Overview
This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation. Subjects will be randomized in a 1:1 ratio to the experimental group (n=140) or the control group (n=140). The primary endpoint is the MSA measured by IVUS immediately after the procedure, with the purpose of verifying the safety and efficacy of the high-pressure cutting balloon in optimizing stent implantation outcomes.
Eligibility
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.
