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NCT06112171

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

Performance of the Shockwave Medical Peripheral Lithotripsy System vs Standard Balloon Angioplasty for Lesion Preparation Prior to Supera Stent Implantation in the Treatment of Symptomatic Severely Calcified Femoropopliteal Lesions in PAD
University of Leipzig·ClinicalTrials.gov·procedureNot yet recruiting
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Study focus
Disease/Condition
Peripheral Arterial Disease
Drug/Device/Intervention
Intravascular lithotripsy
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
University of Leipzig
Location
Leipzig, Germany
Timeline & enrollment
Phase
N/A
Start date
Dec 01, 2023
End date
Dec 31, 2030
Enrollment
120 participants
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
Peripheral vascular disease, unspecifiedOther peripheral vascular diseasesOther specified peripheral vascular diseasesPeripheral angiopathy in diseases classified elsewhereOther congenital malformations of peripheral vascular system
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06112171
Type
Non-Device Trial
About this record

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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