NCT03311360已完成不适用
Chinese Society of Interventional Radiology
Chinese Society of Interventional Radiology9 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2018年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 9
- 主要终点
- Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months
研究概览
简要总结
There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.
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
- •aged between 18 and 80 years old;
- •TIA or non-disabling ischaemic stroke of the posterior circulation;
- •symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication
- •stenosis of the vertebral artery of 50% or greater, diagnosed by both CT angiography or angiography;
- •score on the modified Rankin scale ≤ 3.
排除标准
- •Active bleeding or coagulation disorders or severe renal/liver impairment
- •allergy to iodinated contrast agent or related medicines;
- •acute stroke in 3 weeks
- •more than 1 stenosis at the target vessel or Distal vascular dysplasia (diameter≤3mm)
- •a potential cause of stenosis other than atherosclerosis
- •Severe stenosis was found in the anterior circulation artery(>70%)
- •intracranial hemorrhage or hemorrhagic stroke, intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm in 30 days;
- •ISR patients;
- •Severe calcification lesion；
- •obvious thrombosis in vessel;
- •a potential cause of TIA or minor stroke other than stenosis in a vertebral artery.
结局指标
主要结局
Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months
时间窗: 12 months
vascular death,non-fatal myocardial and non-fatal stroke diagnosed by specialist physician
次要结局
- Incidence of safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke in 30 days(30 days)
- restenosis at 12 months(12 months)
- stent fracture rate at 12 months(12 months)
- lumen loss at 12 months(12 months)
- lumen loss at 6 months(6 months)
- traget lesion revascularizition at 12 months(12 months)
- restenosis at 6 months(6 months)
研究者
研究点 (9)
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