Coronary Artery Disease
Conditions
Interventions
None listed
Sponsors
NPO Associations for Establishment of Evidence in Interventions
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age>=20 years old. 2. Patient who can understand informed consent of the clinical study and signed the consent. 3. Patient who is adaptable to CAG and/or coronary revascularization 4. 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
Exclusion criteria: 1. Patient with known contraindications to ATP and/or papaverine hydrochloride 2. Target vessel diameter<=2.0mm 3. Lesion with CTO (registration allowed if other branch has stenosis more than 50% in visual judgment) 4. Patient with temporary/permanent artificial pacemaker implantation, left bundle branch block, second-degree and third-degree atrioventricular block. 5. AMI patient 6. Patient who is disqualified for FFR and coronary revascularization by the investigator. 7. Lesion is disqualified for PCI by the investigator. 8. Patient who has critical valvular disease of heart. (moderate or severe AS/AR/MS/MR) 9. Patient with a prior CABG on target vessel. 10. Patient with severe renal dysfunction. (serum creatinine>=2.0mg/dl) 11. Patient on hemodialysis. 12. Body weight>=200kg 13. Patient who needs ventricular assist device to ensure hemodynamic stability (heart rate<50/min, SBP<90mmHg) 14. Patient who expects to live less than 2 years at the registration 15. Patient with contraindications to an antithrombotic therapy or an anticoagulant therapy. 16. Patient who is poor compliance with drug treatment. 17. Patient who is allergic to contrast agent. 18. LVEF>=30% 19. Patient who has the history of PCI with DES in recent 3 months before registration. 20. Patient who has the history of PCI with BMS or POBA in recent 1 year before registration. 21. Patient who has possibility of pregnancy, under breast-feeding and positive pregnancy test in 14days prior to the PCI. 22. Patients with inadequacy to join this clinical study. 23. Patient who has been enrolled any other clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary outcome of medical economy The cost-effectiveness of iFR/FFR hybrid strategy 2. Primary outcome of physiological assessment Alteration in treatment protocol Change in SYNTAX score | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
J-DEFINE support center Soiken Inc.
Outcome results
None listed