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- Ensayo clínico NCT02190552
Analysis of Revascularisation in Ischemic Stroke With EmboTrap (ARISE)
A.R.I.S.E. Analysis of Revascularisation in Ischemic Stroke With EmboTrap: Post Marketing Observational Study of CE Marked EmboTrap Mechanical Thrombectomy Device
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
- Aged between 18 years and 80 years (inclusive).
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- NIHSS score ≥8 and ≤25.
- Pre-ictal mRS score of 0 or 1.
- Angiographic confirmation of an occlusion of an ICA (including T and L occlusions), M1 or M2, MCA, or BA with TICI flow of 0-1.
- Confirmation by the interventionalist, after screening CT or MRI, that the treatment site can be accessed with the Neuravi device.
The interventionalist estimates that at least one deployment of the Neuravi device can be completed within 5 hours from the onset of symptoms, or if time of onset of symptoms is unknown or > 5 hours, patients can be included using imaging with the following criteria:
- MRI criterion: ASPECTS 8 to 10, or,volume of diffusion restriction ≤30 mL and mismatch between perfusion reduction and diffusion restriction present.
- CT criterion: ASPECTS 8 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤30 mL and mismatch between perfusion reduction and low CBV present.
Exclusion Criteria:
- Life expectancy of less than 6 months.
- Females who are pregnant or lactating.
- History of severe allergy to contrast medium.
- Has suffered a stroke in the past three months.
- The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma.
- Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0.
- Platelet count < 50,000.
- Glucose < 50 mg/dL.
- Heparin use in previous 24 hours with PTT or ACT > 2X normal.
- Any known hemorrhagic or coagulation deficiency.
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- For basilar artery occlusion, extended early ischemic changes as confirmed by pc-ASPECTS ≤ 7 on baseline CT or CTA-source images, or extensive DWI lesions in the midbrain or pons regions on pre-treatment MRI.
- Baseline CT or MRI showing mass effect or intracranial tumor (except small meningioma).
- Excessive arterial tortuosity that precludes the study device from reaching the target vessel.
- A proximal stenosis or complete occlusion that cannot, as judged by the responsible interventionalist, be treated safely or which prevents access to the occluded vessel with the Neuravi device.
- Evidence of active infection.
- Known cancer with metastases
- Current use of cocaine or other vasoactive substance.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
EmboTrap® Revascularization Device
The EmboTrap® Revascularization Device is the investigational device
|
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Proportion of Revascularisation Following the Use of the Neuravi Device.
Periodo de tiempo: Day 1
|
Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater. mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion |
Day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time to Revascularization
Periodo de tiempo: Day 1
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Defined as time from groin puncture to visualization of final angiographic result.
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Day 1
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Mortality Post Procedure
Periodo de tiempo: 7 and 90(±14) days post procedure
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All procedure related mortality (i.e.
directly traceable to a procedure related SAE).
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7 and 90(±14) days post procedure
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Serious Adverse Device Related Effects (SADE)
Periodo de tiempo: 24(-8/+12) hours Post Procedure
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SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.
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24(-8/+12) hours Post Procedure
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Symptomatic ICH
Periodo de tiempo: 24(-8/+12) hours Post Procedure
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Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment. |
24(-8/+12) hours Post Procedure
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Clinical Outcome at 90 Days
Periodo de tiempo: 90(±14) days Post Procedure
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A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days. mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6: mRS 0 = No symptoms. mRS 1 = No significant disability. mRS 2 = Slight disability. mRS 3 = Moderate disability. mRS 4 = Moderately severe disability. mRS 5 = Severe disability. mRS 6 = Dead. |
90(±14) days Post Procedure
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Rate of New Territory Embolization
Periodo de tiempo: 24(-8/+12) hours Post Procedure
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Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.
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24(-8/+12) hours Post Procedure
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Evidence of Infarction
Periodo de tiempo: 24(-8/+12) hours Post Procedure
|
Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.
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24(-8/+12) hours Post Procedure
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dr. Tommy Andersson, Karolinska Institutet
- Investigador principal: Prof. Dr. Heinrich Mattle, University Hospital Inselspital, Berne
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Carrera
- Enfermedades Vasculares
- Isquémico
- Revascularización
- Isquemia
- Cerebro
- Accidente cerebrovascular isquémico
- Enfermedades Cerebrales
- Trastornos cerebrovasculares
- Infarto cerebral
- Isquemia cerebral
- Coágulo cerebral
- Dispositivo de revascularización EmboTrap®
- Embo Trampa
- Trombectomía mecánica
- Intervención Neurovascular
- Recuperador de stent
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Necrosis
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Isquemia cerebral
- Infarto
- Infarto cerebral
- Carrera
- Accidente cerebrovascular isquémico
- Isquemia
- Infarto cerebral
Otros números de identificación del estudio
- CIP001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Dispositivo de revascularización EmboTrap®
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Niguarda HospitalNeuravi LimitedReclutamientoAccidente cerebrovascular isquémico agudoItalia
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Neuravi Inc.TerminadoIsquemia | CarreraIrlanda, Estados Unidos, Bélgica, Alemania
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Cerenovus, Part of DePuy Synthes Products, Inc.ReclutamientoInfarto cerebralEstados Unidos, Bélgica, Israel, Alemania, Suiza, Francia, Reino Unido