A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter
25 de junio de 2026 actualizado por: GuoQiang Xu, Hebei General Hospital
Balloon Guide Catheter-Assisted Carotid Artery Stenting With Multimodal Cerebral Protection: A Prospective, Multicenter, Randomized Controlled Trial
This prospective, multicenter, randomized controlled study enrolled patients undergoing carotid artery stenting (CAS) with cerebral embolic protection for carotid artery stenosis.
They were randomly assigned to either a combination of proximal balloon occlusion, filter protection, intermediate catheter or filter protection alone.
The study included 132 patients, and the primary endpoint was the number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Carotid artery stenting (CAS) is an established treatment for carotid stenosis, yet the optimal cerebral embolic protection strategy remains uncertain.
This prospective, multicenter, randomized, open-label, controlled trial will enroll 132 patients with symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis, who will be randomly assigned 1:1 to either experimental multimodal protection (Balloon Guide Catheter plus distal filter and intermediate catheter aspiration) or conventional distal filter protection alone.
The primary endpoint is the number of new infarcts on post-procedural diffusion-weighted imaging (DWI) assessed within 48 hours (±24 hours), with secondary endpoints including device success and defect rates, incidences of symptomatic and all intracranial hemorrhage within 48 hours post-procedure, ipsilateral target-vessel stroke, TIA, major adverse events (stroke/death/MI), and adverse/serious adverse events at 30 and 90 days, all-cause mortality at 90 days, changes in mRS score at 30 and 90 days, and procedure-related complications (e.g., dissection, hyperperfusion syndrome).
Tipo de estudio
Intervencionista
Inscripción (Estimado)
132
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yan Zhao
- Número de teléfono: 185 0327 2089
- Correo electrónico: zhaoyan2333@163.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Aged between 18 and 80 years (inclusive), with no gender restriction.
- Imaging diagnosis indicates symptomatic carotid artery stenosis (by NASCET method) ≥50% or asymptomatic carotid artery stenosis (by NASCET method) ≥70%.
- Suitable for carotid artery stenting.
- Good compliance, voluntarily signed the informed consent form, and able to follow up as required.
Exclusion Criteria:
- Severe tortuosity or calcification of the diseased vessel, preventing device delivery.
- Patients with ipsilateral external carotid artery occlusion or severe stenosis of the intracranial segment of the internal carotid artery.
- Patients with contralateral common carotid artery occlusion or severe stenosis or occlusion of the internal carotid artery.
- Patients with severe stenosis or occlusion of the vertebrobasilar artery (excluding non-dominant vertebral artery).
- Spontaneous intracranial hemorrhage, massive cerebral infarction, progressive stroke, or myocardial infarction within the past 3 months.
- Presence of substantial acute or subacute thrombus adjacent to the lesion.
- mRS > 3.
- Patients with a clear risk of cardioembolism, such as atrial fibrillation, or those with definite indications for anticoagulation.
- Chronic obstructive pulmonary disease requiring long-term continuous oxygen therapy.
- Patients with prior stent treatment in the ipsilateral head and neck vessels.
- Patients with end-stage renal failure requiring dialysis.
- Life expectancy less than 6 months.
- Patients unsuitable for magnetic resonance imaging (MRI) for any reason.
- Patients with absolute or relative contraindications to antiplatelet therapy.
- Inability to cooperate with the study due to dementia or mental disorder.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Combined Cerebral Protection (BGC + Filter + intermediate catheter)
Participants in this arm will undergo carotid artery stenting (CAS) with a multimodal cerebral embolic protection strategy, incorporating proximal balloon occlusion via a Balloon Guide Catheter (BGC), distal filter protection, and active aspiration through an intermediate catheter.
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Balloon guide catheter for proximal flow arrest and debris aspiration during carotid stenting.
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Comparador activo: Standard Protection Group (Filter Alone)
Participants in this arm will undergo carotid artery stenting (CAS) with distal filter protection.
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Distal embolic filter deployed beyond the stenosis to capture debris during stent placement.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure
Periodo de tiempo: within 48 hours (±24 hours) post-procedure
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Total number of new DWI positive lesions on post procedural brain MRI within 48 hours (±24 hours).
New lesions are defined as foci of hyperintensity not seen on baseline DWI (if available), or otherwise as lesions consistent with acute embolic infarction.
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within 48 hours (±24 hours) post-procedure
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Device Success Rate
Periodo de tiempo: during the procedure
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Device success for the balloon dilation catheter is defined as successful delivery, complete inflation, and smooth retrieval of the catheter system.
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during the procedure
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Incidence of Major Adverse Events (MAE) within 30 days, including any stroke, death, and myocardial infarction.
Periodo de tiempo: within 30-day post-procedure
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The rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke, or myocardial infarction within 30-day post-procedure.
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within 30-day post-procedure
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Changes in mRS score at 30 days and 90 days post-procedure.
Periodo de tiempo: 30 days and 90 days post-procedure
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Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The range is 0-6 (0 is highest function with no symptoms and 6 is death).
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30 days and 90 days post-procedure
|
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Incidence of ipsilateral target vessel stroke at 30 days and 90 days post-procedure.
Periodo de tiempo: 30 days and 90 days post-procedure
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Stroke is defined as an acute neurological deficit of vascular origin lasting ≥24 hours, or lasting <24 hours with neuroimaging evidence of new infarction, occurring in the territory of the treated carotid artery.
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30 days and 90 days post-procedure
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Incidence of transient ischemic attacks (TIA) at 30 days and 90 days post-procedure.
Periodo de tiempo: 30 days and 90 days post-procedure
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Transient ischemic attacks (TIA) was defined as transient focal neurological deficit of vascular origin lasting <24 hours with no acute infarct on neuroimaging.
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30 days and 90 days post-procedure
|
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Incidence of Procedure-related complications (e.g., vessel dissection, hyperperfusion syndrome, etc.).
Periodo de tiempo: during the procedure
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Procedure related complications include vessel dissection, hyperperfusion syndrome, access site events, and other adverse events directly attributable to carotid artery stenting (CAS).
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during the procedure
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Incidence of adverse events and serious adverse events at 30 days and 90 days post-procedure.
Periodo de tiempo: 30 days and 90 days post-procedure
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The Incidence of Adverse events or severe adverse event at 30 days and 90 days post-procedure.
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30 days and 90 days post-procedure
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Incidence of symptomatic intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
Periodo de tiempo: within 48 hours (±24 hours) post-procedure
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Symptomatic intracranial hemorrhage defined as any intracranial hemorrhage on imaging with new neurological symptoms or NIHSS increase ≥4, or death.
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within 48 hours (±24 hours) post-procedure
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Incidence of intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
Periodo de tiempo: within 48 hours (±24 hours) post-procedure
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Incidence of all intracranial hemorrhage on post-procedural brain imaging within 48 hours.
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within 48 hours (±24 hours) post-procedure
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Incidence of all-cause mortality within 90 days post-procedure.
Periodo de tiempo: 90 days post-procedure
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Incidence of death from any cause occurring within 90 days following the procedure.
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90 days post-procedure
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Incidence of device defects.
Periodo de tiempo: during the procedure
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The Incidence of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.
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during the procedure
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Guodong Xu, Hebei General Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de junio de 2026
Publicado por primera vez (Actual)
1 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BGC-2026-01
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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