NCT04095819

Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)

Status unknown NA Last updated 19 September 2019

What this trial tests

NA trial testing Middle Meningeal Artery procedure in Chronic Subdural Hematoma in 50 participants. Status unknown.

Timeline

19 June 2019

Primary endpoint
19 April 2022

19 April 2022

Quick facts

Lead sponsor	Atlantic Health System
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	19 June 2019
Primary completion	19 April 2022
Estimated completion	19 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Middle Meningeal Artery procedure
• Traditional Surgery

Conditions studied

• Chronic Subdural Hematoma — all drugs for Chronic Subdural Hematoma →

Sponsor

Atlantic Health System — full company profile →

Who can join

18 and older, any sex, with Chronic Subdural Hematoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Middle Meningeal Artery Embolization in Chronic Subdural Hematoma: Implications of Pathophysiology in Trial Design.
   Moshayedi P, Liebeskind DS. · · 2020 · cited 63× · PMID 32973670 · DOI 10.3389/fneur.2020.00923
2. Multidisciplinary consensus-based statement on the current role of middle meningeal artery embolization (MMAE) in chronic SubDural hematoma (cSDH).
   Bartek J, Biondi A, Bonhomme V, Castellan L, et al · · 2024 · cited 13× · PMID 39717364 · DOI 10.1016/j.bas.2024.104143
3. Newer treatment paradigm improves outcomes in the most common neurosurgical disease of the elderly: a literature review of middle meningeal artery embolization for chronic subdural hematoma.
   Debs LH, Walker SE, Rahimi SY. · · 2024 · cited 13× · PMID 38691299 · DOI 10.1007/s11357-024-01173-5
4. A systematic review of middle meningeal artery embolization for minimally symptomatic chronic subdural haematomas that do not require immediate evacuation.
   Rojas-Villabona A, Mohamed S, Kennion O, Padmanabhan R, et al · · 2023 · cited 7× · PMID 38021007 · DOI 10.1016/j.bas.2023.102672
5. Middle Meningeal Artery Embolization for Chronic Subdural Hematoma: A Review of Established and Emerging Embolic Agents.
   Tudor T, Capone S, Vivanco-Suarez J, Salem MM, et al · · 2024 · cited 5× · PMID 41586060 · DOI 10.1161/svin.123.000906
6. 2024 middle meningeal artery embolization trials: A comprehensive review of past, recent, and ongoing trials.
   Gajjar AA, Naqvi A, Chen JY, Custozzo A, et al · · 2025 · cited 5× · PMID 40183372 · DOI 10.1177/15910199251329970
7. Recurrent chronic subdural hematoma caused by active middle meningeal artery bleeding: A case report and review of hybrid embolization techniques.
   Oda K, Lemus M, Marcoux J. · · 2026 · PMID 41783214 · DOI 10.25259/sni_993_2025
8. Updated systematic review of current randomised controlled trials in chronic subdural haematoma.
   Fakhry R, Yesildal C, Bartek J, Duerinck J, et al · · 2025 · PMID 41196366 · DOI 10.1007/s00701-025-06683-5