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
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
Parallel
Intravascular lithotripsy
Procedure/SurgeryLesion preparation with Shockwave Medical Peripheral Lithotripsy System
Standard lesion preparation
Procedure/SurgeryLesion preparation with Standard and/or High-Pressure Balloon Angioplasty
Primary efficacy
Procedural success defined as residual stenosis ≤ 30% without flow-limiting dissection (≥Grade D) in the final angiogram and without the need of additional stent implantation.
Rate of primary outcome events
Composite endpoint defined as freedom from device and procedure-related death, freedom from both target limb major amputation and clinically-driven target lesion revascularization
Rate of vessel rupture
Rate of vessel rupture
Need of additional stent implantation
Need of additional stent implantation
Procedure Time (min)
Procedure Time (min)
Fluoroscopy Duration (min)
Fluoroscopy Duration (min)
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