CClinicalTrials.gg
RecruitingNCT02792075IRIS imagingUpdated Jan 2, 2026

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

An observational study in Coronary Artery Disease, sponsored by Seung-Jung Park. Recruiting at 15 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Seung-Jung Park · Observational

From the registry’s dates

  • Started Jul 2016; still recruiting 10 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary Stenosis
  • Intracoronary Imaging
  • VH-IVUS
  • OCT
  • NIRS
  • gray scale IVUS
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seung-Jung Park is the lead sponsor of 82 studies on the registry; 15 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 intracoronary imaging

Inclusion criteria

  • Patients with intracoronary imaging
  • Written consent

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • VH-IVUS

    Patients with IVUS-derived virtual histology

    Other: 5-year Follow-up

  • OCT

    Patients with Optical coherence tomography

    Other: 5-year Follow-up

  • NIRS

    Patients with Near-infrared spectroscopy

    Other: 5-year Follow-up

  • gray scale IVUS

    Patients with gray-scale IVUS(Intravascular ultrasound)

    Other: 5-year Follow-up

Interventions

  • Other5-year Follow-up
06

What researchers measure

Primary outcomes

  1. Target Vessel Failure

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

    Time frame: 2 years

Secondary outcomes

  1. All-cause death

    Time frame: 5 years

  2. Cardiac death

    Time frame: 5 years

  3. Number of myocardial infarction events

    Q wave myocardial infarction or non Q wave myocardial infarction

    Time frame: 5 years

  4. Composite event of death or myocardial infarction

    Time frame: 5 years

  5. Composite event of cardiac death or myocardial infarction

    Time frame: 5 years

  6. Target Vessel revascularization

    Time frame: 5 years

  7. Target Lesion revascularization

    Time frame: 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;

    Time frame: 5 years

  9. Number of stroke

    Time frame: 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

    Time frame: 7 days

07

Study locations

11 of 15 sites recruiting
  • Asan Medical Center
    Seoul, Songpa-gu 138-736, South Korea
    • Seung-Jung Park, MD · Contact
    • Seung-Jung Park, MD · Principal investigator
    Recruiting
  • Inje University Busan Paik Hospital
    Busan, South Korea
    • Tae-hyun Yang, MD · Contact
    • Tae-hyun Yang, MD · Principal investigator
    Recruiting
  • Soon Chun Hyang University Hospital Cheonan
    Cheonan, South Korea
    • Seung-jin Lee, MD · Contact
    • Seung-jin Lee, MD · Principal investigator
    Recruiting
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
    • Seung-ho Huh, MD · Contact
    • Seung-ho Huh, MD · Principal investigator
    Recruiting
  • Chungnam National University Hospital
    Daejeon, South Korea
    • Jin-ok Jeong, MD · Contact
    • Jin-ok Jeong, MD · Principal investigator
    Recruiting
  • Inje University Ilsan Paik Hospital
    Ilsan, South Korea
    • Sung-yun Lee, MD · Contact
    • Sung-yun Lee, MD · Principal investigator
    Recruiting
  • Gachon University Gil Hospital
    Incheon, South Korea
    Terminated
  • Jeju national university hospital
    Jeju City, South Korea
    • Song-yi Kim, MD · Contact
    • Song-yi Kim, MD · Principal investigator
    Recruiting
  • Pusan National University Hospital
    Pusan, South Korea
    • Jun-hyuck Oh, MD · Contact
    • Jun-hyuck Oh, MD · Principal investigator
    Recruiting
  • Chung-Ang university hospital
    Seoul, South Korea
    • Sang-wook Kim, MD · Contact
    • Sang-wook Kim, MD · Principal investigator
    Recruiting
  • Kangbuk Samsung Hospital
    Seoul, South Korea
    Withdrawn
  • Korea University Guro Hospital
    Seoul, South Korea
    • Seung-Un Na, MD · Contact
    • Seung-Un Na, MD · Principal investigator
    Recruiting
  • Ajou University Hospital
    Suwon, South Korea
    Active, not recruiting
  • Ulsan University Hospital
    Ulsan, South Korea
    Withdrawn
  • Wonju Severance Christian Hospital
    Wŏnju, South Korea
    • Jung-han Yoon, MD · Contact
    • Jung-han Yoon, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — This is not a publicly funded trial.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02792075
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Seung-Jung Park (professor of medicine, Asan Medical Center) — Sponsor-investigator
First posted
Jun 7, 2016
Start date
Jul 2016
Primary completion
Dec 2026 (estimated)
Completion
Jun 2030 (estimated)
Last update
Jan 2, 2026

Study contacts

Seung-jung Park, MD
Contact
sjpark@amc.seoul.kr

Oversight

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

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