Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study （OCIN-AIS-EVT REGISTRY）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Functional outcome
研究概览
简要总结
A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.
详细描述
The OCIN-AIS-EVT REGISTRY is a prospective, multicenter, blinded outcome evaluation, observational trial, and aims to determine the functional outcomes and safety of endovascular treatment for AIS, due to vessel occlusion in anterior and posterior circulation, in routine clinical practice.
The primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke caused by anterior or posterior circulation vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
- •Undergo intravascular therapy (i.e. access to a cath lab and an arterial puncture)
- •The patient or his/her legal representative agreed to participate in the study and has signed the informed consent.
排除标准
- •No exclusion criteria
结局指标
主要结局
Functional outcome
时间窗: 90days
Shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days). The value range 0-6: higher scores mean a worse outcome.
次要结局
- Dichotomized modified Rankin scale (mRS)(90days)
- NIHSS at 24 hours(24 hours post-procedure)
- NIHSS at 7 days(7 days post procedure)
- Target vessel recanalization rate(at 7 days post-procedure)
- Reperfusion outcome(Immediately post-procedure)
- Early successful revascularization rate(During procedure)
研究者
Jian-min Liu
Director of Cerebrovascular Disease Center
Changhai Hospital