Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma

Mashhad University of Medical Sciences

Status: Enrolling

Conditions: Chronic Subdural Hematoma

Treatments: Procedure: Embolization of MMA

Study type: Interventional

Funder types: Other

Identifiers

NCT04574843

990631

Details and patient eligibility

About

The study evaluates the clinical and imaging outcome of middle meningeal artery (MMA) embolization with liquid embolic agent for treatment of chronic subdural hematoma (CSDH)

Full description

This study is a prospective one arm trial designed to assess the safety and efficacy of MMA embolization with liquid embolic agents (onyx/squid/Phil) as the main treatment of CSDH.

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients diagnosed chronic or subacute subdural hematoma
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

1. presentation with coma (GCS =< 8)
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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Embolization arm

Experimental group

Description:

Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil

Treatment:

Procedure: Embolization of MMA