Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent

Study Overview
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Brief Summary
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Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent

Detailed Description
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A prospective, open, multicenter, and observational study will register and compare Xience® groups treated in institutions such as the BioMime ™, Ultimaster® group prospectively registered from June 2016. The Xience® group has already been registered in the previous study (SMARTDESK-BX), so BioMimeTM and Ultimaster® only need to be registered. Follow-up will be conducted until December 2019, and e-CRF will be completed by April 2020.

Official Title
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Real World Drug-Eluting Stent Prospective, Open, Multi-site, Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent By SMart Angioplastry Research Team (SMARTDESK-MX)

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Device: BioMimeTM Stent, Ultimaster® Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years old or older Clinical evidence of coronary artery disease including asymptomatic ischemia, stable angina pectoris, acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction, ST segment elevation myocardial infarction). Vessel diameter 2.25   3.5mm, stenosis more than 50% (However, the number of blood vessels, the number of lesions, and the lesion length are not limited) Voluntary written consent to participate in the trial Exclusion Criteria: Within 24 hours before percutaneous coronary intervention, hemodynamic instability or cardiogenic shock Life expectancy within 2 years

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 |
| --- | --- |
| BioMimeTM Stent<br>No intervention / Ischemic heart disease with percutaneous coronary intervention with BioMimeTM Stent | Device: BioMimeTM Stent, Ultimaster® Stent<br> <br> |
| Ultimaster® Stent<br>No intervention / Ischemic heart disease with percutaneous coronary intervention with Ultimaster® stent | Device: BioMimeTM Stent, Ultimaster® Stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of 1-year target lesion failure | The incidence of 1-year target lesion failure (combination of cardiac death, target vessel myocardial infarction, and target vessel revascularization). | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of 30-day and 2-year target lesion failure |  | 30-day and 2-year | 
| Incidence of 30-day, 1-year, and 2-year deaths |  | 30-day, 1-year, and 2-year | 
| Incidence of 30-day, 1-year, and 2-year cardiac events |  | 30-day, 1-year, and 2-year | 
| Incidence of 30-day, 1-year, and 2-year myocardial infarction |  | 30-day, 1-year, and 2-year | 
| Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction |  | 30-day, 1-year, and 2-year | 
| Incidence of 30-day, 1-year, and 2-year revascularization |  | 30-day, 1-year, and 2-year | 
| Incidence of 30-day, 1-year, and 2-year target revascularization |  | 30-day, 1-year, and 2-year | 
| Incidence of 30-day, 1-year, and 2-year stroke |  | 30-day, 1-year, and 2-year | 
| Incidence of acute stent thrombosis at 24 hours, subacute stent thrombosis at 30 days, and stent thrombosis at 1 and 2 years |  | 24 hours, 30 days, 1 and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BioMime, Ultimaster, Ischemic heart disease, DES