NCT01740895已完成不适用
A Prospective, Observational, Non-randomized, Double Blind, Global, Multi-center Registry With an Adaptive Design, Investigating the Diagnostic Utility of Instantaneous Wave-free Ratio™ (iFR®) in Assessing Coronary Stenosis Relevance.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 818
- 试验地点
- 44
- 主要终点
- Hemodynamic Severity
研究概览
简要总结
To assess the clinical value of iFR to characterize, without concomitant administration of hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as determined with fractional flow reserve (FFR)
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patient must be > 18 and < 85 years of age
- •Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- •Eligible for coronary angiography and/or percutaneous coronary intervention
- •Coronary artery disease with at least 1 or more visually assessed coronary stenoses (>40% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.
- •Stable angina or acute coronary syndromes (non-culprit vessels only and outside of primary intervention during acute myocardial infarction)
排除标准
- •- Known contraindication to adenosine administration
- •Implanted temporary or permanent artificial pacemakers, Left Bundle Branch Block (LBBB), 1st and 2nd degree AV Block
- •STEMI or non STEMI within 48 hours of procedure
- •Any contraindications for FFR interrogation or percutaneous coronary intervention (PCI) as determined by the investigator
- •Severe vessel tortuosity and/or severe calcification by angiogram
- •Significant valvular pathology (moderate or severe AS/AR/MS/MR)
- •Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
- •Weight >200kg (441 lbs.)
- •Hemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg) balloon pump
- •Significant hepatic disease, renal disease, lung disease (pulmonary chronic pulmonary obstructive disease) and/or malignant disease with unfavorable prognosis or presenting with abnormal serum laboratory values that the physician believes is clinically significant
- •Contraindication to antithrombotic regimen or anticoagulation therapy
- •History of or known reaction or sensitivity to contrast agent and is unable to be pre-medicated
- •Left main stenosis, tandem stenosis separated by more than 5 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis), or total occlusions
- •Known Left ventricular ejection fraction (LVEF) <30%
结局指标
主要结局
Hemodynamic Severity
时间窗: at the time of study procedure- 1 day
Percentage of stenosis properly classified in terms of hemodynamic severity by iFR values ≤0.85 and ≥0.94. Hemodynamic severity will be established with an FFR value ≤ 0.80.
次要结局
- Specificity(at the time of study procedure- 1 day)
研究者
研究点 (44)
Loading locations...
相似试验
Unknown
不适用
A Prospective Evaluation of Clinical Impact of Physiology Versus Optical Coherence Tomography Guided PCI in STEMI Patients Without Undergoing Primary PCIST Elevation Myocardial InfarctionNCT04996277CCRF Inc., Beijing, China300
招募中
不适用
Evaluation of Nano Bioactive Glass Combined With i-PRF Scaffold in Vital Pulp TreatmentsPulpitis - IrreversibleApical PeriodontitisNCT05902936Cairo University30
终止
不适用
Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart FailureHeart FailureNCT02698241Medtronic Cardiac Rhythm and Heart Failure79
撤回
3 期
Fresh-Frozen Plasma Infusions to Reduce Risk of Bleeding Related to Invasive ProceduresBlood Coagulation DisordersNCT00233246Massachusetts General Hospital
已完成
不适用
Observational study for clinical importance of fractional flow reserve in patients with organic coronary stenosis and vasospastic anginaAngina pectorisJPRN-UMIN000040342Tohoku University236