An interventional study of Embolization of MMA in Chronic Subdural Hematoma, sponsored by Mashhad University of Medical Sciences. Recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by Mashhad University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 100 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Mashhad University of Medical Sciences is the lead sponsor of 92 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil
Procedure: Embolization of MMA
embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)
Also known as: Onyx, Squid, Phil
Incidence 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
Plan to share: No
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Mashhad University of Medical Sciences