Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma

NCT07751887 | Active Not Recruiting

• 2 other identifiers: FN HKInternal academic grant
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This international multicenter study evaluates the efficacy and safety of middle meningeal artery embolization (MMAE) using PVA particles or liquid embolic agents as a perioperative treatment to prevent the recurrence of chronic subdural hematoma (cSDH). All participating patients across centers in the Czech Republic and Slovakia will receive the minimally invasive MMAE procedure within 7 days prior to or after surgical evacuation, with the primary goal of assessing hematoma recurrence rates and procedure-related complications over a 90-day follow-up period.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic subdural hematoma, embolisation, MMAE, reccurence, hematoma evacuation

Outcome Measures

Primary Outcomes (1)

• Rate of hematoma recurrence or treatment failure requiring surgical evacuation

  The proportion of participants who experience a symptomatic or radiologically confirmed recurrence or progression of chronic subdural hematoma (cSDH) in the target hemisphere that requires surgical intervention (or re-operation for surgically treated patients) within the follow-up period.

  Up to 90 days post-enrollment.

Secondary Outcomes (1)

• Incidence of periprocedural and postprocedural complications

  During hospitalization, up to 7 days post-procedure

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Patients with chronic subdural hematoma (cSDH) who undergo middle meningeal artery embolization (MMAE). This procedure is performed either as a standalone treatment or as an adjunct to surgical evacuation, based on clinical indication.

Device: Middle Meningeal Artery Embolisation

Standard Care Arm

NO INTERVENTION

Patients with chronic subdural hematoma (cSDH) who receive standard clinical care without undergoing middle meningeal artery embolization. This includes standard surgical evacuation (burr-hole craniostomy) or conservative management (observation, medication) based on current guidelines.

Interventions

Middle Meningeal Artery Embolisation DEVICE

Endovascular occlusion of the middle meningeal artery (MMA) performed under fluoroscopic guidance. The procedure aims to devascularize the chronic subdural hematoma membrane to promote hematoma resorption and prevent recurrence.

Intervention Arm

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Diagnosis of a symptomatic or asymptomatic chronic or subacute subdural hematoma (cSDH) confirmed by neuroimaging (CT or MRI).
• Hematoma thickness of 5 mm or greater at its widest point on baseline neuroimaging.
• Patient is managed either conservatively or via standard surgical evacuation (e.g., burr-hole craniostomy) where MMAE is planned as a standalone or adjunctive treatment.
• Written informed consent provided by the patient or a legally authorized representative.

You may not qualify if:

• Acute subdural hematoma requiring emergency surgical decompression due to severe neurological deficit with signs of impending herniation.
• Evidence of an active intracranial infection or sepsis.
• Known vascular malformation, aneurysm, or dural arteriovenous fistula as the source of the hematoma.
• Severe uncorrectable coagulopathy or bleeding disorder (e.g., platelet count \<50,000/µL or INR \>2.0 that cannot be safely corrected before the procedure).
• Severe renal impairment (e.g., eGFR \<30 mL/min/1.73m²) or known severe allergy to iodinated contrast media (unless adequate premedication is possible).
• Life expectancy of less than 3 months due to severe comorbid conditions.

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Related Publications (5)

• Siddiq F, Shakir M, Nguyen TN, Hassan AE, Abdalkader M, Kenmuir CL, Liebeskind DS, Novakovic R, Majidi S, Sheth SA, El-Ghanem M, Ortega-Gutierrez S, Guerrero WR, Malik AM. Consensus Statement on Middle Meningeal Artery Embolization in Chronic Subdural Hematoma Treatment: A Guideline from the Society of Vascular and Interventional Neurology Guidelines and Practice Standards Committee. Stroke Vasc Interv Neurol. 2025 Sep 15;5(6):e001814. doi: 10.1161/SVIN.125.001814. eCollection 2025 Nov.

  PMID: 41608698 RESULT

• Mascitelli JR, Bulsara KR, Marden FA, Raper DMS, Tenser MS, Al Saiegh F, Waldau B, Hetts SW, Schirmer CM. Current state of the field and recommendations for middle meningeal artery embolization in chronic subdural hematoma: A Report of the SNIS Standards and Guidelines Committee, Endorsed by ANZSNR and ESMINT. J Neurointerv Surg. 2026 Apr 29:jnis-2026-024979. doi: 10.1136/jnis-2026-024979. Online ahead of print.

  PMID: 42055825 RESULT

• Maresca G, Ottaviani M, Ryan KM, Brutti S, Appetecchi GB. Improved Compatibility of alpha-NaMnO2 Cathodes at the Interface with Ionic Liquid Electrolytes. ChemSusChem. 2024 Nov 11;17(21):e202400514. doi: 10.1002/cssc.202400514. Epub 2024 Jun 10.

  PMID: 38753581 RESULT

• Brunet-Manquat L, Combedazou A, Ahuja B, Maden A, Ramus C, Mardovina T, Frolet C. Pre-ANDA strategy and Human Factors activities to de-risk pharmaceutical companies ANDA submission of drug-device combination products: case study of a formative Comparative Use Human Factors study. Expert Opin Drug Deliv. 2024 May;21(5):767-778. doi: 10.1080/17425247.2024.2356678. Epub 2024 May 29.

  PMID: 38753579 RESULT

• Peng MY, Zhang X, Li QD, Feng EM, Chen L, Yang HC, Guo B, Di YT, Tang L, Luo RC, Yan Y. Two new jatrophane diterpenoids from Euphorbia helioscopia with activity towards autophagic flux. J Asian Nat Prod Res. 2024 Aug;26(8):900-909. doi: 10.1080/10286020.2024.2345181. Epub 2024 May 16.

  PMID: 38753580 RESULT

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 6 months after the primary publication of the study results and will remain accessible for 36 months following publication.
• Access Criteria: Anonymized data will be shared with qualified academic researchers upon reasonable request. Requests must include a scientifically sound research proposal and a statistical analysis plan. Proposals will be reviewed and approved by the principal investigators of the study. Data will be shared strictly for the purpose of meta-analysis or independent verification of the results via secure data transfer.

Locations

CZ (1)