Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect

Study Overview
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Brief Summary
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To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide change and to analyze the cost-effectiveness of its dual diagnosis. To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.

Official Title
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Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>=20 years old. Patient who can understand informed consent of the clinical study and signed the consent. Patient who is adaptable to CAG and/or coronary revascularization Patient who has evaluated stenotic lesion (stenosis>50% in visual judgment) by CAG at main epicardial vessel and its branch or who suspected to have it. Exclusion Criteria: Patient with known contraindications to Adenosine Triphosphate(ATP) and/or papaverine hydrochloride Target vessel diameter<=2.0mm Lesion with Chronic Total Occlusion(CTO) (registration allowed if other branch has stenosis more than 50% in visual judgment) Patient with temporary/permanent artificial pacemaker implantation, left bundle branch block, second-degree and third-degree atrioventricular block. Acute Myocardial Infarction(AMI) patient Patient who is disqualified for FFR and coronary revascularization by the investigator. Lesion is disqualified for Percutaneous Coronary Intervention(PCI) by the investigator. Patient who has critical valvular disease of heart. (moderate or severe Aortic valve stenosis(AS)/Aortic Regurgitation(AR)/Mitral Stenosis(MS)/Mitral Regurgitation(MR)） Patient with a prior Coronary Artery Bypass Graft(CABG) on target vessel. Patient with severe renal dysfunction. (serum creatinine>=2.0mg/dl) Patient on hemodialysis. Body weight>=200kg Patient who needs ventricular assist device to ensure hemodynamic stability (heart rate<50/min, SBP<90mmHg) Patient who expects to live less than 2 years at the registration Patient with contraindications to an antithrombotic therapy or an anticoagulant therapy. Patient who is poor compliance with drug treatment. Patient who is allergic to contrast agent. Left Ventricular Ejection Fraction(LVEF)>=30% Patient who has the history of PCI with Drug-Eluting Stent(DES) in recent 3 months before registration. Patient who has the history of PCI with Bare Metal Stent(BMS) or Plain Old Balloon Atherectomy(POBA) in recent 1 year before registration. Patient who has possibility of pregnancy, under breast-feeding and positive pregnancy test in 14days prior to the PCI. Patients with inadequacy to join this clinical study. Patient who has been enrolled any other clinical study.

Ages Eligible for Study
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Minimum Age: 20 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical economy | To evaluate the healthcare cost-effectiveness in QALY（Quality Adjusted Life Year）converted by Japanese functional score ; Quality of Life(QOL) questionnaire (EQ-5D) and the cost postulated by CAG strategy with its iFR/FFR hybrid strategy. To collect the healthcare cost related MACCE at the timing of 6 and 12 months FU point. (Included emergency visit) To collect QOL questionnaire (EQ-5D) at the timing of just after the treatment and 12 months follow up point. | 1 year after the procedure | 
| Physiological assessment | Alteration in treatment protocol. Change in SYNTAX score. | baseline pocedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse cardiac and cerebrovascular events(MACCE) | MACCE include all-cause death, cerebrovascular accident(CVA), myocardial infarction(MI), and repeat revascularization. | 1year after the pocedure | 
| correlated analysis | Area under receiver-operating characteristic curve(ROC) Classification agreement between iFR and FFR in this registry, Demonstrated using the area under the receiver-operating characteristic curve(FFR cut-off 0.8 or 0.75). | baseline pocedure | 
| evaluation of variance | Treatment categorization disagreements of iFR and FFR are analyzed by multi-variable analysis processing to calculate Characteristic factors. | beseline procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iFR, FFR, Medical Economy, physiological assessment, SYNTAX score