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