NCT06498960进行中（未招募）不适用
Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
CereVasc Inc59 个研究点 分布在 2 个国家目标入组 230 人开始时间: 2024年11月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 230
- 试验地点
- 59
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
详细描述
The STRIDE study is a prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each subject must meet the following criteria:
- •Patients ≥60 years old on the day of study informed consent
- •Patient or legally authorized representative is able and willing to provide written informed consent
- •History or evidence of gait impairment with a duration ≥3 months
- •Clinical presentation consistent with NPH including two or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with all of the following:
- •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 or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%,
- •CSF opening pressure ≥8 cmH2O,
- •Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
- •Patient is willing and able to attend all scheduled visits and comply with study procedures.
- •Confirmation of anatomy suitable for the eShunt procedure, as determined by evaluation of pre-procedure imaging (CT and MRI) and approved by an independent anatomical screening committee.
排除标准
- •Each subject may not:
- •Be unable to walk 10 meters (33 feet) with or without an assistive device
- •Be diagnosed with obstructive hydrocephalus
- •Have an active systemic infection or infection detected in CSF
- •Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
- •Demonstrate hypersensitivity or contraindication to heparin or radiographic contrast agents against which the subject cannot be adequately pre-medicated, desensitized or where no alternative is available
- •Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
- •Present with venous distension in the neck on physical exam
- •Have medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arteriovenous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain
- •Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency
- •Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure
- •Have documented evidence of a deep vein thrombosis superior to the popliteal vein
- •Have intrinsic blood clotting disorder
- •Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure
- •Have presence of a posterior fossa tumor or mass
- •Have a life expectancy <1 year
- •Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study.
- •Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia
- •Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation
- •Need an intracranial neurosurgical procedure within 180 days of study index procedure
- •Be unwilling or unable to comply with follow-up requirements
- •Have mRS of 0, 5, or 6
研究组 & 干预措施
VP Shunt
Active Comparator
Surgical ventriculo-peritoneal shunt procedure
干预措施: VP Shunt (Device)
eShunt System
Experimental
Endovascular placement of the eShunt Implant
干预措施: CereVasc eShunt System (Device)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 6 months
The Primary Effectiveness Endpoint of this study is change in gait impairment at 6-months, compared to baseline. Change in gait impairment is defined as reduction in time required to complete the Timed Up and Go (TUG) test (stand up, walk 3m, turnaround, walk 3m, sit down).
Primary Safety Endpoint
时间窗: 6 months
All adverse events will be reported for the investigational (eShunt System) and control (VP shunt) arms. Safety will be analyzed based on a review of all AEs in the investigational arm compared to the control arm, through 6-months post-procedure to demonstrate an acceptable safety profile of the eShunt System.
次要结局
未报告次要终点
研究者
研究点 (59)
Loading locations...
相似试验
终止
不适用
Multi-Center Traditional Feasibility Study of Radiofrequency DeviceBody FatNCT04584099Cynosure, Inc.12
已完成
不适用
Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile DysfunctionVasculogenic Erectile DysfunctionNCT02005731Initia58
Unknown
4 期
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser Using LASIKMyopiaHyperopiaNCT02071576Technolas Perfect Vision GmbH42
Unknown
4 期
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIKMyopiaHyperopiaPresbyopiaNCT01977807Technolas Perfect Vision GmbH100
终止
不适用
EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for HypertensionHypertensionNCT01903187Abbott Medical Devices4