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Efficacy and Safety of GENOSS SES in patients with coronary artery disease
GENOSS SES
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GENOSS Sirolimus Eluting Coronary Stent System | patients with coronary artery disease treated with GENOSS SES |
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| Measure | Description | Time Frame |
|---|---|---|
| Device-oriented composite endpoint | DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR). | at 12 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-oriented composite endpoint | POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization. | at 12 months after the procedure |
| All-cause deaths |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with coronary artery disease treated with GENOSS SES
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
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| at 12 months after the procedure |
| Cardiac death | at 12 months after the procedure |
| Non-cardiac death | at 12 months after the procedure |
| Any myocardial infarction | at 12 months after the procedure |
| Target vessel-related myocardial infarction (TV-MI) | at 12 months after the procedure |
| Any revascularization | at 12 months after the procedure |
| Clinically indicated target lesion revascularization (TLR) | at 12 months after the procedure |
| Stent thrombosis | at 12 months after the procedure |
| Lesion success | When the final residual lesion stenosis is less than 50% using any surgical method. | during the procedure |
| Procedure success | When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period. | immediately after the procedure |