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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02792075
Acronym
IRIS imaging
Enrollment
4000
Registered
2016-06-07
Start date
2016-07-31
Completion date
2030-06-30
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary Stenosis, Intracoronary Imaging, VH-IVUS, OCT, NIRS, gray scale IVUS

Brief summary

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

Interventions

OTHER5-year Follow-up

Sponsors

CardioVascular Research Foundation, Korea
CollaboratorOTHER
Seung-Jung Park
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Target Vessel Failure2 yearsdefined as composite event of cardiac death, non-fatal myocardiac infarction, target vessel revascularization

Secondary

MeasureTime frameDescription
Cardiac death5 years
Number of myocardial infarction events5 yearsQ wave myocardial infarction or non Q wave myocardial infarction
Composite event of death or myocardial infarction5 years
Composite event of cardiac death or myocardial infarction5 years
All-cause death5 years
Target Lesion revascularization5 years
Number of stent thrombosis events5 yearsDEFINITE 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;
Number of stroke5 years
Procedural success7 daysDefined as mean lesion diameter stenosis less than 30% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
Target Vessel revascularization5 years

Countries

South Korea

Contacts

Primary ContactSeung-jung Park, MD
sjpark@amc.seoul.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026