Registro EMEA NEVA ONE de reperfusión en un solo paso con el stent retriever NeVa

ReclutandoClinicalTrials.gov

ID: NCT04562194Tipo: INTERVENTIONALInicio: 1 de jul de 2020Fin estimado: 1 de may de 2027

Resumen

Estudio prospectivo, abierto, diseñado para evaluar la seguridad, el rendimiento y la eficacia de la extracción de trombos con los stent retrievers NeVa en sujetos con accidente cerebrovascular isquémico agudo.

Descripción detallada

Se trata de un registro prospectivo, abierto y multicéntrico diseñado para evaluar la seguridad, el rendimiento y la eficacia del stent retriever NeVa en el tratamiento del accidente cerebrovascular por oclusión de gran vaso. Se incluirán hasta 600 sujetos en hasta 30 centros.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.
Age ≥18
NIHSS score ≥ 6
Pre-stroke mRS score ≤ 1
Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA.
Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well \[TLKW\])
The patient should have confirmed LVO and salvageable penumbra. Any automated software for determine the volume of viable tissue is acceptable. patient selection should follow the following guidelines:
ASPECTS 6-10 if treatment started 0-6 hours from TLKW
ASPECTS 8-10 if treatment started 6-24 hours from TLKW
Ischemic core ≤ 50 cc
Subject or legal representative is able and willing to give informed consent within 72 hours after the intervention (may use independent physician consent in this timeframe and gain subject or legal representative consent later than 72 hours).

Criterios de exclusión

Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre- treatment pulmonary aspiration.
Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
Cerebral vasculitis
History of severe allergy to contrast medium.
Known allergy to NeVa materials (nitinol, stainless steel)
Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
Systemic infection
Significant mass effect with midline shift
Evidence of intracranial tumor (except small meningioma)
Inability to deploy NeVA device for at least one pass for any other reason
Life expectancy less than 6 months
Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.

Intervenciones

device

NeVa Stent Retriever

mechanical neurothrombectomy

Ubicaciones

Hospital Espanol de Mendoza

Mendoza, Argentina

Fernando Petra, MD

RECRUITING

Patrocinadores

PrincipalVesalio

Contactos

Antoine Cuijpers

CONTACT

acuijpers@vesalio.com +31 6 51 55 99 37

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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