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Completed

NCT Number: NCT05677711

Safety and Efficacy of the Ultimaster Stent

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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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultimaster

Device

Subjects who received Ultimaster stent will be included.

Primary outcomes

  1. target lesion failures (TLF) per 1 year

    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

Secondary outcomes

  1. Major Cardiac Adverse Events (MACE) in 1 Year

    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

  2. cardiac deaths per year

    Time frame: 12 months

    Number of cardiac death at 1 year

  3. 1-year non-cardiac death

    Time frame: 12 months

    Number of 1-year non-cardiac death

  4. 1-year target vessel myocardial infarction

    Time frame: 12 months

    Number of 1-year target vascular myocardial infarction

  5. 1-year Number of non-target vascular myocardial infarction

    Time frame: 12 months

    Number of 1-year non-target vascular myocardial infarction

  6. ischemia-induced target lesion revascularization in 1 year

    Time frame: 12 months

    Number of 1-year ischemia-induced target lesion revascularization

  7. non-ischemic target lesion revascularization in 1 year

    Time frame: 12 months

    Number of 1-year non-ischemic target lesion revascularization

  8. acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year

    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

  9. strokes per year

    Time frame: 12 months

    Number of 1 year ischemic or hemorrhagic stroke

  10. bleeding events per year

    Time frame: 12 months

    Number of 1-year bleeding rate (Bleeding Academic Research Consortium 2-5)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Terumo Corporation

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 10, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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