Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions

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.

NCT Number	NCT06112171
Lead Sponsor	University of Leipzig
Conditions	Peripheral Arterial Disease
Enrollment	120 participants
Start Date	2024-02-13
Primary Completion	2028-11-01 (estimated)
Study Completion	2032-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-06