Resumen

El sistema eShunt incluye componentes de liberación exclusivos y el implante eShunt, un implante permanente colocado mediante un procedimiento neurointervencionista mínimamente invasivo. El implante eShunt está diseñado para imitar la función de las granulaciones aracnoideas, drenando el exceso de líquido cefalorraquídeo (LCR) desde el espacio subaracnoideo intracraneal (ESA) hacia el sistema venoso.

Descripción detallada

Este es un estudio piloto prospectivo, no aleatorizado, abierto, unicéntrico, en sujetos con hidrocefalia de presión normal en quienes está indicada la colocación de una derivación de LCR tradicional. Hasta 30 sujetos recibirán el implante eShunt en un único sitio de investigación. Los sujetos regresarán para cinco visitas de seguimiento durante el primer año y luego continuarán con visitas cada seis meses durante cinco años tras la implantación. Los objetivos del estudio son demostrar la seguridad del procedimiento eShunt, así como demostrar la seguridad y eficacia del implante eShunt en una pequeña muestra de pacientes. Los sujetos serán seguidos a largo plazo; los resultados del análisis primario se utilizarán para sustentar estudios adicionales.

Elegibilidad

Edad mínima: 65 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Patients 65-85 years old and traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation
Patient is able and willing to provide written informed consent
History or evidence of gait impairment duration ≥6 months
Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with:
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 with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
CSF opening pressure ≥10 cmH2O
Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC
Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC

Criterios de exclusión

Unable to walk 10 meters (33 feet) with or without an assistive device
Conditions impairing gait that are considered to be unrelated to hydrocephalus
Signs or symptoms of obstructive hydrocephalus
Active systemic infection or infection detected in CSF
Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
Occlusion or stenosis of the internal jugular vein
Venous distension in the neck on physical exam
Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram
History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency
Stroke or transient ischemic attack within 180 days of eShunt Procedure
Presence of a deep vein thrombosis superior to the popliteal vein
International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds)
Presence of a posterior fossa tumor or mass
Life expectancy \< 1 year
Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation
Pregnant or planning to become pregnant
Unwilling or unable to comply with follow-up requirements

Intervenciones

device

eShunt Implant

The eShunt System consists of endovascular delivery componentry and a permanent implant intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system in adults.

Ubicaciones

Clínica La Sagrada Familia

Buenos Aires, Ciudad A. de Buenos Aires, Argentina

Patrocinadores

PrincipalCereVasc Inc

ColaboradorAlvaMed, Inc.

ColaboradorSimplified Clinical Data Systems, LLC

ColaboradorBioscience Consulting, Inc.

Estudio piloto para evaluar la seguridad y eficacia del sistema eShunt® de CereVasc® en el tratamiento de la hidrocefalia de presión normal