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| Name | Class |
|---|---|
| Terumo Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultimaster | Ultimaster stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultimaster | Device | Subjects who received Ultimaster stent will be included. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients treated with Ultimaster® stents
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongin Severance Hospital | Yongin | Gyeonggi-do | 16995 | South Korea |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |