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

May 29, 2026 updated by: CereVasc Inc

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426B
        • Recruiting
        • Clínica La Sagrada Familia
        • Contact:
        • Principal Investigator:
          • Pedro Lylyk, MD
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Recruiting
        • University of Calgary - Foothills Medical Centre
        • Contact:
        • Principal Investigator:
          • Mark G Hamilton, MDCM, FRCSC, FAANS, FCNS
    • Ontario
      • Toronto, Ontario, Canada, M5C 2W6
        • Active, not recruiting
        • St. Michael's Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Active, not recruiting
        • University of Southern California
    • Connecticut
      • New Haven, Connecticut, United States, 06511
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Medical Center - Jacksonville
        • Principal Investigator:
          • Ricardo Hanel, MD, PhD
        • Contact:
      • Tampa, Florida, United States, 33606
        • Active, not recruiting
        • University of South Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Park Ridge, Illinois, United States, 60068
        • Active, not recruiting
        • Advocate Lutheran General Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Active, not recruiting
        • Indiana University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Koji Ebersole, MD
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Active, not recruiting
        • University of Kentucky Research Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Active, not recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Active, not recruiting
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Beth Israel Deaconess Medical Center
    • Michigan
      • West Bloomfield, Michigan, United States, 48322
        • Active, not recruiting
        • Henry Ford Health
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Active, not recruiting
        • Cooper Neurological Institute
    • New York
      • Albany, New York, United States, 12208
        • Active, not recruiting
        • Albany Medical Center
      • Buffalo, New York, United States, 14203
        • Active, not recruiting
        • University at Buffalo Neurosurgery
      • Manhasset, New York, United States, 11030
        • Active, not recruiting
        • Northwell Health
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
        • Principal Investigator:
          • Srikanth Boddu, MD
      • New York, New York, United States, 10016
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Principal Investigator:
          • Yafell Serulle, MD, PhD
        • Contact:
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Icahn School of Medicine at Mount Sinaï
      • Rochester, New York, United States, 14642
        • Active, not recruiting
        • University of Rochester Medical Center
      • The Bronx, New York, United States, 10467
        • Active, not recruiting
        • Montefiore Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Mark Bain, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • Pascal M Jabbour, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Active, not recruiting
        • Rhode Island Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • Active, not recruiting
        • University of Texas Southwestern Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • John Reavey-Cantwell, MD
        • Contact:
          • Mally Jones
          • Phone Number: mallory.jones@vcuhealth.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: eShunt System
Endovascular placement of the eShunt Implant
Device: CereVasc eShunt System

The eShunt System consists of the following components:

  • eShunt Implant
  • eShunt Delivery Catheter and Transfer Tool
  • eShunt Anchor
Other Names:
  • eShunt System
  • eShunt Implant
Active Comparator: VP Shunt
Surgical ventriculo-peritoneal shunt procedure
Device: VP Shunt
Control arm - VP shunt

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint
Time Frame: 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).
6 months
Primary Safety Endpoint
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CereVasc Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLIN 0036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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