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Coronary Artery DiseaseIRISUltimasterNCT02719106

IRIS Ultimaster Cohort in the IRIS-DES Registry

An observational study of Coronary Artery Disease, run by Duk-Woo Park, MD at 15 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the relative effectiveness and safety of Ultimaster stent compared to other drug eluting stents. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Ultimaster stent
Type of treatment
Medical device
How many people
1,000 participants
Where
15 sitesSouth Korea
Study dates
20 Jul 2016to 8 Aug 2024
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
  • No healthy volunteers
  • Adult, Older adult

Study population: patients with Ultimaster stent

Who may be able to join

  • Age 19 and more
  • Intervention with Ultimaster stent
  • Agreed with written informed consent form

Who cannot join

  • Intervention with Ultimaster stent and other drug eluting stent at the same time
  • Life expectancy of 1year and under
  • Cardiac shock

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

South Korea15 sites
  • Sejong General hospital

    Bucheon-si

  • Gangwon National Univ. Hospital

    Chuncheon

  • Daegu Catholic University Medical Center

    Daegu

  • Keimyung University Dongsan Medical Center

    Daegu

  • Gangneung Asan Hospital

    Gangneung

  • Inje University Ilsan Paik Hospital

    Ilsan

  • Kwangju Christian Hospital

    Kwangju

  • Pusan National University Hospital

    Pusan

  • Asan Medical Center

    Seoul

  • The Catholic Univ. of Korea Seoul St. Mary's hospital

    Seoul

  • The Catholic University of Korea St. Paul's Hospital

    Seoul

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon

  • Ulsan University Hospital

    Ulsan

  • Wonju Severance Christian Hospital

    Wŏnju

Other trials in South Korea

About this study

Official title: Evaluation of Effectiveness and Safety of Ultimaster® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

The purpose of this study is to evaluate the relative effectiveness and safety of Ultimaster stent compared to other drug eluting stents.

Being tested
Ultimaster stent
Keywords
real world data, percutaneous coronary intervention, drug eluting stent
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.

  • Ultimaster stentDevice

Study groups in NCT02719106
Study groupRoleWhat they receive
Ultimaster stentNot described
Receives: Device: Ultimaster stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite event

    The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)

    Measured: 1year

Secondary outcomes (10)
  1. All death

    Measured: 5years

  2. Cardiac death

    Measured: 5years

  3. Myocardial infarction

    Measured: 5years

  4. Composite event of death or myocardial infarction

    Measured: 5years

  5. Composite event of cardiac death or myocardial infarction

    Measured: 5years

  6. Target Vessel revascularization

    Defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. Clinical-driven Clinically indicated angiography at follow-up shows a percent diameter stenosis ≥ 50% (core lab QCA assessment) and if one of the following occurs: (1) a positive history of recurrent angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG changes) of during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve). Ischemia-driven if one of followings of above-mentioned symptom (clinical-driven) or sign of ischemia or diameter stenosis ≥ 70 %

    Measured: 5years

  7. Target Lesion revascularization

    Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

    Measured: 5years

  8. Stent thrombosis

    DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: >24 hours to 30 days post; late stent thrombosis: >30 days to 1 year post; Very late stent thrombosis: >1 year post;

    Measured: 5years

  9. Stroke

    Measured: 5years

  10. Procedural success

    Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death

    Measured: 3days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2016 (estimated)
  2. Study start20 Jul 2016
  3. Primary completion24 Jul 2020
  4. Study completion8 Aug 2024

Resources

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
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02719106
Sponsor's protocol ID
AMCCV2016-05
Acronym
IRISUltimaster
Status last verified
Dec 2025
First submitted
21 Mar 2016
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Duk-Woo Park, MD at 15 sites 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 3 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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?

Composite event (time frame: 1year). 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 29 Dec 2025.

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