Moderate to severe coronary calcification
Conditions
Interventions
Experimental group:Intravascular lithotripsy (IVL) system + drug-coated balloon (DCB) for coronary angioplasty + rescue DES implantation
Control group:Coronary artery endovascular lithotripsy system (IVL) + Coronary artery cobalt-chromium alloy biodegradable coating rapamycin drug-eluting stent system (DES)
Sponsors
The Second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years and < 80 years; 2. Have clinical indications for percutaneous coronary intervention (PCI); 3. Evaluated as having moderate to severe calcification under DSA; 4. The subjects (or their legal guardians) understand the requirements of the trial and the treatment procedures, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Acute ST-segment elevation myocardial infarction occurred within 30 days before the operation; 2. Patients with cardiogenic shock, known platelet abnormalities (30%; 10. Patients deemed unsuitable for drug-coated balloon or stent implantation treatment by the operator; 11. Target lesions are venous or arterial bypass grafts; 12. Target vessels are located at coronary artery openings, have myocardial bridges, left main coronary artery lesions, or chronic total occlusion (CTO) lesions; 13. Target lesions involve bifurcation lesions (branch vessel stenosis >70%), with a branch vessel diameter =2.5mm and a branch lesion length exceeding 5mm, requiring bifurcation stenting; 14. There is an aneurysm within 10mm of the target lesion; 15. There is definite thrombosis in the target lesion; 16. The target lesion length is >33mm, and the reference vessel diameter of the target lesion is 4.0mm (under angiography).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of major device-related composite endpoints 12 months after the operation;The incidence of DOCE events 24 months after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of DOCE events during the operation and at 1, 3, and 6 months after the operation;The incidence rates of each component event of DOCE at 1 month, 3 months, 6 months, 12 months and 24 months after the operation;The success rate of the instrument immediately after the operation;BARC 3 or 5 type bleeding;Target lesion thrombosis;Any stroke;Any myocardial infarction; | — |
Countries
China
Contacts
Public ContactLi Yan
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed