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Treatment of Ruptured Intracranial Aneurysms in China.

2 ottobre 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Anticipato)

1384

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510282
        • Southern medical university, zhujiang hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

14 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients with ruptured intracranial aneurysms and un-ruptured intracranial aneurysms.

Descrizione

Inclusion Criteria:

  1. At least one imaging methods( CTA/ MRA/DSA ) confirmed ruptured wide-neck intracranial aneurysms (fundus-to-neck ratio < 2 or neck diameter > 4 mm );
  2. Stent-Assisted Coiling of un-ruptured intracranial aneurysms, whether have clinical symptoms or no;
  3. For multiple aneurysms, regardless of previous treatment, the requirement for treatment interval should >6 months;
  4. The subjects age 14 years;
  5. subjects or family members agree to sign informed consent.

Exclusion Criteria:

  1. Subjects with other intracranial vascular malformations, such as AVM, AVF. Etc;
  2. Subjects with malignant tumors in the intracranial or other parts of the body;
  3. Fusiform, traumatic, bacterial or dissecting aneurysm;
  4. Subjects with severe mental illness unable to communicate when diagnosing disease;
  5. 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;
  6. Subjects involved in other intracranial aneurysms related clinical research;
  7. A patient who received surgical clipping or endovascular treatment at once;
  8. Subjects who were not followed up；

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The safety evaluation of interventional therapy and craniotomy clipping.
Lasso di tempo: 6 months later after operation.
2.The safety evaluation including the mortality(mRS=6) rate and disability(3<mRS<6) rate of subjects.
6 months later after operation.
The safety evaluation of interventional therapy and craniotomy clipping.
Lasso di tempo: 6 months later after operation.
The safety evaluation including the mortality(mRS=6) rate of subjects.
6 months later after operation.
Modified Rankin score ( mRS ).
Lasso di tempo: 1 year.

0. completely silent.

  1. despite symptoms, but not visibly disabled, can complete all regular duties and activities
  2. mild disabilities, not all activities previously possible, but can deal with personal affairs without need of assistance
  3. moderate disability requires some help, but walking does not need assistance
  4. severe disabilities, unable to walk independently, no others can not meet their needs
  5. severely disabled, bedridden, Urine, requiring continuous care and care
  6. mortality.
1 year.
Raymond classification.
Lasso di tempo: 1 year.
  1. Complete occlusion
  2. Partial occlusion
  3. Recurrence.
1 year.
The effectiveness evaluation of craniotomy clipping.
Lasso di tempo: 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.
Lasso di tempo: 6 months later after operation.
The effectiveness evaluation including the recurrence ( Raymond classification =3) rate of aneurysms.
6 months later after operation.
The effectiveness evaluation of craniotomy clipping.
Lasso di tempo: 6 months later after operation.
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
6 months later after operation.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The safety evaluation interventional therapy.
Lasso di tempo: 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.
Lasso di tempo: 12 months later after operation.
The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.
12 months later after operation.
The success rate of treatment.
Lasso di tempo: 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.
Lasso di tempo: 3 months.
3 months.
The incidence of major adverse events in 3 months and 6 months later after operation.
Lasso di tempo: 3 months and 6 months later after operation.
3 months and 6 months later after operation.
The incidence of major adverse events in 6 months and 12 months later after operation.
Lasso di tempo: 6 months and 12 months later after operation.
6 months and 12 months later after operation.
The safety evaluation of craniotomy clipping.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 12 months later after operation.
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
12 months later after operation.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zhujiang Hospital

Collaboratori

Second Affiliated Hospital, School of Medicine, Zhejiang University
Xuanwu Hospital, Beijing
The First Affiliated Hospital of Zhengzhou University
Air Force Military Medical University, China
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Nanchang University
First Affiliated Hospital of Harbin Medical University

Investigatori

  • Investigatore principale: Xuying He, PH. D, Study Principal Investigator Department of Neurosurgery, Southern Medical University, Zhujiang Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 novembre 2018

Completamento primario (Anticipato)

31 maggio 2020

Completamento dello studio (Anticipato)

31 maggio 2020

Date di iscrizione allo studio

Primo inviato

7 febbraio 2018

Primo inviato che soddisfa i criteri di controllo qualità

8 marzo 2018

Primo Inserito (Effettivo)

12 marzo 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 ottobre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 ottobre 2018

Ultimo verificato

1 ottobre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2016YFC1300800

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

investigators can share the original data 5 years after the study

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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