RecruitingNot ApplicableNCT06112171

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


Sponsor

University of Leipzig

Enrollment

120 participants

Start Date

Feb 13, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Intravascular lithotripsy and a procedure called Standard lesion preparation for people with peripheral arterial disease. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREIntravascular lithotripsy

Lesion preparation with Shockwave Medical Peripheral Lithotripsy System

PROCEDUREStandard lesion preparation

Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty


Locations(1)

University Clinic Leipzig

Leipzig, Saxony, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06112171


Related Trials