NCT00691314已完成不适用
Safety and Efficacy of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Ischemic stroke in the supply area of stent implantation artery
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of stent implantation in patients with symptomatic extra- and intracranial artery stenosis and to determine its role in secondary prevention of ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between above 40 year-old and 75 year-old.
- •Ischemic stroke related to extra- and intracranial atherosclerosis stenosis, transient ischemic attack (TIA ), onset time within 90 days
- •Implantation of stent should be at least 1 week after stroke onset, and patient's medical condition stable, no time limit for TIA,
- •Stenosed ICA or MCA or BA or VA is the candidate arteries for stent implantation.
- •Degree of stenosis of target artery ranges between 51%-99%
- •Modified Rankin score≤3 or NIHSS Score ≤4
- •Informed consent is obtained.
排除标准
- •Patients will be excluded from entry if any of the criteria listed below are met:
- •Target stenosis artery is not suitable for stent implantation after evaluation.
- •Previous carotid endarterectomy or carotid artery stent ,or intracranial artery stent implantation.
- •Ischemic stroke is caused by conditions other than atherosclerosis .
- •Documented non-atherosclerosis angiopathy.
- •Clinically unstable at the time of enrollment,
- •Conditions which may lead to cardiogenic embolism : arterial fibrillation，left ventricular thrombi,Myocardiac infarction within 6 weeks,etc.
- •Severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
- •Severe co-morbid or unstable medical condition, ie，severe heart failure, pulmonary failure or renal failure, liver dysfunction (serum liver enzyme twice or more than normal level),malignancy with likelihood of death within the next 2 years
- •Significant memory or behavioral disorder, ie, Alzheimer disease, etc.daily care needed.
- •Concurrent participation in another clinical trial
- •Unable to return follow up
- •History of hemorrhagic disease(ie, intracranial hemorrhage, Idiopathic Thrombocytopenic Purpura,etc ) or bleeding tendency conditions.
- •Intracranial arteriovenous malformation or aneurysm.
研究组 & 干预措施
1
Experimental
干预措施: Stent implantation (Wingspan, Coroflex, and TiTAN2) (Device)
2
Active Comparator
干预措施: Standard medical treatment (Drug)
结局指标
主要结局
Ischemic stroke in the supply area of stent implantation artery
时间窗: 30 days and 1 year after the procedure
次要结局
- Ischemic stroke in the supply area of non-stent implantation artery(30 days and 1 year after the procedure)
- All-cause death(30 days and 1 year after the procedure)
- Hemorrhagic stroke(30 days and 1 year after the procedure)
- Acute coronary syndrome(30 days and 1 year after the procedure)
- Transient ischemic attack(30 days and 1 year after the procedure)
- Degree of re-stenosis of the stent implantation artery(30 days and 1 year after the procedure)
研究者
研究点 (10)
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