Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China

ConditionBrain Arteriovenous Malformation

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

This trial does not accept healthy volunteers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

2,000 Participants

are divided into 2 treatment groups

Group A: experimental group1 intervention

Group B: control group0 interventions

Trial outcomes

Primary outcomes

modified Rankin Scale

The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.

Time frame