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)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)
Ghaem Hospital, Mashhad University of Medical Sciences
Mashhad, Iran
RECRUITINGIncidence of CSDH regression
Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization
Time frame: 60 dyas
Incidence of CSDH progression or recurrence
Increase in volume of CSDH
Time frame: 60 days
Incidence of new neurological deficit (ND)
ND includes: dementia, memory loss, cognitive problems, monoparesis/hemiparesis, cranial nerve paresis, dysphasia/aphasia
Time frame: 60 days
incidence of Death
Time frame: 60 days
Incidence of new ischemic stroke
new ischemia in imaging (DWI/MRI or CT scan) within 60 days of operation
Time frame: 60 days
Incidence of myocardial infarction/myocardial ischemia
new ischemic heart attack within 60 days of operation
Time frame: 60 days
Incidence of embolization complication in brain
cranial nerve palsy (especially VII), vision loss (ophthalmic/retinal artery occlusion), ...
Time frame: 48 hours
incidence of embolization complication out of brain
puncture hematoma, major artery dissection, new renal failure, ...
Time frame: 15 days
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