Safety and Efficacy of the Ultimaster Stent
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)
1 other identifier
observational
204
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2021
CompletedFirst Submitted
Initial submission to the registry
December 12, 2022
CompletedFirst Posted
Study publicly available on registry
January 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2025
CompletedNovember 25, 2025
November 1, 2025
3.2 years
December 12, 2022
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Major Cardiac Adverse Events (MACE) in 1 Year
12 months
cardiac deaths per year
12 months
1-year non-cardiac death
12 months
1-year target vessel myocardial infarction
12 months
1-year Number of non-target vascular myocardial infarction
12 months
- +5 more secondary outcomes
Study Arms (1)
Ultimaster
Ultimaster stent
Interventions
Eligibility Criteria
patients treated with Ultimaster® stents
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yonsei Universitylead
- Terumo Corporationcollaborator
Study Sites (1)
Yongin Severance Hospital
Yongin, Gyeonggi-do, 16995, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 12, 2022
First Posted
January 10, 2023
Study Start
July 20, 2021
Primary Completion
September 24, 2024
Study Completion
January 3, 2025
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share