Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR (iLITRO Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 38
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations.
Studies with a limited number of patients have shown that a value of FFR (Fractional Flow Reserve) above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.
详细描述
The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. In the case of intermediate stenoses (25-60%), invasive imaging tests, intravascular ultrasound (IVUS) or optical coherence tomography (OCT) or functional by determining the Fractional Flow Reserve (FFR), have been proposed to identify those patients who could benefit from revascularization.
Studies with a limited number of patients have shown that a value of FFR above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR in assessing the prognosis of patients with intermediate lesions, the validation of the prognostic power of this index in patients with intermediate LMCA lesions has not been demonstrated, although it is used in clinical practice assuming the results in other locations of the lesions.
The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with intermediate lesion in the LMCA (25-60% angiographic stenosis) by visual estimation) in which the realization of a study with guide of pressure for the determination of the iFR.
- •Patients aged ≥18 years.
- •Patients able of giving informed consent.
排除标准
- •Patients with indication for coronary surgery regardless of the significance of the LMCA lesion.
- •Patients with a LMCA lesion presenting with ulceration, dissection or thrombus.
- •Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected).
- •Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA.
- •Patients unable to obtain informed consent.
- •Patients with known terminal illness that conditions a life expectancy less than 1 year.
- •Patients with hemodynamic instability with Killip III or IV class.
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: 5 years
Composite of death, myocardial infarction, unplanned revascularisation
Assessment correlation between FFR>=0.80 and iFR >=0.89
时间窗: 1 day
Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions of the LMCA with a cut-off point to defer the treatment of FFR\> = 0.80 (with intravenous adenosine) and iFR \> = 0.89. the LMCA.
次要结局
- Assessment correlation between iFR and IVUS(5 years)
- Death (cardiovascular)(30 days, 1 and 5 years)
- Myocardial Infarction related to target lesion revascularization(30 days, 1 and 5 years)
- Stent Thrombosis in the target lesion revascularization(30 days, 1 and 5 years)
- Non-fatal Myocardial Infarction(30 days, 1 and 5 years)
- Revascularization of the target lesion(30 days, 1 and 5 years)
- Death (all cause)(30 days, 1 and 5 years)
- New revascularization of the target lesion(30 days, 1 and 5 years)
- Non-fatal Myocardial Infarction related to the LMCA lesion(30 days, 1 and 5 years)
- Revascularization(30 days, 1 and 5 years)
- Restenosis of the stent in target lesion(30 days, 1 and 5 years)