Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China
NCT04572568 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000
Last updated 2022-05-23
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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