Intracranial AneurysmNCT03133598
Treatment of Unruptured Intracranial Aneurysms in China
An observational study of Intracranial Aneurysm and Stent Embolisation, run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Intracranial Aneurysm, Stent Embolisation, Craniotomy
- How many people
- 5,126 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with un-ruptured intracranial aneurysms.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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。
Trial locations and contacts
1 site in 1 country.
China1 site
Southern Medical University, Zhujiang Hospital
Guangzhou, Guangdong, 510282
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients with intracranial aneurysms who underwent endovascular or miro-neurosurgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months later after operation.
The effectiveness evaluation of interventional treatment .
The effectiveness evaluation including the complete occlusion（Raymond classification=1） rate of aneurysms.
Measured: 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
Measured: 1 year
Raymond classification
- Complete occlusion
- Partial occlusion
- Recurrence
Measured: 1 year
The effectiveness evaluation of craniotomy clipping.
The effectiveness evaluation including the recurrence（Raymond classification=3） rate of aneurysms.
Measured: 6 months later after operation.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: up to 24 months
The incidence of major adverse events during follow-up.
cerebrovascular complications including any intracranial hemorrhage, ischemia, or death
Measured: up to 24 months
The cost of interventional therapy or craniotomy clipping.
All costs associated with treatment
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Jan 2016
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Beijing Tiantan Hospital, Guangdong Provincial People's Hospital, First Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Southwest Medical University, West China Hospital, Shenzhen Second People's Hospital, Guangdong 999 Brain Hospital, Shantou Central Hospital, ZhuHai Hospital, Zhongshan Hospital Of Traditional Chinese Medicine, Third Affiliated Hospital, Sun Yat-Sen University, Eighth Affiliated Hospital, Sun Yat-sen University
- Responsible party
- Principal investigator, Duan Chuanzhi, Zhujiang Hospital
- Investigators
- Chuanzhi Duan, Ph.D., Principal investigator, Department of Neurosurgery, Southern Medical University, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133598
- Sponsor's protocol ID
- 2016YFC1300804
- Status last verified
- Sep 2024
- First submitted
- 7 Apr 2017
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data are available upon reasonable request. The data supporting this study's findings are available from the Principal Investigator （Chuanzhi Duan） upon reasonable request.
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.
PubMed 29794089
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Interventional Therapy and Craniotomy for Unruptured Aneurysms
- ClinicalTrials.gov ID
- NCT03133598
- Acronym / sponsor ID
- 2016YFC1300804
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,126 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Beijing Tiantan Hospital, Guangdong Provincial People's Hospital, First Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Southwest Medical University, West China Hospital, Shenzhen Second People's Hospital, Guangdong 999 Brain Hospital, Shantou Central Hospital, ZhuHai Hospital, Zhongshan Hospital Of Traditional Chinese Medicine, Third Affiliated Hospital, Sun Yat-Sen University, Eighth Affiliated Hospital, Sun Yat-sen University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with intracranial aneurysms who underwent endovascular or miro-neurosurgical treatment |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with un-ruptured intracranial aneurysms.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The safety evaluation of interventional therapy and craniotomy clipping.
Time frame: 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 .
Time frame: 6 months later after operation.
The effectiveness evaluation including the complete occlusion（Raymond classification=1） rate of aneurysms.
Clinical function prognosis
Time frame: 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
Time frame: 1 year
1. Complete occlusion 2. Partial occlusion 3. Recurrence
The effectiveness evaluation of craniotomy clipping.
Time frame: 6 months later after operation.
The effectiveness evaluation including the recurrence（Raymond classification=3） rate of aneurysms.
5 secondary outcomes
The safety evaluation of interventional therapy or craniotomy clipping.
Time frame: up to 24 months
The effectiveness evaluation of interventional treatment or craniotomy clipping.
Time frame: up to 24 months
The success rate of treatment or craniotomy clipping.
Time frame: up to 24 months
The incidence of major adverse events during follow-up.
Time frame: up to 24 months
The cost of interventional therapy or craniotomy clipping.
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Derived from this study: PubMed 29794089Chen 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.
- Individual participant dataSharing planned: No. Data are available upon reasonable request. The data supporting this study's findings are available from the Principal Investigator （Chuanzhi Duan） upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuanzhi Duan, Ph.D. principal investigator
Department of Neurosurgery, Southern Medical University, Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm and Stent Embolisation, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety evaluation of interventional therapy and craniotomy clipping. (time frame: 6 months later after operation.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.