This is a pragmatic, prospective, multicenter, randomized controlled trial with intention to treat analysis. In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH).
This study will enroll up to 400 subjects who will be randomized to receive either unilateral or bilateral coil MMA embolization. The study will assess the effect of the procedures on hematoma size and patient functional outcomes over 1 to 3 months of follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
In the bilateral approach, both middle meningeal arteries are accessed and embolized using coils, regardless of hematoma location. Imaging guidance is used throughout the procedure to ensure proper coil placement, and post-procedure imaging confirms that both vessels are fully occluded.
In the unilateral approach, the middle meningeal artery (MMA) on the side of the hematoma is accessed via a catheter and occluded using coils under imaging guidance. The procedure targets only the affected side, and follow-up imaging is used to confirm successful embolization and vessel occlusion.
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
RECRUITINGChange in cSDH Maximum thickness From Baseline on Non-contrast Head CT
Change in maximum hematoma thickness (mm) and Volume (mL) measured on non-contrast head CT compared with baseline. Measurements will be performed using standardized imaging review.
Time frame: Baseline, 1 month (3-6 weeks), and 3 months (10-14 weeks)
Number of Participants Requiring Additional surgical Intervention
Number of participants requiring additional surgical treatment after randomization, including initial surgical evacuation in the medical management cohort or repeat hematoma evacuation in the surgical cohort.
Time frame: Through 3 months
Change from Baseline in Modified Rankin scale (mRS) Score
Functional outcome measured using the Modified Rankin Scale (range 0-6). change from baseline will be reported.
Time frame: Baseline, 1 month, and 3 months
Number of participants with Procedure-related Serious Adverse Events
Number of participants experiencing procedure related adverse events, including but not limited to ischemic stroke, intracranial hemorrhage, arterial dissection, vessel perforation, access-site complications requiring intervention, or death.
Time frame: through 3 months after embolization
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