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【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

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

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

试验分类

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

试验机构

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

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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