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RECRUITING
NCT07715656
NA

Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas

Sponsor: Lahey Clinic

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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