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

Official title

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

Overview

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).

Detailed description

This study will enroll up to 400 subjects who will be randomized to receive either unilateral or bilateral coil MMA embolization. The study will assess the effect of the procedures on hematoma size and patient functional outcomes over 1 to 3 months of follow-up.

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.

Primary outcome measures

• 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)]

Secondary outcome measures (3)

• Number of Participants Requiring Additional surgical Intervention [Time frame: Through 3 months]
• Change from Baseline in Modified Rankin scale (mRS) Score [Time frame: Baseline, 1 month, and 3 months]
• Number of participants with Procedure-related Serious Adverse Events [Time frame: through 3 months after embolization]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Lahey Hospital & Medical Center — Burlington

Identifiers

NCT: NCT07715656 · 20253018

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗