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

Eligibility Criteria

• 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.
• 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.
• 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.