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CompletedNCT02719106IRISUltimasterUpdated Dec 29, 2025

IRIS Ultimaster Cohort in the IRIS-DES Registry

An observational study in Coronary Artery Disease, sponsored by Duk-Woo Park, MD. Completed at 15 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by Duk-Woo Park, MD · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • real world data
  • percutaneous coronary intervention
  • drug eluting stent
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's enrollment of 1,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Duk-Woo Park, MD is the lead sponsor of 15 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with Ultimaster stent

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Intervention with Ultimaster stent and other drug eluting stent at the same time
  • of 1year and under
  • Cardiac shock
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Ultimaster stent

    Device: Ultimaster stent

Interventions

  • DeviceUltimaster stent
06

What researchers measure

Primary outcomes

  1. Composite event

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

    Time frame: 1year

Secondary outcomes

  1. All death

    Time frame: 5years

  2. Cardiac death

    Time frame: 5years

  3. Myocardial infarction

    Time frame: 5years

  4. Composite event of death or myocardial infarction

    Time frame: 5years

  5. Composite event of cardiac death or myocardial infarction

    Time frame: 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 %

    Time frame: 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.

    Time frame: 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;

    Time frame: 5years

  9. Stroke

    Time frame: 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

    Time frame: 3days

07

Study locations

15 sites
  • Sejong General hospital
    Bucheon-si, South Korea
  • Gangwon National Univ. Hospital
    Chuncheon, South Korea
  • Daegu Catholic University Medical Center
    Daegu, South Korea
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
  • Gangneung Asan Hospital
    Gangneung, South Korea
  • Inje University Ilsan Paik Hospital
    Ilsan, South Korea
  • Kwangju Christian Hospital
    Kwangju, South Korea
  • Pusan National University Hospital
    Pusan, South Korea
  • Asan Medical Center
    Seoul, South Korea
  • The Catholic Univ. of Korea Seoul St. Mary's hospital
    Seoul, South Korea
  • The Catholic University of Korea St. Paul's Hospital
    Seoul, South Korea
  • The Catholic University of Korea, Yeouido St. Mary's Hospital
    Seoul, South Korea
  • The Catholic University of Korea St. Vincent's Hospital
    Suwon, South Korea
  • Ulsan University Hospital
    Ulsan, South Korea
  • Wonju Severance Christian Hospital
    Wŏnju, South Korea
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2016 to primary completion in Jul 2020, 48 months.

Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's 48 months is close to that.

Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2016
First posted
Mar 25, 2016
StartActual
Jul 20, 2016
Primary completionActual
Jul 24, 2020
CompletionActual
Aug 8, 2024
Last update
Dec 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02719106
Lead sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Duk-Woo Park, MD (Sponsor-investigator, Asan Medical Center) — Sponsor-investigator
First posted
Mar 25, 2016
Start date
Jul 20, 2016
Primary completion
Jul 24, 2020
Completion
Aug 8, 2024
Last update
Dec 29, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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