NeVa International, MulTi-center, Retrospective cOmparative Stent Retriever Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 5
- 主要终点
- Reperfusion Effectiveness
研究概览
简要总结
To compare safety and effectiveness of NeVa Stent Retriever (SR) to Control SR in the treatment of stroke caused by large vessel occlusion. The main questions it aims to answer are:
How do recanalization rates for NeVa SR compare with those of the Control SR? How does NeVa SR safety compare with Control SR safety?
详细描述
NITRO is a multicenter, retrospective, comparative, non-inferiority, cohort study designed to compare NeVa SR with Control SR for safety and effectiveness when removing thrombus in subjects presenting with acute ischemic stroke (AIS) due to large vessel occlusion (LVO). The objective of the NeVa International, Multi-center, Retrospective Comparative stent retriever (SR) study (NITRO) study is to compare safety and effectiveness of the NeVa SR to commonly used SR with CE-mark, and US FDA clearance, to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion. NITRO aims to collect data describing real-world clinical practices when using SRs according to their indicated use within the indicated population. As such, the eligibility criteria define patients who are diagnosed with AIS and are indicated for endovascular MT aligning to the target population for the proposed device. The present study will include data from subjects treated with either NeVa SR or one of the Control SR. Control SR will include any SR commonly used in thrombectomy trials as first-line strategies and which represent CE-mark, and US FDA cleared stent retrievers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment during the enrollment period
- •Baseline modified Thrombolysis in Cerebral Infarction (mTICI) score ≤ 1
- •Pre-stroke modified Rankin score (mRS) of 0 or 1
- •Internal Carotid Artery (ICA), Middle Cerebral Artery (first segment M1/ second segment M2), basilar artery or vertebral artery occlusion
- •National Institutes of Health Stroke Scale (NIHSS) score ≥ 8 and ≤ 25
- •Thrombectomy procedure initiated within 8h of Time Last Known Well (TLKW)
- •Intravenous Tissue Plasminogen Activator (IV-tPA) failed, given within 3h of TLKW, or ineligibility for thrombolytic drug
排除标准
- •First line contact aspiration alone or non-study device as first-line device
结局指标
主要结局
Reperfusion Effectiveness
时间窗: Procedural
Number of patients with a Modified Thrombolysis in cerebral infarction (mTICI) ≥2B and mTICI≥2C recanalization after 1st pass and at end of procedure
次要结局
- Procedure Safety(Within 24 hours post intervention)
- Device relationship to serious adverse events(Within 24 hours post intervention)
- Procedural symptomatic bleeding events(Within 24 hours post intervention)