NCT03890380终止不适用
Safety and Performance Evaluation of the Magneto Wire
Magneto Thrombectomy Solutions1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2018年12月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Safety Assessment
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 Wire 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
- •Acute ischemic stroke within defined timelines.
- •Age 18-85 years old
- •NIHSS ≥ 8
- •No significant pre-stroke functional disability (mRS ≤ 1)
排除标准
- •Life expectancy of less than 90 days
- •Neurological signs that are rapidly improving prior to or at time of treatment
- •NIHSS≥30 or state of coma
- •Ongoing seizure
- •Current use of cocaine or other vasoactive substance
- •Known bleeding diathesis
- •Known hemorrhagic or coagulation deficiency
- •Evidence of active systemic infection
- •Current use of oral anticoagulants INR > 3
- •Administration of heparin or Novel Oral Anticoagulants within 48 hours preceding the onset of stroke and have an abnormal aPTT at presentation
- •Platelet count < 50,000/mm3
- •Glucose <50 mg/dL (2.8 mmol, 2.6mM)
- •Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management
- •Known hypersensitivity or allergy to radiographic contrast agents
- •Pregnancy or lactating female
- •Subject already enrolled in a clinical study involving experimental medication or device
- •CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score<6, mass effect and/or intracranial tumor.
- •Angiographic evidence of carotid dissection, or high grade stenosis that will prevent access to the clot, or cerebral vasculitis, or intracranial stenosis
- •Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
- •Angiographic evidence of carotid dissection, complete cervical carotid occlusions or vasculitis.
结局指标
主要结局
Safety Assessment
时间窗: 24 (±8) hours post procedure
Occurrence of Device-related Serious Adverse Events (SAEs)
次要结局
- Safety Assessment(90 (±10) days)
- Distal Embolism(immediate)
- Revascularization(immediate)
- National Institutes of Health Stroke Scale (NIHSS)(24 (±8) hours post procedure)
- Modified Rankin Scale(90 (±10) days)
研究者
研究点 (1)
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