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Study identifier: NCT05208749 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial

Condition: Calcified Atheroma · Coronary Artery Disease  ·  Sponsor: Universitaire Ziekenhuizen KU Leuven

PhaseNA
Planned participants170
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Percutaneous coronary interventions (PCI) is intended to relieve myocardial ischemia by improving blood flow in the epicardial coronary arteries. However, the efficacy of PCI may be compromised by incidental microvascular obstruction and peri-procedural myocardial infarction (PPMI), which occurs in about 10-15% of cases and is associated with increased rates of major adverse cardiovascular events (MACE). The mechanism of PPMI is thought to be related to side branch occlusion, coronary artery dissection and acute microvascular damage caused by embolization of plaque debris during the PCI and is more frequently seen in calcified coronary artery disease. Calcium modification by rotational atherectomy (RA) results in peri-procedural myocardial infarction in 24% of cases and myocardial injury in 70% of cases. The Shockwave coronary intravascular lithotripsy (IVL) balloon catheter emits sonic pressure waves in a circumferential field causing the selective fracture of calcium, altering vessel compliance and permitting further expansion of the vessel wall. This provides a potentially safer alternative to other calcium-modifying devices since there is a low risk of dissection and perforation. It is also proposed that this IVL device reduces the risk of atheromatous embolization, which would reduce the risk of PPMI and microvascular dysfunction. The SONAR Trial is a pilot study measuring peri-procedural myocardial injury, PPMI and microvascular dysfunction in patients (with calcified c…

This description comes directly from the study's public registry record.

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Locations (1)

University Hopsitals LeuvenLeuven, Brabant, BelgiumRecruiting

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Source record: clinicaltrials.gov/study/NCT05208749