NCT04466033已完成不适用
Evaluation of the Safety and Performance of Magneto Microcatheter for Endovascular Thrombectomy in Patients With Acute Ischemic Stroke
Magneto Thrombectomy Solutions3 个研究点 分布在 2 个国家目标入组 4 人开始时间: 2020年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure
研究概览
简要总结
A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Microcatheter in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs consistent with acute ischemic stroke
- •Patient with Acute Ischemic Stroke within 24 hours from symptoms o
- •Age 18-85 years old
- •Consent process is completed per international and local regulations
排除标准
- •Known use of cocaine or other vasoactive substance
- •Known bleeding diathesis
- •Any known hemorrhagic or coagulation deficiency.
- •Current use of oral anticoagulants with International Normalized Ratio (INR) > 3;
- •PTT (Partial Thromboplastin Time)>2 at screening
- •Uncontrolled hypertension (Systolic blood pressure>185 or Diastolic blood pressure>110) refractory to pharmacological management
- •Pregnant or lactating female
- •CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score<6, mass effect and/or intracranial tumor
- •Angiographic evidence of either carotid dissection or vasculitis at the target site or any condition that may limit device access to the target site (i.e high grade stenosis) per the treating physician's discretion.
结局指标
主要结局
Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure
时间窗: 24 hours
Occurrence of device related Serious Adverse Events
次要结局
- Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure(90 days)
- Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use(During Procedure)
研究者
研究点 (3)
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