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

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 stent implantation, drug balloon dilatation and PTCA.
• •6. Uncontrollable severe hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \> 110 mmHg).
• •7. Severe hepatic and renal impairment, transaminase more than 3 times the upper limit of normal, serum creatinine \> 2.5 mg/dL (221 μmol/L), or chronic kidney failure requiring long-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 ischemic attack (TIA) and lacunar infarction.
• •11. A history of active peptic ulcer or upper gastrointestinal bleeding within 6 months before enrollment.
• •12. Patients known to be allergic to heparin, contrast media, aspirin, clopidogrel and anesthetics.
• •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 reach the primary end point.
• •15. The researchers judged that the patients had poor compliance and could not complete the study according to the protocol.
• •1. The target lesion was in the opening position (LAD, LCX or RCA, within 5 mm of the opening) or unprotected left main coronary artery.
• •2. Stents were implanted 10mm proximal or distal to the target lesion.
• •3. The target lesion had unprotected branch vessels more than 2.5mm in diameter.
• •4. The target lesion was distal to the saphenous vein or LIMA (Left internal mammary artery) /RIMA (Right internal mammary artery) bypass graft.
• •5. Existed an aneurysm within 10mm of the target lesion.
• •6. Angiography confirmed the presence of severe target lesion dissection (type D-F dissection (NHLBI classification) before the treatment of the Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus
• •7. The target lesion had definite thrombosis.
• •8. The researchers determined that the target lesion was unsuitable for vasodilation in patients.