NCT04973332已完成不适用
A Prospective, Multicenter, Randomized Controlled, Non-inferiority Study to Investigate the Effectiveness and Safety of Intracranial Embolization Stents for Endovascular Treatment of Acute Ischemic Stroke
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 15
- 主要终点
- Success rate of immediate recanalization
研究概览
简要总结
A prospective, multicenter, randomized controlled, non-inferiority study to investigate the effectiveness and safety of SINOMED SR for endovascular treatment of acute ischemic stroke
详细描述
This is a multicenter, prospective, randomized, 1:1, controlled trial with blinded outcome assessment assessing non-inferiority of SINOMED SR compared to Solitaire FR. The trial aims to randomize 220 patients 1:1 to receive SINOMED SR or Solitaire FR.The primary outcome is the Success rate of immediate recanalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Success rate of immediate recanalization
时间窗: Within 24 hours post-procedure
The criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade
次要结局
- The incidence of symptomatic intracranial hemorrhage within 24 h post-procedure(within 24 hours post-procedure)
- Incidence of AE (adverse events)(intra-operative, 24 hours, 7 days and 90 days post-procedure)
- mRS 0-2 ratio(pre-procedure, and 90 days post-procedure)
- The time from femoral artery puncture to vascular recanalization or the end time of surgery for patients with no vascular recanalization(intra-operative)
- Success rate of instrument operation(intra-operative)
- Incidence of SAE (serious adverse events)(intra-operative, 24 hours, 7 days and 90 days post-procedure)
- The NIHSS score decreased the rate of subjects with > 4 points(pre-procedure, 24 hours and 7 days post-procedure)
- Mortality within 90 days(within 90 days)
- Incidence of device defects(intra-operative)
研究者
研究点 (15)
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