Yongin Severance Hospital
Yongin, Gyeonggi-do, 16995, South Korea
NCT Number: NCT05677711
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.
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Notify Me19 year and older
All sexes
Observational
Yongin, Gyeonggi-do, 16995, South Korea
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects who received Ultimaster stent will be included.
Time frame: 12 months
Number of 1-year TLF are defined as combination of cardiac death, target vascular myocardial infarction, and ischemia-induced target lesion revascularization
Time frame: 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
Time frame: 12 months
Number of cardiac death at 1 year
Time frame: 12 months
Number of 1-year non-cardiac death
Time frame: 12 months
Number of 1-year target vascular myocardial infarction
Time frame: 12 months
Number of 1-year non-target vascular myocardial infarction
Time frame: 12 months
Number of 1-year ischemia-induced target lesion revascularization
Time frame: 12 months
Number of 1-year non-ischemic target lesion revascularization
Time frame: 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
Time frame: 12 months
Number of 1 year ischemic or hemorrhagic stroke
Time frame: 12 months
Number of 1-year bleeding rate (Bleeding Academic Research Consortium 2-5)
Yonsei University
Other
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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