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

Part of paid clinical trials in Burlington, Massachusetts.

Sponsor
Lahey Clinic
Study ID
NCT07715656
Status
Recruiting
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Conditions

  • Chronic Subdural Hematoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • embolization therapy Bilateral — DEVICE
    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 — DEVICE
    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.

Study Details

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).

Key Dates

First listed
Jul 20, 2026
Start date
Apr 9, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Medical Management
    In this cohort, subjects will undergo either unilateral or bilateral middle meningeal artery (MMA) embolization using coils as part of their medical management for chronic subdural hematoma (cSDH). In the unilateral arm, the MMA on the side of the hematoma is embolized, while in the bilateral arm, both sides are embolized regardless of hematoma location.
  • Active Comparator: Surgical
    In this cohort, subjects will undergo either unilateral or bilateral middle meningeal artery (MMA) embolization using coils in addition to standard surgical management for chronic subdural hematoma (cSDH). In the unilateral arm, the MMA on the side of the hematoma is embolized, while in the bilateral arm, both sides are embolized regardless of hematoma location.

Primary Outcome Measure

Change in cSDH Maximum thickness From Baseline on Non-contrast Head CT [ Time Frame: Baseline, 1 month (3-6 weeks), and 3 months (10-14 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lahey Hospital & Medical CenterBurlingtonMassachusetts01803
Kimberly Silverman
[email protected]
7817443330

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Lahey Hospital & Medical Center· Burlington, MA

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