Chronic Subdural HematomaEMMA-CSNCT07751887
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
A study testing Middle Meningeal Artery Embolisation in people with Chronic Subdural Hematoma, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Middle Meningeal Artery Embolisation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2026to 1 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multicentric Study of Middle Meningeal Artery Embolisation Combined With Surgical Treatment for Chronic Subdural Hematoma
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
- Being tested
- Middle Meningeal Artery Embolisation
- Keywords
- Chronic subdural hematoma, embolisation, middle meningeal artery, recurrence, hematoma evacuation, REDCap
- Medical subject headings
- Hematoma, Subdural, Chronic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle Meningeal Artery EmbolisationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 90 days post-enrollment.
Secondary outcomes (1)
Incidence of periprocedural and postprocedural complications
Safety outcomes evaluating complications related to the middle meningeal artery embolisation (MMAE) procedure or the embolic material. This includes technical failure, ischemic stroke, new intracranial hemorrhage, facial nerve palsy, visual impairment, local arterial access site complications (e.g., hematoma, pseudoaneurysm), or severe allergic reactions to contrast media.
Measured: During hospitalization, up to 7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Jun 2026
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751887
- Sponsor's protocol ID
- FN HK
- Other IDs
- Internal academic grant
- Acronym
- EMMA-CS
- Status last verified
- Jun 2026
- First submitted
- 3 Aug 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) including baseline demographics, clinical characteristics, neuroimaging metrics (hematoma thickness and volume), procedural details of middle meningeal artery embolisation, and follow-up clinical and radiological outcomes will be shared. Only data that underlie the results reported in the final published article will be made available.
Publications
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.
PubMed 41608698Mascitelli 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.
PubMed 42055825Maresca 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.
PubMed 38753581Brunet-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.
PubMed 38753579Peng 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.
PubMed 38753580
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Study of Middle Meningeal Artery Embolisation Combined With Surgical Treatment for Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT07751887
- Acronym / sponsor ID
- EMMA-CS / FN HK
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic subdural hematoma, embolisation, middle meningeal artery, recurrence, hematoma evacuation, REDCap
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 7 Aug 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Middle Meningeal Artery EmbolisationPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
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 EmbolisationEndovascular 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. | Device | Intervention Arm |
Primary outcome
Rate of hematoma recurrence or treatment failure requiring surgical evacuation
Time frame: Up to 90 days post-enrollment.
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.
1 secondary outcome
Incidence of periprocedural and postprocedural complications
Time frame: During hospitalization, up to 7 days post-procedure
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 30 Sep 2026.
- Results publication: PubMed 41608698Siddiq 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.
- Results publication: PubMed 42055825Mascitelli 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.
- Results publication: PubMed 38753581Maresca 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.
- Results publication: PubMed 38753579Brunet-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.
- Results publication: PubMed 38753580Peng 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) including baseline demographics, clinical characteristics, neuroimaging metrics (hematoma thickness and volume), procedural details of middle meningeal artery embolisation, and follow-up clinical and radiological outcomes will be shared. Only data that underlie the results reported in the final published article will be made available.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Middle Meningeal Artery Embolisation in people with Chronic Subdural Hematoma, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Rate of hematoma recurrence or treatment failure requiring surgical evacuation (time frame: Up to 90 days post-enrollment.). 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 NCT07751887, which also lists 5 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 30 Sep 2026.