Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-26

Study Completion Date

2031-01-01

Brief Summary

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Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.

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Detailed Description

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The STRIDE study is a prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.

Conditions

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Normal Pressure Hydrocephalus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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eShunt System

Endovascular placement of the eShunt Implant

Group Type EXPERIMENTAL

CereVasc eShunt System

Intervention Type DEVICE

The eShunt System consists of the following components:

* eShunt Implant
* eShunt Delivery Catheter and Transfer Tool
* eShunt Anchor

VP Shunt

Surgical ventriculo-peritoneal shunt procedure

Group Type ACTIVE_COMPARATOR

VP Shunt

Intervention Type DEVICE

Control arm - VP shunt

Interventions

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CereVasc eShunt System

The eShunt System consists of the following components:

* eShunt Implant
* eShunt Delivery Catheter and Transfer Tool
* eShunt Anchor

Intervention Type DEVICE

VP Shunt

Control arm - VP shunt

Intervention Type DEVICE

Other Intervention Names

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eShunt System eShunt Implant

Eligibility Criteria

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Inclusion Criteria

Each subject must meet the following criteria:

1. Patients ≥60 years old on the day of study informed consent
2. Patient or legally authorized representative is able and willing to provide written informed consent
3. History or evidence of gait impairment with a duration ≥3 months
4. 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:

1. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy,
2. Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%,
3. CSF opening pressure ≥8 cmH2O,
4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
5. Patient is willing and able to attend all scheduled visits and comply with study procedures.
6. 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.

Exclusion Criteria

Each subject may not:

1. Be unable to walk 10 meters (33 feet) with or without an assistive device
2. Be diagnosed with obstructive hydrocephalus
3. Have an active systemic infection or infection detected in CSF
4. Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
5. 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
6. Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
7. Present with venous distension in the neck on physical exam
8. 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
9. Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency
10. Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure
11. Have documented evidence of a deep vein thrombosis superior to the popliteal vein
12. Have intrinsic blood clotting disorder
13. Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure
14. Have presence of a posterior fossa tumor or mass
15. Have a life expectancy \<1 year
16. Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study.
17. Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia
18. Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation
19. Need an intracranial neurosurgical procedure within 180 days of study index procedure
20. Be unwilling or unable to comply with follow-up requirements
21. Have mRS of 0, 5, or 6

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No