Brain Arteriovenous MalformationMATCHNCT04572568
Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China
An observational study of Brain Arteriovenous Malformation, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Brain Arteriovenous Malformation
- What is being tested?
- Multi-disciplinary assessment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2011to 1 Apr 2033
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with the diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Capital medical university affiliated Beijing Tiantan hospital
Beijing, Beijing Municipality, 101100
Jin Hengwei, MD, +8615001189679, jinhengwei1987@163.com
Chen Yu, MD, +8618801239327, chenyu_tiantan@126.com
About this study
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.
Read the detailed description
This study is a multi-center, prospective registry study led by Beijing Tiantan Hospital, and a number of comprehensive hospitals in mainland China, aiming to uncover the long-term outcomes of AVM in Real-World in China and to discover a standardized diagnosis and treatment process for the comprehensive treatment of brain AVMs. This study is an observational study that will last for 20 years. All patients were enrolled prospectively, and the study will not influence the choice of treatment modalities.
The study cohort of this study was AVM patients aged 1-80 years. The inclusion criteria were as follows: 1. The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI); 2.Patients with complete clinical and imaging data; 3. Patient or patient's legal representative agreed to collection of information for this study and signed informed consent. The exclusion criteria were as follows: 1. Received other treatment (surgery, embolization or SRS)before inclusion; 2. Expected survival time is less than 6 months; 3. Spinal AVMs; 4. Patients missing critical baseline and imaging data.
Patients will be divided into two groups: experimental group and control group. Experimental group: Patients who had received a multidisciplinary assessment to develop a treatment plan were included in the experimental group. The details were as follows: 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. 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.
An electronic data capture system (EDC) was developed and used for data collection. All the clinical baseline data and imaging data were stored through a cloud server to facilitate the input work at different locations and at different times. Follow-up was conducted at the first 3-6 months and annually after surgery by clinical visit and telephone interview. The evaluation of mRS score was conducted by neurosurgeons who have at least 5 years' experience of clinical practice and all the images were interpreted by at least 2 radiologists independently who are with at least 5 years of clinical experience in radiology center of our institute. Researchers who performed follow-up assessments were blinded to treatment modalities.
The primary outcomes were as follows: modified Rankin Scale, obliteration rate, subsequent hemorrhage, complication rate (such as morbidity rate, new-onset neurological dysfunction, and radiation-related complications) at 3 months, 12 months, and 3 years after treatment. The secondary outcomes were as follows: improvement of clinical symptoms (epilepsy, headache, neurological dysfunction) at 3 months, 12 months, and 3 years after treatment.
Through the final follow-up data, we could compare the short-term outcomes and long-term outcomes between experimental and control group. In addition, intra-group comparisons can be made among subgroups of different intervention strategies to explore the best individualized treatment strategies for different AVM patients.
Treatment criteria for craniotomy: 1. For patients with a history of rupture and bleeding: a. If the lesion is not located in the deep functional area, surgical treatment is recommended; b. If the lesion is multi-system blood supply or high blood flow, the volume is large, and with a deep blood supply, hybrid surgery (embolization + resection) can be performed; c. If the lesion is located in the deep functional area, craniotomy is not recommended. 2. For patients with unruptured hemorrhage: a. If the lesion is not located in the deep brain tissue, and is not located in an important functional area or the fiber bundle is more than 5mm away from the lesion, then surgery or combined surgery can be performed; b. If the lesion is located in the deep brain tissue, important functional areas or fiber bundles are less than 5mm away from the lesion, craniotomy is not recommended; c. If the lesion does not have the above characteristics, surgical resection alone can be performed.
Interventional embolization treatment standards: 1. Ruptured bAVM should be actively treated. If there is no need for craniotomy to clear the hematoma in the acute phase, DSA should be performed 2-6 weeks after hemorrhage, and individualized treatment plans should be developed and actively treated. 2. Unruptured bAVM, if there are bleeding-related risk factors (aneurysm or high-flow fistula), relevant risk factors should be actively treated; When stereotactic radiation is planned, when craniotomy or SRS was planned, preoperative embolization for flow reduction or volume reduction is recommended; 3. Unruptured bAVM, without the above risk factors, conservative treatment was suggested if symptoms could be well controlled.
Stereotactic radiosurgery standard treatment: 1. No history of bleeding: Patients with no indications for craniotomy and with appropriate volume for radiosurgery, and poor symptom controlled. Pre-treatment imaging assessment DSA (required) and enhanced MRI was required to clarify the structure of the malformation; 2. There is a history of bleeding: the period between bleeding time and the time of consultation is less than 3 months, it is recommended to wait head-enhanced MRI and DSA were performed after the hemorrhage was absorbed (3 months) to confirm the vascular architecture. 3.Volume-stage or dose-stage can be used for giant AVMs involving important eloquent areas.
Conservation standard treatment: 1. Ruptured AVMs: Patients prone to severe disability due to intervention; 2. Unruptured AVMs: Patients were assessed as having a low rupture risk, or without refractory epilepsy or with a high risk of postoperative neurological deficits.
- Conditions
- Brain Arteriovenous Malformation
- Being tested
- Multi-disciplinary assessment
- Keywords
- Brain Arteriovenous Malformation, multi-disciplinary treatment, embolization, stereotactic radiosurgery, microsurgical resection, hybrid surgery, conservative/medical treatment, hemodynamic, outcomes, subsequent hemorrhage, obliteration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-disciplinary assessmentOther
- Comprehensive evaluation by multidisciplinary experts;
- Preoperative multi-modal imaging examination was applied to determine the angioarchitecture, functional fiber bundle, and hemodynamics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months, 1 year, and 3 years after treatment
complication rate
such as morbidity rate, new-onset neurological dysfunction, and radiation-related complications
Measured: 3 months, 1 year, and 3 years after treatment
Secondary outcomes (3)
Improvement of epilepsy
Improvement of epilepsy at 3 months, 1 year, and 3 years after treatment The prognosis of epilepsy was assessed by Engle classification: Grade I, the seizures disappear completely or only with aura; Grade II, the seizures are very few (≤3 times/year); Grade III, the seizures are >3 times/year, but the seizures are reduced by ≥75%; Grade IV, the seizures are reduced <75 %.
Measured: 3 months, 1 year, and 3 years after treatment
Improvement of headache
Improvement of headache at 3 months, 1 year, and 3 years after treatment Headache was assessed by the WHO pain grading classification:Grade 0: No pain; Grade I: mild pain, intermittent pain, no medication; Grade II: moderate pain, continuous pain, affecting rest, need analgesics; level III: severe pain, continuous pain, need analgesics relieve pain; Grade IV: severe pain, continuous severe pain with changes in blood pressure and pulse.
Measured: 3 months, 1 year, and 3 years after treatment
Improvement of neurological dysfunction
The modified Rankin score was used to evaluate neurological dysfunction: Grade 0, completely asymptomatic; Grade 1, able to complete all daily duties and activities despite symptoms, but without obvious dysfunction; Grade 2, mildly disabled, unable to complete all activities before illness, but does not need help, can take care of themself; Grade 3, moderately disabled, requires some help, but does not need help while walking; Grade 4, severely disabled, unable to walk independently, unable to meet their own needs without help from others; Grade 5, severely disabled, bedridden, incontinence, requiring continuous care And attention; Grade 6, death.
Measured: 3 months, 1 year, and 3 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Aug 2011
- Primary completion1 Apr 2032 (estimated)
- Study completion1 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Brain Arteriovenous MalformationStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Neurosurgical Institute, Peking University International Hospital, West China Hospital, First Affiliated Hospital of Harbin Medical University, Sichuan Provincial People's Hospital, The First Hospital of Jilin University, Shanxi Provincial People's Hospital, The Second Hospital of Shandong University, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University, The General Hospital of Central Theater Command, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Guangxi Medical University, Tianjin Medical University Second Hospital, The First Affiliated Hospital of Shanxi Medical University, Shengjing Hospital, Second Affiliated Hospital of Guangzhou Medical University, Hainan People's Hospital, The Second Affiliated Hospital of Kunming Medical University, The Affiliated Hospital of Qingdao University, Second Xiangya Hospital of Central South University, Second Affiliated Hospital of Soochow University, General Hospital of Ningxia Medical University, Lanzhou University Second Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Zhejiang University, Qilu Hospital of Shandong University, Jining Medical University, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Fujian Medical University, Shandong Provincial Hospital, The Affiliated Hospital of Xuzhou Medical University, Henan Provincial People's Hospital, Binzhou Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Sponsor
- Investigators
- Wang Shuo, MD, Study chair, Beijing Tiantan HospitalLi Youxiang, MD, Principal investigator, Beijing Neurosurgical InstituteLiu Ali, MD, Principal investigator, Beijing Neurosurgical InstituteZhao Yuanli, MD, Principal investigator, Beijing Neurosurgical InstituteChen Xiaolin, MD, Principal investigator, Beijing Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572568
- Sponsor's protocol ID
- KY 2020-003-01
- Acronym
- MATCH
- Status last verified
- May 2022
- First submitted
- 7 Sep 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35276397Meng 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.
PubMed 34988014Li 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.
PubMed 34872987Yan 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.
PubMed 34712200Meng 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.
PubMed 33859610Chen 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.
PubMed 32922955Chen 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.
PubMed 32928999Chen 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.
PubMed 33679374Deng 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.
PubMed 32078085Chen 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.
PubMed 33193013Yuan K, Hu N, Li Z, Zhang H, Han H, Wang K, Jin H, Gao D, Sun S, Li Y, Wang S, Chen Y, Chen X, Zhao Y; Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China (MATCH). Treatment patterns and outcomes in elderly patients with brain arteriovenous malformations: a multicenter prospective cohort study. BMC Geriatr. 2026 Jun 15. doi: 10.1186/s12877-026-07762-7. Online ahead of print.
PubMed 42298422Yu 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.
PubMed 40194846Yan D, Yuan K, Chen Y, Zheng K, Han H, Li Z, Zhang H, Li R, Wang K, Zhang Y, Chen X, Zhao Y. Risk factors for delayed postoperative hemorrhage in patients with brain arteriovenous malformations: an analysis of the nationwide multicenter prospective registry MATCH study. J Neurosurg. 2024 Mar 8;141(2):316-322. doi: 10.3171/2023.12.JNS231539. Print 2024 Aug 1.
PubMed 38457809Han 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.
PubMed 37720924Li 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.
PubMed 37650957
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China
- ClinicalTrials.gov ID
- NCT04572568
- Acronym / sponsor ID
- MATCH / KY 2020-003-01
- Conditions
- Brain Arteriovenous Malformation
- Keywords
- Brain Arteriovenous Malformation, multi-disciplinary treatment, embolization, stereotactic radiosurgery, microsurgical resection, hybrid surgery, conservative/medical treatment, hemodynamic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Neurosurgical Institute, Peking University International Hospital, West China Hospital, First Affiliated Hospital of Harbin Medical University, Sichuan Provincial People's Hospital, The First Hospital of Jilin University, Shanxi Provincial People's Hospital, The Second Hospital of Shandong University, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University, The General Hospital of Central Theater Command, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Guangxi Medical University, Tianjin Medical University Second Hospital, The First Affiliated Hospital of Shanxi Medical University, Shengjing Hospital, Second Affiliated Hospital of Guangzhou Medical University, Hainan People's Hospital, The Second Affiliated Hospital of Kunming Medical University, The Affiliated Hospital of Qingdao University, Second Xiangya Hospital of Central South University, Second Affiliated Hospital of Soochow University, General Hospital of Ningxia Medical University, Lanzhou University Second Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Zhejiang University, Qilu Hospital of Shandong University, Jining Medical University, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Fujian Medical University, Shandong Provincial Hospital, The Affiliated Hospital of Xuzhou Medical University, Henan Provincial People's Hospital, Binzhou Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 1 Apr 2032 (estimated)
- Study completion
- 1 Apr 2033 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a multi-center, prospective registry study led by Beijing Tiantan Hospital, and a number of comprehensive hospitals in mainland China, aiming to uncover the long-term outcomes of AVM in Real-World in China and to discover a standardized diagnosis and treatment process for the comprehensive treatment of brain AVMs. This study is an observational study that will last for 20 years. All patients were enrolled prospectively, and the study will not influence the choice of treatment modalities.
The study cohort of this study was AVM patients aged 1-80 years. The inclusion criteria were as follows: 1. The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI); 2.Patients with complete clinical and imaging data; 3. Patient or patient's legal representative agreed to collection of information for this study and signed informed consent. The exclusion criteria were as follows: 1. Received other treatment (surgery, embolization or SRS)before inclusion; 2. Expected survival time is less than 6 months; 3. Spinal AVMs; 4. Patients missing critical baseline and imaging data.
Patients will be divided into two groups: experimental group and control group. Experimental group: Patients who had received a multidisciplinary assessment to develop a treatment plan were included in the experimental group. The details were as follows: 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. 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.
An electronic data capture system (EDC) was developed and used for data collection. All the clinical baseline data and imaging data were stored through a cloud server to facilitate the input work at different locations and at different times. Follow-up was conducted at the first 3-6 months and annually after surgery by clinical visit and telephone interview. The evaluation of mRS score was conducted by neurosurgeons who have at least 5 years' experience of clinical practice and all the images were interpreted by at least 2 radiologists independently who are with at least 5 years of clinical experience in radiology center of our institute. Researchers who performed follow-up assessments were blinded to treatment modalities.
The primary outcomes were as follows: modified Rankin Scale, obliteration rate, subsequent hemorrhage, complication rate (such as morbidity rate, new-onset neurological dysfunction, and radiation-related complications) at 3 months, 12 months, and 3 years after treatment. The secondary outcomes were as follows: improvement of clinical symptoms (epilepsy, headache, neurological dysfunction) at 3 months, 12 months, and 3 years after treatment.
Through the final follow-up data, we could compare the short-term outcomes and long-term outcomes between experimental and control group. In addition, intra-group comparisons can be made among subgroups of different intervention strategies to explore the best individualized treatment strategies for different AVM patients.
Treatment criteria for craniotomy: 1. For patients with a history of rupture and bleeding: a. If the lesion is not located in the deep functional area, surgical treatment is recommended; b. If the lesion is multi-system blood supply or high blood flow, the volume is large, and with a deep blood supply, hybrid surgery (embolization + resection) can be performed; c. If the lesion is located in the deep functional area, craniotomy is not recommended. 2. For patients with unruptured hemorrhage: a. If the lesion is not located in the deep brain tissue, and is not located in an important functional area or the fiber bundle is more than 5mm away from the lesion, then surgery or combined surgery can be performed; b. If the lesion is located in the deep brain tissue, important functional areas or fiber bundles are less than 5mm away from the lesion, craniotomy is not recommended; c. If the lesion does not have the above characteristics, surgical resection alone can be performed.
Interventional embolization treatment standards: 1. Ruptured bAVM should be actively treated. If there is no need for craniotomy to clear the hematoma in the acute phase, DSA should be performed 2-6 weeks after hemorrhage, and individualized treatment plans should be developed and actively treated. 2. Unruptured bAVM, if there are bleeding-related risk factors (aneurysm or high-flow fistula), relevant risk factors should be actively treated; When stereotactic radiation is planned, when craniotomy or SRS was planned, preoperative embolization for flow reduction or volume reduction is recommended; 3. Unruptured bAVM, without the above risk factors, conservative treatment was suggested if symptoms could be well controlled.
Stereotactic radiosurgery standard treatment: 1. No history of bleeding: Patients with no indications for craniotomy and with appropriate volume for radiosurgery, and poor symptom controlled. Pre-treatment imaging assessment DSA (required) and enhanced MRI was required to clarify the structure of the malformation; 2. There is a history of bleeding: the period between bleeding time and the time of consultation is less than 3 months, it is recommended to wait head-enhanced MRI and DSA were performed after the hemorrhage was absorbed (3 months) to confirm the vascular architecture. 3.Volume-stage or dose-stage can be used for giant AVMs involving important eloquent areas.
Conservation standard treatment: 1. Ruptured AVMs: Patients prone to severe disability due to intervention; 2. Unruptured AVMs: Patients were assessed as having a low rupture risk, or without refractory epilepsy or with a high risk of postoperative neurological deficits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Other: Multi-disciplinary assessmentRuptured 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. |
| 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. |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with the diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-disciplinary assessment1. Comprehensive evaluation by multidisciplinary experts; 2. Preoperative multi-modal imaging examination was applied to determine the angioarchitecture, functional fiber bundle, and hemodynamics. | Other | experimental group |
Primary outcome
modified Rankin Scale
Time frame: 3 months, 1 year, and 3 years after treatment
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.
obliteration rate
Time frame: 3 months, 1 year, and 3 years after treatment
Complete obliteration of the nidus was confirmed by DSA or MRA, then compare the obliteration rate between each group.
subsequent hemorrhage
Time frame: 3 months, 1 year, and 3 years after treatment
Intracranial hemorrhage that could be attributed to AVMs, and can be confirmed by CT and other imaging.
complication rate
Time frame: 3 months, 1 year, and 3 years after treatment
such as morbidity rate, new-onset neurological dysfunction, and radiation-related complications
3 secondary outcomes
Improvement of epilepsy
Time frame: 3 months, 1 year, and 3 years after treatment
Improvement of headache
Time frame: 3 months, 1 year, and 3 years after treatment
Improvement of neurological dysfunction
Time frame: 3 months, 1 year, and 3 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Results publication: PubMed 35276397Meng 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.
- Results publication: PubMed 34988014Meng 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.
- Results publication: PubMed 34872987Li 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.
- Results publication: PubMed 34712200Yan 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.
- Results publication: PubMed 33859610Meng 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.
- Results publication: PubMed 32922955Chen 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.
- Results publication: PubMed 32928999Chen 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.
- Results publication: PubMed 33679374Chen 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.
- Results publication: PubMed 32078085Deng 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.
- Results publication: PubMed 33193013Chen 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.
- Derived from this study: PubMed 42298422Yuan K, Hu N, Li Z, Zhang H, Han H, Wang K, Jin H, Gao D, Sun S, Li Y, Wang S, Chen Y, Chen X, Zhao Y; Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China (MATCH). Treatment patterns and outcomes in elderly patients with brain arteriovenous malformations: a multicenter prospective cohort study. BMC Geriatr. 2026 Jun 15. doi: 10.1186/s12877-026-07762-7. Online ahead of print.
- Derived from this study: PubMed 40194846Yu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wang Shuo, MD study chair
Beijing Tiantan Hospital
Li Youxiang, MD principal investigator
Beijing Neurosurgical Institute
Liu Ali, MD principal investigator
Beijing Neurosurgical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Arteriovenous Malformation, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Yu, MD (+8618801239327, chenyu_tiantan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (time frame: 3 months, 1 year, and 3 years after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572568, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.