NCT04562194招募中不适用
NEVA ONE One-Pass Reperfusion With the NeVa Stent-Retriever EMEA Registry
Vesalio3 个研究点 分布在 3 个国家目标入组 600 人开始时间: 2020年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- First Pass Success Rate
研究概览
简要总结
A prospective, open label study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.
详细描述
This is a prospective, open label, multi-center registry designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 600 subjects will be enrolled at up 30 sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.
- •NIHSS score ≥ 6
- •Pre-stroke mRS score ≤ 1
- •Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA.
- •Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well [TLKW])
- •Imaging Inclusion Criteria:
- •The patient should have confirmed LVO and salvageable penumbra. Any automated software for determine the volume of viable tissue is acceptable. patient selection should follow the following guidelines:
- •ASPECTS 6-10 if treatment started 0-6 hours from TLKW
- •ASPECTS 8-10 if treatment started 6-24 hours from TLKW
- •Ischemic core ≤ 50 cc
- •Subject or legal representative is able and willing to give informed consent within 72 hours after the intervention (may use independent physician consent in this timeframe and gain subject or legal representative consent later than 72 hours).
排除标准
- •Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
- •Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre- treatment pulmonary aspiration.
- •Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
- •Cerebral vasculitis
- •History of severe allergy to contrast medium.
- •Known allergy to NeVa materials (nitinol, stainless steel)
- •Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
- •Systemic infection
- •Significant mass effect with midline shift
- •Evidence of intracranial tumor (except small meningioma)
- •Inability to deploy NeVA device for at least one pass for any other reason
- •Life expectancy less than 6 months
- •Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
结局指标
主要结局
First Pass Success Rate
时间窗: post-procedure day 0
The primary study endpoint is the first pass success rate with the NeVa device defined as eTICI score ≥ 2B \& eTICI ≥2C
次要结局
未报告次要终点
研究者
研究点 (3)
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