- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03210623
Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)
The Efficacy and Safety Study of Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The main objective is to determine whether stent retriever(TonbridgeMT) will have non-inferior successful recanalization rate compared to Solitaire™ when applied to endovascular therapy for AIS.
The secondary objectives is to verify whether there isn't significant differences in time to achieve recanalization, NIHSS score, mRS score, and transportation performance between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.
The third objectives is to verify whether there isn't significant differences in the rate of symptomatic intracranial hemorrhage, subarachnoid hemorrhage, adverse event(AE), serious adverse event(SAE), actual condition of AE and device deficiencies between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing, Porcelana
- The 306th Hospital of Chinese PLA
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Changchun, Porcelana
- The First Hospital of Jilin University
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Changchun, Porcelana
- China-Japan Union Hospital
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Changzhou, Porcelana
- The First People's Hospital Of Changzhou
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Guangzhou, Porcelana
- The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
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Guiyang, Porcelana
- The Affiliated Hospital of Guizhou Medical University
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Hangzhou, Porcelana
- Hangzhou First People's Hospital
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Hanzhou, Porcelana
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Nanjing, Porcelana
- Nanjing First Hospital Affiliated to Nanjing Medicine University
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Nanning, Porcelana
- Nanning People's Hospital
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Wuhan, Porcelana
- The Third People's Hospital of Hubei Province
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Xi'an, Porcelana
- Tangdu Hospital
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Zhengzhou, Porcelana
- Henan Provincial People's Hospital
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Zhengzhou, Porcelana
- The First Affiliated Hospital of Zhengzhou University
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Zhongshan, Porcelana
- Zhongshan People's Hospital
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Zhuhai, Porcelana
- The Fifth Affiliated Hospital Sun Yat-Sen University
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Shanghai
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Shanghai, Shanghai, Porcelana
- Changhai Hospital of Shanghai
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18≤ages≤80;
- Baseline NIHSS score obtained prior to randomization must be lower than 30 points;
- Acute occlusion(TICI 0-1) of the intracranial segment of internal carotid artery(ICA), or M1/M2 middle cerebral artery(MCA), or A1/A2 anterior cerebral artery(ACA), as evidenced by digital subtraction angiography(DSA);
- Patient treatable within 6 hours of symptom onset(symptoms onset is defined as point in time the patient was last seen well (at baseline)) can accept the complete femoral artery puncture;
- Pre-AIS mRS score lower than 2.
Exclusion Criteria:
- Computed tomography (CT) or magnetic resonance imaging (MRI) evidence of intracranial hemorrhage or massive cerebral infarction (ASPECTS score of<6 or infarct volume≥70ml or volume>1/3 blood supplying areas of MCA on CT/diffusion weighted imaging(DWI);
- DSA evidence of simultaneous acute bilateral carotid occlusion;
- DSA evidence of occlusions in the initial segment of carotid artery or carotid artery dissection or arteritis;
- DSA evidence of tortuosity of cervical vessels precluding device delivery/deployment;
- Hypertension (Systolic blood pressure(SBP)>185 mm Hg or diastolic blood pressure(DBP)>110 mm Hg) after using drug;
- Platelet count<40,000/μL and use of Novel Anticoagulant with International Normalized Ratio(INR)>3.0;
- Random blood glucose of<2.7mmol/L or>22.2mmol/L;
- Patients with heart or lung or liver or renal failure or other sever disease(intracranial tumors, cerebral arteriovenous malformation (AVM), systemic infection, active disseminated intravascular coagulation, myocardial infarction within the past 12 months before enrollment, history of sever psychosis);
- Patients who will not cooperate or tolerate interventional operation;
- Anticipated life expectancy of less than 90 days;
- Allergy to contrast medium;
- Females who are pregnant or breastfeeding;
- Participation in any other clinical trial within the past 1 months before screening and follow-up;
- The patient or the patient's legally authorized representative hasn't signed and dated an informed consent form;
- Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence as per investigator's judgement.
Plan de estudios
¿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: group A
subjects applying the stent retriever(TonbridgeMT)
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mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
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Comparador activo: group B
subjects applying Solitaire™
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mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
successful recanalization rate in patients
Periodo de tiempo: intraoperative immediate
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Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3.
And it is evaluated by DSA intraoperative immediately in both treatment groups
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intraoperative immediate
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
successful recanalization rate in vessels
Periodo de tiempo: intraoperative immediate
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The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment
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intraoperative immediate
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Time to achieve recanalization
Periodo de tiempo: intraoperative immediate
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The period from femoral artery puncture to successful recanalization
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intraoperative immediate
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NIHSS score
Periodo de tiempo: baseline, 24±6d and 7±2d after operation
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National Institutes of Health Stroke Scale
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baseline, 24±6d and 7±2d after operation
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mRS score
Periodo de tiempo: baseline, 90±14d after operation
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The modified Rankin Scale (mRS) is a commonly used 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.
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baseline, 90±14d after operation
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the ratio of mRS 0-2
Periodo de tiempo: baseline, 90±14d after operation
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The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment
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baseline, 90±14d after operation
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transportation performance
Periodo de tiempo: intraoperative immediate
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The proportion of stent retriever which can push and draw back well during the operation.
The operator will grade each stent retriever at four level, namely great, good, average,and bad
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intraoperative immediate
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y 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 (Actual)
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
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
- JCQ-B-010
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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. .
Ensayos clínicos sobre stent retriever(TonbridgeMT)
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Suzhou Zenith Vascular Scitech Co., Ltd.Aún no reclutandoEP - Embolia pulmonar | PE - Tromboembolismo pulmonarPorcelana
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Hopital FochTerminadoAccidente cerebrovascular isquémico agudoFrancia
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The University of Hong KongQueen Mary Hospital, Hong Kong; Ruttonjee Hospital, Hong KongTerminadoAccidente cerebrovascular isquémico agudoHong Kong
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Medical University of South CarolinaIcahn School of Medicine at Mount SinaiTerminadoAccidente Cerebrovascular IsquémicoEstados Unidos
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Hopital FochReclutamientoAccidente cerebrovascular agudoFrancia
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Xuanwu Hospital, BeijingReclutamientoCarrera | Accidente cerebrovascular isquémico agudoPorcelana
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Hopital FochReclutamiento
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Beijing Tiantan HospitalReclutamientoOclusión de la arteria basilar | Tratamiento endovascularPorcelana
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Kobe City General HospitalDesconocido
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ThrombX MedicalAún no reclutandoAccidente cerebrovascular isquémico