Un Estudio del Stent de Malla Dirigido por Flujo Choydar en el Tratamiento de Aneurismas Intracraneales No Rotos (CROWN)
Estudio observacional multicéntrico, prospectivo, de un solo brazo para evaluar la seguridad y eficacia de la malla de stent dirigida por flujo Choydar en el tratamiento de aneurismas intracraneales no rotos
The purpose of this study is to assess how safe choydar flow-directed mesh stent is and how well it works in the treatment of unruptured intracranial aneurysms (a condition in which a bulging blood vessel in the brain can burst and cause bleeding) in a real-world setting.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Yuanyuan Gu
- Número de teléfono: 86 15692105615
- Correo electrónico: ygu51@its.jnj.com
Ubicaciones de estudio
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Chenzhou, Porcelana, 432000
- Reclutamiento
- Chenzhou No.1 People's Hospital
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Guangzhou, Porcelana, 519041
- Reclutamiento
- Guangdong Provincial People's Hospital
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Nanjing, Porcelana, 210008
- Reclutamiento
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Nanjing, Porcelana, 210029
- Reclutamiento
- The First Affiliated Hospital of Nanjing Medical University
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Nanyang, Porcelana, 473000
- Reclutamiento
- Nanyang Central Hospital
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Taiyuan, Porcelana, 30012
- Reclutamiento
- Shanxi Provincial People's Hospital
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Wuhu, Porcelana, 241001
- Reclutamiento
- The First Affiliated Hospital of Wannan Medical College
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Zhengzhou, Porcelana, 450052
- Reclutamiento
- The First Affiliated Hospital of Zhengzhou University
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adult participants with unruptured wide-neck (neck width >= 4 mm or dome-to-neck ratio <2) saccular or fusiform aneurysms in the internal carotid artery (from the petrous segment to the distal end) and the vertebral artery arising from a parent vessel with a diameter >= 2.0 mm and <= 6.0 mm.
Descripción
Inclusion criteria:
Participants meeting all the following inclusion criteria will be included:
Preoperative inclusion criteria:
- Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA) prior to surgery, wide-neck (neck width greater than or equal to [>=] 4 millimeters [mm] or dome-to-neck ratio less than [<] 2) saccular or fusiform aneurysms, and the parent artery diameter must be >= 2.0 mm and less than or equal to [<=] 6.0 mm
- Participants and/or their authorized representatives understand the purpose of the study, and are willing to voluntarily participate in the study and sign the informed consent form (ICF)
- Prior to enrollment, a clinical decision has already been made to use the choydar flow-directed mesh stent
- Participants who are willing and able to return for all follow-up visits as required by the study protocol
Intraoperative inclusion criteria:
- Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by DSA during the procedure, wide-neck (neck width >= 4 mm or dome-to-neck ratio <2) saccular or fusiform aneurysms, and the parent artery diameter must be >= 2.0 mm and <= 6.0 mm
Exclusion criteria:
Participants meeting any of the following exclusion criteria will be excluded:
- Participants with anatomy are unsuitable for flow diverter passage or placement or lesions unsuitable for flow diverter delivery and deployment (for example, the lesion vessel is excessively tortuous or tiny, the flow diverter cannot reach the lesion site, stenosis exists in the target vessel of recurrent aneurysm, or the flow diverter is not completely deployed)
- Participants who are allergic to contrast media
- Participants who are allergic to nickel-titanium alloy or platinum-tungsten alloy
- Participants who are contraindicated for antiplatelet and/or anticoagulant therapy
- Participants with active bacterial infections
- Participants who are confirmed positive pregnancy (for example, via test or oral communication) according to the site-specific standard of care
- Participants who are currently participating in an investigational (drug, device, etc.) clinical study that may confound the study endpoints (excluding observational, natural history, and/or epidemiological studies that do not require interventions)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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Choydar Flow-Directed Mesh Stent
The choydar flow-directed mesh stent will be used in accordance to its Instructions For Use (IFU) in participants with unruptured intracranial aneurysms. Participants will not receive any other intervention as a part of this study. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Complete Aneurysm Occlusion Rate at 12 Months Post-Procedure (Raymond-Roy Class I)
Periodo de tiempo: At 12 months follow-up post-procedure
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Complete aneurysm occlusion rate as per Raymond Roy classification criteria (Class I) is defined as complete obliteration (no contrast filling in aneurysm body or neck). It is calculated as follows: number of target aneurysms achieving Raymond-Roy Class I occlusion at 12-month follow-up post-procedure/number of target aneurysms with 12-month imaging evaluation * 100 percent (%). |
At 12 months follow-up post-procedure
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Adequate Aneurysm Occlusion Rate at 12-month Follow-up Post-Procedure (Raymond-Roy Classes I and II)
Periodo de tiempo: At 12 months follow-up post-procedure
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Adequate aneurysm occlusion rate as per Raymond Roy classification criteria (Class II and III) is defined as Class II: residual neck (contrast filling in aneurysm neck but none in aneurysm body) and Class III: residual aneurysm (contrast filling in aneurysm body). It is calculated as follows: number of target aneurysms achieving Raymond-Roy Class I/II occlusion at 12-month follow-up post-procedure/number of target aneurysms with 12-month imaging evaluation * 100 %. |
At 12 months follow-up post-procedure
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Percentage of Participants with Immediate Technical Success Rate of Procedure
Periodo de tiempo: At Day 0 (Day of procedure)
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Percentage of participants with immediate technical success rate of procedure will be reported. Immediate technical success of the procedure is defined as the percentage of participants in whom the flow diverter is successfully deployed during the procedure, with accurate positioning confirmed by intra-procedure angiography, and with effective coverage of the aneurysm neck by the implant. It is calculated as follows: number of participants with successful placement of the investigational device/total number of participants undergoing the treatment * 100 %. |
At Day 0 (Day of procedure)
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Re-treatment Rate of Target Aneurysm at 12-Month Follow-up Post-Procedure
Periodo de tiempo: At 12 months follow-up post-procedure
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The incidence of re-treatment of the target aneurysm at 12 months follow-up post-procedure will be reported. |
At 12 months follow-up post-procedure
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Percentage of Participants with Modified Rankin Scale (mRS) Score of 0-2 at 12 Months Post-Procedure
Periodo de tiempo: At 12 months follow-up post-procedure
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Percentage of participants with mRS score of 0-2 at 12 months post-procedure will be reported. The mRS score is issued to evaluate the improvement of neurological function. It assesses the ability of participants with neurological disease to live independently. There are 7 levels of this score, 0 points represent no symptoms of disability, higher scores mean worse prognosis of participants , and 6 points represent death. |
At 12 months follow-up post-procedure
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Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During Perioperative Period
Periodo de tiempo: Perioperative
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Number of participants with major ischemic/hemorrhagic events and/or death during perioperative period will be reported. Major ischemic/hemorrhagic events are defined as an increase of >= 4 points in the National Institutes of Health Stroke Scale (NIHSS) score compared with the previous score. |
Perioperative
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Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During 12-Month Follow-up
Periodo de tiempo: At 12 months follow-up post-procedure
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Number of participants with major ischemic/hemorrhagic events and/or death during 12 months follow-up period will be reported. Major ischemic/hemorrhagic events are defined as an increase of >= 4 points in the NIHSS score compared with the previous score. |
At 12 months follow-up post-procedure
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Number of Participants with Severe in-Stent Stenosis (Greater Than [>] 50%) During 12-Month Follow-up
Periodo de tiempo: At 12 months follow-up post-procedure
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Number of participants with severe in-stent stenosis during 12-month follow-up period will be reported. The percent stenosis is calculated according to the calculation method of Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) study as follows: (1 - Ds [Diameter of the artery at the site of the most severe stenosis]/Dn [Diameter of the normal artery]) * 100%. |
At 12 months follow-up post-procedure
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Rupture Rate of Target Aneurysm During 12-Month Follow-Up Post-Procedure
Periodo de tiempo: At 12 months follow-up post-procedure
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The incidence of rupture of the target aneurysm within 12 months post-procedure will be reported. |
At 12 months follow-up post-procedure
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial, Johnson & Johnson Medical (Shanghai) Ltd.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- CNV202507
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The data sharing policy of Johnson & Johnson MedTech is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .