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Purpose

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

Condition

Eligibility

Eligible Ages
Over 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky Research Foundation
Lexington, Kentucky 40506
Contact:
Rachel Norris
rachel.norris@uky.edu

More Details

NCT ID
NCT06498960
Status
Recruiting
Sponsor
CereVasc Inc

Study Contact

Ona Whelove
917-275-5340
clinicaltrials@cerevasc.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.