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

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 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)

Single-arm, multi-center, pivotal 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 65 patients meeting the inclusion/exclusion 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.