Genoss DES in Patients With a High Risk of Ischemic Events

Study Overview
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Brief Summary
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This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features.

Detailed Description
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It is known that ischemic events after percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) increase as the anatomical, physiological, or functional complexity of coronary artery disease increases. Recently, the concept of complex higher-risk and clinically indented procedure (CHIP) has been proposed, which includes patients with various medical conditions, patients with various heart conditions, and patients with technically complex PCI. Until now, Genoss stents have no data on the evaluation of stents in patients with coronary artery disease and high ischemic features.

Official Title
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Safety and Efficacy of Sirolimus-eluting Biodegradable Abluminal Coating Stents in Patients With a High Risk of Ischemic Events: a Single-center, Prospective, Observational Trial

Conditions
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Drug-eluting Stent, 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: Subject is ≥ 19 years Subject has signed informed consent for data release Exclusion Criteria: Subject did not sign informed consent for data release Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media Pregnancy Subject with life expectancy less than 12 months Subject with cardiogenic shock

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 |
| --- | --- |
| High Ischemic Group<br>Acute myocardial infarction (AMI) ≥ 2 stents implanted bifurcation lesion Left main lesion Lesion treated with rotational atherectomy Chronic total occlusion (CTO) lesion | Device: Genoss DES<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 |
| --- | --- | --- |
| 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 all death, all myocardial infarction, and all revascularization | 12 months | 
| Number of participants with all death | A composite rate of all death | 12 months | 
| Number of participants with cardiac death | A composite rate of cardiac death | 12 months | 
| Number of participants with non-cardiac death | A composite rate of non-cardiac death | 12 months | 
| Number of participants with all myocardial infarction | A composite rate of all myocardial infarction | 12 months | 
| Number of participants with target-vessel myocardial infarction (TV-MI) | A composite rate of target-vessel myocardial infarction (TV-MI) | 12 months | 
| Number of participants with all revascularization | A composite rate of all revascularization | 12 months | 
| Number of participants with ischemic driven target lesion revascularization (ID-TLR) | A composite rate of ischemic driven target lesion revascularization (ID-TLR) | 12 months | 
| Number of participants with stent thrombosis | A composite rate of stent thrombosis | 12 months |