Percutaneous Recanalization in Ischemic Stroke Management in Europe Observational Registry
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 主要终点
- Procedural Efficacy
研究概览
简要总结
To determine the revascularization rate, clinical efficacy and safety of the CE-marked MindFrame System in ischemic stroke patients
详细描述
To determine the revascularization rate, clinical efficacy and safety in a "real-world setting" of the CE-marked MindFrame System in ischemic stroke patients with thrombotic neurovascular occlusions caused by an embolus deemed appropriate for endovascular treatment. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.
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
- •Clinical diagnosis of ischemic stroke for whom the physician has prescribed mechanical thrombectomy as appropriate therapy
排除标准
- •Intracranial hemorrhage
结局指标
主要结局
Procedural Efficacy
时间窗: Immediate postprocedure
The ability of the MindFrame System to restore blood flow by removing thrombus and establishing final Thrombolysis in Cerebral Infarction (TICI) 2b or 3 perfusion
Safety
时间窗: 90 days postprocedure
The rate of device-related serious adverse events
Clinical Efficacy
时间窗: 90 days postprocedure
The rate of modified Rankin Scale (mRS) score 0-2 at 90 days
次要结局
未报告次要终点