Registry of Multimodality Treatment for Brain Arteriovenous Malformation in China (MATCH)
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|ClinicalTrials.gov Identifier: NCT04572568|
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
This study is a multi-center, prospective, registry study. All patients are divided into experimental group and control group according to treatment modalities. 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, surgical information, and follow-up information were registered. All patients were evaluated for neurofunction at baseline, 24 hours after surgery, and 6 months (For neurosurgery and endovascular therapy) or 3 years (For stereotactic radiosurgery). Main observation endpoints: 1. Overall cure rate of AVM in experimental group and control group; 2. Overall complication rate and clinical outcome in experimental group and control group; 3. AVM bleeding rate and rebleeding rate in experimental group and control group. Secondary observation endpoint: improvement of clinical symptoms (epilepsy, headache, neurological dysfunction) at discharge and at last follow-up.
|Condition or disease||Intervention/treatment|
|Cerebral Arteriovenous Malformation||Other: Multi-disciplinary assessment|
This study is a multi-center, prospective registry study led by Beijing Tiantan Hospital, and a number of comprehensive hospitals in China, aiming to uncover the treatment result of AVM in Real-World in China and discover a standard diagnosis and treatment process for the comprehensive treatment of arteriovenous malformations. This study lasted for 5 years and was an observational study. All patients were enrolled prospectively, and the study will not influence the choice of treatment modalities. All the patients clinical baseline data and imaging data were stored through a cloud server to facilitate the input work at different locations and at different times. According to different treatment modalities, patients receive corresponding follow-up procedures. Through the final follow-up data, the differences in the prognosis of patients under different treatment modalities are compared, and the best diagnosis and treatment modality for arteriovenous malformations is obtained. Patients of experimental group is discussed at multi-disciplinary conference and must meet the following standard treatment criteria:
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, active treatment is required for volume reduction(10cm3) when craniotomy was planned, preoperative embolization for flow 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Registry of Multimodality Treatment for Brain Arteriovenous Malformation in China|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||April 1, 2024|
Treatment applied accordingly with the following standard criteria , patients are selected into this group:
Other: Multi-disciplinary assessment
Patients who received treatment that did not meet the standard group treatment plan were included in this control group.
- cure rate [ Time Frame: 3 years after treatment ]total obliteration rate of all patients and of each group
- complication rate [ Time Frame: 3 years after treatment ]compare the complication rate and poor prognosis rate between two groups
- Intracranial hemorrhage and rebleeding rate [ Time Frame: 3 years after treatment ]the Intracranial hemorrhage and rebleeding rate after treatment of each group were compared.
- Improvement of epilepsy [ Time Frame: 2 weeks, 6 months and 1 year after treatment ]Improvement of epilepsy at 2 weeks, 6 months and 1 year 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 %.
- Improvement of headache [ Time Frame: 2 weeks, 6 months and 1 year after treatment ]Improvement of headache at 2 weeks, 6 months and 1 year 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.
- Improvement of neurological dysfunction [ Time Frame: 2 weeks, 6 months and 1 year after treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572568
|Contact: Jin Hengwei, MDemail@example.com|
|Contact: Li Youxiang, MD||+8613501038666|
|Capital medical university affiliated Beijing Tiantan hospital||Recruiting|
|Beijing, Beijing, China, 101100|
|Contact: Jin Hengwei, MD +8615001189679 firstname.lastname@example.org|
|Principal Investigator: Meng Xiangyu, MD|
|Principal Investigator:||Wang Shuo, MD||Beijing Tiantan Hospital|
|Principal Investigator:||Li Youxiang, MD||Beijing Neurosurgical Institute|
|Principal Investigator:||Liu Ali, MD||Beijing Neurosurgical Institute|