Treatment of Ruptured Intracranial Aneurysms in China.
2 de octubre de 2018 actualizado por: He xuying, Zhujiang Hospital
The Safety and Efficacy of Ruptured Intracranial Aneurysms Embolized Assisted With Stents（SERIAES）.
Ruptured intracranial aneurysms is currently a common disease that seriously affects human health and quality of life due to its high morbidity,high mortality and high disability. At present,Ruptured intracranial aneurysms are treated with craniotomy clipping and interventional embolization ,but for ruptured wide-neck intracranial aneurysms, the treatment of craniotomy clipping and coiling embolization are not effective.With the improvement of endovascular treatment materials and techniques, three dimensional coil basket technique, double microcatheter technique, balloon assisted ONYX embolization, simple stent covered aneurysm neck, balloon or stent assisted neck remodeling and coil embolization are used in endovascular treatment of ruptured wide-neck intracranial aneurysms. The treatment methods are different in the intervention effect of ruptured wide-neck intracranial aneurysms, for example, the complications of interventional therapy are lower than craniotomy clipping,but the rate of well functional outcome (mRS ≤2) differed significantly by 3 months follow-up (65.0% vs.75.0%), and there is not standard of treatment in different parts of ruptured wide-neck intracranial aneurysms in our country, the choice of interventional therapy or craniotomy clipping are different in different clinical centers; on the other hand, there are serious problems in the treatment of ruptured wide-neck intracranial aneurysms, because without the relevant guidelines of diagnosis and treatment of ruptured wide-neck intracranial aneurysms, different clinical centers will cause excessive treatment of ruptured wide-neck intracranial aneurysms, not only bring unreasonable utilization of medical resources, but also cause the subject's life and property to be threatened.
The patients with ruptured wide-neck intracranial aneurysms(n=1084) and unruptured intracranial aneurysms(n=300) were included in prospective cohort study, after interventional therapy and craniotomy clipping, setting fixed time for postoperative follow-up, the clinical data and image data were recorded, the safety, efficacy and economic benefits of interventional treatment and craniotomy clipping were compared, providing strategies for the standardized treatment of ruptured wide-neck intracranial aneurysms.
Descripción general del estudio
Estado
Desconocido
Descripción detallada
For this study, investigators consulted and hired professionals and experts about data collection, data and methodology, including Data Monitoring Committee, Data Management Committee, Project Academic Committee,Executive Group Project Manager, Project Statistician, Technical Support Center, investigators have a scientific regulations for this project, Project Manager and Executive Group: To ensure the successfully implementation of this project, including charging the daily operations of the study in 6 different research hospitals, organizing the monthly meeting to consider issues raised during the monthly progress of the study, liaising with the steering committee the data management center and statistical center , Data management Committee: To be responsible for setting up and maintain the Electronic Data Capture(EDC) System according to the paper case Report Form (pCRF) designed by principal investigators.
To collect and save the pCRF coming from sub-centers.
To entry the data into EDC system and keep the same with CRF.
To organize training for the investigators about the rules in filling the EDC and pCRF.To determine the frequency of the Data Management Report and to fed it back to the steering committee every three months, Data Monitoring Committee: To determine the frequency of the data monitoring including the source data(Medical records) accuracy, completeness and representativeness comparing the external data(EDC,pCRF） in 12 centers.To report the results after the monitoring back to the steering committee about the missing data, non-reported and other problems about the study.
To make a Standard Operation Procedure (SOP) from getting data to using data.
Academic Committee: To supervise the academic issues including patient recruitment, protocol deviation, adverse events evaluating.
To settle down the question and problem in the process of the study, Project Statistician: We cooperate with the Statisticians of Medical Research & Biometrics center National Center for Cardiovascular Diseases, China ti get the professional statistical report.
Technical Support Center: To provide technical support during the process of the study.
Tipo de estudio
De observación
Inscripción (Anticipado)
1384
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.
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510282
- Southern medical university, zhujiang hospital
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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
14 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with ruptured intracranial aneurysms and un-ruptured intracranial aneurysms.
Descripción
Inclusion Criteria:
- At least one imaging methods( CTA/ MRA/DSA ) confirmed ruptured wide-neck intracranial aneurysms (fundus-to-neck ratio < 2 or neck diameter > 4 mm );
- Stent-Assisted Coiling of un-ruptured intracranial aneurysms, whether have clinical symptoms or no;
- For multiple aneurysms, regardless of previous treatment, the requirement for treatment interval should >6 months;
- The subjects age 14 years;
- subjects or family members agree to sign informed consent.
Exclusion Criteria:
- Subjects with other intracranial vascular malformations, such as AVM, AVF. Etc;
- Subjects with malignant tumors in the intracranial or other parts of the body;
- Fusiform, traumatic, bacterial or dissecting aneurysm;
- Subjects with severe mental illness unable to communicate when diagnosing disease;
- The body condition is poor, the survival time is less than 1 year or poor physical condition, cannot tolerate the general anesthesia or aneurysm surgery;
- Subjects involved in other intracranial aneurysms related clinical research;
- A patient who received surgical clipping or endovascular treatment at once;
- Subjects who were not followed up；
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The safety evaluation of interventional therapy and craniotomy clipping.
Periodo de tiempo: 6 months later after operation.
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2.The safety evaluation including the mortality(mRS=6) rate and disability(3<mRS<6) rate of subjects.
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6 months later after operation.
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The safety evaluation of interventional therapy and craniotomy clipping.
Periodo de tiempo: 6 months later after operation.
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The safety evaluation including the mortality(mRS=6) rate of subjects.
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6 months later after operation.
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Modified Rankin score ( mRS ).
Periodo de tiempo: 1 year.
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0. completely silent.
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1 year.
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Raymond classification.
Periodo de tiempo: 1 year.
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1 year.
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The effectiveness evaluation of craniotomy clipping.
Periodo de tiempo: 6 months later after operation.
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The effectiveness evaluation including the complete occlusion( Raymond classification=1) rate of aneurysms.
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6 months later after operation.
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The effectiveness evaluation of interventional treatment.
Periodo de tiempo: 6 months later after operation.
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The effectiveness evaluation including the recurrence ( Raymond classification =3) rate of aneurysms.
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6 months later after operation.
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The effectiveness evaluation of craniotomy clipping.
Periodo de tiempo: 6 months later after operation.
|
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
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6 months later after operation.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The safety evaluation interventional therapy.
Periodo de tiempo: 12 months later after operation.
|
The safety evaluation including the mortality( mRS=6)rate and disability(3<mRS<6 ) rate of subjects.
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12 months later after operation.
|
|
The effectiveness evaluation of interventional treatment.
Periodo de tiempo: 12 months later after operation.
|
The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.
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12 months later after operation.
|
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The success rate of treatment.
Periodo de tiempo: 6 months later after operation.
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Angiography revealed total or near total occlusion of aneurysm in 6 months after operation, no recurrence of aneurysm was found.
the treatment was considered successful.
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6 months later after operation.
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The incidence of major adverse events after 3 months of surgery.
Periodo de tiempo: 3 months.
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3 months.
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The incidence of major adverse events in 3 months and 6 months later after operation.
Periodo de tiempo: 3 months and 6 months later after operation.
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3 months and 6 months later after operation.
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The incidence of major adverse events in 6 months and 12 months later after operation.
Periodo de tiempo: 6 months and 12 months later after operation.
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6 months and 12 months later after operation.
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The safety evaluation of craniotomy clipping.
Periodo de tiempo: 12 months later after operation.
|
The safety evaluation including the mortality( MRS=6 ) rate and disability(3<MRS <6) rate of subjects.
|
12 months later after operation.
|
|
The effectiveness evaluation of interventional treatment.
Periodo de tiempo: 12 months later after operation.
|
The effectiveness evaluation including the recurrence( Raymond classification=3 ) rate of aneurysms.
|
12 months later after operation.
|
|
The effectiveness evaluation of craniotomy clipping.
Periodo de tiempo: 12 months later after operation.
|
The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.
|
12 months later after operation.
|
|
The effectiveness evaluation of craniotomy clipping.
Periodo de tiempo: 12 months later after operation.
|
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
|
12 months later after operation.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Xuying He, PH. D, Study Principal Investigator Department of Neurosurgery, Southern Medical University, Zhujiang 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 (Anticipado)
1 de noviembre de 2018
Finalización primaria (Anticipado)
31 de mayo de 2020
Finalización del estudio (Anticipado)
31 de mayo de 2020
Fechas de registro del estudio
Enviado por primera vez
7 de febrero de 2018
Primero enviado que cumplió con los criterios de control de calidad
8 de marzo de 2018
Publicado por primera vez (Actual)
12 de marzo de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de octubre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
2 de octubre de 2018
Última verificación
1 de octubre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016YFC1300800
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
investigators can share the original data 5 years after the study
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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