Moderate to severe coronary calcification
Conditions
Interventions
Shock wave balloon + drug coated balloon:Shock wave balloon + drug coated balloon
Shock balloon + drug-eluting stent:Shock balloon + drug-eluting stent
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, 35% at 6 months (note: in the case of multiple LVEF evaluations, the measure closest to enrollment will be used); 5. Single lesion stenosis >= 70%, or >= 50% but <70% and exercise plate test showed evidence of ischemia; 6.Moderate to severe calcification lesions under angiography (moderate calcification lesions refer to the clearer calcification shadow seen when the heart beats, but no calcification shadow can be seen when the heart is not moving; Severe calcification means that calcification shadows can be clearly seen in both beating and immovable heart, and calcification shadows are usually visible on both sides of the tube wall. 7. Target lesion length: 2.5-4 mm; 8. The subject (or legal guardian) understands the test requirements and treatment procedures and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients who could not tolerate dual antiplatelet therapy for 6 months and did not receive oral anticoagulant therapy or had major bleeding or stroke within 6 months; 2.Acute myocardial infarction occurred within 30 days before surgery; 3.There are clinical symptoms of progressive ischemia, combined with myocardial enzymology, electrocardiogram and related imaging to determine new myocardial injury and necrosis; 4.Cardiogenic shock, known platelet, white blood cell count abnormalities, liver disease (hepatitis, liver function impairment), renal insufficiency (eGFR<20 mL/min/1.73m2) or abnormal laboratory results are not suitable for participating investigators; 5.A history of allergy to iodine contrast agents, or any known allergy to clopidogrel, ticagrelor, aspirin, heparin, etc.; 6.Other contraindications for long-term DAPT (at least 1 year); 7.The program only applies rotary grinding, orbital rotary grinding, and spinal balloon as pre-treatment measures for calcification lesions or stent implantation after baseline imaging; Or stent implantation in target vessels (including collateral) within the last one year or stent implantation or drug balloon treatment within 10mm of target lesions; 8.Target vessels (including collateral vessels) within the range of proximal or distal lesion < 10mm received any type of PCI at any time prior to baseline surgery; 9.Non-target lesions were treated with any type of PCI within 24 hours before baseline surgery; 10. Patients assessed by the surgeon as unsuitable for drug balloon or stent implantation; 11. participating in any other ongoing trial or intending to participate in a clinical trial of another drug or device within 12 months of baseline surgery; 12. At baseline, there were thrombus in the target vessel (visually) or flow-limiting, spiral dissection; 13. The target lesions were venous or arterial bypass grafts; 14.The target vessel is located in the coronary artery opening, the presence of myocardial bridge, left main artery disease or CTO disease; 15. Stent restenosis requiring revascularization (i.e., angiographic stenosis exceeding 50%); 16.The IVUS-OCT catheter or shock balloon catheter or guide wire cannot pass through the lesion; 17.Patients suffering from malignant tumors or other diseases with a life expectancy of less than 1 year; 18.Patients who refuse to sign informed consent; 19.Pregnant or lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of major instrument-related composite end points (DoCE) (cardiac death, myocardial infarction, or target revascularization) and their component events during surgery, 6 months, 12 months, and 24 months.;Clean lumen obtained;Immediate lumen gain rate;Clinical operation success rate;Length, thickness, Angle of calcified lesions, morphological changes of calcified nodules and number, depth, length of calcified fractures, OCt-based coronary flow fraction (OUFR) (IVUS-OCT subgroup); | — |
Countries
China
Contacts
Public ContactLi Yan
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed