Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus

Inclusion Criteria:

1. Age 18-80 years, male or non-pregnant female.
2. Evidence of symptomatic ischemia, stable or unstable angina, or MI for more than 7days.
3. Patients who can understand the purpose of the trial, voluntarily participate and signthe informed consent form, and are willing to undergo angiography, OCT and clinicalfollow-up. Angiogram inclusion criteria
4. The target lesion was primary and in situ coronary artery disease.
5. Target lesion length ≤40 mm, target lesion reference vessel diameter 2.25-4.0 mm (visual inspection).
6. The target lesion diameter stenosis ≥70% or ≥50% (visual inspection) with evidence ofischemia.
7. Clear, high-density shadows can be seen both when the heart is beating and when it isnot.
8. TIMI flow grade 3(allowing predilation) in the target vessel before use of the testequipment.
9. The target lesion was the only calcified lesion to be treated with the shock wave, andthe non-target lesion needed to be treated successfully before the target lesion.
10. Suitable for patients undergoing metallic stent implantation

Exclusion Criteria:

1. Severe myocardial infarction occurred within 7 days before operation.
2. At the same time, the lesions were treated with rotational grinding or special balloon (chocolate balloon, nicked balloon, cutting balloon, double guide wire balloon,spinous process balloon, etc.).
3. NYHA Class III or IV.
4. Left ventricular ejection fraction <35% .
5. The target lesion was expected to be treated by fully biodegradable stentimplantation, drug balloon dilatation and PTCA.
6. Uncontrollable severe hypertension (systolic blood pressure >180 mmHg or diastolicblood pressure > 110 mmHg).
7. Severe hepatic and renal impairment, transaminase more than 3 times the upper limit ofnormal, serum creatinine > 2.5 mg/dL (221 μmol/L), or chronic kidney failure requiringlong-term dialysis.
8. Preoperative hemoglobin <100 g/l.
9. Platelet count <60×109/L.
10. Cerebral Stroke occurred within 6 months of enrollment, excluding transient ischemicattack (TIA) and lacunar infarction.
11. A history of active peptic ulcer or upper gastrointestinal bleeding within 6 monthsbefore enrollment.
12. Patients known to be allergic to heparin, contrast media, aspirin, clopidogrel andanesthetics.
13. Definite diagnosis of malignancy or life expectancy would be less than 12 months.
14. Participation in clinical trials of other drugs or medical devices that did not reachthe primary end point.
15. The researchers judged that the patients had poor compliance and could not completethe study according to the protocol. Angiographic exclusion criteria:
16. The target lesion was in the opening position (LAD, LCX or RCA, within 5 mm of theopening) or unprotected left main coronary artery.
17. Stents were implanted 10mm proximal or distal to the target lesion.
18. The target lesion had unprotected branch vessels more than 2.5mm in diameter.
19. The target lesion was distal to the saphenous vein or LIMA (Left internal mammaryartery) /RIMA (Right internal mammary artery) bypass graft.
20. Existed an aneurysm within 10mm of the target lesion.
21. Angiography confirmed the presence of severe target lesion dissection (type D-Fdissection (NHLBI classification) before the treatment of the Intracoronarylithotripsy balloon catheter and Intracoronary lithotripsy apparatus
22. The target lesion had definite thrombosis.
23. The researchers determined that the target lesion was unsuitable for vasodilation inpatients.