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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

• Study Type: Observational
• Enrollment (Actual): 421

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Minato, Tokyo, Japan, 105-0013
      • NPO Associations for Establishment of Evidence in Interventions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient who is adaptable to CAG and/or coronary revascularization

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Associations for Establishment of Evidence in Interventions

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: iFR; FFR; SYNTAX score; Medical Economy; physiological assessment
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: J-DEFINE