Evaluating Efficacy and Safety of 1-year of DAPT After Genoss DES Sirolimus-eluting Stent Implantation in Patients

Study Overview
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Brief Summary
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In this prospective, multicenter observational study, The investigators evaluated the safety and effectiveness of DAPT over 1 year in all patients with coronary artery disease, including patients with complex high-risk coronary artery disease (CHIP), who underwent PCI using the Genoss DES stent, and performed subgroup analysis. Through this, the investigators aim to determine whether there are differences in safety and effectiveness depending on whether or not the patient is a subject with complex high-risk coronary artery disease.

Detailed Description
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This study is a sponsor-initiated clinical trial (SIT) that enrolls patients with coronary artery disease who underwent PCI using the GENOSS DES drug-eluting stent as research subjects, collects data on Honaza's clinical practice and procedures, and determines the occurrence of clinical events. The investigators will track this. This study is a prospective, multicenter study enrolling patients with coronary artery disease who underwent percutaneous coronary intervention with GENOSS DES. A total of eight institutions will recruit subjects. This study is a registered observation study and does not calculate a separate number of subjects, but plans to recruit a total of 1,000 subjects during the study registration period.

Official Title
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Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of 1-year of Dual Antiplatelet Therapy After Genoss DES Sirolimus-eluting Stent Implantation in Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy

Intervention / Treatment
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* Device: Genoss DES stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 19 or older Subjects treated for coronary artery disease using the Genoss DES™ stent Subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and provide written consent in the research subject consent form. Exclusion Criteria: Psychogenic shock at the time of hospitalization Expecting to become pregnant, pregnant or lactating woman In cases where the remaining survival period is expected to be less than 1 year due to a concomitant medical disease Subjects participating in other medical device randomization studies Subjects who received treatment using a different DES or BMS at the time of registration (however, due to failure of Genoss DES™ stent insertion, insertion of other stents is allowed)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| complex coronary artery disease<br><Clinical factors> Age 75 or older History of diabetes (those who have had diabetes in the past or are taking diabetes medication) History of chronic kidney disease (GFR <60ml/min/1.73m2) or dialysis History of stroke History of coronary artery bypass surgery Left ventricular dysfunction (LVEF <40%) Severe valve disease Troponin positive acute coronary syndrome <Lesion/procedure factors> Left main lesion Chronic total occlusion Bifurcation lesion with branches larger than 2 mm Calcified lesion (moderate to severe calcified lesion) Restenosis (in-stent restenosis) Multivessel PCI Three or more stents implanted (≥3 stents implanted) When the stent length of one lesion is more than 50 mm (total stent length >50 mm in a lesion) | Device: Genoss DES stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device-oriented composite end point | cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, clinically indicated target-lesion revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-oriented composite end point | all-cause mortality, any myocardial infarction, any revascularization All deaths at 12 months Psychogenic death at 12 months Non-cardiac death at 12 months All myocardial infarctions at 12 months All myocardial infarctions that are not clearly related to non-target vessels at 12 months All reperfusions at 12 months Reperfusion of clinically appropriate target lesions at 12 months Stent thrombosis by ARC definition at 12 months Lesion success during the procedure: When the final remaining lesion stenosis is less than 30% using any surgical method. Procedure success: When the final residual lesion stenosis is less than 30% using any surgical method, and there is no death, myocardial infarction, or reperfusion after the procedure during the hospitalization period. | 12 months |