BM Shockwave Devices Clinical Study in Coronary Calcified Lesions

Inclusion Criteria: * General inclusion criteria: 1. Age 18-85 years, male or female; 2. Patients with evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction; 3. Patient is able and willing to comply with all assessments in the study. Angiography inclusion criteria: 1. The target lesion is a de novo, in-situ coronary artery lesion; 2. The target lesion length is ≤40 mm, and the target lesion reference vessel diameter is 2.0-4.0 mm (visual estimation); 3. The target lesion diameter stenosis is visually estimated to be ≥70%, or \<70% but ≥50% with evidence of ischemia; 4. Clear high-density calcification shadows are visible both during cardiac contraction and at rest; 5. Target vessel TIMI flow grade 3 prior to use of the investigational device (pre-dilatation is permitted); 6. The target lesion is the only calcified lesion to be treated with shock wave therapy in this session; if non-target lesions are present, they must be successfully treated prior to the target lesion; 7. Patients suitable for treatment with metal stent implantation. Exclusion Criteria: * General exclusion criteria: 1. ST-segment elevation myocardial infarction within 3 days prior to the procedure; 2. Use of rotational atherectomy or special balloons (chocolate balloon, scoring balloon, cutting balloon, etc.) for lesion pretreatment; 3. New York Heart Association (NYHA) functional class III or IV; 4. Target lesion expected to require full biodegradable scaffold implantation, drug-eluting balloon dilation, or percutaneous transluminal coronary angioplasty (PTCA) treatment; 5. Uncontrolled severe hypertension (persistent: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg); 6. Severe liver or kidney dysfunction, with transaminase levels exceeding three times the upper limit of normal, serum creatinine \>2.5 mg/dL (221 μmol/L), or chronic kidney failure requiring long-term dialysis; 7. Platelet count \<60 × 10⁹/L; 8. Stroke within the past 6 months prior to enrollment, excluding transient ischemic attack (TIA) and lacunar infarction; 9. Active peptic ulcer or history of upper gastrointestinal bleeding within the past 6 months prior to enrollment; 10. Known allergy to heparin, contrast agents, aspirin, clopidogrel, or anesthetics; 11. Patients with a life expectancy of less than 12 months due to severe medical conditions; 12. Patients who have participated in other drug or device clinical trials and failed to meet the primary endpoint; 13. Pregnant or breastfeeding women; 14. Patients deemed by the investigator to have poor compliance and unable to complete the study according to the protocol. Contrast exclusion criteria: 1. The target lesion and non-target lesion are in the same vascular branch; 2. The target lesion is at the origin (LAD, LCX, or RCA, within 5 mm of the origin) or an unprotected left main lesion; 3. A stent has been implanted within 10 mm of the proximal or distal end of the target lesion; 4. The target lesion has an unprotected branch vessel with a diameter of 2.5 mm or greater; 5. The target lesion is located distal to the saphenous vein or LIMA (left internal mammary artery)/RIMA (right internal mammary artery) bypass graft; 6. An aneurysm is present within 10 mm of the target lesion; 7. Contrast imaging confirms the presence of an NHLBI classification D-F type arterial dissection at the target lesion prior to the use of the investigational device; 8. The target lesion has definite thrombus formation; 9. The investigator determines that the target lesion is not suitable for vascular dilation in the patient.