Safety and Utility Profile of the Asahi Chikai Black 18 neuRovascular guidewirE in Large Vessel Occlusive Stroke: SURE 18 Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to clot engagement
研究概览
简要总结
The objective of this study is to obtain post market data on the Asahi Chikai Black 18 neurovascular guidewire in the treatment of intracranial large vessel occlusive stroke. This will be compared to a historical control that will include the prior 50 consecutive patients fitting the same selection criteria.
详细描述
This is a prospective registry collecting information on 50 patients treated with the ASAHI Chikai Black 18 microguidewire. Patients will undergo mechanical thrombectomy for acute large vessel occlusive stroke within the anterior circulation as is standard of care.
Additionally, this study will have a retrospective portion which will examine 50 consecutive patients who meet inclusion/exclusion criteria treated for acute anterior circulation large vessel occlusive stroke prior to the initiation of the Sure -18 Registry. This retrospective cohort will be 50 consecutive mechanical thrombectomy cases performed using any neurovascular microguidewire other than the device under study (Asahi Chikai Black 18) at the same enrolling centers leading up to December 10, 2018.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients presenting with acute anterior cerebral circulation large vessel occlusive stroke
- •ASPECT score 5 or better
- •Occlusion of the ICA terminus and M1 MCA
- •Favorable CT perfusion with clinical/radiologic mismatch
- •Last known well out to 24 hours
- •Age limit >18 years
- •Baseline mRS 0-3
排除标准
- •Intracranial hemorrhage
- •ASPECTS (Alberta stroke program early CT score) <5
- •Unfavorable CT perfusion
- •Baseline mRS 4 or greater
- •Large vessel occlusive stroke with tandem lesion of the cervical internal carotid artery or posterior circulation
结局指标
主要结局
Time to clot engagement
时间窗: 30 days
Time from guide catheter placement within the target ICA to clot engagement
Number of device related serious adverse events
时间窗: Day 1
Safety profile as measured by number of Intra-procedural device related serious adverse events
次要结局
- Change in NIH Stroke Scale (NIHSS)(24 hours)
- Number of neurovascular guidewires required per case(Day 1)
- Modified Rankin Scale (mRS)(90 days post procedure)
研究者
Reade A De Leacy
Assistant Professor of Neurosurgery and Radiology; Director of Neurointerventional Spine
Icahn School of Medicine at Mount Sinai