Evaluating Efficacy and Safety of GENOSS Stent in Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of the GENOSS stent in patients with coronary artery disease who underwent treatment using the GENOSS stent manufactured with domestic technology.

Detailed Description
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This study is a prospective, registered observational study that is recruiting patients with coronary artery disease who underwent treatment using the GENOSS stent at a total of 6 institutions. This study is a registered observation study and does not calculate a separate number of subjects. A total of 1,200 subjects are scheduled to be registered during the study subject registration period.

Official Title
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Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Genoss DES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Research subjects aged 19 years or older Those eligible for coronary artery disease treatment Research subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and give written consent in the research subject consent form. Exclusion Criteria: Research subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, cobalt chromium, contrast medium (however, even research subjects with hypersensitivity to contrast medium can be controlled with steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded) Subjects who are women of childbearing age and planning to become pregnant during this study period Subjects scheduled for surgery that requires discontinuation of antiplatelet medication within 12 months from registration Those whose remaining life expectancy is less than 1 year Patients who visited the hospital due to psychogenic shock and whose chances of survival are predicted to be low based on medical judgment Subjects who received treatment using a different DES (Drug Eluting Stent), BVS (Bioresorbable vascular scaffolds), or BMS (Bare metal stent) on the same vascular adjacent lesion at the time of registration Subjects participating in medical device randomization research

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Genoss DES|The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with device-oriented compopsite endpoint (TLF) | A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with patient-oriented composite endpoint | A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR) All death Psychogenic death Non-cardiac death All myocardial infarctions All myocardial infarctions that are not clearly related to non-target vessels All reperfusions Reperfusion of clinically appropriate target lesions Lesion success during the procedure: When the final remaining lesion stenosis is less than 50% using any surgical method. Procedure success: When the final residual lesion stenosis is less than 50% using any surgical method, and there is no death, myocardial infarction, or reperfusion after the procedure during the hospitalization period. | 12 months |