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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embolization arm | Experimental | Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embolization of MMA | Procedure | embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CSDH regression | Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization | 60 dyas |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CSDH progression or recurrence | Increase in volume of CSDH | 60 days |
| Incidence of new neurological deficit (ND) | ND includes: dementia, memory loss, cognitive problems, monoparesis/hemiparesis, cranial nerve paresis, dysphasia/aphasia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Humain Baharvahdat, MD | Contact | +98-915-110-0400 | humainbv@yahoo.fr | |
| Masoud Pishjoo, MD | Contact | â€+98 915 362 8792‬ | masoud.pishjoo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Humain Baharvahdat, MD | Department of Neurosurgery, Mashhad University of Medical Sciences, Mashhad, Iran | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghaem Hospital, Mashhad University of Medical Sciences | Recruiting | Mashhad | Iran |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| C020320 | ethylene-vinyl alcohol copolymer |
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| 60 days |
| incidence of Death | 60 days |
| Incidence of new ischemic stroke | new ischemia in imaging (DWI/MRI or CT scan) within 60 days of operation | 60 days |
| Incidence of myocardial infarction/myocardial ischemia | new ischemic heart attack within 60 days of operation | 60 days |
| Incidence of embolization complication in brain | cranial nerve palsy (especially VII), vision loss (ophthalmic/retinal artery occlusion), ... | 48 hours |
| incidence of embolization complication out of brain | puncture hematoma, major artery dissection, new renal failure, ... | 15 days |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |