Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-80
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

Qualifiers

The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).

Patients with complete clinical and imaging data.

Patient or patient's legal representative agreed to collection of information for this study and signed informed consent.

Disqualifiers

Received other treatment (surgery, embolization or SRS)before inclusion;

Expected survival time is less than 6 months;

Spinal AVMs;

Patients missing critical baseline and imaging data.

Trial design

Treatments tested in this trial

  • Multi-disciplinary assessment

Treatment groups

2,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Tiantan Hospital

Lead sponsor

Beijing Neurosurgical Institute

Collaborator

Peking University International Hospital

Collaborator

West China Hospital

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator

Sichuan Provincial People's Hospital

Collaborator

The First Hospital of Jilin University

Collaborator

Shanxi Provincial People's Hospital

Collaborator

The Second Hospital of Shandong University

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

First Affiliated Hospital of Xinjiang Medical University

Collaborator

The General Hospital of Central Theater Command

Collaborator

The Affiliated Hospital Of Guizhou Medical University

Collaborator

First Affiliated Hospital of Guangxi Medical University

Collaborator

Tianjin Medical University Second Hospital

Collaborator

The First Affiliated Hospital of Shanxi Medical University

Collaborator

Shengjing Hospital

Collaborator

Second Affiliated Hospital of Guangzhou Medical University

Collaborator

Hainan People's Hospital

Collaborator

The Second Affiliated Hospital of Kunming Medical University

Collaborator

The Affiliated Hospital of Qingdao University

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Second Affiliated Hospital of Soochow University

Collaborator

General Hospital of Ningxia Medical University

Collaborator

Lanzhou University Second Hospital

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

First Affiliated Hospital of Zhejiang University

Collaborator

Qilu Hospital of Shandong University

Collaborator

Jining Medical University

Collaborator

First Affiliated Hospital of Chongqing Medical University

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator

Shandong Provincial Hospital

Collaborator

The Affiliated Hospital of Xuzhou Medical University

Collaborator

Henan Provincial People's Hospital

Collaborator

Binzhou Medical University

Collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborator