Treatment of Unruptured Intracranial Aneurysms in China

NCT03133598 | Completed DMC

• 1 other identifier: 2016YFC1300804
• Study Type: observational
• Target: 5,126
• Locations: 1 country
• Sites: 1

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(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.

Conditions

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

Keywords

Un-ruptured intracranial aneurysm; Interventional therapy and craniotomy; Prospective cohort study; China

Outcome Measures

Primary Outcomes (5)

• 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.

• The effectiveness evaluation of interventional treatment .

  The effectiveness evaluation including the complete occlusion（Raymond classification=1） rate of aneurysms.

  6 months later after operation.

• Clinical function prognosis

  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

  1. Complete occlusion 2. Partial occlusion 3. 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.

Secondary Outcomes (5)

• The safety evaluation of interventional therapy or craniotomy clipping.

  up to 24 months

• The effectiveness evaluation of interventional treatment or craniotomy clipping.

  up to 24 months

• The success rate of treatment or craniotomy clipping.

  up to 24 months

• The incidence of major adverse events during follow-up.

  up to 24 months

• The cost of interventional therapy or craniotomy clipping.

  up to 24 months

Study Arms (1)

1

patients with intracranial aneurysms who underwent endovascular or miro-neurosurgical treatment

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with un-ruptured intracranial aneurysms.

You may qualify if:

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

You may not qualify if:

• Intracranial aneurysms and with 30 days of unexplained subarachnoid hemorrhage;
• Subjects with other intracranial vascular malformations, such as AVM, AVF, etc.;
• Subjects with malignant tumors in the intracranial or other parts of the body;
• Fusiform, traumatic, bacterial or dissecting aneurysm;
• Subjects with severe mental illness unable to communicate when diagnosing disease;
• 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;
• Subjects involved in other intracranial aneurysms related clinical research;
• A patient who received surgical clipping or endovascular treatment at once;
• Subjects who were not followed up.
• \< 3 mm intracranial aneurysm。

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Xuanwu Hospital, Beijing: collaborator
• Beijing Tiantan Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• The Affiliated Hospital Of Southwest Medical University: collaborator
• West China Hospital: collaborator
• Shenzhen Second People's Hospital: collaborator
• Guangdong 999 Brain Hospital: collaborator
• Shantou Central Hospital: collaborator
• ZhuHai Hospital: collaborator
• Zhongshan Hospital Of Traditional Chinese Medicine: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Eighth Affiliated Hospital, Sun Yat-sen University: collaborator

Study Sites (1)

Southern Medical University, Zhujiang Hospital

Guangzhou, Guangdong, 510282, China

Location

Related Publications (1)

• 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.

  PMID: 29794089 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chuanzhi Duan, Ph.D.

  Department of Neurosurgery, Southern Medical University, Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director, department of neurosurgery, southern medical university, Guangzhou

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 28, 2017
• Study Start: January 1, 2016
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)