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

Recruiting now · Not applicable

Conditions studied: Chronic Total Occlusion of Artery of the Extremities

In brief

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)

Key facts

Study ID

NCT06492733

Run by

Versono Medical Ltd

People needed

65

Starts

2024-11-05

Expected to finish

2026-07-01

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.
• Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice.
• Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min or creatine level >2.5mg/ml.
• 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:
• 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.
• Has an acute or sub-acute intraluminal thrombus within the target vessel.
• Aneurysm distal to puncture access site at least twice the reference vessel diameter, located in the index vessel, abdominal aorta, iliac, or popliteal.
• 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 it is running

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

Full record on ClinicalTrials.gov

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