Post-Marketing Clinical Study of High-Pressure Cutting Balloon

Inclusion criteria

• Age ≥18 years;
• Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;
• Moderate-to-severe calcified lesions on coronary angiography;
• Target lesion is a de novo lesion in a native vessel that has not received any prior interventional treatment;
• Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion;
• In patients with multiple lesions, only one lesion will be selected as the target lesion in this study. If target and non-target lesions are treated during the same procedure, the target and non-target lesions must be located in different vessel branches; furthermore, the non-target lesion must be treated first, and the target lesion may be treated only after successful revascularization of the non-target lesion without severe angiographic complications;
• Provision of written informed consent.

Exclusion criteria

• Life expectancy <1 year;
• Cardiogenic shock or hemodynamic instability;
• Left main coronary artery disease;
• Chronic total occlusion;
• Bifurcation lesions planned for a "two-stent strategy";
• Active bleeding;
• Known history of allergy to contrast media or metals;
• Patients with a bleeding tendency, contraindications to antiplatelet or anticoagulant therapy, or inability to receive anticoagulation therapy;
• New-onset stroke/transient ischemic attack within 6 months;
• Pregnant or lactating women;
• Left ventricular ejection fraction <25%, or NYHA functional class IV, or Killip class ≥2;
• Non-target vessel revascularization within 30 days before randomization with complications.