Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China

NCT04572568 | Recruiting

• 1 other identifier: KY 2020-003-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Brain Arteriovenous Malformation; multi-disciplinary treatment; embolization; stereotactic radiosurgery; microsurgical resection; hybrid surgery; conservative/medical treatment; hemodynamic; outcomes; subsequent hemorrhage; obliteration

Outcome Measures

Primary Outcomes (4)

• 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.

  3 months, 1 year, and 3 years after treatment

• obliteration rate

  Complete obliteration of the nidus was confirmed by DSA or MRA, then compare the obliteration rate between each group.

  3 months, 1 year, and 3 years after treatment

• subsequent hemorrhage

  Intracranial hemorrhage that could be attributed to AVMs, and can be confirmed by CT and other imaging.

  3 months, 1 year, and 3 years after treatment

• complication rate

  such as morbidity rate, new-onset neurological dysfunction, and radiation-related complications

  3 months, 1 year, and 3 years after treatment

Secondary Outcomes (3)

• Improvement of epilepsy

  3 months, 1 year, and 3 years after treatment

• Improvement of headache

  3 months, 1 year, and 3 years after treatment

• Improvement of neurological dysfunction

  3 months, 1 year, and 3 years after treatment

Study Arms (2)

experimental group

Ruptured AVMs: 1. AVMs not involved vital eloquent areas, or more than 5 mm away from functional fiber bundles, microsurgery or hybrid surgery can be performed; 2. Targeted embolization for hemorrhagic predictors could be considered as a monotherapy; embolization can be used as an adjunctive strategy to reduce flow or volume before microsurgery or stereotactic radiosurgery (SRS). 3. SRS for patients with a volume less than 10ml and not in the acute phase(\< 3months) of hemorrhage. Volume-stage or dose-stage can be used for giant AVMs involving important eloquent areas. 4. Conservation can be used for AVMs that are prone to severe disability due to intervention. Unruptured AVMs: Interventions are recommended if unruptured AVMs are assessed as being at high rupture risk, or have refractory epilepsy or acceptable postoperative neurological deficits, otherwise conservative treatment is recommended. The choice of intervention strategy was the same as for ruptured AVM.

Other: Multi-disciplinary assessment

control group

Patients who had not received a multidisciplinary assessment to develop a treatment plan were included in the control group. It should be noted that the multidisciplinary team for AVM was formed in June 2018, so the prospective AVM cohort from August 2011 to June 2018 and the AVM cohort after June 2018 without comprehensive evaluation of treatment regimens by the multidisciplinary team served as the control group.

Interventions

Multi-disciplinary assessment OTHER

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

experimental group

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Expected survival time is less than 6 months;
• Spinal AVMs;
• Patients missing critical baseline and imaging data.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• 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

Study Sites (1)

Capital medical university affiliated Beijing Tiantan hospital

Beijing, Beijing Municipality, 101100, China

RECRUITING

Related Publications (16)

• Meng X, Gao D, He H, Sun S, Liu A, Jin H, Li Y. A Machine Learning Model Predicts the Outcome of SRS for Residual Arteriovenous Malformations after Partial Embolization: A Real-World Clinical Obstacle. World Neurosurg. 2022 Jul;163:e73-e82. doi: 10.1016/j.wneu.2022.03.007. Epub 2022 Mar 9.

  PMID: 35276397 RESULT

• Meng X, Gao D, Jin H, Wang K, Bao E, Liu A, Li Y, Sun S. Factors Affecting Volume Reduction Velocity for Arteriovenous Malformations After Treatment With Dose-Stage Stereotactic Radiosurgery. Front Oncol. 2021 Dec 20;11:769533. doi: 10.3389/fonc.2021.769533. eCollection 2021.

  PMID: 34988014 RESULT

• Li Z, Chen Y, Chen P, Li R, Ma L, Yan D, Zhang H, Han H, Zhao Y, Zhang Y, Meng X, Jin H, Li Y, Chen X, Zhao Y. Quantitative evaluation of hemodynamics after partial embolization of brain arteriovenous malformations. J Neurointerv Surg. 2022 Nov;14(11):1112-1117. doi: 10.1136/neurintsurg-2021-018187. Epub 2021 Dec 6.

  PMID: 34872987 RESULT

• Yan D, Chen Y, Li Z, Zhang H, Li R, Yuan K, Han H, Meng X, Jin H, Gao D, Li Y, Sun S, Liu A, Chen X, Zhao Y. Stereotactic Radiosurgery With vs. Without Prior Embolization for Brain Arteriovenous Malformations: A Propensity Score Matching Analysis. Front Neurol. 2021 Oct 12;12:752164. doi: 10.3389/fneur.2021.752164. eCollection 2021.

  PMID: 34712200 RESULT

• Meng X, He H, Liu P, Gao D, Chen Y, Sun S, Liu A, Li Y, Jin H. Radiosurgery-Based AVM Scale Is Proposed for Combined Embolization and Gamma Knife Surgery for Brain Arteriovenous Malformations. Front Neurol. 2021 Mar 30;12:647167. doi: 10.3389/fneur.2021.647167. eCollection 2021.

  PMID: 33859610 RESULT

• Chen Y, Meng X, Ma L, Zhao Y, Gu Y, Jin H, Gao D, Li Y, Sun S, Liu A, Zhao Y, Chen X, Wang S. Contemporary management of brain arteriovenous malformations in mainland China: a web-based nationwide questionnaire survey. Chin Neurosurg J. 2020 Sep 1;6:26. doi: 10.1186/s41016-020-00206-0. eCollection 2020.

  PMID: 32922955 RESULT

• Chen Y, Li R, Ma L, Meng X, Yan D, Wang H, Ye X, Jin H, Li Y, Gao D, Sun S, Liu A, Wang S, Chen X, Zhao Y. Long-term outcomes of brainstem arteriovenous malformations after different management modalities: a single-centre experience. Stroke Vasc Neurol. 2021 Mar;6(1):65-73. doi: 10.1136/svn-2020-000407. Epub 2020 Sep 14.

  PMID: 32928999 RESULT

• Chen Y, Yan D, Li Z, Ma L, Zhao Y, Wang H, Ye X, Meng X, Jin H, Li Y, Gao D, Sun S, Liu A, Wang S, Chen X, Zhao Y. Long-Term Outcomes of Elderly Brain Arteriovenous Malformations After Different Management Modalities: A Multicenter Retrospective Study. Front Aging Neurosci. 2021 Feb 18;13:609588. doi: 10.3389/fnagi.2021.609588. eCollection 2021.

  PMID: 33679374 RESULT

• Deng Z, Chen Y, Ma L, Li R, Wang S, Zhang D, Zhao Y, Zhao J. Long-term outcomes and prognostic predictors of 111 pediatric hemorrhagic cerebral arteriovenous malformations after microsurgical resection: a single-center experience. Neurosurg Rev. 2021 Apr;44(2):915-923. doi: 10.1007/s10143-019-01210-4. Epub 2020 Feb 20.

  PMID: 32078085 RESULT

• Chen Y, Li R, Ma L, Zhao Y, Yu T, Wang H, Ye X, Wang R, Chen X, Zhao Y. Single-Stage Combined Embolization and Resection for Spetzler-Martin Grade III/IV/V Arteriovenous Malformations: A Single-Center Experience and Literature Review. Front Neurol. 2020 Oct 29;11:570198. doi: 10.3389/fneur.2020.570198. eCollection 2020.

  PMID: 33193013 RESULT

• Yu T, Han H, Ma L, Zhao Y, Zhang Y, Li Y, Wang S, Chen Y, Chen X. Learning curve and embolisation strategy in single-stage surgery combined embolisation and microsurgery for brain arteriovenous malformations: results from a nationwide multicentre prospective registry study. Stroke Vasc Neurol. 2025 Dec 23;10(6):691-701. doi: 10.1136/svn-2025-004051.

  PMID: 40194846 DERIVED

• Han H, Gao D, Ma L, Li R, Li Z, Zhang H, Yuan K, Wang K, Zhang Y, Zhao Y, Jin W, Jin H, Meng X, Yan D, Li R, Lin F, Hao Q, Wang H, Ye X, Kang S, Pu J, Shi Z, Chao X, Lin Z, Lu J, Li Y, Zhao Y, Sun S, Chen Y, Chen X, Wang S; Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China (MATCH). Long-term outcomes of microsurgery and stereotactic radiosurgery as the first-line treatment for arteriovenous malformations: a propensity score-matched analysis using nationwide multicenter prospective registry data. Int J Surg. 2023 Dec 1;109(12):3983-3992. doi: 10.1097/JS9.0000000000000751.

  PMID: 37720924 DERIVED

• Li R, Chen P, Han H, Li Z, Chen X, Chen Y, Zhao Y. Association of nidus size and rupture in brain arteriovenous malformations: Insight from angioarchitecture and hemodynamics. Neurosurg Rev. 2023 Aug 31;46(1):216. doi: 10.1007/s10143-023-02113-1.

  PMID: 37650957 DERIVED

• Chen Y, Han H, Jin H, Meng X, Ma L, Li R, Li Z, Yan D, Zhang H, Yuan K, Wang K, Zhao Y, Zhang Y, Jin W, Li R, Lin F, Hao Q, Wang H, Ye X, Kang S, Gao D, Pu J, Shi Z, Chao X, Lin Z, Lu J, Li J, Sun S, Liu A, Chen X, Li Y, Zhao Y, Wang S; Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China (MATCH). Association of embolization with long-term outcomes in brain arteriovenous malformations: a propensity score-matched analysis using nationwide multicenter prospective registry data. Int J Surg. 2023 Jul 1;109(7):1900-1909. doi: 10.1097/JS9.0000000000000341.

  PMID: 37226884 DERIVED

• Chen Y, Han H, Ma L, Li R, Li Z, Yan D, Zhang H, Yuan K, Wang K, Zhao Y, Zhang Y, Jin W, Li R, Lin F, Meng X, Hao Q, Wang H, Ye X, Kang S, Jin H, Li Y, Gao D, Sun S, Liu A, Wang S, Chen X, Zhao Y. Multimodality treatment for brain arteriovenous malformation in Mainland China: design, rationale, and baseline patient characteristics of a nationwide multicenter prospective registry. Chin Neurosurg J. 2022 Oct 17;8(1):33. doi: 10.1186/s41016-022-00296-y.

  PMID: 36253875 DERIVED

• Li N, Yan D, Li Z, Chen Y, Ma L, Li R, Han H, Meng X, Jin H, Zhao Y, Chen X, Wang H, Zhao Y. Long-term outcomes of Spetzler-Martin grade IV and V arteriovenous malformations: a single-center experience. Neurosurg Focus. 2022 Jul;53(1):E12. doi: 10.3171/2022.4.FOCUS21648.

  PMID: 35901717 DERIVED

Study Officials

• Wang Shuo, MD

  Beijing Tiantan Hospital

  STUDY CHAIR

• Li Youxiang, MD

  Beijing Neurosurgical Institute

  PRINCIPAL INVESTIGATOR

• Liu Ali, MD

  Beijing Neurosurgical Institute

  PRINCIPAL INVESTIGATOR

• Zhao Yuanli, MD

  Beijing Neurosurgical Institute

  PRINCIPAL INVESTIGATOR

• Chen Xiaolin, MD

  Beijing Neurosurgical Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Yu, MD

CONTACT

+8618801239327; chenyu_tiantan@126.com

Chen Xiaolin, MD

CONTACT

+8613810624845; xiaolinchen488@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: October 1, 2020
• Study Start: August 1, 2011
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2033
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

CN (1)