Treatment of Ruptured Intracranial Aneurysms in China.

Unruptured Intracranial Aneurysms Clinical Trial

Official title:

The Safety and Efficacy of Ruptured Intracranial Aneurysms Embolized Assisted With Stents（SERIAES）.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03462433
• Other study ID #: 2016YFC1300800
• Status: Not yet recruiting
• Start date: November 1, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2018
• Source: Zhujiang Hospital
• Contact: Wenxian Zeng, M.D
• Phone: +86-013926290871
• Email: 602057619[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1384
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Aneurysm
• Craniotomy Clipping
• Intracranial Aneurysm
• Non-Stent-Assisted Coiling
• Rupture
• Ruptured Intracranial Aneurysms
• Stent-Assisted Coiling
• Unruptured Intracranial Aneurysms

Locations

Country	Name	City	State
China	Southern Medical University, Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
Zhujiang Hospital	First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Wenzhou Medical Univeristy, Fourth Military Medical University, Second Affiliated Hospital of Nanchang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, The First Affiliated Hospital of Zhengzhou University, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety evaluation of interventional therapy and craniotomy clipping.	2.The safety evaluation including the mortality(mRS=6) rate and disability(3	6 months later after operation.
Primary	The safety evaluation of interventional therapy and craniotomy clipping.	The safety evaluation including the mortality(mRS=6) rate of subjects.	6 months later after operation.
Primary	Modified Rankin score ( mRS ).	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.
Primary	Raymond classification.	Complete occlusion; Partial occlusion; Recurrence.	1 year.
Primary	The effectiveness evaluation of craniotomy clipping.	The effectiveness evaluation including the complete occlusion( Raymond classification=1) rate of aneurysms.	6 months later after operation.
Primary	The effectiveness evaluation of interventional treatment.	The effectiveness evaluation including the recurrence ( Raymond classification =3) rate of aneurysms.	6 months later after operation.
Primary	The effectiveness evaluation of craniotomy clipping.	The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.	6 months later after operation.
Secondary	The safety evaluation interventional therapy.	The safety evaluation including the mortality( mRS=6)rate and disability(3	12 months later after operation.
Secondary	The effectiveness evaluation of interventional treatment.	The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.	12 months later after operation.
Secondary	The success rate of treatment.	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.
Secondary	The incidence of major adverse events after 3 months of surgery.		3 months.
Secondary	The incidence of major adverse events in 3 months and 6 months later after operation.		3 months and 6 months later after operation.
Secondary	The incidence of major adverse events in 6 months and 12 months later after operation.		6 months and 12 months later after operation.
Secondary	The safety evaluation of craniotomy clipping.	The safety evaluation including the mortality( MRS=6 ) rate and disability(3	12 months later after operation.
Secondary	The effectiveness evaluation of interventional treatment.	The effectiveness evaluation including the recurrence( Raymond classification=3 ) rate of aneurysms.	12 months later after operation.
Secondary	The effectiveness evaluation of craniotomy clipping.	The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.	12 months later after operation.
Secondary	The effectiveness evaluation of craniotomy clipping.	The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.	12 months later after operation.