Coronary Artery DiseaseNCT05677711
Safety and Efficacy of the Ultimaster Stent
An observational study of Coronary Artery Disease and Drug-eluting Stents, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Drug-eluting Stents
- What is being tested?
- ultimaster
- Type of treatment
- Medical device
- How many people
- 204 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2021to 3 Jan 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Study population: patients treated with Ultimaster® stents
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Drug-eluting Stents
- Being tested
- ultimaster
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultimasterDevice
Subjects who received Ultimaster stent will be included.
| Study group | Role | What they receive |
|---|---|---|
| Ultimaster | Ultimaster stent Receives: Device: ultimaster |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (10)
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
Measured: 12 months
cardiac deaths per year
Number of cardiac death at 1 year
Measured: 12 months
1-year non-cardiac death
Number of 1-year non-cardiac death
Measured: 12 months
1-year target vessel myocardial infarction
Number of 1-year target vascular myocardial infarction
Measured: 12 months
1-year Number of non-target vascular myocardial infarction
Number of 1-year non-target vascular myocardial infarction
Measured: 12 months
ischemia-induced target lesion revascularization in 1 year
Number of 1-year ischemia-induced target lesion revascularization
Measured: 12 months
non-ischemic target lesion revascularization in 1 year
Number of 1-year non-ischemic target lesion revascularization
Measured: 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
Measured: within 24 hours, within 30 days, and late stent thrombosis at 1 year
strokes per year
Number of 1 year ischemic or hemorrhagic stroke
Measured: 12 months
bleeding events per year
Number of 1-year bleeding rate (Bleeding Academic Research Consortium 2-5)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start20 Jul 2021
- Primary completion24 Sep 2024
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Corporation
- Responsible party
- Principal investigator, Deok-Kyu Cho, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677711
- Sponsor's protocol ID
- 9-2021-0152
- Status last verified
- Nov 2025
- First submitted
- 12 Dec 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05677711
- Acronym / sponsor ID
- 9-2021-0152
- Conditions
- Coronary Artery Disease, Drug-eluting Stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Terumo Corporation
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultimaster | – | Device: ultimasterUltimaster stent |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients treated with Ultimaster® stents
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultimasterSubjects who received Ultimaster stent will be included. | Device | Ultimaster |
Primary outcome
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
10 secondary outcomes
Major Cardiac Adverse Events (MACE) in 1 Year
Time frame: 12 months
cardiac deaths per year
Time frame: 12 months
1-year non-cardiac death
Time frame: 12 months
1-year target vessel myocardial infarction
Time frame: 12 months
1-year Number of non-target vascular myocardial infarction
Time frame: 12 months
ischemia-induced target lesion revascularization in 1 year
Time frame: 12 months
non-ischemic target lesion revascularization in 1 year
Time frame: 12 months
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
strokes per year
Time frame: 12 months
bleeding events per year
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Drug-eluting Stents, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target lesion failures (TLF) per 1 year (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.