1. Prospective, randomized, multicenter clinical study 2. This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways. Adopting non - inferiority design, 2700 cases were enrolled. 3. EDC system (eCRF electronic data collection system) 4. Follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation;
1. Subjects are eligible for coronary intervention 2. The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations 3. The selection of target vessel is based on the criteria of a diameter between 2.25mm and 4.0mm 4. If a stent needs to be placed at the target vessel, it is recommended that there be at least 2mm overlap between the stents; if the stent expansion is not sufficient, post-dilatation treatment is required.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,700
a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent
JW Medical System
Beijing, Beijing Municipality, China
Target lesion failure at 12-Month
The target lesion failure (TLF) rate at 12 months after operation involves cardiac death, target-vessel myocardial infarction, and clinical-symptom driven target vessel revascularization.
Time frame: 12-month
MACE rate
Incidence of major adverse cardiac events (MACE) at different follow-up points of 1-month,3-month,6-month,12-month,24-month,36-month,48-month,60-montjh. 2\. Stent implantation success rate (covering the device success, the lesion success and the clinical success); 3. Target lesion failure (TLF) at 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation; 4. Subject-related cardio-clinical composite end points at the follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation, covering all-cause mortality, all myocardial infarctions and any revascularization; 5. The incidence of ARC-defined stent thrombosis events (defined, probable and non-excludable stent thrombosis in early, late, and delayed stages);
Time frame: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Device success rates , lesion success rates , clinical success rates
The success of the instrument refers to the degree of stenosis in the final bracket after the instrument was implanted. Lt; 30 %(visual), TIMI level 3 blood flow, and no residual stenosis and thrombus. The success of the lesion refers to the degree of ultimate diameter stenosis of the target lesion after the application of any interventional treatment. 50 %(visual), TIMI level 3 blood flow, and no residual stenosis and thrombus. The success of surgery refers to the absence of major cardiac adverse events caused by ischemia during the patient's hospitalization(up to 7 days after surgery) based on the success of the lesion.
Time frame: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Definite and probable stent thrombosis
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According to ARC definition
Time frame: 1-month,3-month, 12-month, 24-month, 36-month, 48-month and 60-month.