Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Device and/or procedure-related serious adverse events (SAEs)
研究概览
简要总结
The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure. The eShunt Implant is designed to mimic the function of the arachnoid granulations by draining excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
详细描述
This is a prospective, non-randomized, open-label, single-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional CSF shunt implant is indicated.
Up to 30 subjects will receive the eShunt Implant at one investigational site. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months for five years post-implantation.
The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a small sample of patients.
Subjects will be followed long-term; primary analysis results will be used to support additional studies.
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 65-85 years old and traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation
- •Patient is able and willing to provide written informed consent
- •History or evidence of gait impairment duration ≥6 months
- •Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with:
- •Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans Index >0.3) and the absence of severe hippocampal atrophy
- •Pre-procedure spinal tap test with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
- •CSF opening pressure ≥10 cmH2O
- •Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
- •Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by 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
- •Unable to walk 10 meters (33 feet) with or without an assistive device
- •Conditions impairing gait that are considered to be unrelated to hydrocephalus
- •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
- •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
- •Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation
- •Pregnant or planning to become pregnant
- •Unwilling or unable to comply with follow-up requirements
研究组 & 干预措施
Treatment Arm
The Treatment Arm receives the eShunt Implant.
干预措施: eShunt Implant (Device)
结局指标
主要结局
Device and/or procedure-related serious adverse events (SAEs)
时间窗: 90 days following eShunt Implant deployment
Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)
次要结局
- Number of participants with abnormal CT findings(90 days following eShunt Implant deployment)
- Change in gait compared to baseline(90, 180 and 365 days following eShunt Implant deployment)
- Number of participants with abnormal MRI findings(90 days following eShunt Implant deployment)
- Change in cognitive ability compared to baseline(90, 180 and 365 days following eShunt Implant deployment)
- Change in urinary symptoms compared to baseline(90, 180 and 365 days following eShunt Implant deployment)
- Change in Modified Rankin Scale compared to baseline(90, 180 and 365 days following eShunt Implant deployment)
- Number of participants with clinically significant abnormal neurological exam findings(90, 180 and 365 days following eShunt Implant deployment and at study completion)
- Number of participants with adverse events(90, 180 and 365 days following eShunt Implant deployment and at study completion)
- Number of participants with clinically significant abnormal complete blood count (CBC) results(90, 180 and 365 days following eShunt Implant deployment)
- Number of participants with clinically significant abnormal blood chemistry results(90, 180 and 365 days following eShunt Implant deployment)