NCT01830413Unknown不适用
Stenting for Symtomatic Intracranial Artery Stenosis Registry in China
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2013年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Safety during peri-operation period
研究概览
简要总结
Stenting for systematic Intracranial artery stenosis is challenged recently, especially for safety. This registry is aimed to explore the safety profile during peri-operation period in Stenting procedures for systematic Intracranial artery stenosis in Chinese population in real world.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 year old
- •medical failure patient with systematic Intracranial artery stenosis
- •More than 3 weeks after most recent ischemic stroke
- •Digital Subtraction Angiography(DSA) showed ≥70% stenosis in target intracranial artery
- •Imaging test within 1 week showed bad collateral circulation in target vessel area
- •Diseased vessel diameter≥2mm, length <15mm, distal vessel is normal
排除标准
- •Diffused intracranial stenosis
- •Acute stroke or TIA within 3 weeks
- •Pure penetrating branch stenosis showed by cerebral imaging
- •Non-atherosclerosis pathology for the stenosis
- •Intracranial hemorrhage in target vessel area within 6 weeks; or potential cardiac thrombus source
- •Intracranial tumor, arterial aneurysm or intracranial arteriovenous malformation
- •>50% stenosis in extracranial carotid artery or vertebral artery in operation side; Known contradiction to heparin, aspirin, clopidogrel, anesthesia or contrast; hemoglobin <10g/dl，platelet count <100000
- •Modified Rankin score ≥3 related to target vessel;
- •INR(International Normalized Ratio)>1.5(irreversible），persist hemorrhage risk; life expectancy < 1year
- •Pregnant or beast-feeding
- •Not suitable for endovascular stenting judged by Indication Judgement Committee
结局指标
主要结局
Safety during peri-operation period
时间窗: 30 days after operation
Stroke in target cerebral vessel or death within 30 days after stenting procedure for systematic Intracranial artery stenosis
次要结局
- Any stroke or death(within 1 year)
- Serious adverse event(within 1year)
- Death in 30 days- 1 year after stenting(30 days- 1 year after stenting)
- disabled stroke(within 1year)
- Recurrent stroke in 30days to 1 year after stenting in target vessel area.(30days to 1 year after stenting)
- Successful recanalization rate right after stenting(right after stenting)
- Stent restenosis rate(Within 1 year after stenting)
- Ischemic stroke outside target vessel area(30 days - 1 year after stenting)
- Cerebral haemorrhage(30 days - 1year after)
- Myocardial infarction(within 1 year)
- non-stroke haemorrhage(within 1year)
- National Institutes of Health Stroke Scale score(NIHSS score)(at 30 days and 1 year after stenting)
- Modified Rankin score(mRS)(at 30 days and 1 year after stenting)
- MoCA scale score(at 30 days and 1 year after stenting)
- Life quality scale score(at 1 year after stenting)
研究者
Zhongrong Miao
Doc.
Beijing Tiantan Hospital
研究点 (1)
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