NCT07715656 Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas
| NCT ID | NCT07715656 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lahey Clinic |
| Condition | Chronic Subdural Hematoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-04-09 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-04-09 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: Candidates for this study must meet ALL of the following criteria: 1. Subject is 18 years of age or older. 2. Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms. 3. 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. 4. 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 5. 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. 6. Patient or designated Legal Authorized Representative, confirms the patient has the mental capacity, willingness and ability to comply with protocol and follow-up requirements 7. 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: 1. Patients presenting with an acute SDH (e.g. patient with presenting with a SDH due to trauma); mixed density is permitted. 2. Subject presents with bilateral cSDHs requiring treatment (contralateral cSDH \<5mm and not requiring treatment is permitted. 3. Subject presents with Glasgow Coma Scale \< 9 4. Markwalder assessment \>4 5. 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 6. Prior carotid stent placement that crosses the origin of the External Carotid Artery (ECA) ipsilateral to the subdural hematoma 7. Presumed septic embolus, or suspicion of microbial superinfection 8. CT or MRI evidence of intra-cranial tumor or mass lesion 9. Significant contraindication to angiography (eg. kidney failure). 10. Life expectancy of less than 1-year 11. 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 12. 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 13. Patient unwilling to follow SOC recommendations (e.g. refuses surgery or lifestyle modifications)
Contact & Investigator
Jonathan Pace, MD
PRINCIPAL INVESTIGATOR
Lahey Hospital & Medical Center
Frequently Asked Questions
Who can join the NCT07715656 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Subdural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07715656 currently recruiting?
Yes, NCT07715656 is actively recruiting participants. Contact the research team at sandy.l.alvarez@lahey.org for enrollment information.
Where is the NCT07715656 trial being conducted?
This trial is being conducted at Burlington, United States.
Who is sponsoring the NCT07715656 clinical trial?
NCT07715656 is sponsored by Lahey Clinic. The principal investigator is Jonathan Pace, MD at Lahey Hospital & Medical Center. The trial plans to enroll 400 participants.