Pilot Study to Evaluate the CereVasc® eShunt® System

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Brief Title

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

Official Title

Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus

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 Type

Interventional


Primary Outcome

Device and/or procedure-related serious adverse events (SAEs)

Secondary Outcome

 Number of participants with abnormal MRI findings

Condition

Hydrocephalus, Normal Pressure

Intervention

eShunt Implant

Study Arms / Comparison Groups

 Treatment Arm
Description:  The Treatment Arm receives the eShunt Implant.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

30

Start Date

March 10, 2022

Completion Date

April 2027

Primary Completion Date

February 2023

Eligibility Criteria

        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
      

Gender

All

Ages

65 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Pedro Lylyk, MD, 5129947597, [email protected]

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT05250505

Organization ID

CLIN-0012


Responsible Party

Sponsor

Study Sponsor

CereVasc Inc

Collaborators

 AlvaMed, Inc.

Study Sponsor

Pedro Lylyk, MD, Principal Investigator, Clínica La Sagrada Familia


Verification Date

July 2022