Endovascular Stenting of Medically Refractory Intracranial Arterial Stenotic (ICAS) Disease (Clinical and Sonographic Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Clinical improvement of IC stented patients in comparison to medically treated
研究概览
简要总结
Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels with Recurrent Ischemic Strokes patients
详细描述
Fifty patients were enrolled with 25 underwent Intracranial Stenting 25 received optimal medicall treatment without stenting and comparative study of primary outcome was conducted
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age between 30-80 years.
- •Symptomatic ICAS: presented with TIA or stroke, attributed to 70%-99% stenosis of a major intracranial artery: Internal carotid artery (ICA), middle cerebral artery (MCA) [M1segment], vertebral artery (VA), or basilar artery (BA).
- •Patient with recurrent TIA or stroke despite medical therapy, including anti-coagulation or antiplatelet and control of all vascular risk factors (DM, HTN and Hyperlipidemia).
排除标准
- •Patients previously stented at the target lesion or had extracranial stenosis.
- •Patient with acute stroke (within two weeks from the onset).
- •Complete occlusion of the artery on the imaging assessment.
- •Massive cerebral infarction (more than half the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI scans.
- •Contraindications to antithrombotic and/or anticoagulant therapies.
研究组 & 干预措施
Intracranial Stenting
25 Patients presented with recurrent Ischemic CVS with Large ICSD received ICS
干预措施: Intracranial Stenting by Intracranial Stent Device (Device)
Aspirin+Clopidogrel
25 Patients presented with recurrent Ischemic CVS with Large ICSD received optimal medical treatment
干预措施: Optimum medical treatment (Drug)
结局指标
主要结局
Clinical improvement of IC stented patients in comparison to medically treated
时间窗: 3 months
clinical assessment by National Institute of Health Stroke Scale (NIHSS) for clinical impr
Functional improvement of IC stented patients in comparison to medically treated
时间窗: 3 months
Functional assessment by modified Rankin Scale (mRS) for functional improvement
Blood flow velocity accrossed Stenotic Large IC Vessels in comparison to medically treated
时间窗: 3 months
Transcranial doppler (TCD) assessment of Mean Flow Velocity (MFV) across IC vessels
次要结局
- No Recurrent Ischemic stroke in stented ICSD patients(6 months)
研究者
Mohamed Ahmed Shafik Abdallah
Clinical professor of Neurology-Faculty of Medicine-ASU
Ain Shams University