MAGIC-MT study is multi-center, prospective, randomized (1:1) controlled trial designed to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed patients.
The objective of this study is to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
722
Embolization of the Middle Meningeal Artery using the liquid embolic material
Burr-hole drainage of subdural hematoma
best medical management
Huashan Hospital
Shanghai, Shanghai Municipality, China
Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure
SDH recurrence (\>10 mm max. thickness) or receiving re-operation in patients who underwent surgery/ symptomatic SDH progression (\>3 mm increase in max thickness or receiving surgical rescue in patients who did not undergo sugery) at 90 days "Symptomatic" is hereby defined as one or more of the following features which are attributed to the progression/recurrence: headache, short-term cognitive decline, speech difficulty or aphasia, gait impairment, focal weakness, sensory deficits, seizures
Time frame: 90 days
Effectiveness
Incidence of SDH recurrence/ progression at 1 year post-procedure
Time frame: 1 year post-procedure
Effectiveness
Rate of successful embolization of the target vessels (MMA trunk and branches) with ONYX base on DSA imaging
Time frame: day 0
Effectiveness
Change in hematoma thickness based on CT/MRI imaging at 90 days post-procedure
Time frame: 90 days post-procedure
Effectiveness
Changes in hematoma volume at 90 days post-procedure
Time frame: 90 days post-procedure
Effectiveness
Change in Midline shift based on CT/MRI imaging at 90 days post-procedure
Time frame: 90 days post-procedure
Effectiveness
Change in the Modified Rankin Scale score (mRS) Grade 0 (no symptoms) to 6 (death) at 90 days and 1 year post-procedure
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Time frame: 90 days and 1 year post-procedure
Effectiveness
Percentage of patients with favorable functional outcome defined as Modified Rankin Scale of 0 to 3 at 90 days and 1year post-procedure
Time frame: 90 days and 1 year post-procedure
Effectiveness
Percentage of patients with good functional outcome defined as Modified Rankin Scale of 0 to 2 at 90 days and 1 year post-procedure
Time frame: 90 days and 1 year post-procedure
Effectiveness
Quality of life assessed by (EuroQol) EQ-5D scale Grade 0 (worst health) to 100 (best health) at 90 days and 1 year post-procedure
Time frame: 90 days and 1 year post-procedure
Safety endpoint
Total patients with SAEs within 90 days post-procedure
Time frame: 90 days
Safety endpoint
Incidence of neurological death within 90 days post-procedure
Time frame: 90 days
Safety endpoint
Incidence of procedural serious complications within 30 days post-procedure: * symptomatic procedure-related intracranial hemorrhage * any procedure-related intracranial hemorrhage * any procedure-related neurological deficit * CNS infection caused by procedure * procedure-related artery dissection, vessel wall damage and vessel perforation * procedure-related ischemic event * retroperitoneal hematoma (femoral access)/wrist hematoma (radial access) * neuropathy at the puncture site * contrast agent allergy or encephalopathy
Time frame: 30 days