What is the aim of this study?

In patients with peripheral arterial occlusive disease (PAD), the presence of calcification indicates a poorer prognosis and makes endovascular revascularization considerably more difficult. Heavily calcified arteries are difficult to dilate with conventional balloon angioplasty (BA) and often require mechanical removal or modification of the plaque, for example with focal force balloons or atherectomy.

Intravascular lithotripsy (IVL) is a new method of modifying calcium deposits. It uses sound pressure waves to break up both intimal and medial calcium. These sound pressure waves penetrate the soft tissue without causing damage and break up the calcium, minimizing the risk to the non-calcified parts of the vessel.

The aim of the study is to evaluate the efficacy of IVL-based lesion preparation compared to conventional balloon angioplasty in heavily calcified femoropopliteal lesions. All devices used are CE-certified and approved for routine clinical use in Germany.

Who can participate?

We are looking for the following people:

• At least 18 years old
• No presence of de novo or restenotic lesion with angiographically documented stenosis of ≥ 70% and no previous stent in the target lesion

The following exclusion criteria apply:

• Previous vascular surgery on the target lesion
• Stroke or myocardial infarction within 3 months prior to enrollment in the study
• Participation in another drug, device or biologics study
• Known allergies or hypersensitivity to heparin, aspirin, other anticoagulants/antiplatelet agents, sirolimus, paclitaxel or contrast agents that cannot be adequately pretreated prior to the index procedure
• Pregnant or breastfeeding women
• Major amputation of the same limb as the target lesion in the past

What happens in the study?

The study is an investigator-initiated, prospective, randomized 1:1 pilot study at one center. The study investigates the safety and efficacy of intravascular lithothripsy compared to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease. A Supera stent is subsequently implanted in all patients. The additional implantation of a nitinol bare-metal stent (BMS), a drug-eluting stent or a covered stent is at the discretion of the physician. At 6, 12, 24 and 36 MFU after the index procedure, the occurrence of restenosis is examined using duplex ultrasound as part of an outpatient check-up.

How much time does it require?

The total duration of the study is 60 months. The restenosis examination is scheduled after 6, 12, 24 and 36 months. A telephone follow-up takes place after 1, 48 and 60 months.