Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions - Trial NCT06112171
Access comprehensive clinical trial information for NCT06112171 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Leipzig and is currently Not yet recruiting. The study focuses on Peripheral Arterial Disease. Target enrollment is 120 participants.
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Study Focus
Sponsor & Location
University of Leipzig
Timeline & Enrollment
N/A
Dec 01, 2023
Dec 31, 2030
Primary Outcome
Primary efficacy,Primary safety
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06112171
Non-Device Trial