronic total occlusions (CTOs) in the arteries of the lower limbs. It is a single-arm, multi-center investigation involving up to 65 patients who have significant arterial blockages causing ischemia. The FastWire System aims to facilitate the placement of guidewires or treatment devices beyond these blockages, potentially improving blood flow and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with chronic total occlusions in their lower limb arteries causing severe claudication or critical limb threat.

Not a fit: Patients with non-occlusive arterial disease or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this could significantly improve blood flow and quality of life for patients with severe leg ischemia.

How similar studies have performed: Other studies using similar interventional approaches have shown promise, but the FastWire System represents a novel application in this context.

Eligibility criteria

General Inclusion Criteria: Subjects who meet all the following criteria are eligible for this clinical investigation:

1. The patient signed and dated an Informed Consent Form.
2. Aged between 18 years and 85 years (inclusive).
3. Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD.

Angiographic Inclusion Criteria

Unless otherwise specified, the Investigator performing the procedure bases angiographic inclusion on the visual determination of qualification imaging taken at the time of the procedure. Subject must meet ALL the following angiographic inclusion criteria:

1. 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.)
2. 100% stenosis by a visual estimate of angiography at the time of procedure.
3. 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.

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible for this clinical investigation:

1. Life expectancy of less than 12 months.
2. Females who are pregnant or lactating (urine test for women of childbearing age).
3. Myocardial infarction or stroke in two months prior to the index procedure.
4. Known, unstable coronary artery disease or other, uncontrolled comorbidity.
5. Any known haemorrhagic or coagulation deficiency.
6. Known sensitivity to nickel, titanium, or their alloys.
7. Evidence of active infection, including but not limited to the target limb.
8. Current use of cocaine or other substances of abuse.
9. Patients who have received any thrombolytic therapy in the last two weeks.
10. History of severe allergy or contraindication, to contrast medium or other medications used during or after endovascular therapy.
11. Subject participating in another study involving an investigational drug or device.
12. Patient has surgery or vascular intervention planned within 30 days of the index procedure.
13. Patient has had a previous peripheral bypass that includes the target vessel.
14. Patient has had a previous intervention in the target CTO (angioplasty, stenting) including previous attempt at time of index procedure.
15. Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice.
16. Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min or creatine level \>2.5mg/ml.
17. Platelet count \< 50,000/μL.

Angiographic Exclusion Criteria

Unless otherwise specified, the Investigator performing the procedure bases angiographic exclusion on a visual determination of qualification imaging taken at the time of the procedure. Subject is excluded if ANY of the following angiographic exclusion criteria is met:

1. For below-the-knee CTOs, a target limb without at least one patent (\<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at the time of the procedure.
2. Has an acute or sub-acute intraluminal thrombus within the target vessel.
3. Aneurysm distal to puncture access site at least twice the reference vessel diameter, located in the index vessel, abdominal aorta, iliac, or popliteal.
4. Has perforation, dissection, or other injury of the access site or index vessel requiring stenting or surgical intervention prior to attempting crossing of the target lesion with the FastWire System.

Where this trial is running

Wilmington, Delaware and 5 other locations

• EndoVascular Consultants — Wilmington, Delaware, United States (RECRUITING)
• Vascular & Embolization Specialists — Cocoa, Florida, United States (RECRUITING)
• Vascular Institute of the Midwest — Davenport, Iowa, United States (RECRUITING)
• Cardiovascular Institute of the South-ASC — Gray, Louisiana, United States (RECRUITING)
• Dearborn Cardiology — Dearborn, Michigan, United States (RECRUITING)
• Vascular Institute of Chattanooga — Chattanooga, Tennessee, United States (RECRUITING)

Study contacts

• Study coordinator: Hugh O'Donoghue Chief Technology Officer

Conditions: Chronic Total Occlusion of Artery of the Extremities, Chronic Total Occlusion, Peripheral, CTO, FastWire System, FastWire wire, intra-luminal, Active wire