The Safety and Performence of ShockPulse-10 in Patients with Coronary Artery Calcification

Key Inclusion Criteria: 1. Patient is ≥ 18 years of age; 2. Patients with significant coronary artery disease (including stable or unstable angina and asymptomatic myocardial ischemia) who are suitable for PCI treatment; 3. A single newly developed stenosis of the target vessel, which is the left anterior descending artery, right coronary artery, or circumflex artery (or its branches), with stenosis degree ≥70% or ≥50% (Visually inspect ) and accompanied by evidence of ischemia; 4. The target lesion is a primary, in situ coronary artery lesion; 5. The reference vessel diameter for the target lesion is 2.0-4.0mm, and the length of the target lesion is ≤40mm (Visually inspect); 6. Visual assessment indicates that the lesion site can accommodate the passage of a pre-dilator or trial instrument through the lesion; 7. The target lesion site has moderate to severe calcification (meeting one of the following conditions)： ① Angiography: Moderate calcification :clearer and more easily visible high-density shadows during cardiac pulsation; Severe calcification :clear high-density shadows both during and at rest; ② IVUS calcium score ≥2 points for superficial intimal, deep medial, and mixed calcification; 8. TIMI grade 3 in target vessel before registration (pre-dilation is allowed); Key exclusion Criteria: 1. Left ventricular ejection fraction \< 40%； 2. NYHA class III or IV heart failure； 3. Patients with single coronary artery supply; 4. Patients with evidence of dissection at the site of the lesion on imaging; 5. The imaging suggests that the vascular pathway is tortuous, making it difficult for the pre-dilatation device to reach the target location or to be retrieved; 6. Patients with active systemic infections; 7. Patients with uncontrollable severe hypertension (systolic pressure \> 180 mmHg or diastolic pressure \> 110 mmHg); 8. Patients with coagulopathy, hypercoagulable state or significant bleeding tendency (hemoglobin \<10g/dL or platelet count \<80×10\^9/L);