NCT01877174已完成不适用
MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Percentage of patients with debris captured in the MICHI(TM) inline filter
研究概览
简要总结
This study will be conducted in up to 10 hospitals in Europe, up to 75 patients will be enrolled. The purpose of the study is to evaluate any debris that may be captured in the inline filter of the MICHI(TM) Neuroprotection System with Filter (NPS+f) during its use in a transcarotid stenting procedure. The MICHI NPS+f is an embolic protection device that uses reverse flow to protect the brain during stenting of the Internal Carotid Artery. It is CE marked and is used in routine practice for the purpose of this study.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate central venous access
- •Common carotid artery reference diameter of at least 6 mm
- •Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography
排除标准
- •Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated
- •Patients with unresolved bleeding disorders
- •Patients with severe disease of the ipsilateral common carotid artery
结局指标
主要结局
Percentage of patients with debris captured in the MICHI(TM) inline filter
时间窗: During MICHI(TM) NPS+f procedure
The percentage of patients with any debris captured in the MICHI(TM) inline filter will be calculated
次要结局
- Volume of debris captured in the MICHI(TM) inline filter(During MICHI(TM) NPS+f procedure)
- Histological analysis of debris captured in the MICHI(TM) inline filter(During MICHI(TM) NPS+f procedure)
研究者
研究点 (6)
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