A Comparative Study of The Efficacy and Safety of Direct Mechanical Thrombectomy Versus Bridging Therapy in Large Vessel Occlusion: An Egyptian Single-Center Experience
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Complication rate
研究概览
简要总结
This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt.
详细描述
This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt. In the first arm, 17 patients were recruited and underwent direct mechanical thrombectomy without receiving recombinant tissue plasminogen activator. In the bridging therapy arm, 34 patients received first tissue plasminogen activator then underwent direct mechanical thrombectomy. The efficacy was evaluated by the NIHSS improvement 24 hours following stroke onset and the modified Rankin scale 3 months following stroke. Safety was assessed by the procedural complications rate especially the hemorhagic transformation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with anterior ischemic stroke due to large vessel occlusion.
- •A previous autonomous modified Rankin Scale (mRS) of less than
- •A National Institutes of Health Stroke Scale (NIHSS)≥4
- •A groin puncture within 4.5 hours of the neurological deficit onset.
排除标准
- •Imaging documentation of intracranial haemorrhage
- •A premorbid mRS score of 2 or more
- •Absence of diffusion perfusion mismatch in CT perfusion.
研究组 & 干预措施
Direct mechanical thrombectomy
Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator.
干预措施: Trevo and or Merci devices for stent retreival (Device)
Direct mechanical thrombectomy
Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator.
干预措施: Penumbra system for stent aspiration (Device)
Bridging therapy
Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg
干预措施: Trevo and or Merci devices for stent retreival (Device)
Bridging therapy
Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg
干预措施: Penumbra system for stent aspiration (Device)
Bridging therapy
Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg
干预措施: recombinant tissue plasminogen activator (Drug)
结局指标
主要结局
Complication rate
时间窗: within one week postoperatively
The rate and type of complications occuring postoperatively
Modified Rankin Scale score
时间窗: 3 months
A measurement of functional independence following ischemic stroke
次要结局
- The National Institutes of Health Stroke Scale (NIHSS) score(at 24 hours postoperatively)
研究者
Mohamed Anwar
Principal Investigator
Alexandria University