Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus

ReclutandoClinicalTrials.gov

ID: NCT06498960Tipo: INTERVENTIONALInicio: 26 de nov de 2024Fin estimado: 1 de jun de 2031

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Resumen

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

Descripción detallada

The STRIDE study is a prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.

Elegibilidad

Edad mínima: 60 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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
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

Intervenciones

device

CereVasc eShunt System

The eShunt System consists of the following components: * eShunt Implant * eShunt Delivery Catheter and Transfer Tool * eShunt Anchor

device

VP Shunt

Control arm - VP shunt

Ubicaciones

Clinica La Sagrada Familia

Buenos Aires, Argentina

Carlos Toranzo · ctoranzo@lylyk.com.ar

RECRUITING

Patrocinadores

PrincipalCereVasc Inc

Contactos

Ona Whelove

CONTACT

clinicaltrials@cerevasc.com 917-275-5340

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