Treatment of Ruptured Intracranial Aneurysms in China.

NCT03462433 | Unknown DMC

• 1 other identifier: 2016YFC1300800
• Study Type: observational
• Target: 1,384
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  6 months later after operation.

• Modified Rankin score ( mRS ).

  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 complete occlusion( Raymond classification=1) rate of aneurysms.

  6 months later after operation.

• The effectiveness evaluation of interventional treatment.

  The effectiveness evaluation including the recurrence ( Raymond classification =3) rate of aneurysms.

  6 months later after operation.

• 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 (10)

• The safety evaluation interventional therapy.

  12 months later after operation.

• The effectiveness evaluation of interventional treatment.

  12 months later after operation.

• The success rate of treatment.

  6 months later after operation.

• The incidence of major adverse events after 3 months of surgery.

  3 months.

• The incidence of major adverse events in 3 months and 6 months later after operation.

  3 months and 6 months later after operation.

Eligibility Criteria

• Age: 14 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 ruptured intracranial aneurysms and un-ruptured intracranial aneurysms.

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Xuanwu Hospital, Beijing: collaborator
• Air Force Military Medical University, China: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

Southern Medical University, Zhujiang Hospital

Guangzhou, Guangdong, 510282, China

Location

Study Officials

• Xuying He, PH. D

  Study Principal Investigator Department of Neurosurgery, Southern Medical University, Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxian Zeng, M.D

CONTACT

+86-013926290871; 602057619@qq.com

Xifeng Li, PH. D

CONTACT

+86-018620993755; nflxf@126.com

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: February 7, 2018
• First Posted: March 12, 2018
• Study Start: November 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)