AzTrials
AzTrials

Coronary Artery DiseaseIRIS imagingNCT02792075

Prognosis of Coronary Stenosis Based on Intracoronary Imaging; A Multicenter, Prospective Observational Study

An observational study of Coronary Artery Disease, run by Seung-Jung Park at 15 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the prognosis of coronary stenosis based on intracoronary Imaging. 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?
5-year Follow-up
How many people
4,000 participants
Where
15 sitesSouth Korea
Study dates
Jul 2016to Jun 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 intracoronary imaging

Who may be able to join

  • Patients with intracoronary imaging
  • Written consent

Who cannot join

  • Severe calcification and/or severe tortuosity
  • Lesion with previous bypass graft surgery (CABG)
  • Left ventricular ejection fraction less than 30 %
  • Coronary spasm
  • Life expectancy less than 2 years
  • Pregnancy or breast-feeding

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Seung-jung Park, MD contact

sjpark@amc.seoul.kr

15 sites in 1 country

South Korea15 sites, 11 recruiting

  • Inje University Busan Paik Hospital

    Busan

    Tae-hyun Yang, MD

    Tae-hyun Yang, MD

    Recruiting

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan

    Seung-jin Lee, MD

    Seung-jin Lee, MD

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Seung-ho Huh, MD

    Seung-ho Huh, MD

    Recruiting

  • Chungnam National University Hospital

    Daejeon

    Jin-ok Jeong, MD

    Jin-ok Jeong, MD

    Recruiting

  • Inje University Ilsan Paik Hospital

    Ilsan

    Sung-yun Lee, MD

    Sung-yun Lee, MD

    Recruiting

  • Gachon University Gil Hospital

    Incheon

    Terminated

  • Jeju national university hospital

    Jeju City

    Song-yi Kim, MD

    Song-yi Kim, MD

    Recruiting

  • Pusan National University Hospital

    Pusan

    Jun-hyuck Oh, MD

    Jun-hyuck Oh, MD

    Recruiting

  • Asan Medical Center

    Seoul, Songpa-gu, 138-736

    Seung-Jung Park, MD

    Seung-Jung Park, MD

    Recruiting

  • Chung-Ang university hospital

    Seoul

    Sang-wook Kim, MD

    Sang-wook Kim, MD

    Recruiting

  • Kangbuk Samsung Hospital

    Seoul

    Withdrawn

  • Korea University Guro Hospital

    Seoul

    Seung-Un Na, MD

    Seung-Un Na, MD

    Recruiting

  • Ajou University Hospital

    Suwon

    Active, not recruiting

  • Ulsan University Hospital

    Ulsan

    Withdrawn

  • Wonju Severance Christian Hospital

    Wŏnju

    Jung-han Yoon, MD

    Jung-han Yoon, MD

    Recruiting

Other trials in South Korea

About this study

The purpose of this study is to evaluate the prognosis of coronary stenosis based on intracoronary Imaging.

Being tested
5-year Follow-up
Keywords
Coronary Stenosis, Intracoronary Imaging, VH-IVUS, OCT, NIRS, gray scale IVUS
Medical subject headings
Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-year Follow-upOther

Study groups in NCT02792075
Study groupRoleWhat they receive
VH-IVUSPatients with IVUS-derived virtual histology
Receives: Other: 5-year Follow-up
OCTPatients with Optical coherence tomography
Receives: Other: 5-year Follow-up
NIRSPatients with Near-infrared spectroscopy
Receives: Other: 5-year Follow-up
gray scale IVUSPatients with gray-scale IVUS(Intravascular ultrasound)
Receives: Other: 5-year Follow-up

What is being measured

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

  1. Target Vessel Failure

    defined as composite event of cardiac death, non-fatal myocardiac infarction, target vessel revascularization

    Measured: 2 years

Secondary outcomes (10)

  1. All-cause death

    Measured: 5 years

  2. Cardiac death

    Measured: 5 years

  3. Number of myocardial infarction events

    Q wave myocardial infarction or non Q wave myocardial infarction

    Measured: 5 years

  4. Composite event of death or myocardial infarction

    Measured: 5 years

  5. Composite event of cardiac death or myocardial infarction

    Measured: 5 years

  6. Target Vessel revascularization

    Measured: 5 years

  7. Target Lesion revascularization

    Measured: 5 years

  8. Number of stent thrombosis events

    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: 5 years

  9. Number of stroke

    Measured: 5 years

  10. Procedural success

    Defined as mean lesion diameter stenosis less than 30% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death

    Measured: 7 days

Timeline

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

  1. First posted7 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2030 (estimated)

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
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02792075
Sponsor's protocol ID
AMCCV2016-09
Acronym
IRIS imaging
Status last verified
Dec 2025
First submitted
2 Jun 2016
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is not a publicly funded trial.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Seung-Jung Park 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seung-jung Park, MD (sjpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Vessel Failure (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02792075.

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 2 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in