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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
PROCEDURE	Intravascular lithotripsy	Lesion preparation with Shockwave Medical Peripheral Lithotripsy System
PROCEDURE	Standard lesion preparation	Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty

Timeline

• Start date: 2024-02-13
• Primary completion: 2026-11-01
• Completion: 2030-12-31
• First posted: 2023-11-01
• Last updated: 2025-01-23

Locations

1 site across 1 country: Germany