Safety and Efficacy of the Ultimaster Stent

Study Overview
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Brief Summary
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Durable polymer was considered to be the cause of a chronic inflammatory response that leadas to impaired endothelialization of the stent strut and subsequently increases the risk of stent thrombosis. Ultimaster stent (Ultimaster, Terumo Corporation, Tokyo, Japan) are thin strut, silorimus-eluting, biodegradable copolymer to completely degrade over 3-4 months.

Detailed Description
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Drug-eluting stents (DES) significantly improved outcome compared wiht bare-metal stents because of slow-elution of the antiproliferative drug mixed with a polymer coated on the stent surface. However, the polymers used in the first-generation DES were considered to be the cause of a chronic inflammatory response that leadas to impaired endothelialization of the stent strut and subsequently increases the risk of stent thrombosis. One strategy to mitigate this problem is a biodegradable polymer, which dissolves over time and leaves only the metalic struts behind. Ultimaster stent are silorimus-eluting, biodegradable poly DL-lactide-co-caprolactone copolymer (PDLLA+PCL) to completely degrade over 3-4 months and is also made of 80μm thin strut. The aim of the current study is to investigate the efficacy and safety outcomes in patients treated with ultimaster stents in real-world.

Official Title
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A Prospective, Observational Study of the Real World Safety and Effectiveness of the Ultimaster Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions in All-comer Patients (MASTER Trial)

Conditions
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Coronary Artery Disease, Drug-eluting Stents

Intervention / Treatment
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* Device: ultimaster


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 or older Clinical evidence of coronary artery disease, including asymptomatic ischemia, stable angina, and acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction, ST-elevation myocardial infarction) No restrictions on the number of blood vessels, number of lesions, and length of lesions Those who voluntarily gave written consent to participate in this clinical study Exclusion Criteria: Life expectancy within 1 year Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor If other researchers judge that it is inappropriate to participate in this study

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ultimaster<br>Ultimaster stent | Device: ultimaster<br>* Subjects who received Ultimaster stent will be included.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target lesion failures (TLF) per 1 year | Number of 1-year TLF are defined as combination of cardiac death, target vascular myocardial infarction, and ischemia-induced target lesion revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Cardiac Adverse Events (MACE) in 1 Year | Number of 1-year MACE are defined as combination of summation of death, myocardial infarction, stent thrombosis, composite variable of target lesion revascularization | 12 months | 
| cardiac deaths per year | Number of cardiac death at 1 year | 12 months | 
| 1-year non-cardiac death | Number of 1-year non-cardiac death | 12 months | 
| 1-year target vessel myocardial infarction | Number of 1-year target vascular myocardial infarction | 12 months | 
| 1-year Number of non-target vascular myocardial infarction | Number of 1-year non-target vascular myocardial infarction | 12 months | 
| ischemia-induced target lesion revascularization in 1 year | Number of 1-year ischemia-induced target lesion revascularization | 12 months | 
| non-ischemic target lesion revascularization in 1 year | Number of 1-year non-ischemic target lesion revascularization | 12 months | 
| acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year | Number of acute certain or probable stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year | within 24 hours, within 30 days, and late stent thrombosis at 1 year | 
| strokes per year | Number of 1 year ischemic or hemorrhagic stroke | 12 months | 
| bleeding events per year | Number of 1-year bleeding rate (Bleeding Academic Research Consortium 2-5) | 12 months |