NCT02533778暂停不适用
ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Thrombolysis in Cerebral Infarction (TICI) score
研究概览
简要总结
A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.
详细描述
Ischemic stroke patients who are 8-24 hrs from symptom onset without prior mechanical or IV thrombolytic treatment and are screen with CT or MR perfusion imaging showing penumbra and infarction not > 1/3rd the territory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Over 18 years last seen normal between 8 - 24 hours, without prior history of intravenous plasminogen activator (IV t-PA ) or
- •mechanical thrombectomy Vessels - intracranial vertebral artery, basilar artery, intracranial ICA, ICA terminus bifurcation, MCA M1/M2, or
- •ACA NIHSS ≥ 7 MRI DWI/PWI or
- •CTA/P, which demonstrates an area of mismatch ≥ 2/3 rd
- •Signed informed consent
排除标准
- •creat >= 2
- •NIHSS < 7
- •Baseline mRS >= 2
- •infarct > 1/3rd MCA territory
- •competing trials
- •prior IV or IA treatment
研究组 & 干预措施
Interventional mechanical thrombectomy
Experimental
Mechanical thrombectomy with either Penumbra system, TREVO, or Solitaire device for acute stroke symptom onset between 8 - 24 hours
干预措施: mechanical thrombectomy (Device)
结局指标
主要结局
Thrombolysis in Cerebral Infarction (TICI) score
时间窗: 6 months
次要结局
- Modified Rankin Scale(6 months)
- National Institutes of Health Stroke Scale (NIHSS) score(6 months)
- Montreal Cognitive Assessment (MoCA) tool(6 months)
研究者
Patricia Bussinger
MBA CRNP
Abington Memorial Hospital
研究点 (2)
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