Treatment of Unruptured Intracranial Aneurysms in China

Prospective Cohort Study of Interventional Therapy and Craniotomy for Unruptured Aneurysms

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(estimated sample number over 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.

Study Overview

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

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 participanted 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 Type: Observational
• Enrollment (Actual): 5126

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with un-ruptured intracranial aneurysms.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; patients with intracranial aneurysms who underwent endovascular or miro-neurosurgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effectiveness evaluation of interventional treatment .	The effectiveness evaluation including the complete occlusion（Raymond classification=1） rate of aneurysms.	6 months later after operation.
Raymond classification	Complete occlusion; Partial occlusion; Recurrence	1 year
The effectiveness evaluation of craniotomy clipping.	The effectiveness evaluation including the recurrence（Raymond classification=3） rate of aneurysms.	6 months later after operation.
The safety evaluation of interventional therapy and craniotomy clipping.	The safety evaluation including the mortality（mRS=6） rate and disability（2<mRS<6） rate of subjects.	6 months later after operation.
Clinical function prognosis	0 completely silent; despite symptoms, but not visibly disabled, can complete all regular duties and activities; mild disabilities, not all activities previously possible, but can deal with personal affairs without need of assistance; moderate disability requires some help, but walking does not need assistance; severe disabilities, unable to walk independently, no others can not meet their needs; severely disabled, bedridden, Urine, requiring continuous care and care; mortality	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: Beijing Tiantan Hospital; West China Hospital; Xuanwu Hospital, Beijing; Guangdong Provincial People's Hospital; Third Affiliated Hospital, Sun Yat-Sen University; Shenzhen Second People's Hospital; Shantou Central Hospital; First Affiliated Hospital of Chongqing Medical University; The Affiliated Hospital Of Southwest Medical University; Guangdong 999 Brain Hospital; ZhuHai Hospital; Eighth Affiliated Hospital, Sun Yat-sen University; Zhongshan Hospital Of Traditional Chinese Medicine
• Investigators: Principal Investigator: Chuanzhi Duan, Ph.D., Department of Neurosurgery, Southern Medical University, Zhujiang Hospital

Publications and helpful links

General Publications

• Chen Y, Fan H, He X, Guo S, Li X, He M, Qu Y, Yang X, Zhang H, Sun X, Wang L, Wang Z, Tong X, Zhong M, Maimaitili A, Tong Z, Duan C. China Intracranial Aneurysm Project (CIAP): protocol for a prospective cohort study of interventional treatment and craniotomy for unruptured aneurysms. BMJ Open. 2018 May 24;8(5):e019333. doi: 10.1136/bmjopen-2017-019333.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: China; Prospective cohort study; Un-ruptured intracranial aneurysm; Interventional therapy and craniotomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 2016YFC1300804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data are available upon reasonable request. The data supporting this study's findings are available from the Principal Investigator （Chuanzhi Duan） upon reasonable request.