Effectiveness and Safety of a Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions(COCALP)

A Prospective, Multi-center, Single-arm, Objective Performance Goal Pre-specified Study to Evaluate the Safety and Effectiveness of Intravascular Lithotripsy Generator Combined with SONICO-CX Coronary Intravascular Lithotripsy (IVL) Catheter for Pre-treatment of Coronary Calcification Before Stent Implantation

This study is a prospective, multicenter, single-arm trial designed to investigate the effectiveness and safety of this intravascular lithotripsy system to treat severely calcified coronary lesions before stenting.

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). 266 subjects at 11 sites will be enrolled.Subjects will be followed through discharge, 30 days, 6months.

Inclusion Criteria:

• General inclusion 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 informed consent, and are willing to undergo angiography, OCT, and clinical follow-up.

• Angiographic Inclusion Criteria

  1. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  2. Length of the target lesion ≤60mm, diameter of the target lesion 2.5-4.0mm
  3. Target lesion diameter stenosis ≥70%, the doctor determines the need for stent implantation
  4. The lesion allows 0.014 guide wires to pass through
  5. Under multi-angle contrast conditions, it can be seen that there are calcified angiography lesions on both sides of the lesion blood vessel wall (the target lesion meets the definition of severe calcification).

Exclusion Criteria:

• General inclusion criteria

Patients who fit any of the following criteria were excluded:

1. Acute myocardial infarction occurred within 30 days before procedural
2. Simultaneous use of spinning or special balloons (chocolate balloons, scoring balloons, spinous balloons, etc.) to treat the lesion
3. Troponin was 5 times greater than the upper limit of laboratory normal within one week before procedural
4. Severe cardiac insufficiency (Grade III or IV)
5. Left ventricular ejection fraction < 40%
6. The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery.
7. Uncontrolled severe hypertension (ystolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg)
8. Severe renal failure (serum creatinine > 221μmol/L)
9. Preprocedural hemoglobin < 100g/L
10. Significant 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 prior to enrollment)
11. Hypercoagulable blood disorders (e.g. Polycythemia vera, platelet count >750× 109/L, etc.)
12. History of stroke or TIA within 3 months
13. History of active digestive ulcer or upper gastrointestinal bleeding within 6 months
14. The patients has a life expectancy of less than 12 months
15. The patient has an active systemic infection
16. The patient has a connective tissue disease (such as Marfan's syndrome)
17. The patient is allergic to contrast material
18. Patients undergoing heart transplantation
19. Patients with pacemakers implanted
20. The patient is pregnant or breastfeeding
21. Those who have participated in clinical trials of other drugs or medical devices within 1 month before enrollment
22. Other circumstances that the investigator deems inappropriate to participate in the trial - Angiographic Exclusion Criteria

Patients who met any of the following criteria were excluded:

1. Unprotected left main disease (left main visual stenosis > 50%)
2. Baseline TIMI blood flow less than grade 3 (allows evaluation after pre-dilation)
3. A stent has been implanted within 10mm of the proximal or distal end of the target lesion
4. The target lesion is located at the distal end of the saphenous vein or LIMA/RIMA bypass graft
5. Aneurysm within the target blood vessel
6. Angiography confirmed the presence of thrombus in the target vessel
7. Chronic total occlusive lesions
8. Angiography confirmed the presence of severe dissection of the target lesion prior to hydroelectric shock wave lithotripsy treatment (D-F dissection (NHLBI classification)）
9. The investigators determined that the target lesion was unsuitable for patients undergoing vasodilation