US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® EShunt® System in the Treatment of Communicating Hydrocephalus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Reduction in ICP
研究概览
简要总结
The purpose of this study will be to evaluate a novel, minimally invasive method of treating hydrocephalus in adults. The eShunt® System includes a proprietary eShunt® Delivery System and the eShunt® Implant, a permanent implant that is deployed in a mildly invasive, neuro-interventional procedure. The eShunt® Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
详细描述
This is a prospective, multi-center, open label, pilot study of the eShunt® System. The study population consists of patients with post-aneurysmal subarachnoid hemorrhage (SAH) treated for increased intracranial pressure (ICP) resulting in symptomatic hydrocephalus using an external ventricular drain (EVD) to facilitate CSF drainage and who cannot be "weaned" from the EVD after the hemorrhagic event.
After completion of the procedure to place the eShunt® device, the ICP will be monitored and recorded for up to 48 hours. Subjects will then return for follow-up visits that include standard neurological evaluations at 30, 60, 90, 180, and 365 days postimplantation; imaging will also be acquired at 30, 90 and 365 days after implant. Subjects will continue to attend follow-up visits every 180 days thereafter until the study is closed or up to 5 years post-implantation.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 21 years old
- •Patient or legally authorized representative is able and willing to provide written informed consent
- •Post-aneurysmal SAH with Hunt and Hess Grades I-IV with EVD in place for at least 7 days with the need for a permanent CSF shunt determined through a failed EVD clamping trial defined as:
- •Post-clamping ICP of > 20 cmH2O for 15 minutes, or
- •Post-clamping ICP > 25 cmH2O for < 15 minutes with patient intolerance to EVD clamping, or
- •Significant radiographic signs of increasing ventriculomegaly, or
- •Neurological decline attributable to ventriculomegaly and requiring CSF diversion
- •Clinical signs and symptoms of communicating hydrocephalus
- •Neurologically stable without evidence of severe vasospasm
- •Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by subject screening committee (SSC)
- •Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC
排除标准
- •Presence of gross blood in CSF
- •Signs or symptoms of obstructive hydrocephalus
- •Active systemic infection or infection detected in CSF
- •Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
- •Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
- •Occlusion or stenosis of the internal jugular vein
- •Venous distension in the neck on physical exam
- •Medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arterial venous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain
- •Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram
- •History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency
- •Stroke or transient ischemic attack within 180 days of eShunt Procedure
- •Presence of a deep vein thrombosis superior to the popliteal vein
- •International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds)
- •Presence of a posterior fossa tumor or mass
- •Life expectancy < 1 year
- •Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
- •Unwilling or unable to comply with follow-up requirements
结局指标
主要结局
Reduction in ICP
时间窗: 24-48 hours after eShunt Implant placement
At 24 to 48 hours after eShunt Implant deployment (with EVD remaining clamped) an ICP measurement that indicates: * ICP below 20 cmH2O with no periods longer than 15 minutes above 20 cmH2O * No episodes of ICP above 25 cmH2O with associated symptoms
次要结局
- Incidence of clinically significant changes in Computed Tomography Imaging (CT/CTA) from baseline.(1 year post procedure)
- Changes in Modified Rankin Scale Scores(1 year post procedure)
- Summary of Adverse Events(90 days post procedure and at study completion)
- Number of subjects requiring conversion to conventional CSF shunt(1 year post procedure)
- Occurrence of Serious Adverse Events(90 days post procedure)
- Number of participants with clinically significant changes in physical and neurologic examination assessments from baseline(1 year post procedure)