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

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.

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.