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)

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 (\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 (\