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

Not Applicable

Recruiting

• Conditions: Hydrocephalus; Hydrocephalus, Normal Pressure
• Interventions: Device: eShunt Implant

• Registration Number: NCT05250505
• Lead Sponsor: CereVasc Inc

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-22
• Study Start: 2022-03-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10
• Primary Completion: 2023-12
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients 65-85 years old and traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation

2. Patient is able and willing to provide written informed consent

3. History or evidence of gait impairment duration ≥6 months

4. 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:

   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 with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
   3. CSF opening pressure ≥10 cmH2O
   4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12

5. Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC

6. Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC

Exclusion Criteria

1. Unable to walk 10 meters (33 feet) with or without an assistive device
2. Conditions impairing gait that are considered to be unrelated to hydrocephalus
3. Signs or symptoms of obstructive hydrocephalus
4. Active systemic infection or infection detected in CSF
5. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
6. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
7. Occlusion or stenosis of the internal jugular vein
8. Venous distension in the neck on physical exam
9. Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram
10. History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency
11. Stroke or transient ischemic attack within 180 days of eShunt Procedure
12. Presence of a deep vein thrombosis superior to the popliteal vein
13. International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds)
14. Presence of a posterior fossa tumor or mass
15. Life expectancy < 1 year
16. Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
17. Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation
18. Pregnant or planning to become pregnant
19. Unwilling or unable to comply with follow-up requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	eShunt Implant	The Treatment Arm receives the eShunt Implant.

Primary Outcome Measures

Name	Time	Method
Device and/or procedure-related serious adverse events (SAEs)	90 days following eShunt Implant deployment	Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)

Secondary Outcome Measures

Name	Time	Method
Number of participants with abnormal CT findings	90 days following eShunt Implant deployment	Number of participants with abnormal CT findings and descriptive summaries of findings
Change in gait compared to baseline	90, 180 and 365 days following eShunt Implant deployment	Change in gait compared to baseline as measured by the duration in seconds of the Timed Up and Go Test (shorter durations indicate improvement (increased mobility))
Number of participants with abnormal MRI findings	90 days following eShunt Implant deployment	Number of participants with abnormal MRI findings and descriptive summaries of findings
Change in cognitive ability compared to baseline	90, 180 and 365 days following eShunt Implant deployment	Change in cognitive ability compared to baseline as measured by Montreal Cognitive Assessment (MoCA) scores (scores range from 0-30; higher scores indicate improvement (less cognitive disability))
Change in urinary symptoms compared to baseline	90, 180 and 365 days following eShunt Implant deployment	Change in urinary symptoms compared to baseline as measured by the Neurogenic Bladder Symptom Score (NBSS) (scores range from 0-28; lower scores indicate improvement (fewer symptoms))
Change in Modified Rankin Scale compared to baseline	90, 180 and 365 days following eShunt Implant deployment	Change in degree of disability compared to baseline as measured by Modified Rankin Scale (mRS) scores (scores range from 0-6; lower scores indicate improvement (less disability))
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 clinically significant abnormal findings and descriptive summaries of neurological exam finding
Number of participants with adverse events	90, 180 and 365 days following eShunt Implant deployment and at study completion	Tabulation of all adverse events
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 results and descriptive summaries of CBC results
Number of participants with clinically significant abnormal blood chemistry results	90, 180 and 365 days following eShunt Implant deployment	Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results

Trial Locations

Locations (1)

Clínica La Sagrada Familia; 🇦🇷 Buenos Aires, Ciudad A. de Buenos Aires, Argentina