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

A vizsgálat adatai

Ki végzi

CereVasc Inc

Azonosító

NCT06498960

A regiszteradat frissítve

2026. június 25.

Eredeti leírás

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

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.

Bevonási feltételek: 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,; 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.

Kizáró feltételek: Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus; Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study; Have an active systemic infection or infection detected in CSF; 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; 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 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; Each subject may not:; Be unable to walk 10 meters (33 feet) with or without an assistive device; Be diagnosed with obstructive hydrocephalus; 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 presence of a posterior fossa tumor or mass; Have a life expectancy <1 year; 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.

ClinicalTrials.gov NCT06498960