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Long-term Outcomes After Different Management Strategies for High-level Cerebral Arteriovenous Malformation (OHAVM)

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ClinicalTrials.gov Identifier: NCT04136860
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
Peking University International Hospital
Information provided by (Responsible Party):
yuanli Zhao, Beijing Tiantan Hospital

Brief Summary:
Arteriovenous malformations (AVMs) are complex and rare cerebral vascular dysplasia. The main purpose of treatment is to avoid the neurological impairment caused by hemorrhagic stroke. The Spetzler-Martin (SM) grading system is widely used to estimate the risk of postoperative complication based on maximum AVM nidus diameter, pattern of venous drainage, and eloquence of location. Generally, grade I and II are amenable to surgical resection alone. Grade III is typically treated via a multimodal approach, including microsurgical resection, embolization, and radiosurgery (SRS). Grade IV and V are generally observed unless ruptured. However, some previous studies indicated that despite the high rate of poor outcomes for high-level unruptured AVMs, the mortality for high-level unruptured AVMs are likely lower than untreated patients. With the development of new embolic materials and new intervention strategies, patients with high-level AVMs may have more opportunities to underwent more aggressive interventions. The OHAVM study aims to clarify the clinical outcomes for patients with SM grade IV and V AVMs after different management strategies.

Condition or disease
Arteriovenous Malformation of Brain

Detailed Description:

Follow-up: In our neurosurgical center, follow-up was conducted for all patients at the first 3-6 months and annually after discharge by clinical visit and telephone interview.

Study overview: The population in the OHAVM study will be divided into two parts. Clinical and imaging data of high-level AVM patients from 2012/04 to 2019/09 were retrospectively collected. And the high-level AVM patients from 2019/09 to 2019/12 were prospectively collected. The intervention strategies in our institution for high-level AVMs are of four categories: microsurgical resection, embolization, embolization+radiosurgery, and single-stage hybrid surgery (embolization-resection). Each participants will be followed at least for 5 year since enrollment. Finally, we will clarify the clinical outcomes and prognostic predictors for patients with SM grade IV and V AVMs after different management strategies.

Sample size: About 1000 patients will be enrolled in this study, and half of them were unruptured. The population distribution of different management strategies is expected as follows: conservative:100 cases, microsurgical resection: 300 cases, embolization:250 cases, embolization+radiosurgery: 250 cases, single-stage hybrid surgery: 100 cases.

Study endpoints: The neurological function prognosis, occlusion rate and complications were evaluated at 2 weeks, 1 year, 3 years, 5 years after the treatment and the last follow-up, respectively.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Long-term Outcomes of High-level Cerebral Arteriovenous Malformation
Actual Study Start Date : April 1, 2012
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : December 2024


Group/Cohort
Conservative management
Patients refused to accept any interventional treatment or patients were not suitable for any interventional treatment.
Microsurgical resection
All microsurgical procedures were performed with intraoperative neuronavigation, ultrasonography, indocyanine fluorescence angiography (ICG), continuous monitoring of electroencephalogram and somatosensory evoked potential.
Embolization
Embolization or radiosurgery was recommended as a priority for lesions located in deep functional locations such as brainstem and basal ganglia. Multi-stage embolization and target embolization were widely used within the embolization. Onyx was the main embolization material.
Embolization+Radiosurgery
Embolization or radiosurgery was recommended as a priority for lesions located in deep functional locations such as brainstem and basal ganglia. Radiosurgery management was recommended for the residual lesions about 3 months after the embolization if necessary.
Single-stage hybrid surgery
Hybrid surgery is a new surgical strategy defined as single-stage combined microsurgical resection and embolization in which embolization is performed firstly on the deep feeding artery, aneurysm, AVF, and meningeal arteries involved in blood supply of the nidus, and then, the microsurgical resection was performed immediately. Intraoperative angiography was performed repeatedly before the skull was closed, confirming complete occlusion of the malformation.



Primary Outcome Measures :
  1. modified Ranking Scale score at 2 weeks after the operation [ Time Frame: 2 weeks after operation ]

    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

  2. modified Ranking Scale score at 1 year after the operation [ Time Frame: 1 year after operation ]

    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. modified Ranking Scale score at 3 years after the operation [ Time Frame: 3 years after operation ]

    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

  4. modified Ranking Scale score at 5 years after the operation [ Time Frame: 5 years after the operation ]

    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

  5. modified Ranking Scale score at the last follow-up [ Time Frame: up to 10 years after the operation ]

    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

  6. Long-term hemorrhagic rate [ Time Frame: Conservative group: from the diagnosis to the last follow-up (up to 10 years); Intervention group: from 2 weeks after the operation to the last follow-up (up to 10 years) ]
    For conservative group, the observation period was from the diagnosis to the last follow-up. For the intervention group, to rule out the influence of transient unstable blood flow in the perioperative period, the observation period was defined as from 2 weeks after the operation to the last follow-up.


Secondary Outcome Measures :
  1. Obliteration rate [ Time Frame: At least 3 years, up to 10 years ]
    Confirmed by postoperative DSA or MRI/MRA


Other Outcome Measures:
  1. Incidence of postoperative epilepsy [ Time Frame: 2 weeks and 1 years after the operation and the last follow-up (up to 10 years) ]
    It can only be diagnosed as postoperative epilepsy with the evidence of typical convulsions and other systemic seizures or EEG evidence.

  2. Incidence of perioperative hemorrhage [ Time Frame: 2 weeks after the operation ]
    Bleeding within two weeks after the operation may be related to the redistribution of cerebral blood flow. The diagnosis of perioperative hemorrhage requires CT confirmation.

  3. Incidence of perioperative infarction [ Time Frame: 2 weeks after the operation ]
    Perioperative infarction within two weeks after the operation may be related to the redistribution of cerebral blood flow. The diagnosis of perioperative infarction requires CT confirmation or MRI confirmation.

  4. Incidence of endovascular embolization injury [ Time Frame: 2 weeks after the operation ]
    Endovascular embolization injuries include arterial dissection, catheter failure, etc.

  5. Incidence of radiation necrosis [ Time Frame: Half a year and 1 years after the operation and the last follow-up (up to 10 years) ]
    Radiation necrosis usually starts to appear within half a year after gamma knife operation. MRI evidence is needed to diagnose radiation necrosis.



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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Spetzler-Martin (SM) grade IV and V brain arteriovenous malformation.
Criteria

Inclusion Criteria:

  1. The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).
  2. The SM grade was IV and V.

Exclusion Criteria:

  1. Patients with multiple AVMs.
  2. Patients with hereditary hemorrhagic telangiectasia (HHT).
  3. Patients with missing clinical and imaging data.

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): NCT04136860


Contacts
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Contact: Yu Chen, MD 8618801239327 chenyu_tiantan@126.com
Contact: Yuanli Zhao, MD 86-010-59978478 zhaoyuanli@126.com

Locations
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China, Beijing
Capital medical university affiliated Beijing Tiantan hospital Recruiting
Beijing, Beijing, China, 101100
Contact: Yu Chen, MD    +8618801239327    chenyu_tiantan@126.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Peking University International Hospital
Investigators
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Principal Investigator: Yu Chen, MD Beijing Tiantan Hospital

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Responsible Party: yuanli Zhao, Director of Department of Cerebrovascular Neurosurgery, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04136860    
Other Study ID Numbers: KY 2019-09-15
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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