Performance of the Shockwave Medical Peripheral Lithotripsy System vs Standard Balloon Angioplasty for Lesion Preparation Prior to Supera Stent Implantation in the Treatment of Symptomatic Severely Calcified Femoropopliteal Lesions in PAD
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease. All patients will receive subsequent Supera stent implantation at the operator's discretion. Additional standard nitinol bare metal stent (BMS), drug-eluting stent or covered stent implantation is at the operator's discretion. Patients will be stratified for total occlusions.
• 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)