Coronary calcified lesions
Conditions
Interventions
Experimental group:The SONICO-CX shockwave balloon catheter pretreats the lesion
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
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 the informed consent form, and are willing to undergo angiography, OCT examination and clinical follow-up. Image Selection Criteria: 1. The target lesion is a primary, in situ coronary artery lesion 2. Target lesion length= 60mm, target lesion diameter 2.5-4.0mm (visual method) 3. The narrowing degree of the diameter of the target lesion is = 70%, and the doctor judges that a stent needs to be implanted (visual method) 4. The lesion allows 0.014 guidewire 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) Note: This trial only performs hydroelectric shockwave balloon treatment for one calcified target lesion, which can treat the branch blood vessels of the target blood vessel, and the non-target lesion is treated after 30 days after surgery.
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1. Acute myocardial infarction occurred within 30 days before surgery 2. Simultaneous use of spinning or special balloons (chocolate balloons, scoring balloons, spinous balloons, etc.) to treat the lesion 3. Troponin is 5 times greater than the upper limit of normal laboratory value within one week before surgery 4. Severe cardiac insufficiency (grade III or IV) 5. Left ventricular ejection fraction 180 mm Hg or diastolic blood pressure >110 mm Hg) 8. Severe renal failure (serum creatinine> 221µmol/L) 9. Preoperative hemoglobin 1.7, INR is only required for patients who have taken warfarin orally within 2 weeks prior to enrollment) 11. Blood hypercoagulable 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 patient's life expectancy is less than 12 months 15. The patient has an active systemic infection 16. The patient has a connective tissue disorder (e.g., Marfon's syndrome) 17. The patient is allergic to contrast agent materials 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 Image exclusion criteria: 1. Unprotected left main lesion (left main stenosis > 50%) 2. Baseline TIMI blood flow less than grade 3 (allows evaluation after predilation) 3. A stent has been implanted within 10 mm 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 within the target blood vessel 6. Contrast confirmed the presence of thrombus in the target blood vessel 7. Chronic total occlusive lesions 8. Contrast confirmed the presence of severe dissection of the target lesion prior to hydroelectric shock wave lithotripsy treatment ( D-F dissection (NHLBI classification) 9. Patients whose target lesion is determined by the investigator to be unsuitable for vasodilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate; | — |
Countries
China
Contacts
Public ContactGe Junbo
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed