RecruitingNot ApplicableNCT07715656

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

Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas: A Randomized Controlled Trial.

Sponsor

Lahey Clinic

Enrollment

400 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Subdural Hematoma

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called embolization therapy Bilateral and a medical device called embolization therapy Unilateral for people with chronic subdural hematoma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEembolization 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.

DEVICEembolization 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.