Clinical Trial

ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions

Study acronym: IVL
Recruiting
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Record status
This record was last updated June 29, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
Coronary artery disease is caused by narrowing of the artery lumen. Treatment with Percutaneous Coronary Intervention (PCI) may be needed. This is a minimally invasive procedure used to treat narrowed or blocked coronary arteries. Sometimes a stent is placed to keep the artery open. If the lesions in the coronary artery are calcified, this may cause difficulties for successful stent placement. The calcified plaques can be fractured via intravascular lithotripsy (IVL) with devices like ShockWave IVL and ShockFast IVL. The aim of this study is to compare the this relatively new ShockFast IVl with the more widely used ShockWave IVL.
Protocol Amendment History 1 change
critical Recruitment opened 2026-06-30
Trial Details
NCT Number NCT07407738
Lead Sponsor Shunmei Medical
Conditions Coronary Arterial Disease, Calcified Coronary Artery Disease
Enrollment 120 participants
Start Date 2026-02-16
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-29