Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China

NCT04572568 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2022-05-23

No results posted yet for this study

Summary

This study is a multi-center, prospective, registry study. This research was supported by the National Key Research and Development Program. They were divided into experimental group and control group according to whether the treatment plan was formulated by a multidisciplinary team. Patients of experimental group is strictly in accordance with standardized multi-disciplinary treatment protocols and meet the following criteria: 1. A multi-disciplinary conference discussion; 2. Detailed preoperative evaluation based on CT, MRI, fMRI and DSA. 3. Treatment modalities meet the following treatment criteria(craniotomy, embolization and stereotactic radiosurgery). The control group was patients who had not been treated according to a multi-disciplinary treatment protocol.

Patient baseline data, AVM angioarchitectural features, imaging DICOM data, surgical information, and follow-up information were registered. All patients were evaluated for neurofunction at baseline, 3 months, 12 months, and 3 years after treatment. Main observation endpoints: 1. Modified Rankin Scale; 2. Obliteration rate; 3. Subsequent hemorrhage; 4. Complication rate (such as morbidity rate, new-onset neurological dysfunction, and radiation-related complications). Secondary observation endpoint: improvement of clinical symptoms (epilepsy, headache, neurological dysfunction) at 3 months, 12 months, and 3 years after treatment.

Conditions

  • Brain Arteriovenous Malformation

Interventions

OTHER

Multi-disciplinary assessment

1. Comprehensive evaluation by multidisciplinary experts; 2. Preoperative multi-modal imaging examination was applied to determine the angioarchitecture, functional fiber bundle, and hemodynamics.

Sponsors & Collaborators

  • Beijing Neurosurgical Institute

    collaborator OTHER
  • Peking University International Hospital

    collaborator OTHER
  • West China Hospital

    collaborator OTHER
  • First Affiliated Hospital of Harbin Medical University

    collaborator OTHER
  • Sichuan Provincial People's Hospital

    collaborator OTHER
  • The First Hospital of Jilin University

    collaborator OTHER
  • Shanxi Provincial People's Hospital

    collaborator OTHER_GOV
  • The Second Hospital of Shandong University

    collaborator OTHER
  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER
  • First Affiliated Hospital of Xinjiang Medical University

    collaborator OTHER
  • The General Hospital of Central Theater Command

    collaborator OTHER
  • The Affiliated Hospital Of Guizhou Medical University

    collaborator OTHER
  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER
  • Tianjin Medical University Second Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Shanxi Medical University

    collaborator OTHER
  • Shengjing Hospital

    collaborator OTHER
  • Second Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER
  • Hainan People's Hospital

    collaborator OTHER
  • The Second Affiliated Hospital of Kunming Medical University

    collaborator OTHER
  • The Affiliated Hospital of Qingdao University

    collaborator OTHER
  • Second Xiangya Hospital of Central South University

    collaborator OTHER
  • Second Affiliated Hospital of Soochow University

    collaborator OTHER
  • General Hospital of Ningxia Medical University

    collaborator OTHER
  • Lanzhou University Second Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER
  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER
  • Qilu Hospital of Shandong University

    collaborator OTHER
  • Jining Medical University

    collaborator OTHER
  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER
  • First Affiliated Hospital of Fujian Medical University

    collaborator OTHER
  • Shandong Provincial Hospital

    collaborator OTHER_GOV
  • The Affiliated Hospital of Xuzhou Medical University

    collaborator OTHER
  • Henan Provincial People's Hospital

    collaborator OTHER
  • Binzhou Medical University

    collaborator OTHER
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER
  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Wang Shuo, MD · Beijing Tiantan Hospital

  • Li Youxiang, MD · Beijing Neurosurgical Institute

  • Liu Ali, MD · Beijing Neurosurgical Institute

  • Zhao Yuanli, MD · Beijing Neurosurgical Institute

  • Chen Xiaolin, MD · Beijing Neurosurgical Institute

Eligibility

Min Age
1 Year
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-01
Primary Completion
2032-04-01
Completion
2033-04-01

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 NCT04572568 on ClinicalTrials.gov