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Trial record 2 of 6 for:    radiosurgery and epilepsy

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
Sponsor:
Collaborators:
Beijing Neurosurgical Institute
Peking University International Hospital
Information provided by (Responsible Party):
Beijing Tiantan Hospital

Brief Summary:

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

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
experimental group

Treatment applied accordingly with the following standard criteria , patients are selected into this group:

Ruptured lesion:

  1. Lesions not at the brainstem, thalamus, basal ganglia, or deep location,craniotomy can be performed;
  2. Target embolization of aneurysms and arteriovenous fistulas should be applied;
  3. Stereotactic radiosurgery for patients with a volume less than 10ml and not in the acute phase(< 3months) of intracranial hemorrhage.

Unruptured lesion:

  1. 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;
  2. If there are bleeding-related risk factors (aneurysm or high-flow fistula), relevant risk factors should be actively treated with embolization;
  3. Patients with no indications for craniotomy and poor symptom controlled, or with appropriate volume for radiosurgery or hybrid surgery (embolization +radiosurgery).
Other: Multi-disciplinary assessment
  1. Comprehensive evaluation by multidisciplinary experts;
  2. Preoperative multi-modal imaging examination was applied to determine the angioarchitecture of AVM.

control group
Patients who received treatment that did not meet the standard group treatment plan were included in this control group.



Primary Outcome Measures :
  1. cure rate [ Time Frame: 3 years after treatment ]
    total obliteration rate of all patients and of each group

  2. complication rate [ Time Frame: 3 years after treatment ]
    compare the complication rate and poor prognosis rate between two groups

  3. Intracranial hemorrhage and rebleeding rate [ Time Frame: 3 years after treatment ]
    the Intracranial hemorrhage and rebleeding rate after treatment of each group were compared.


Secondary Outcome Measures :
  1. 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 %.

  2. 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.

  3. 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.



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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  1. Received other treatment (surgery, embolization or SRS)before inclusion, and could not provide the treatment data such as imaging data before or after treatment;
  2. Expected survival time is less than 6 months

Information from the National Library of Medicine

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


Contacts
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Contact: Jin Hengwei, MD +8615001189679 jinhengwei1987@163.com
Contact: Li Youxiang, MD +8613501038666

Locations
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China, Beijing
Capital medical university affiliated Beijing Tiantan hospital Recruiting
Beijing, Beijing, China, 101100
Contact: Jin Hengwei, MD    +8615001189679    jinhengwei1987@163.com   
Principal Investigator: Meng Xiangyu, MD         
Sponsors and Collaborators
Beijing Tiantan Hospital
Beijing Neurosurgical Institute
Peking University International Hospital
Investigators
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Principal Investigator: Wang Shuo, MD Beijing Tiantan Hospital
Principal Investigator: Li Youxiang, MD Beijing Neurosurgical Institute
Principal Investigator: Liu Ali, MD Beijing Neurosurgical Institute
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Responsible Party: Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04572568    
Other Study ID Numbers: KY 2020-003-01
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Tiantan Hospital:
Cerebral Arteriovenous Malformation
multi-disciplinary treatment
endovascular treatment
stereotactic radiosurgery
craniotomy
Additional relevant MeSH terms:
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Hemangioma
Intracranial Arteriovenous Malformations
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases