NCT03611790已完成不适用
The Vesalio Neva VS for the Treatment of Symptomatic Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage (aSAH) (The VITAL Study)
Vesalio19 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年12月19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
- 30
- 试验地点
- 19
- 主要终点
- Procedural Success
研究概览
简要总结
The objective of the study is to assess the safety and probable benefit of the Neva VS device in patients presenting with symptomatic cerebral vasospasm despite maximal medical management following aSAH.
详细描述
This is a prospective, open label, single-arm study. Up to 30 eligible subjects at up to 15 sites will participate in the study. Subjects will be followed up for 30 days post-intervention.
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
- •Age ≥ 18 years.
- •Subarachnoid hemorrhage secondary to ruptured aneurysm.
- •Ruptured aneurysm secured with surgical clipping or endovascular intervention.
- •Digital subtraction angiography (DSA) or CT angiography at the time of aSAH clinical presentation or aSAH intervention with well-visualized intra-cerebral vessels is available for review.
- •Vasospasm in one or more of the following: the internal carotid artery (ICA), basilar, middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory on transcranial Doppler (TCD), and/or CT angiography, and/or clinical signs of symptomatic vasospasm (change in level of consciousness, focal neurological deficit) confirmed by > 50% narrowing in these territories on DSA.
- •Vasospasm despite maximized medical management defined as oral Nimodipine (unless contraindicated), systemic hypertension with SBP greater than 130 mmHg and euvolemia.
- •Target vessel pre-vasospasm diameter ≥ 2 mm and ≤ 4.0 mm.
- •Subject or legal representative is able and willing to give informed consent.
排除标准
- •The presence of an unsecured ruptured aneurysm. Note unsecured unruptured aneurysms remote to the site of treated aSAH are not an exclusionary.
- •Symptoms attributable to other causes (e.g., hydrocephalus, metabolic, infection).
- •Hunt and Hess Grade of 5
- •Large infarct on CT scan defined as ASPECTS 0-
- •Intracranial hemorrhage not caused by aneurysm rupture.
- •History of bleeding disorders.
- •Baseline platelets < 30,
- •International normalized ratio (INR) > 1.
- •Any known contraindications to mechanical dilation of vasospastic vessels including but not limited to:
- •Excessive vessel tortuosity that prevents the placement of the device
- •Evidence of rapidly improving neurological signs of stroke
- •Large territory completed cerebral infarction, edema with mass effect and intra-parenchymal hemorrhage in vascular territory to be treated, or
- •any other vascular anatomic variants or anomalies
- •Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
- •History of severe allergy to contrast medium.
- •Known allergy to NeVa materials (nitinol, stainless steel).
- •Suspected or confirmed septic embolus, or bacterial endocarditis.
- •Septic shock or central nervous system (CNS) infection confirmed via cerebrospinal fluid (CSF) sampling.
- •Known current or recent use of illicit drugs or alcohol abuse.
- •Females who are pregnant or breastfeeding.
- •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 is performed.
结局指标
主要结局
Procedural Success
时间窗: within 30 minutes of completion of procedure
defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory
次要结局
未报告次要终点
研究者
研究点 (19)
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