NCT05631470已完成不适用
Diagnostic Accuracy for Hemodynamical Intracranial Atherosclerotic Diseases (ICAS) of Magnetic-Resonance-based Fractional Flow Reserve (MR-FFR) Comparing With Pressure-wire-based FFR.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of MR-FFR measurement.
研究概览
简要总结
The aim of this study was to determine the diagnostic accuracy of MR-FFR to detect functionally significant ICAS comparing with pressure-wire-based FFR.
详细描述
This study will perform a head-to-head comparison between MR-FFR and pressure-wire-based FFR in patients with ICAS. Pressure-wire-based FFR will be used as the gold standard for intravascular pressure gradient measurement. The efficacy and safety of non-invasive FFR will be assessed in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 aged 18 years or older.
- •Patients with transient ischemic attack (TIA) or nondisabling ischemic stroke caused by a focal ICAS lesion located in intracranial anterior circulation (intracranial internal carotid artery and their major branches).
- •50% to 99% stenosis (calculated by modified WASID method) of responsible arterial occlusion, confirmed by digital subtraction angiography (DSA).
- •Informed of the study protocol and objectives.
排除标准
- •Non-atherosclerotic MCA stenosis
- •Combined with moderate or severe stenosis of other extracranial and intracranial arteries
- •Previous endovascular treatment or surgery for cerebrovascular diseases
- •Large cerebral infarction (more than 1/2 MCA perfusion area)
- •Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
- •Vascular abnormality or stunting, resulting in the impossibility of endovascular intervention
- •Liver and kidney dysfunction, or severe allergy to the contrast agent
- •Severe coagulation dysfunction
- •Pregnancy or in the preparation for pregnancy
- •Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
- •Patients with severe dementia or mental disorders, who cannot cooperate with examination
结局指标
主要结局
Diagnostic accuracy of MR-FFR measurement.
时间窗: 3 days
The consistency of the two groups in the interpretation of hemodynamic conditions across the ICAS lesion.
次要结局
- The rate of all-cause stroke and mortality.(3 months)
研究者
研究点 (1)
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