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

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: Active, not recruiting
• Conditions: Normal Pressure Hydrocephalus
• Intervention / Treatment: Device: CereVasc eShunt System; Device: VP Shunt

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: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426B
    • Clínica La Sagrada Familia
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary - Foothills Medical Centre
  • Ontario
    • Toronto, Ontario, Canada, M5C 2W6
      • St. Michael's Hospital
• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center - Jacksonville
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky Research Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Health
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Neurological Institute
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Buffalo, New York, United States, 14203
      • University at Buffalo Neurosurgery
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	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	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

• Sponsor: CereVasc Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Hydrocephalus, Normal Pressure; Surgical Procedures, Operative; Neurosurgical Procedures; Anastomosis, Surgical; Cerebrospinal Fluid Shunts; Ventriculoperitoneal Shunt
• Other Study ID 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