Last updated 15 days ago

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

230 patients around the world
Available in Argentina, United States
The STRIDE study is a prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
CereVasc Inc
1Research sites
230Patients around the world

This study is for people with

Hydrocephalus
Normal Pressure Hydrocephalus

Requirements for the patient

From 60 Years
All Gender

Medical requirements

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 together with all of the following.
Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy and the absence of severe hippocampal atrophy.
Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement of at least 20%.
CSF opening pressure ≥8 cmH2O.
Baseline cognitive evaluation assessed by Montreal Cognitive Assessment 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 and approved by an independent anatomical screening committee.
Be unable to walk 10 meters 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.
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.
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 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 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.

Sites

Clínica La Sagrada Familia
Recruiting
José Hernández 1642, C1426EOB Cdad. Autónoma de Buenos Aires, Argentina
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