RecruitingNCT04572568

Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China


Sponsor

Beijing Tiantan Hospital

Enrollment

2,000 participants

Start Date

Aug 1, 2011

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 80 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria4

  • 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.

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Interventions

OTHERMulti-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.


Locations(1)

Capital medical university affiliated Beijing Tiantan hospital

Beijing, Beijing Municipality, China

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NCT04572568


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