Treatment of Ruptured Intracranial Aneurysms in China.

NCT03462433 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1384

Last updated 2018-10-03

No results posted yet for this study

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

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    collaborator OTHER
  • Air Force Military Medical University, China

    collaborator OTHER
  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER
  • First Affiliated Hospital of Harbin Medical University

    collaborator OTHER
  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER
  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER
  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER
  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Xuying He, PH. D · Study Principal Investigator Department of Neurosurgery, Southern Medical University, Zhujiang Hospital

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462433 on ClinicalTrials.gov