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

Peripheral Arterial Disease Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

All enrolled subjects will be followed up through 60 months. At 6, 12, 24, 36 MFU after index procedure the incidence of restenosis will be assessed by DUS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06112171
Study type Interventional
Source University of Leipzig
Contact Sabine Steiner, Prof. Dr.
Phone +49-341-97
Email Sabine.Steiner@medizin.uni-leipzig.de
Status Not yet recruiting
Phase N/A
Start date February 1, 2024
Completion date December 31, 2030
View Details
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