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Clinical Trial Summary

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 coronary artery lesions not responding to usual balloon dilatation) randomized to RA or Shockwave IVL. The primary outcome is peri-procedural myocardial infarction. Secondary outcomes include peri-procedural myocardial injury, acute microvascular dysfunction, procedural success, and procedural costs.


Clinical Trial Description

In this multicentre, prospective, randomized-controlled open label pilot study the investigators will measure rates of peri-procedural myocardial infarction and changes in microvascular function after PCI in 170 patients (85 per arm) treated with Shockwave intravascular lithotripsy (IVL) versus RA. Patients with moderately and/or severely calcified coronary lesions, which are equally suitable for IVL and RA and do not dilate fully (100%) with an appropriately sized non-compliant balloon at 16 atmospheres, will be recruited. The calcified lesion must be suitable for both IVL and RA and the operator believes that either IVL or RA could be used. The primary outcome will be difference in the rate of peri-procedural myocardial infarction (Type 4a of the universal Definition of Myocardial Infarction). Peri-procedural myocardial injury and infarction will be defined by an increase in high-sensitivity Troponin T according to the Fourth Universal Definition of Myocardial Infarction,15 while microvascular dysfunction will be defined by an Index of Microcirculatory Resistance (IMR) of ≥25.16 Patients will undergo study-related clinical follow up at 30 days and 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05208749
Study type Interventional
Source Universitaire Ziekenhuizen Leuven
Contact
Status Recruiting
Phase N/A
Start date February 4, 2022
Completion date January 1, 2025

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