Clinical Trial

SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study

Recruiting
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Record status
This record was last updated December 2, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
Interventional cardiologists are facing an increasing burden of calcified coronary arteries in keeping with an ageing population and rising prevalence of diabetes mellitus and chronic kidney disease. Heavily calcified plaques impede balloon dilatation and successful stent delivery, resulting stent under-expansion, malposition, and damage to the drug-eluting polymer coats. This translates to poorer procedural outcomes and increased risk of Major Adverse Cardiovascular Events (MACE). The investigators' proposal seeks to determine the feasibility of the SoniCracker IVL in patients with calcified coronary lesions.
Trial Details
NCT Number NCT07259239
Lead Sponsor National Heart Centre Singapore
Collaborators: Biosensor Interventional Technologies Pte Ltd
Conditions Cardiovascular Diseases
Enrollment 40 participants
Start Date 2025-09-30
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-12-02