Treatment of Ruptured Intracranial Aneurysms in China.
2 octobre 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
1384
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Wenxian Zeng, M.D
- Numéro de téléphone: +86-013926290871
- E-mail: 602057619@qq.com
Sauvegarde des contacts de l'étude
- Nom: Xifeng Li, PH. D
- Numéro de téléphone: +86-018620993755
- E-mail: nflxf@126.com
Lieux d'étude
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Guangdong
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Guangzhou, Guangdong, Chine, 510282
- Southern Medical University, Zhujiang Hospital
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Contact:
- Xuying He, PH. D
- Numéro de téléphone: +86-013688877133
- E-mail: hexuyingzj@163.com
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Contact:
- Wenxian Zeng, M.D
- Numéro de téléphone: 86-013926290871
- E-mail: 602057619@qq.com
-
Chercheur principal:
- Xuying He, PH. D
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Sous-enquêteur:
- Wenxian Zeng, M.D
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Sous-enquêteur:
- Xin Zhang, PH. D
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Sous-enquêteur:
- Xifeng Li, PH. D
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
14 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients with ruptured intracranial aneurysms and un-ruptured intracranial aneurysms.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The safety evaluation of interventional therapy and craniotomy clipping.
Délai: 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.
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The safety evaluation of interventional therapy and craniotomy clipping.
Délai: 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.
|
|
Modified Rankin score ( mRS ).
Délai: 1 year.
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0. completely silent.
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1 year.
|
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Raymond classification.
Délai: 1 year.
|
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1 year.
|
|
The effectiveness evaluation of craniotomy clipping.
Délai: 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.
Délai: 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.
Délai: 6 months later after operation.
|
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
|
6 months later after operation.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The safety evaluation interventional therapy.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 6 months and 12 months later after operation.
|
6 months and 12 months later after operation.
|
|
|
The safety evaluation of craniotomy clipping.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 12 months later after operation.
|
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
|
12 months later after operation.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Xuying He, PH. D, Study Principal Investigator Department of Neurosurgery, Southern Medical University, Zhujiang Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 novembre 2018
Achèvement primaire (Anticipé)
31 mai 2020
Achèvement de l'étude (Anticipé)
31 mai 2020
Dates d'inscription aux études
Première soumission
7 février 2018
Première soumission répondant aux critères de contrôle qualité
8 mars 2018
Première publication (Réel)
12 mars 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 octobre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 octobre 2018
Dernière vérification
1 octobre 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2016YFC1300800
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
investigators can share the original data 5 years after the study
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .