Treatment of Ruptured Intracranial Aneurysms in China.
2 de outubro de 2018 atualizado 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.
Visão geral do estudo
Status
Desconhecido
Descrição detalhada
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 estudo
Observacional
Inscrição (Antecipado)
1384
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Wenxian Zeng, M.D
- Número de telefone: +86-013926290871
- E-mail: 602057619@qq.com
Estude backup de contato
- Nome: Xifeng Li, PH. D
- Número de telefone: +86-018620993755
- E-mail: nflxf@126.com
Locais de estudo
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Guangdong
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Guangzhou, Guangdong, China, 510282
- Southern Medical University, Zhujiang Hospital
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Contato:
- Xuying He, PH. D
- Número de telefone: +86-013688877133
- E-mail: hexuyingzj@163.com
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Contato:
- Wenxian Zeng, M.D
- Número de telefone: 86-013926290871
- E-mail: 602057619@qq.com
-
Investigador principal:
- Xuying He, PH. D
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Subinvestigador:
- Wenxian Zeng, M.D
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Subinvestigador:
- Xin Zhang, PH. D
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Subinvestigador:
- Xifeng Li, PH. D
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
14 anos e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients with ruptured intracranial aneurysms and un-ruptured intracranial aneurysms.
Descrição
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；
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The safety evaluation of interventional therapy and craniotomy clipping.
Prazo: 6 months later after operation.
|
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.
|
|
The safety evaluation of interventional therapy and craniotomy clipping.
Prazo: 6 months later after operation.
|
The safety evaluation including the mortality(mRS=6) rate of subjects.
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6 months later after operation.
|
|
Modified Rankin score ( mRS ).
Prazo: 1 year.
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0. completely silent.
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1 year.
|
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Raymond classification.
Prazo: 1 year.
|
|
1 year.
|
|
The effectiveness evaluation of craniotomy clipping.
Prazo: 6 months later after operation.
|
The effectiveness evaluation including the complete occlusion( Raymond classification=1) rate of aneurysms.
|
6 months later after operation.
|
|
The effectiveness evaluation of interventional treatment.
Prazo: 6 months later after operation.
|
The effectiveness evaluation including the recurrence ( Raymond classification =3) rate of aneurysms.
|
6 months later after operation.
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The effectiveness evaluation of craniotomy clipping.
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The safety evaluation interventional therapy.
Prazo: 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.
|
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The effectiveness evaluation of interventional treatment.
Prazo: 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.
Prazo: 6 months later after operation.
|
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.
|
6 months later after operation.
|
|
The incidence of major adverse events after 3 months of surgery.
Prazo: 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.
Prazo: 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.
Prazo: 6 months and 12 months later after operation.
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6 months and 12 months later after operation.
|
|
|
The safety evaluation of craniotomy clipping.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Xuying He, PH. D, Study Principal Investigator Department of Neurosurgery, Southern Medical University, Zhujiang Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de novembro de 2018
Conclusão Primária (Antecipado)
31 de maio de 2020
Conclusão do estudo (Antecipado)
31 de maio de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
7 de fevereiro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de março de 2018
Primeira postagem (Real)
12 de março de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de outubro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de outubro de 2018
Última verificação
1 de outubro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2016YFC1300800
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
investigators can share the original data 5 years after the study
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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