Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
- Conditions
- Chronic Subdural Hematoma
- Interventions
- Procedure: Embolization of MMA
- Registration Number
- NCT04574843
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
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)
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- patients diagnosed chronic or subacute subdural hematoma
- Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ...
- Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment
- presentation with coma (GCS =< 8)
- patients needs emergent evacuation of hematoma,
- patients could not participate in 60 days follow-up
- pregnant patients
- acute subdural hematoma
- contraindication to contrast
- contradiction to angiography
- difficult access to MMA due to anatomical variation
- contraindication to liquid embolic agent
- unmanaged/uncontrollable bleeding disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Embolization arm Embolization of MMA Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil
- Primary Outcome Measures
Name Time Method Incidence of CSDH regression 60 dyas Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization
- Secondary Outcome Measures
Name Time Method Incidence of CSDH progression or recurrence 60 days Increase in volume of CSDH
Incidence of new neurological deficit (ND) 60 days ND includes: dementia, memory loss, cognitive problems, monoparesis/hemiparesis, cranial nerve paresis, dysphasia/aphasia
Incidence of new ischemic stroke 60 days new ischemia in imaging (DWI/MRI or CT scan) within 60 days of operation
incidence of Death 60 days Incidence of myocardial infarction/myocardial ischemia 60 days new ischemic heart attack within 60 days of operation
Incidence of embolization complication in brain 48 hours cranial nerve palsy (especially VII), vision loss (ophthalmic/retinal artery occlusion), ...
incidence of embolization complication out of brain 15 days puncture hematoma, major artery dissection, new renal failure, ...
Trial Locations
- Locations (1)
Ghaem Hospital, Mashhad University of Medical Sciences
🇮🇷Mashhad, Iran, Islamic Republic of