Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions

Inclusion Criteria: * Subject age ≥ 18 * Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved inform consent form * Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing * Rutherford Classification 2-5 * Subject has a de novo or restenotic lesion in SFA and/or PPA not exceeding the medial femoral epicondyle with ≥ 70% stenosis documented angiographically * No previous stent in the target lesion, if target vessel was previously stented the stent should be at least 3cm apart * Target lesion length is ≥ 10cm, no maximum lesion length limit * Severe calcification on fluoroscopy defined by PACSS Grade 4: 1) bilateral calcification and 2) extending ≥50mm in length * Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion * Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation * Patency of at least one infrapopliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the native femoropopliteal artery * A guidewire has successfully traversed the target treatment segment (both intraluminal and subintimal crossing allowed) Exclusion Criteria: * Failure to successfully cross the target lesion * Presence of fresh thrombus in the lesion * Presence of aneurysm in the target vessel/s * Presence of a stent in the target lesion, at least 3cm from any previously stent in target vessel * Prior vascular surgery of the target lesion * Stroke or heart attack within 3 months prior to enrollment * Enrolled in another investigational drug, device or biologic study that has not reached the primary endpoint * Life expectancy of less than one year * Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies or contrast media that cannot be adequately pre-treated prior to index procedure * Rutherford Classification of 0, 1, or 6 * Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy * Receiving immunosuppressant therapy * Pregnant or breast-feeding females * History of major amputation (defined as amputation above ankle joint) in the same limb as the target lesion