Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
NCT ID: NCT04574843
Last Updated: 2023-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-08-01
2024-03-31
Brief Summary
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Detailed Description
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The subjects are enrolled in the study according to inclusion and exclusion criteria. Imaging and clinical presentations of patients are recorded. Within 48 hours of embolization, patients are assessed with clinical examination and with a brain CT scan to evaluate in any change in their symptoms and CSDH volume. 2-4 weeks after embolization, patients are evaluated in clinic for any change in their symptoms and signs. 60 days after embolization patients are examined clinically and are assessed for SDH volume change in CT scan and MRI.
If there is any significant increase in CSDH volume or any deterioration of patient, evacuation of hematoma is considered.
MMA embolization is performed under general anesthesia using biplane or monoplane angiography. Femoral or radial accesses are used. Guiding catheter is advanced into external carotid artery in corresponding side. The corresponding MMA is catheterized distally by micro-catheter and is embolized by liquid embolic agents. Patients are discharge next day if they are stable.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Embolization arm
Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil
Embolization of MMA
embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)
Interventions
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Embolization of MMA
embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ...
3. Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment
Exclusion Criteria
2. patients needs emergent evacuation of hematoma,
3. patients could not participate in 60 days follow-up
4. pregnant patients
5. acute subdural hematoma
6. contraindication to contrast
7. contradiction to angiography
8. difficult access to MMA due to anatomical variation
9. contraindication to liquid embolic agent
10. unmanaged/uncontrollable bleeding disorders
18 Years
ALL
No
Sponsors
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Mashhad University of Medical Sciences
OTHER
Responsible Party
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Humain Baharvahdat
Associate Professor
Principal Investigators
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Humain Baharvahdat, MD
Role: STUDY_DIRECTOR
Department of Neurosurgery, Mashhad University of Medical Sciences, Mashhad, Iran
Locations
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Ghaem Hospital, Mashhad University of Medical Sciences
Mashhad, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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990631
Identifier Type: -
Identifier Source: org_study_id
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