Clinical trial NCT06498960: Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Official title: Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Normal Pressure Hydrocephalus
Lead sponsor: CereVasc Inc
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 230
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 6 months
measure: Primary Safety Endpoint
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Medical Center - Jacksonville
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Research Foundation
state: Kentucky
city: West Bloomfield
country: United States
facility: Henry Ford Health
state: Michigan
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References: