Study of Treatment of Unruptured Intracranial Aneurysms in China

• Conditions: Intracranial Aneurysm; Stent Embolisation; Craniotomy; Coil-assissted Embolisation; Covered Stent; Woven EndoBridge

• Registration Number: NCT03133598
• Lead Sponsor: Zhujiang Hospital

Brief Summary

Un-ruptured intracranial aneurysm is a complex disease that seriously affects human life and health. At present, the treatment of intracranial aneurysm is divided into interventional treatment and craniotomy clipping, the two treatment methods are different in the intervention effect of aneurysm, for example, the complications of interventional therapy are lower than craniotomy clipping, but the long-term patency rate is lower than craniotomy clipping, and there is no standard of treatment in different parts of aneurysm in our country, the choice of intervention measures of un-ruptured aneurysm is different in different clinical centers; on the other hand, there are serious problems in the treatment of aneurysms, because without the relevant guidelines of diagnosis and treatment of intracranial aneurysms, different clinical centers will cause excessive treatment of un-ruptured aneurysms, not only bring unreasonable utilization of medical resources, but also cause the subject's life and property to be threatened.

The patients with un-ruptured intracranial aneurysm(n=1500) were included in prospective cohort study, after clipping and intervention operation, 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 un-ruptured intracranial aneurysms.

Detailed Description

For this study,investigators consulted and hired professionals and experts about data collection, data and methodology,including Data Monitoring Committee, Data Management Committee, Progect 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 20 different research hospitals, organizing the monthly meeting to consider issures raised during the monthly progress of the study, liaising with the steering committee,the data management centre and statistical centre. Data management Committee: To be responsible for setting up and maintain the Electronic Data Capture (EDC) System according to the papera 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 Mornitoring Committee: To determine the frequency of the data mornitoring 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 mornitoring 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 evalutating. 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 to get the perfessional statistical report. Technical Support Center:To provide technical support during the process of the study.

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-27
• Last Update Submitted: 2017-04-27
• Study First Posted: 2017-04-28
• Last Update Posted: 2017-04-28
• Study Start: 2017-05-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. At least one imaging methods( CTA / MRA / DSA ) confirmed un-ruptured intracranial aneurysms, whether have clinical symptoms or not;
2. For multiple aneurysms, regardless of previous treatment, the requirement for treatment interval should > 6 months.
3. The patient has the autonomous life ability, the scores of MRS≤ 3 points;
4. The subjects age > 14 years
5. subjects or family members agree to sign informed consent.

Exclusion Criteria

1. Intracranial aneurysms and with 30 days of unexplained subarachnoid hemorrhage;
2. Subjects with other intracranial vascular malformations, such as AVM, AVF, etc.;
3. Subjects with malignant tumors in the intracranial or other parts of the body;
4. Fusiform, traumatic, bacterial or dissecting aneurysm;
5. Subjects with severe mental illness unable to communicate when diagnosing disease;
6. The body condition is poor, the survival time is less than 1 year or poor physical condition, can not tolerate the general anesthesia or aneurysm surgery;
7. Subjects involved in other intracranial aneurysms related clinical research;
8. A patient who received surgical clipping or endovascular treatment at once;
9. Subjects who were not followed up.
10. < 3 mm intracranial aneurysm。

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety evaluation of interventional therapy and craniotomy clipping.	6 months later after operation.	The safety evaluation including the mortality（mRS=6） rate and disability（2\<mRS\<6） rate of subjects.
The effectiveness evaluation of interventional treatment .	6 months later after operation.	The effectiveness evaluation including the complete occlusion（Raymond classification=1） rate of aneurysms.
Clinical function prognosis	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
Raymond classification	1 year	1. Complete occlusion; 2. Partial occlusion; 3. Recurrence
The effectiveness evaluation of craniotomy clipping.	6 months later after operation.	The effectiveness evaluation including the recurrence（Raymond classification=3） rate of aneurysms.

Secondary Outcome Measures

Name	Time	Method
The safety evaluation of interventional therapy or craniotomy clipping.	up to 24 months	The safety evaluation including the mortality（mRS=6） rate and disability（2\<mRS\<6） rate of subjects.
The effectiveness evaluation of interventional treatment or craniotomy clipping.	up to 24 months	The effectiveness evaluation including the complete occlusion（Raymond classification=1） rate of aneurysms.
The success rate of treatment or craniotomy clipping.	up to 24 months	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.
The incidence of major adverse events during follow-up.	up to 24 months	cerebrovascular complications including any intracranial hemorrhage, ischemia, or death
The cost of interventional therapy or craniotomy clipping.	up to 24 months	All costs associated with treatment

Trial Locations

Locations (1)

Southern Medical University, Zhujiang Hospital; 🇨🇳 Guangzhou, Guangdong, China