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

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02002910
• Lead Sponsor: Associations for Establishment of Evidence in Interventions

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Primary Completion: 2015-11
• Study Completion: 2016-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medical economy	1 year after the procedure	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.
Physiological assessment	baseline pocedure	Alteration in treatment protocol. Change in SYNTAX score.

Secondary Outcome Measures

Name	Time	Method
correlated analysis	baseline pocedure	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).
Incidence of major adverse cardiac and cerebrovascular events(MACCE)	1year after the pocedure	MACCE include all-cause death, cerebrovascular accident(CVA), myocardial infarction(MI), and repeat revascularization.
evaluation of variance	beseline procedure	Treatment categorization disagreements of iFR and FFR are analyzed by multi-variable analysis processing to calculate Characteristic factors.

Trial Locations

Locations (1)

NPO Associations for Establishment of Evidence in Interventions; 🇯🇵 Minato, Tokyo, Japan