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Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas
Sponsor: Lahey Clinic
Summary
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).
Official title: Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas: A Randomized Controlled Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-04-09
Completion Date
2027-06-30
Last Updated
2026-07-20
Healthy Volunteers
No
Conditions
Interventions
embolization therapy Bilateral
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.
embolization therapy Unilateral
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.
Locations (1)
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States