跳至主要内容
临床试验/NCT04973332
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

Sinomed Neurovita Technology Inc.15 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2021年8月8日最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (15)

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