Normal Pressure HydrocephalusSTRIDENCT06498960
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
A study testing CereVasc eShunt System and VP Shunt in people with Normal Pressure Hydrocephalus, run by CereVasc Inc at 32 sites in 3 countries.
Trial summary
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- CereVasc eShunt System and VP Shunt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 32 sitesin 3 countries
- Study dates
- 26 Nov 2024to Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each subject must meet the following criteria:
- Patients ≥60 years old on the day of study informed consent
- Patient or legally authorized representative is able and willing to provide written informed consent
- History or evidence of gait impairment with a duration ≥3 months
- 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:
- Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index >0.3) and the absence of severe hippocampal atrophy,
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- Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%,
- CSF opening pressure ≥8 cmH2O,
- Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
- Patient is willing and able to attend all scheduled visits and comply with study procedures.
- 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.
Who cannot join
- Each subject may not:
- Be unable to walk 10 meters (33 feet) with or without an assistive device
- Be diagnosed with obstructive hydrocephalus
- Have an active systemic infection or infection detected in CSF
- Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
- 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
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- Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
- Present with venous distension in the neck on physical exam
- 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
- Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency
- Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure
- Have documented evidence of a deep vein thrombosis superior to the popliteal vein
- Have intrinsic blood clotting disorder
- Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure
- Have presence of a posterior fossa tumor or mass
- Have a life expectancy <1 year
- Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study.
- Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia
- Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation
- Need an intracranial neurosurgical procedure within 180 days of study index procedure
- Be unwilling or unable to comply with follow-up requirements
- Have mRS of 0, 5, or 6
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
United States29 sites
Albany Medical Center
Albany, New York, 12208
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University at Buffalo Neurosurgery
Buffalo, New York, 14203
Cooper Neurological Institute
Camden, New Jersey, 08103
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Indiana University
Indianapolis, Indiana, 46202
Baptist Medical Center - Jacksonville
Jacksonville, Florida, 32207
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky Research Foundation
Lexington, Kentucky, 40506
University of Southern California
Los Angeles, California, 90033
Northwell Health
Manhasset, New York, 11030
Yale University
New Haven, Connecticut, 06511
NYU Langone Health
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Weill Cornell Medicine
New York, New York, 10065
Lenox Hill Hospital
New York, New York, 10075
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Rochester Medical Center
Rochester, New York, 14642
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Henry Ford Health
West Bloomfield, Michigan, 48322
Canada2 sites
University of Calgary - Foothills Medical Centre
Calgary, Alberta, T2N 4N1
St. Michael's Hospital
Toronto, Ontario, M5C 2W6
About this study
Official title: 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.
Read the 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.
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- CereVasc eShunt System, VP Shunt
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CereVasc eShunt SystemDevice
Also called eShunt System, eShunt Implant
The eShunt System consists of the following components:
- eShunt Implant
- eShunt Delivery Catheter and Transfer Tool
- eShunt Anchor
VP ShuntDevice
Control arm - VP shunt
| Study group | Role | What they receive |
|---|---|---|
| eShunt System | Experimental | Endovascular placement of the eShunt Implant Receives: Device: CereVasc eShunt System |
| VP Shunt | Active comparator | Surgical ventriculo-peritoneal shunt procedure Receives: Device: VP Shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start26 Nov 2024
- Primary completionJan 2027 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CereVasc Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498960
- Sponsor's protocol ID
- CLIN 0036
- Acronym
- STRIDE
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT06498960
- Acronym / sponsor ID
- STRIDE / CLIN 0036
- Conditions
- Normal Pressure Hydrocephalus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- CereVasc IncIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eShunt System | Experimental | Device: CereVasc eShunt SystemEndovascular placement of the eShunt Implant |
| VP Shunt | Active comparator | Device: VP ShuntSurgical ventriculo-peritoneal shunt procedure |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients ≥60 years old on the day of study informed consent
- Patient or legally authorized representative is able and willing to provide written informed consent
- History or evidence of gait impairment with a duration ≥3 months
- 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:
- Patient is willing and able to attend all scheduled visits and comply with study procedures.
Key exclusion criteria (22 listed)
- Be unable to walk 10 meters (33 feet) with or without an assistive device
- Be diagnosed with obstructive hydrocephalus
- Have an active systemic infection or infection detected in CSF
- Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CereVasc eShunt SystemAlso: eShunt System, eShunt ImplantThe eShunt System consists of the following components: * eShunt Implant * eShunt Delivery Catheter and Transfer Tool * eShunt Anchor | Device | eShunt System |
| VP ShuntControl arm - VP shunt | Device | VP Shunt |
Primary outcome
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Normal Pressure Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
Recruiting
Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Recruiting
Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
NPH (Normal Pressure Hydrocephalus)
RecruitingObservational study
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
RecruitingObservational study
Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CereVasc eShunt System and VP Shunt in people with Normal Pressure Hydrocephalus, run by CereVasc Inc at 32 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.