Clinical Trials of Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater

Inclusion Criteria: 1. 18≤age≤80 years old, males or females; 2. Life expectancy ≥ 6 months; 3. Patients with evidence of asymptomatic myocardial ischemia, stability or instability; with angina, or obsolete heart infarction for interventional therapy; 4. The target lesion is primary, in situ coronary artery lesion; 5. The target vessel reference diameter is 1.5-4.0mm, and the lesion length is ≤40mm (visual inspection); 6. Target lesion is with a visually estimated stenosis of ≥70%(or≥50% with evidence of myocardial ischemia) ; 7. Highly calcified lesions; 8. Only one target lesion requiring sonic balloon treatment is allowed; 9. The number of non-target lesions requiring interventional treatment is no more than 2, and the target lesions should be treated after the non-target lesions are successfully treated; 10. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and can accept required clinical follow-up. Exclusion Criteria: 1. New York Heart Association (NYHA) class III or IV; 2. Severe liver and kidney damage, transaminase more than 3 times the upper limit of normal, creatinine \> 2.5mg/dL (221μmol/L) or chronic renal failure requiring long-term dialysis; 3. Stroke occurred within 6 months of joining the group, excluding transient is chemic attack (TIA) and cavity infarction; 4. Have a history of active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months of joining the group; 5. Platelet count \<80×10⁹/L; 6. Subject refuses or is not suitable for CABG surgery; 7. The target lesion is planned to undergo coronary atherectomy, laser, double guide wire balloon, mastoid balloon, cutting balloon or thrombus aspiration; 8. Dissection of the target vessel after preoperative angiography or guide wire pass through; 9. The stent has been implanted within 10mm of the proximal or distal end of the target lesion, and there is a definite or possible thrombus in the target vessel; 10. The target lesion is located or involved within 5mm of the opening of LAD, LCX and RCA; 11. Left main stem disease or bridge vascular disease; 12. Angiography shows that the blood vessel path is tortuous, and the test device is difficult to reach the target position or difficult to recover; 13. Patients with implanted pacemakers or cardiac rhythm devices; 14. Evidence of aneurysm within 10 mm of the target lesion; 15. Patients who are known to be allergic to heparin, contrast agents, aspirin, clopidogrel, and anesthetics; 16. The subject is currently participating in another drug or device clinical study that has not yet completed; 17. Pregnant or nursing subjects; 18. Other patients should be excluded based on the assessment of the investigators;