Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 421
- 试验地点
- 1
- 主要终点
- Medical economy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Medical economy
时间窗: 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
时间窗: baseline pocedure
Alteration in treatment protocol. Change in SYNTAX score.
次要结局
- correlated analysis(baseline pocedure)
- Incidence of major adverse cardiac and cerebrovascular events(MACCE)(1year after the pocedure)
- evaluation of variance(beseline procedure)