Middle Meningeal Artery EmbolizationNCT07806552
Middle Meningeal Artery Embolization in Patients With Chronic Subdural Hematoma
A study testing middle meningeal artery embolization in people with Middle Meningeal Artery Embolization and Chronic Subdural Hematomas, run by Assiut University.
Trial summary
Primary : to evaluate the efficacy of MMAE on resolution and recurrence of hematoma in patients with CSDH. Secondary : evaluate the effect of MMAE on functional outcome, radiological changes, the need to repeat surgery, duration of hospital stay, time for hematoma to resolve. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Middle Meningeal Artery Embolization, Chronic Subdural Hematomas
- What is being tested?
- middle meningeal artery embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any age.
- Radiologically confirmed chronic subdural hematoma (CSDH) on CT or MRI either Unilateral or Bilateral CSDH.
- Patients considered suitable for standard surgical treatment of CSDH.
- First presentation or recurrent CSDH requiring treatment.
Who cannot join
- Acute subdural hematoma or acute-on-chronic SDH where the acute component is the primary pathology.
- Acute and severe neurological deterioration.
- Subdural hematomas secondary to:
- Intracranial tumors.
- Intracranial infections.
- Contraindications to angiography or embolization (for the MMAE group), such as:
Show all 10Show fewer
- Severe contrast allergy.
- Untreatable coagulopathy.
- Severe renal failure precluding contrast administration
- Severe tortuosity or anatomical variations of the external carotid artery/MMA making catheterization unfeasible.
About this study
Official title: Impact of Middle Meningeal Artery Embolization on Recurrence and Functional Outcomes in Patients With Chronic Subdural Hematoma
Primary : to evaluate the efficacy of MMAE on resolution and recurrence of hematoma in patients with CSDH.
Secondary : evaluate the effect of MMAE on functional outcome, radiological changes, the need to repeat surgery, duration of hospital stay, time for hematoma to resolve.
Read the detailed description
Chronic subdural hematoma(CSDH) is one of the most common neurosurgical disorders, particularly among older adults, and its incidence continues to increase worldwide because of population aging and the growing use of anticoagulant and antiplatelet medications. The condition usually develops following minor head trauma that results in rupture of bridging veins; however, current evidence suggests that the persistence and enlargement of CSDH are primarily driven by chronic inflammation, angiogenesis, and recurrent microhemorrhages originating from fragile neovascular membranes rather than the initial bleeding event alone. These pathological mechanisms contribute to progressive hematoma expansion, neurological deterioration, and substantial morbidity and mortality if left untreated.Surgical evacuation through burr-hole remains the standard treatment for symptomatic CSDH and is generally associated with rapid neurological improvement. Nevertheless, postoperative recurrence remains a major challenge, with recurrence rates ranging from approximately 8% to 20%, often necessitating repeat surgical intervention. Recurrent hematomas increase healthcare costs, prolong hospitalization, and are associated with poorer functional recovery, particularly in elderly and medically frail patients. Consequently, there has been increasing interest in adjunctive therapies that target the underlying pathophysiology responsible for recurrence rather than simply evacuating the hematoma.Middle meningeal artery embolization (MMAE) has recently emerged as a promising minimally invasive treatment for CSDH. The rationale for MMAE is based on occluding the vascular supply to the outer neomembrane of the hematoma, thereby reducing ongoing inflammatory exudation and recurrent microhemorrhage that sustain hematoma growth. Unlike conventional surgery, which addresses the hematoma itself, embolization targets the biological process responsible for hematoma persistence and recurrence. As a result, MMAE has been investigated both as a standalone therapy for selected patients and as an adjunct to surgical evacuation to reduce postoperative recurrence.MMAE significantly reduces the risk of hematoma recurrence and the need for repeat surgery compared with standard treatment alone, without increasing serious complications or mortality. However, although recurrence outcomes have shown clear improvement, the effect of MMAE on functional recovery, commonly assessed using the Glasgow Coma Scale (GCS).
- Being tested
- middle meningeal artery embolization
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
middle meningeal artery embolizationProcedure or surgery
Middle meningeal artery (MMA) embolization is a minimally invasive endovascular procedure designed to treat chronic subdural hematomas by blocking blood flow to the MMA, preventing recurrent bleeding.
Under local or general anesthesia, a catheter is inserted through a micro-puncture in the femoral or radial artery and navigated up to the external carotid system into the MMA under real-time fluoroscopic (X-ray) guidance. Angiography is performed to map the arterial anatomy and identify any dangerous anastomoses with the ophthalmic or internal carotid arteries.
Once positioned safely, an embolic agent such as liquid embolic systems (e.g., Onyx, n-BCA), liquid-suspended microparticles (PVA), or microcoils is injected into the anterior and posterior branches of the MMA. This occludes the fragile, hypervascular membranes driving the hematoma, allowing the body to naturally reabsorb the collected blood and reducing the need for open surgical evacuation.
| Study group | Role | What they receive |
|---|---|---|
| Embolization of middle meningeal artery | Experimental | Not described Receives: Procedure: middle meningeal artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Requiring Additional Surgical Intervention
Composite outcome defined as recurrence of chronic subdural hematoma requiring repeat surgical intervention within 6 months. Recurrence may be identified by radiological enlargement or reaccumulation of the hematoma on CT associated with recurrent or worsening neurological symptoms leading to reoperation.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Middle Meningeal Artery EmbolizationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali El-deen Alaa Ezzat Abdelmoneim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806552
- Sponsor's protocol ID
- MMAE in CSDH
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
https://doi.org/10.1016/j.clineuro.2024.108323
https://doi.org/10.1212/CPJ.0000000000200501
https://doi.org/10.1227/neu.0000000000002505
https://doi.org/10.20452/jmr.2025.20007
https://doi.org/10.1016/j.jns.2025.123469
https://doi.org/10.1159/000543041
https://doi.org/10.3389/fsurg.2025.1623619
https://doi.org/10.1080/01616412.2025.2592857
https://doi.org/10.1016/j.clineuro.2025.109128
Liu J, Ni W, Zuo Q, Yang H, Peng Y, Lin Z, Li Z, Wang J, Zhen Y, Luo J, Lin Y, Chen J, Hua X, Lu H, Zhong M, Liu M, Zhang J, Wang Y, Wan J, Li Y, Li T, Mao G, Zhao W, Gao L, Li C, Chen E, Cheng X, Zhang P, Wang Z, Chen L, Zhang Y, Tian B, Shen F, Lei Y, Wu Y, Li Y, Duan G, Xu L, Lv N, Yu J, Xu X, Du Z, Zhang H, Hu J, Li Z, Yuan Q, Zhou Y, Wu G, Zhang L, Gao C, Dai D, Wu X, Zhang Y, Jiang H, Zhao R, Su J, Xu Y, Ospel JM, Majoie CBLM, Goyal M, Li Q, Yang P, Gu Y, Mao Y; MAGIC-MT Investigators. Middle Meningeal Artery Embolization for Nonacute Subdural Hematoma. N Engl J Med. 2024 Nov 21;391(20):1901-1912. doi: 10.1056/NEJMoa2401201.
PubMed 39565989
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Middle Meningeal Artery Embolization on Recurrence and Functional Outcomes in Patients With Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT07806552
- Acronym / sponsor ID
- MMAE in CSDH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary : to evaluate the efficacy of MMAE on resolution and recurrence of hematoma in patients with CSDH.
Secondary : evaluate the effect of MMAE on functional outcome, radiological changes, the need to repeat surgery, duration of hospital stay, time for hematoma to resolve.
Detailed description
Chronic subdural hematoma(CSDH) is one of the most common neurosurgical disorders, particularly among older adults, and its incidence continues to increase worldwide because of population aging and the growing use of anticoagulant and antiplatelet medications. The condition usually develops following minor head trauma that results in rupture of bridging veins; however, current evidence suggests that the persistence and enlargement of CSDH are primarily driven by chronic inflammation, angiogenesis, and recurrent microhemorrhages originating from fragile neovascular membranes rather than the initial bleeding event alone. These pathological mechanisms contribute to progressive hematoma expansion, neurological deterioration, and substantial morbidity and mortality if left untreated.Surgical evacuation through burr-hole remains the standard treatment for symptomatic CSDH and is generally associated with rapid neurological improvement. Nevertheless, postoperative recurrence remains a major challenge, with recurrence rates ranging from approximately 8% to 20%, often necessitating repeat surgical intervention. Recurrent hematomas increase healthcare costs, prolong hospitalization, and are associated with poorer functional recovery, particularly in elderly and medically frail patients. Consequently, there has been increasing interest in adjunctive therapies that target the underlying pathophysiology responsible for recurrence rather than simply evacuating the hematoma.Middle meningeal artery embolization (MMAE) has recently emerged as a promising minimally invasive treatment for CSDH. The rationale for MMAE is based on occluding the vascular supply to the outer neomembrane of the hematoma, thereby reducing ongoing inflammatory exudation and recurrent microhemorrhage that sustain hematoma growth. Unlike conventional surgery, which addresses the hematoma itself, embolization targets the biological process responsible for hematoma persistence and recurrence. As a result, MMAE has been investigated both as a standalone therapy for selected patients and as an adjunct to surgical evacuation to reduce postoperative recurrence.MMAE significantly reduces the risk of hematoma recurrence and the need for repeat surgery compared with standard treatment alone, without increasing serious complications or mortality. However, although recurrence outcomes have shown clear improvement, the effect of MMAE on functional recovery, commonly assessed using the Glasgow Coma Scale (GCS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization of middle meningeal artery | Experimental | Procedure: middle meningeal artery embolization |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Any age.
- Radiologically confirmed chronic subdural hematoma (CSDH) on CT or MRI either Unilateral or Bilateral CSDH.
- Patients considered suitable for standard surgical treatment of CSDH.
- First presentation or recurrent CSDH requiring treatment.
Key exclusion criteria (10 listed)
- Acute subdural hematoma or acute-on-chronic SDH where the acute component is the primary pathology.
- Acute and severe neurological deterioration.
- Subdural hematomas secondary to:
- Contraindications to angiography or embolization (for the MMAE group), such as:
- Severe tortuosity or anatomical variations of the external carotid artery/MMA making catheterization unfeasible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| middle meningeal artery embolizationMiddle meningeal artery (MMA) embolization is a minimally invasive endovascular procedure designed to treat chronic subdural hematomas by blocking blood flow to the MMA, preventing recurrent bleeding. Under local or general anesthesia, a catheter is inserted through a micro-puncture in the femoral or radial artery and navigated up to the external carotid system into the MMA under real-time fluoroscopic (X-ray) guidance. Angiography is performed to map the arterial anatomy and identify any dangerous anastomoses with the ophthalmic or internal carotid arteries. Once positioned safely, an embolic agent such as liquid embolic systems (e.g., Onyx, n-BCA), liquid-suspended microparticles (PVA), or microcoils is injected into the anterior and posterior branches of the MMA. This occludes the fragile, hypervascular membranes driving the hematoma, allowing the body to naturally reabsorb the collected blood and reducing the need for open surgical evacuation. | Procedure or surgery | Embolization of middle meningeal artery |
Primary outcome
Recurrence Requiring Additional Surgical Intervention
Time frame: six months
Composite outcome defined as recurrence of chronic subdural hematoma requiring repeat surgical intervention within 6 months. Recurrence may be identified by radiological enlargement or reaccumulation of the hematoma on CT associated with recurrent or worsening neurological symptoms leading to reoperation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Backgroundhttps://doi.org/10.1016/j.clineuro.2024.108323
- Backgroundhttps://doi.org/10.1212/CPJ.0000000000200501
- Backgroundhttps://doi.org/10.1227/neu.0000000000002505
- Backgroundhttps://doi.org/10.20452/jmr.2025.20007
- Backgroundhttps://doi.org/10.1016/j.jns.2025.123469
- Backgroundhttps://doi.org/10.1159/000543041
- Backgroundhttps://doi.org/10.3389/fsurg.2025.1623619
- Backgroundhttps://doi.org/10.1080/01616412.2025.2592857
- Backgroundhttps://doi.org/10.1016/j.clineuro.2025.109128
- Background: PubMed 39565989Liu J, Ni W, Zuo Q, Yang H, Peng Y, Lin Z, Li Z, Wang J, Zhen Y, Luo J, Lin Y, Chen J, Hua X, Lu H, Zhong M, Liu M, Zhang J, Wang Y, Wan J, Li Y, Li T, Mao G, Zhao W, Gao L, Li C, Chen E, Cheng X, Zhang P, Wang Z, Chen L, Zhang Y, Tian B, Shen F, Lei Y, Wu Y, Li Y, Duan G, Xu L, Lv N, Yu J, Xu X, Du Z, Zhang H, Hu J, Li Z, Yuan Q, Zhou Y, Wu G, Zhang L, Gao C, Dai D, Wu X, Zhang Y, Jiang H, Zhao R, Su J, Xu Y, Ospel JM, Majoie CBLM, Goyal M, Li Q, Yang P, Gu Y, Mao Y; MAGIC-MT Investigators. Middle Meningeal Artery Embolization for Nonacute Subdural Hematoma. N Engl J Med. 2024 Nov 21;391(20):1901-1912. doi: 10.1056/NEJMoa2401201.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing middle meningeal artery embolization in people with Middle Meningeal Artery Embolization and Chronic Subdural Hematomas, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Requiring Additional Surgical Intervention (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07806552, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.