NCT04416659已完成不适用
Flow Arrest Safety and Technical Success With Balloon Guide Catheters
Medtronic Neurovascular Clinical Affairs9 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年1月12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
- 52
- 试验地点
- 9
- 主要终点
- Safety Evaluation
研究概览
简要总结
The objective of this post-market registry is to assess technical efficacy and safety associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures while providing temporary arrest of blood flow.
详细描述
This is a prospective, multi-center, non-randomized observational registry evaluating use of BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Acute ischemic stroke vessel occlusion (ICA, M1 or M2) of the anterior circulation with associated symptoms
- •Adult patient willing to provide Informed Consent
- •Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6
排除标准
- •Posterior circulation stroke
- •Tandem occlusions
- •Cervical carotid stenosis
- •Participating in another clinical trial
结局指标
主要结局
Safety Evaluation
时间窗: Hospital discharge or 7 days
Incidence of device-related adverse events
Performance Evaluation
时间窗: Completion of procedure
Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment
次要结局
未报告次要终点
研究者
研究点 (9)
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