【ChiCTR-TRC-06000689】Early stent-assisted angioplasty in symptomatic intracranial stenosis (ESASIS)

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基本信息

登记号

ChiCTR-TRC-06000689

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2006-10-13

临床申请受理号

靶点

适应症

Intracranial atherosclerotic disease

试验通俗题目

Early stent-assisted angioplasty in symptomatic intracranial stenosis (ESASIS)

试验专业题目

Early stent-assisted angioplasty in symptomatic intracranial stenosis (ESASIS)

申办单位信息

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联系人邮编

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临床试验信息

试验目的

Early stent-assisted angioplasty in symptomatic intracranial stenosis (ESASIS)

试验分类

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试验类型

随机平行对照

试验分期

Ⅱ期

随机化

RCT

盲法

Open label

试验项目经费来源

Division of Neurology, Department of Medicine and Therapeutics; Prince of Wales Hospital, The Chinese University of Hong Kong; and Vascular and Intervention Radiology Foundation

试验范围

目标入组人数

200

实际入组人数

第一例入组时间

2006-12-01

试验终止时间

2012-12-31

是否属于一致性

入选标准

1)Patient is at least 18 to 80 years of age, inclusive; 2)Acute ischemic stroke (within 4 weeks) attributable to a >70% stenosis of an intracranial artery (i.e. C6/7 internal carotid artery, M1 middle cerebral artery, V4 vertebral artery, or basilar artery) evidenced in DSA; 3)The target intracranial artery has a normal diameter of 2.00 mm to 4.5 mm; and the target area of stenosis is less than or equal to 14 mm in length; 4)A modified Rankin score of <3; 5)Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.；

排除标准

Exclusion Criteria: 1)Any medical condition that would not allow the patient to adhere to the protocol or complete the study; 2)Patients for whom the required medications for the study are contra-indicated; 3)Brain infarct within previous 30 days of enrollment that is of sufficient size (> 5 cms) to be at risk of hemorrhagic conversion during or after stenting; 4)Active peptic ulcer disease, history of intracerebral (parenchymal) hemorrhage, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets <100,000, hematocrit <30, INR >1.5, clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115mm Hg), severe liver impairment (SGOT > 3 x normal, cirrhosis), creatinine > 3.0 (unless on dialysis); 5)Stroke etiology other than intracranial atherosclerosis, such as cardioembolism (atrial fibrillation, prosthetic heart valve, myocardial infarction within 6 weeks, mitral stenosis, intracardiac clot, bacterial endocarditis, or ventricular aneurysm), or a tandem high-grade (>70%) proximal extra-cranial carotid or vertebral stenosis; 6)Non-atherosclerotic intracranial stenosis, such as MoyaMoya disease, fibromuscular dysplasia, vasculitis or dissection; 7)Women who are pregnant or intend to become pregnant during the study; 8)Known intracranial tumor, arterio-venous malformation or aneurysm; 9)Life expectancy less than one year; 10)Previous intracranial stenting of the target artery; 11)Major surgical operation within the past 30 days.；

研究者信息

研究负责人姓名

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试验机构

Division of Neurology, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong

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