Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter

Inclusion Criteria:

• Clinical Criteria:

  1. Age ≥ 18 years old
  2. Evidence of asymptomatic ischemia, stable or unstable angina
  3. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to accept angiography, OCT examination and clinical follow-up.

• Angiographic Criteria:

  1. The target lesion is primary and in situ coronary artery lesion
  2. The length of the target lesion is ≤60mm, and the diameter of the target lesion is 2.5-4.0mm (visually)

  3. The stenosis rate of the target lesion diameter is ≥70%, and the doctor judges that it is necessary to implant a stent (visual inspection method) to meet one of the following:

     1. Diameter stenosis ≥ 70%, < 100%
     2. ≥50%, <70% with evidence of ischemia
  4. The lesion allows a 0.014 guidewire to pass
  5. Under multi-angle imaging conditions, calcified shadow lesions can be seen on both sides of the lesion vessel wall (the target lesion meets the definition of severe calcification)

Exclusion Criteria:

• Clinical Criteria:

  1. Acute myocardial infarction occurred within 30 days before operation
  2. Use special balloons (chocolate balloons, scored balloons, spinous balloons, etc.) to treat lesions at the same time
  3. Troponin is greater than 5 times the upper limit of laboratory normal value within one week before operation
  4. Severe cardiac dysfunction (grade III or IV)
  5. Left ventricular ejection fraction <25%
  6. The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery
  7. Severe uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg)
  8. Severe renal failure (serum creatinine > 221 μmol/L)
  9. Preoperative hemoglobin <100g/L
  10. Obvious coagulation dysfunction (platelet count<100×109/L or INR>1.7, INR is only required for patients who have taken warfarin orally within 2 weeks before enrollment)
  11. Blood hypercoagulability diseases (such as polycythemia vera, platelet count >750×109/L, etc.)
  12. History of stroke or TIA within 3 months
  13. History of active peptic ulcer or upper gastrointestinal bleeding within 6 months
  14. The life expectancy of the patient is less than 12 months
  15. The patient has an active systemic infection
  16. The patient has a connective tissue disorder (such as Marfan syndrome)
  17. Patient is allergic to contrast material
  18. Patients undergoing heart transplantation
  19. Patients with implanted cardiac pacemakers
  20. The patient is pregnant or breastfeeding
  21. Those who have participated in clinical trials of other drugs or medical devices within one month before enrollment;
  22. Other circumstances that the investigator considers inappropriate to participate in the trial

• Angiographic Criteria:

  1. Unprotected left main lesion (left main visual stenosis >50%)
  2. Baseline TIMI blood flow is less than grade 3 (evaluation after pre-dilation is allowed)
  3. A stent has been implanted within 10mm of the proximal or distal end of the target lesion
  4. The target lesion is located distal to the saphenous vein or LIMA/RIMA bypass graft
  5. Aneurysm in the target vessel
  6. Angiography confirmed the presence of thrombus in the target vessel
  7. Chronic total occlusive disease
  8. Angiography confirmed the presence of severe dissection of the target lesion before hydroelectric shock wave lithotripsy (D-F type dissection (NHLBI classification)
  9. The investigator judged that the target lesion is not suitable for patients with vasodilation