Physician-Initiated PMCF Trial Investigating Shockwave Intravascular Lithotripsy and a Drug Eluting Vascular Stent System Deployment for Heavily Calcified Femoropopliteal Disease
The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for PACSS 3 and PACSS 4 calcified femoropopliteal disease.
• Subject must be between 21 and 85 years old
• Clinical diagnosis of symptomatic peripheral artery disease, defined by Rutherford Becker Classification score 3-5
• Willing to comply with the specified follow-up evaluation
• Written informed consent prior to any study procedures
• Stenotic, restenotic after PTA or occlusive lesion(s) located in the native Superficial Femoral Artery (SFA) and/or proximal Popliteal Artery (PPA):
‣ Degree of stenosis ≥ 70% by visual agiographic assessment
⁃ Vessel diameter ≥ 4 and ≥ 6 mm
⁃ Total lesion length (or series of lesions) ≥ 30 mm and 210 mm (Note: Lesion segment(s) must be filly covered with one or two overlapping DES stent (s) be fully covered with one or two overlapping DES stent(s)
⁃ Target lesion located at least three centimeters above the inferior edge of the femur
• Severity of calcification PACSS 3-4
• Patent infrapopliteal and popliteal artery; i.e. single vessel runoff or better with at least one of three vessels patent (\>50% stenosis) to the ankle or foot with no planned intervention.
• Study entry after successful target lesion crossing of the guidewire (guidewire located intraluminally or subintimally); Both crossing devices as well as retrograde recanalization can be used.
• Non-target lesion interventions to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion and should be completed successfully.