Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04572568

Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

1 Year - 80 Years

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2011-08-01

Completion Date

2033-04-01

Last Updated

2022-05-23

Healthy Volunteers

No

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.

Locations (1)

Capital medical university affiliated Beijing Tiantan hospital

Beijing, Beijing Municipality, China