Ruptured Intracranial AneurysmsNCT03462433
Treatment of Ruptured Intracranial Aneurysms in China.
An observational study of Ruptured Intracranial Aneurysms and Unruptured Intracranial Aneurysms, run by Zhujiang Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Ruptured Intracranial Aneurysms, Unruptured Intracranial Aneurysms, Stent-Assisted Coiling
- How many people
- 1,384 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 31 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ruptured intracranial aneurysms and un-ruptured intracranial aneurysms.
Who may be able to join
- At least one imaging methods( CTA/ MRA/DSA ) confirmed ruptured wide-neck intracranial aneurysms (fundus-to-neck ratio < 2 or neck diameter > 4 mm );
- Stent-Assisted Coiling of un-ruptured intracranial aneurysms, whether have clinical symptoms or no;
- For multiple aneurysms, regardless of previous treatment, the requirement for treatment interval should >6 months;
- The subjects age 14 years;
- subjects or family members agree to sign informed consent.
Who cannot join
- 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, cannot 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；
Trial locations and contacts
1 site in 1 country.
China1 site
Southern Medical University, Zhujiang Hospital
Guangzhou, Guangdong, 510282
Xuying He, PH. D, +86-013688877133, hexuyingzj@163.com
Wenxian Zeng, M.D, 86-013926290871, 602057619@qq.com
About this study
Official title: The Safety and Efficacy of Ruptured Intracranial Aneurysms Embolized Assisted With Stents（SERIAES）.
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.
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, 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.
- Conditions
- Ruptured Intracranial Aneurysms, Unruptured Intracranial Aneurysms, Stent-Assisted Coiling, Non-Stent-Assisted Coiling, Craniotomy Clipping
- Keywords
- Ruptured Intracranial Aneurysms, Unruptured Intracranial Aneurysms, Prospective cohort study, China
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.
2.The safety evaluation including the mortality(mRS=6) rate and disability(3<mRS<6) rate of subjects.
Measured: 6 months later after operation.
The safety evaluation of interventional therapy and craniotomy clipping.
The safety evaluation including the mortality(mRS=6) rate of subjects.
Measured: 6 months later after operation.
Modified Rankin score ( mRS ).
- 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 complete occlusion( Raymond classification=1) rate of aneurysms.
Measured: 6 months later after operation.
The effectiveness evaluation of interventional treatment.
The effectiveness evaluation including the recurrence ( Raymond classification =3) rate of aneurysms.
Measured: 6 months later after operation.
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 (10)
The safety evaluation interventional therapy.
The safety evaluation including the mortality( mRS=6)rate and disability(3<mRS<6 ) rate of subjects.
Measured: 12 months later after operation.
The effectiveness evaluation of interventional treatment.
The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.
Measured: 12 months later after operation.
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.
Measured: 6 months later after operation.
The incidence of major adverse events after 3 months of surgery.
Measured: 3 months.
The incidence of major adverse events in 3 months and 6 months later after operation.
Measured: 3 months and 6 months later after operation.
The incidence of major adverse events in 6 months and 12 months later after operation.
Measured: 6 months and 12 months later after operation.
The safety evaluation of craniotomy clipping.
The safety evaluation including the mortality( MRS=6 ) rate and disability(3<MRS <6) rate of subjects.
Measured: 12 months later after operation.
The effectiveness evaluation of interventional treatment.
The effectiveness evaluation including the recurrence( Raymond classification=3 ) rate of aneurysms.
Measured: 12 months later after operation.
The effectiveness evaluation of craniotomy clipping.
The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.
Measured: 12 months later after operation.
The effectiveness evaluation of craniotomy clipping.
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
Measured: 12 months later after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Nov 2018 (estimated)
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured Intracranial AneurysmsStudies 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
- 1,384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Air Force Military Medical University, China, Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Principal investigator, He xuying, Zhujiang Hospital
- Investigators
- Xuying He, PH. D, Principal investigator, Study Principal Investigator Department of Neurosurgery, Southern Medical University, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462433
- Sponsor's protocol ID
- 2016YFC1300800
- Status last verified
- Oct 2018
- First submitted
- 7 Feb 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: investigators can share the original data 5 years after the study
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Ruptured Intracranial Aneurysms Embolized Assisted With Stents（SERIAES）.
- ClinicalTrials.gov ID
- NCT03462433
- Acronym / sponsor ID
- 2016YFC1300800
- Conditions
- Ruptured Intracranial Aneurysms, Unruptured Intracranial Aneurysms, Stent-Assisted Coiling, Non-Stent-Assisted Coiling, Craniotomy Clipping
- Keywords
- Ruptured Intracranial Aneurysms, Unruptured Intracranial Aneurysms, Prospective cohort study, China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,384 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Air Force Military Medical University, China, Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 12 Mar 2018 (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.
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.
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, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ruptured intracranial aneurysms and un-ruptured intracranial aneurysms.
Key inclusion criteria (5 listed)
- At least one imaging methods( CTA/ MRA/DSA ) confirmed ruptured wide-neck intracranial aneurysms (fundus-to-neck ratio < 2 or neck diameter > 4 mm );
- Stent-Assisted Coiling of un-ruptured intracranial aneurysms, whether have clinical symptoms or no;
- For multiple aneurysms, regardless of previous treatment, the requirement for treatment interval should >6 months;
- The subjects age 14 years;
- subjects or family members agree to sign informed consent.
Key exclusion criteria (8 listed)
- 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, cannot tolerate the general anesthesia or aneurysm surgery;
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.
2.The safety evaluation including the mortality(mRS=6) rate and disability(3<mRS<6) rate of subjects.
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 of subjects.
Modified Rankin score ( mRS ).
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 complete occlusion( Raymond classification=1) rate of aneurysms.
The effectiveness evaluation of interventional treatment.
Time frame: 6 months later after operation.
The effectiveness evaluation including the recurrence ( Raymond classification =3) rate of aneurysms.
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.
10 secondary outcomes
The safety evaluation interventional therapy.
Time frame: 12 months later after operation.
The effectiveness evaluation of interventional treatment.
Time frame: 12 months later after operation.
The success rate of treatment.
Time frame: 6 months later after operation.
The incidence of major adverse events after 3 months of surgery.
Time frame: 3 months.
The incidence of major adverse events in 3 months and 6 months later after operation.
Time frame: 3 months and 6 months later after operation.
The incidence of major adverse events in 6 months and 12 months later after operation.
Time frame: 6 months and 12 months later after operation.
The safety evaluation of craniotomy clipping.
Time frame: 12 months later after operation.
The effectiveness evaluation of interventional treatment.
Time frame: 12 months later after operation.
The effectiveness evaluation of craniotomy clipping.
Time frame: 12 months later after operation.
The effectiveness evaluation of craniotomy clipping.
Time frame: 12 months later after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Individual participant dataSharing planned: Yes. investigators can share the original data 5 years after the study
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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.
Xuying He, PH. D principal investigator
Study 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 Ruptured Intracranial Aneurysms and Unruptured Intracranial Aneurysms, 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 8 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: status not confirmed, as of the sponsor's last update on 3 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenxian Zeng, M.D (+86-013926290871, 602057619@qq.com), or a site near the patient. 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 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2018.