Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease

Study Overview
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Brief Summary
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This study is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary artery lesion.

Detailed Description
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This trial is a prospective, randomized, open label, two arm designed multi-center trial. When diagnostic coronary angiogram shows that the target lesion is intermediate stenosis, IVUS and/or FFR will be performed in order to decide PCI or defer by 1:1 randomization. The patients would be followed up to 2 years clinically.

Official Title
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Fractional Flow Reserve- And Intra-vascular Ultrasound-Guided Percutaneous Coronary Intervention With Drug-Eluting Stents in Intermediate Coronary Artery Lesion (FAVOR Study)

Conditions
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Coronary Artery Stenosis

Intervention / Treatment
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* Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)
* Device: Pressure wire(Radi Medical Systems)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical indication: Patients with angina or patients with documented silent ischemia Patients who are eligible for intracoronary stenting Age > 18 years old, < 75 years old Angiographic indication: Intermediate coronary artery disease (30-70% diameter stenosis) by visual estimation Reference vessel diameter ≥ 3.0mm by visual estimation Exclusion Criteria: Acute or old myocardial infarction Previous coronary artery bypass graft Left main disease (≥ 50% stenosis) In-stent restenosis lesion Chronic total occlusion Low ejection fraction (< 40 %) Graft vessel lesion History of bleeding diathesis or coagulopathy Limited life-expectancy (less than 1 year) due to combined serious disease Contra-indication to heparin, everolimus Contraindication to aspirin, clopidogrel or cilostazol Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravascular ultrasound<br> | Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)<br>* minimal lumen area on Intravascular ultrasound<br>* Other names: Virtual histology (Volcano);|
| Active Comparator: Fractional flow reserve<br> | Device: Pressure wire(Radi Medical Systems)<br>* Fractional flow reserve measured by pressure wire<br>* Other names: Pressure wire (Radi Medical Systems);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death |  | 1 and 2 years | 
| Myocardial infarction (MI) |  | 1 and 2 years | 
| Composite of cardiac death or myocardial infarction |  | 1 and 2 years | 
| Target vessel revascularization (ischemia- and clinically-driven) |  | 1 and 2 years | 
| Target lesion revascularization (ischemia- and clinically-driven) |  | 1 and 2 years | 
| Stent thrombosis (Academic Research Consortium criteria) |  | 1 and 2 years | 
| In-stent and in-segment late loss on angiographic follow-up |  | 1 year | 
| In-stent and in-segment restenosis rate |  | 1 year | 
| Incidence and angiographic pattern of restenosis |  | 1 year | 
| Canadian Cardiovascular Society Classification status |  | 1 and 2 years | 
| The number of anti-angina medication |  | 1 and 2 years | 
| Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group |  | Baseline (day 0) | 
| Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravascular ultrasound, fractional flow reserve