Unruptured Intracranial Aneurysms Clinical Trial
Official title:
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03063541 -
Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms
|
Phase 3 | |
| Completed |
NCT02862756 -
Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms
|
N/A | |
| Completed |
NCT01490463 -
Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms
|
N/A |