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NCT Number: NCT02792075

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center, Seoul, Songpa-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with intracoronary imaging
  • Written consent

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

Treatment and study plan

5-year Follow-up

Other

Primary outcomes

  1. Target Vessel Failure

    Time frame: 2 years

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

Secondary outcomes

  1. All-cause death

    Time frame: 5 years

  2. Cardiac death

    Time frame: 5 years

  3. Number of myocardial infarction events

    Time frame: 5 years

    Q wave myocardial infarction or non Q wave myocardial infarction

  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

    Time frame: 5 years

    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;

  9. Number of stroke

    Time frame: 5 years

  10. Procedural success

    Time frame: 7 days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Seung-jung Park, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Acronym: IRIS imaging

Important dates

Study start
2016
Primary completion
2026
Study completion
2030
First posted
Jun 7, 2016
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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