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

NCT ID: NCT02002910

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 421 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-09-30

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associations for Establishment of Evidence in Interventions

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masato Nakamura, M.D

Role: STUDY_CHAIR

Locations

NPO Associations for Establishment of Evidence in Interventions

Minato, Tokyo, Japan

Countries

Japan

Other Identifiers

J-DEFINE

Identifier Type: -

Identifier Source: org_study_id