An Observational Study of the Q Aspiration Catheter Used During Neurointervention for Acute Large Vessel Ischemic Stroke in Spain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Symptomatic Intracranial Haemorrhage Rate
研究概览
简要总结
The purpose of this study is to collect real-world safety and performance data on the MIVI Neuroscience, Inc. Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke.
详细描述
The purpose of this study is to demonstrate the safety and performance of the MIVI Neuroscience, Inc. CE Marked Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke. The study is an observational study collecting Q Aspiration Catheter use that will enroll a maximum of 50 subjects at a maximum of 5 sites in Spain. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit. This study is designed for observational data to be collected and reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age 18 to 85 years;
- •Diagnosis of acute ischemic stroke with mechanical thrombectomy procedure < 8 hours from onset of symptoms/ last known well;
- •Large Vessel Occlusion on CT or MRI in the anterior cerebral vasculature up to A1, M1, or M2 or the posterior cerebral vasculature;
- •ASPECTS 6 - 10 or volume of diffusion restriction < 50 mL;
- •Use of the Q Aspiration Catheter as the first line treatment according to the IFU;
- •Signed informed consent by patient or legally authorized representative.
排除标准
- •Occlusions in multiple vascular territories, extracranial occlusion or tandem occlusion;
- •Evidence of dissection in the carotid or target artery for treatment;
- •Evidence of recent/fresh haemorrhage on presentation;
- •Unwilling to agree to a 3-month follow up visit.
结局指标
主要结局
Symptomatic Intracranial Haemorrhage Rate
时间窗: 24 hours post procedure
Defined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of \>/= 4 points
Successful Revascularization Rate
时间窗: intra-procedural
Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel
次要结局
- Rate of Embolization to a New Neurovascular Territory (ENT)(intra-procedural)
- Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2(90 days)
- Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device(intra-procedural)
- Mortality Rate(90 days)