Coronary Artery Disease, Drug-eluting Stents
Conditions
Brief summary
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
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.
Interventions
DEVICEultimaster
Subjects who received Ultimaster stent will be included.
Sponsors
Terumo Corporation
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Inclusion criteria
1. Age 19 or older 2. 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) 3. No restrictions on the number of blood vessels, number of lesions, and length of lesions 4. Those who voluntarily gave written consent to participate in this clinical study
Exclusion criteria
1. Life expectancy within 1 year 2. Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor 3. If other researchers judge that it is inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| target lesion failures (TLF) per 1 year | 12 months | Number of 1-year TLF are defined as combination of cardiac death, target vascular myocardial infarction, and ischemia-induced target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cardiac deaths per year | 12 months | Number of cardiac death at 1 year |
| 1-year non-cardiac death | 12 months | Number of 1-year non-cardiac death |
| 1-year target vessel myocardial infarction | 12 months | Number of 1-year target vascular myocardial infarction |
| 1-year Number of non-target vascular myocardial infarction | 12 months | Number of 1-year non-target vascular myocardial infarction |
| Major Cardiac Adverse Events (MACE) in 1 Year | 12 months | Number of 1-year MACE are defined as combination of summation of death, myocardial infarction, stent thrombosis, composite variable of target lesion revascularization |
| non-ischemic target lesion revascularization in 1 year | 12 months | Number of 1-year non-ischemic target lesion revascularization |
| acute 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 | Number of acute certain or probable stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year |
| strokes per year | 12 months | Number of 1 year ischemic or hemorrhagic stroke |
| bleeding events per year | 12 months | Number of 1-year bleeding rate (Bleeding Academic Research Consortium 2-5) |
| ischemia-induced target lesion revascularization in 1 year | 12 months | Number of 1-year ischemia-induced target lesion revascularization |
Countries
South Korea
Outcome results
None listed