Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions

Study Overview
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Brief Summary
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Recent studies have shown that optimal IVUS criteria defining the functional significance (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate these results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

Detailed Description
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Both physiologic information from fractional flow reserve (FFR) and anatomical information from intravascular ultrasound (IVUS) in assessing intermediate coronary stenotic lesions are useful. Functional significance of a coronary stenosis is determined by both the severity of a stenosis and the amount of myocardium supplied. Therefore, when the functional significance of a lesion is assessed by lumen area measured by IVUS, different criteria should be applied according to lesion location and anatomical variations of the coronary artery. However, previous studies included only patients with proximal lesions or small vessel disease, and the sample sizes were too small to assess these differences. In a recent study, the investigators have shown that optimal IVUS criteria defining the functional significance (FFR < 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate the our results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

Official Title
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Comparison of Fractional Flow Reserve (FFR) and Minimal Luminal Area (MLA) by Intravascular Ultrasound (IVUS) in Evaluating Intermediate Coronary Artery Stenosis: International Multi-center Study

Conditions
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Coronary Artery Stenosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intermediate coronary stenosis by visual estimation Exclusion Criteria: history of coronary artery bypass graft surgery previously revascularized lesion creatinine > 1.6 mg/dL or eGFR < 30 ml/min/1.73m2 pre-procedure per institutional standards known pregnancy contrast agent allergy that cannot be adequately premedicated severe PVD precluding cardiac catheterization patient not a candidate for IVUS and FFR inability or unwillingness to provide informed consent inability or unwillingness to perform required follow up procedures

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| intermediate lesion<br>intermediate lesions evaluated by both IVUS and FFR | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lumen area | lumen area cut-off that can predict functional significance of a lesion | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic stenosis, % plaque area | angiographic and intravascular ultrasound parameters that can best predict the functional significance of lesions | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery stenosis, Fractional flow reserve, Intravascular ultrasonography