Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)
this trial aimed to evaluate the stent expansion through optical coherence tomography (OCT) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions
• Age \> 18 years and \< 80 years
• Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).
• Have an indication for drug-eluting stent (DES) implantation
• Denovo coronary artery calcified lesions
• Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and \< 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).
• Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm
• Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT)
• Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of \< 30% under maximal inflation pressure.
• Provision of written informed consent