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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPT 3M or DAPT 12M | Other | After stent implantation in DAPT 3M or DAPT 12M |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXCROSSAL | Device | a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| 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); |
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Inclusion Criteria:
Exclusion Criteria:
1. Left main disease, transplanted vessel lesions, stent restenosis; 2. The balloon cannot be predilated or/or the severe calcification lesion of rotatory failure; 3. The distortion of the stent is difficult to pass;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei M Ge, Ph.D | Contact | +86 10 50981788 | 2 | ge.lei@zs-hospital.sh.cn |
| Junbo M Ge, Ph.D | Contact | +86 10 50981788 | 1 | ge.junbo@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hao M Lu, Ph.D | Zhongshan hospital of ShangHai FuDan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JW Medical System | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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the EXCROSSAL stent in CAD patients with 3-month DAPT or 12-month DAPT
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| 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. | 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month. |
| Definite and probable stent thrombosis | According to ARC definition | 1-month,3-month, 12-month, 24-month, 36-month, 48-month and 60-month. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |