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

NCT07715656 | Recruiting FDA Device

• 1 other identifier: 20253018
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Subdural Hematoma

Keywords

cSDH; Chronic subdural hematoma; Coils; Embolization; eMMA

Outcome Measures

Primary Outcomes (1)

• Change 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.

  Baseline, 1 month (3-6 weeks), and 3 months (10-14 weeks)

Secondary Outcomes (3)

• Number of Participants Requiring Additional surgical Intervention

  Through 3 months

• Change from Baseline in Modified Rankin scale (mRS) Score

  Baseline, 1 month, and 3 months

• Number of participants with Procedure-related Serious Adverse Events

  through 3 months after embolization

Study Arms (2)

Medical Management

ACTIVE COMPARATOR

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.

Device: embolization therapy Bilateral; Device: embolization therapy Unilateral

Surgical

ACTIVE COMPARATOR

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.

Device: embolization therapy Bilateral; Device: embolization therapy Unilateral

Interventions

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.

Medical Management; Surgical

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.

Medical Management; Surgical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates for this study must meet ALL of the following criteria:
• Subject is 18 years of age or older.
• Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms.
• Pre-randomization modified Rankin Score (mRS) ≤3
• a. Surgical Cohort: Assessment should reflect the subject's condition just prior to undergoing surgery. Assessment may be performed post-surgery using pre-surgical data.
• Subdural Hematoma Size
• Medical Management Cohort:
• Midline shift \< 10mm and hematoma thickness \> 10 mm as measured on coronal imaging perpendicular to the skull.
• No focal deficit related to the chronic subdural hematoma requiring surgical intervention
• Surgical Cohort:
• No requirement
• A CT performed prior to randomization demonstrating stability of the hematoma. Stability is defined as no worsening of midline shift or increase in the size of the cSDH from the screening image that results in new or worsening clinical symptoms.
• Patient or designated Legal Authorized Representative, confirms the patient has the mental capacity, willingness and ability to comply with protocol and follow-up requirements
• In the opinion of the treating physician, MMA embolization is technically feasible, including evaluation of preoperative CTA, if available, or presence of a foramen spinosum bilaterally.

You may not qualify if:

• Candidates will be excluded from participation if ANY of the following apply:
• Patients presenting with an acute SDH (e.g. patient with presenting with a SDH due to trauma); mixed density is permitted.
• Subject presents with bilateral cSDHs requiring treatment (contralateral cSDH \<5mm and not requiring treatment is permitted.
• Subject presents with Glasgow Coma Scale \< 9
• Markwalder assessment \>4
• cSDH that developed with underlying conditions such as vascular lesions, brain tumor, arachnoid cyst, spontaneous intracranial hypotension, end stage renal disease (ESRD) on hemodialysis, end stage liver disease or other comorbidities causing a coagulopathy
• Prior carotid stent placement that crosses the origin of the External Carotid Artery (ECA) ipsilateral to the subdural hematoma
• Presumed septic embolus, or suspicion of microbial superinfection
• CT or MRI evidence of intra-cranial tumor or mass lesion
• Significant contraindication to angiography (eg. kidney failure).
• Life expectancy of less than 1-year
• Women who are pregnant, lactating, plan on becoming pregnant during the course of the clinical investigation. We routinely do pregnancy tests prior to this procedure, to avoid radiation exposure to the fetus including radiation on follow up CT scans
• Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Subjects in observational, natural history, and/or epidemiological studies not involving intervention are eligible
• Patient unwilling to follow SOC recommendations (e.g. refuses surgery or lifestyle modifications)

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01803, United States

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Jonathan Pace, MD

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandy L Alvarez, MD

CONTACT

7865800186; sandy.l.alvarez@lahey.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: July 20, 2026
• Study Start: April 9, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-03

Locations

US (1)