About this trial
This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloon in treating coronary calcified lesions at our center.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with coronary angiography showing vessel diameter stenosis ≥ 70% and moderate to severe calcification;
Reference vessel diameter ≥ 2.5 mm;
Signed informed consent form.
Disqualifiers
Patients with comorbid conditions such as malignant tumors and an expected lifespan of less than 1 year;
Patients with hemodynamic instability;
Patients classified as New York Heart Association (NYHA) functional class IV;
Any other conditions deemed by the investigator as unsuitable for enrollment.
Trial population
Patients with coronary Artery disease and moderate to severe coronary artery calcification scheduled for PCI treatment.
Trial design
Cohort
Prospective
Treatments tested in this trial
percutaneous coronary intervention
Procedure/SurgeryAll enrolled patients underwent Intravascular Lithotripsy (IVL) and Percutaneous Coronary Intervention (PCI) under guideline-directed management.
Treatment groups
Trial outcomes
Primary outcomes
MACE: All-Cause Death, Recurrent Myocardial Infarction, Unplanned Target Vessel Revascularization, Acute Stent Thrombosis.
Secondary outcomes
Residual stenosis rate after PCI.
Sponsors and contacts
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