- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03462433
Treatment of Ruptured Intracranial Aneurysms in China.
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Wenxian Zeng, M.D
- Phone Number: +86-013926290871
- Email: 602057619@qq.com
Study Contact Backup
- Name: Xifeng Li, PH. D
- Phone Number: +86-018620993755
- Email: nflxf@126.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510282
- Southern Medical University, Zhujiang Hospital
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Contact:
- Xuying He, PH. D
- Phone Number: +86-013688877133
- Email: hexuyingzj@163.com
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Contact:
- Wenxian Zeng, M.D
- Phone Number: 86-013926290871
- Email: 602057619@qq.com
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Principal Investigator:
- Xuying He, PH. D
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Sub-Investigator:
- Wenxian Zeng, M.D
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Sub-Investigator:
- Xin Zhang, PH. D
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Sub-Investigator:
- Xifeng Li, PH. D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The safety evaluation of interventional therapy and craniotomy clipping.
Time Frame: 6 months later after operation.
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2.The safety evaluation including the mortality(mRS=6) rate and disability(3<mRS<6) rate of subjects.
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6 months later after operation.
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The safety evaluation of interventional therapy and craniotomy clipping.
Time Frame: 6 months later after operation.
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The safety evaluation including the mortality(mRS=6) rate of subjects.
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6 months later after operation.
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Modified Rankin score ( mRS ).
Time Frame: 1 year.
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0. completely silent.
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1 year.
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Raymond classification.
Time Frame: 1 year.
|
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1 year.
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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.
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6 months later after operation.
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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.
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6 months later after operation.
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The effectiveness evaluation of craniotomy clipping.
Time Frame: 6 months later after operation.
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The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
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6 months later after operation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The safety evaluation interventional therapy.
Time Frame: 12 months later after operation.
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The safety evaluation including the mortality( mRS=6)rate and disability(3<mRS<6 ) rate of subjects.
|
12 months later after operation.
|
The effectiveness evaluation of interventional treatment.
Time Frame: 12 months later after operation.
|
The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.
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12 months later after operation.
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The success rate of treatment.
Time Frame: 6 months later after operation.
|
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.
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6 months later after operation.
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The incidence of major adverse events after 3 months of surgery.
Time Frame: 3 months.
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3 months.
|
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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.
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3 months and 6 months later after operation.
|
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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.
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6 months and 12 months later after operation.
|
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The safety evaluation of craniotomy clipping.
Time Frame: 12 months later after operation.
|
The safety evaluation including the mortality( MRS=6 ) rate and disability(3<MRS <6) rate of subjects.
|
12 months later after operation.
|
The effectiveness evaluation of interventional treatment.
Time Frame: 12 months later after operation.
|
The effectiveness evaluation including the recurrence( Raymond classification=3 ) rate of aneurysms.
|
12 months later after operation.
|
The effectiveness evaluation of craniotomy clipping.
Time Frame: 12 months later after operation.
|
The effectiveness evaluation including the complete occlusion( Raymond classification=1 ) rate of aneurysms.
|
12 months later after operation.
|
The effectiveness evaluation of craniotomy clipping.
Time Frame: 12 months later after operation.
|
The effectiveness evaluation including the recurrence( Raymond classification=3) rate of aneurysms.
|
12 months later after operation.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Xuying He, PH. D, Study Principal Investigator Department of Neurosurgery, Southern Medical University, Zhujiang Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016YFC1300800
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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