Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

  • STATUS
    Recruiting
  • End date
    Apr 9, 2027
  • participants needed
    30
  • sponsor
    CereVasc Inc
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Updated on 9 April 2022
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Summary

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.

Description

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.

Details
Condition Hydrocephalus, Normal Pressure, Hydrocephalus
Treatment eShunt Implant
Clinical Study IdentifierNCT05250505
SponsorCereVasc Inc
Last Modified on9 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 12-25 (consistent with mild to moderate cognitive dysfunction)
Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described
in Section [1.8.3.4](telnet://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](telnet://1.8.3.4).2 and confirmed by SSC

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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