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

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

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: 5-year Follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VH-IVUS<br>Patients with IVUS-derived virtual histology | Other: 5-year Follow-up<br> <br> |
| OCT<br>Patients with Optical coherence tomography | Other: 5-year Follow-up<br> <br> |
| NIRS<br>Patients with Near-infrared spectroscopy | Other: 5-year Follow-up<br> <br> |
| gray scale IVUS<br>Patients with gray-scale IVUS(Intravascular ultrasound) | Other: 5-year Follow-up<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure | defined as composite event of cardiac death, non-fatal myocardiac infarction, target vessel revascularization | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 5 years | 
| Cardiac death |  | 5 years | 
| Number of myocardial infarction events | Q wave myocardial infarction or non Q wave myocardial infarction | 5 years | 
| Composite event of death or myocardial infarction |  | 5 years | 
| Composite event of cardiac death or myocardial infarction |  | 5 years | 
| Target Vessel revascularization |  | 5 years | 
| Target Lesion revascularization |  | 5 years | 
| 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; | 5 years | 
| Number of stroke |  | 5 years | 
| 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 | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Stenosis, Intracoronary Imaging, VH-IVUS, OCT, NIRS, gray scale IVUS