Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone in Europe

Inclusion Criteria: * Age of subject is ≥ 18. * Estimated life expectancy ≥1 year. * Subject is able and willing to comply with all assessments in the study. * Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form. * Rutherford Category classification of 4 or 5 of the target limb. * Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines. Angiographic Inclusion Criteria * Target lesion that is located in a native, de novo infra-popliteal artery (extending from P3 of the popliteal artery to the margin of the ankle mortise). * Target lesions(s) must be viewed angiographically and have 50-100% stenosis. * Only a single lesion is included in the study per subject. * The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis). * Lesion length ≥50mm and ≤300mm. * Intraluminal crossing of the lesion. Successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations. If this is not certain, IVUS or OCT may be used to verify this at the operator's discretion. * Target Lesion reference vessel diameter (RVD) between 1.5mm - 4.5mm by investigator estimate. Exclusion Criteria: * Target lesion is in a vessel graft or synthetic graft. * Treatment of target lesion with radial access. * Planned t…