Clinical Research Directory

Prospective MMA Embolization Registry

Chronic subdural hematoma (cSDH) is a common condition, particularly in older adults, that can substantially impair patients' quality of life, functional independence, and neurological well-being. Blood accumulates in the subdural space and persists due to the formation of a highly vascularized outer hematoma membrane. This membrane continuously rebleeds through fragile neovessels, driven in large part by branches of the middle meningeal artery (MMA), preventing spontaneous resolution and promoting hematoma growth. The standard treatment is surgical drainage, but recurrence rates reach up to 30%, largely because surgery does not address the underlying membrane vascularity. Middle meningeal artery embolization (MMAE) is a minimally invasive angiographic procedure that targets this root cause by occluding the arterial supply to the hematoma membrane, thereby reducing rebleeding and promoting resolution. Recent clinical trials and meta-analyses have demonstrated high efficacy and safety of MMAE, both as a standalone treatment and as an adjunct to surgery. Despite this evidence, standardized prospective data on patient selection, predictors of treatment success, and optimal follow-up are still lacking. PRO-EMMA is a prospective, single-center registry at the Charité - Universitätsmedizin Berlin, a tertiary center consisting of three separate campuses. Pro-Emma systematically collects clinical, radiological, and procedural data from patients with cSDH who undergo MMAE. In addition to routine clinical care, participants undergo a structured follow-up protocol: CT scans within 7 days and at 3 months after the procedure, and standardized assessments of neurological status, functional outcome, and quality of life - using the Glasgow Coma Scale (GCS), Markwalder score, modified Rankin Scale (mRS), Glasgow Outcome Scale Extended (GOS-E), and EQ-5D-5L- before the procedure and at days 30, 90, and 120 post-intervention. The study tests the hypothesis that MMAE leads to good functional outcomes, rapid hematoma resolution, and low recurrence rates, and that specific clinical, interventional, and imaging features predict treatment success. Findings will help identify which patients benefit most from MMAE, optimize treatment decisions, and establish a practical, evidence-based follow-up standard. The registry aims to enroll 75-150 patients over approximately 12 months.

PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial

This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to either initial surgical evacuation (Control Arm) or initial MMAE with PHIL™ (investigational arm).

Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop. Recent studies suggest that arteries nourished by the middle meningeal artery (MMA) may be responsible for hematoma progression and that MMA embolization is clinically useful. There is less evidence, that embolization of MMA also may be a treatment option for individuals without surgical treatment. The investigators propose a multicentre study to investigate both potentials: (1) Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; Arms 1 and 2), (2) Assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, Arms 3 and 4).

Implementation of an Enhanced Recovery Pathway for Burr-hole Drainage in Patients With a Chronic Subdural Hematoma

A chronic subdural hematoma (cSDH) is a type of intracranial hematoma that primarily affects older adults. The rising incidence of this condition, coupled with the high healthcare burden of this disease, calls for an update of the medical care program. We introduced an enhanced recovery protocol (ERP) at our center for patients undergoing surgical treatment (by means of burr-hole drainage) for a cSDH. Our ERP includes guidelines for treatment decisions (surgery or middle meningeal artery embolization), modifications in surgical techniques, and standardized postoperative management strategies. This study prospectively analyses the safety and efficacy of this enhanced recovery protocol for patients undergoing burr hole drainage of a chronic subdural hematoma. Safety and efficacy outcomes will be compared with outcomes of a historical patient cohort. Safety of the protocol will be measured in terms of recurrence rate (6-month follow-up, primary outcome), complication incidence, and 30-day mortality. Efficacy of the enhanced recovery protocol will be represented by the length-of-stay.

Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy

All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.

Embolization of Middle Meningeal Artery in Chronic Subdural Hematoma

Chronic subdural hematoma (cSDH) is a common neurological affliction which affects mostly frail and elderly patients. Surgical evacuation by using burr hole craniostomy (BHC) is the most frequently used treatment but carries a recurrence rate varying between 10-30% in the literature. Especially in this frail population re-operation is undesirable. Embolization of the middle meningeal artery is an adjuvant treatment which has been reported in multiple case reports and larger case series, showing a beneficial effect on recurrence rate, reducing it to \<5%, without complications. Objectives: Primary: To evaluate whether additional embolization of the middle meningeal artery after surgery for cSDH reduces the recurrent surgery rate. Secondary: to evaluate whether the use of middle meningeal artery embolization after surgical treatment in symptomatic cSDH patients increases quality of life (SF-36 and the EQ-5D-5L), performance in activities of daily living (AMC Linear Disability Score), functional outcome (mRS), cognitive functioning (MOCA) and reduces mortality, occurrence of complications, recurrence rate, size and volume of the hematoma, neurological impairment (mNIHSS, Markwalder score) and the use of care and health-related costs (iMCQ and iPCQ). Study design: Multicenter, randomized controlled open-label superiority trial. Study population: Patients diagnosed with a cSDH who require surgery. Intervention: The intervention group will receive embolization in addition to standard surgical treatment. The control group will receive surgery only. Main study endpoint: The number of patients who require reoperation within 24 weeks after the intervention. Symptomatic cSDH patients will undergo peri-operative embolization of the middle meningeal artery until 72 hours after surgical treatment. Complications are monitored during hospital admission and follow-up. Radiological and clinical follow-up is at eight, 16 and 24 weeks post-intervention with a CT-scan of the head and assessment of mRS, MOCA, mNIHSS, Markwalder score, SF-36, EQ-5D-5L, ALDS, iMCQ and iPCQ. Standard care after surgery entails outpatient follow-up with on average two CT-scans, indicated by clinical signs and symptoms.