Hematoma, Subdural, ChronicOTEMACSNCT04742920
The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma
A study testing Middle Meningeal Artery Embolization and Standard Management in people with Hematoma, Subdural, Chronic and Brain Diseases, run by University Hospital, Montpellier at 6 sites in France.
Trial summary
Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach might increase the likelihood of resolution and might prevent reaccumulation of Chronic Subdural Hematoma (CSDH). Read more about this study
- Who is it for?
- Ages 18 to 115 years
- Conditions the study is for
- Hematoma, Subdural, Chronic, Brain Diseases, Central Nervous System Diseases
- What is being tested?
- Middle Meningeal Artery Embolization and Standard Management
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 6 sitesFrance
- Study dates
- 12 Oct 2021to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 115 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 18 years old at inclusion (no upper age limit).
- CSDH confirmed on cranial imaging (e.g. CT/magnetic resonance imaging [MRI]), as documented by a radiologist.
- One or more symptoms attributable to CSDH including headache, cognitive impairment, gait instability, seizure, mild focal neurologic deficit, speech disturbance, or decreased consciousness.
- No significant pre-morbid disability (baseline mRS score ≤3).
- Decision of conventional therapy (neurosurgeon blinded to the randomization group)
- Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent Form, or fulfilling the criteria for emergency consent.
Who cannot join
- CSDH developing with underlying conditions: vascular lesions, brain tumor, arachnoid cyst, or spontaneous intracranial hypotension.
- CSDH that have a focal location (confined to the frontal or temporal base or the interhemispheric space without cerebral convexity involvement), is 10 mm or less in thickness, or have no mass effect (cortical flattening or midline shifting).
- Known absence of vascular access or any local cause prohibiting femoral catheterization.
- Known contrast or endovascular or anesthetic product allergy or contraindications.
- Any contraindications to the use of the Onyx™.
- Female who is known to be pregnant or lactating at time of admission.
Show all 12Show fewer
- Patient presenting severe or fatal co-morbidities or Life expectancy under 6 months that will likely interfere with improvement or follow-up or that will render the procedure unlikely to benefit the patient.
- Patient unable to be present or available for follow-up
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g. severe dementia).
- Current participation in another investigational drug or device study.
- Major patients under court protection, guardianship or curatorship.
- Not be affiliated to a French social security system or a beneficiary of such a system
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Bordeaux Hôpital Pellegrin
Bordeaux
CHU Lyon
Bron, 69677
CHU de Dijon
Dijon, 69003
Chu de Montpellier - Gui de Chauliac
Montpellier, 34 295
CHU de Nîmes
Nîmes, 34090
CHU de Toulouse Hôpital Pierre Paul Riquet
Toulouse, 31059
About this study
Official title: The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)
Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach might increase the likelihood of resolution and might prevent reaccumulation of Chronic Subdural Hematoma (CSDH). The purpose of the OTEMACS Trial is to assess the safety and effect on recurrence rate and functional outcome of endovascular treatment in patients with CSDH.
Read the detailed description
The OTEMACS study is a prospective, multicenter clinical trial with randomized treatment allocation, open label treatment and blinded endpoint evaluation (PROBE), designed to demonstrate that MMA embolization via a minimally invasive endovascular approach combined with standard (surgical/conservative) management is superior to standard management alone, in reducing the rate of CSDH-related surgical interventions and the recurrence rate in patient with CSDH at 90 days.
Eligible symptomatic CSDH patients will be randomly assigned, in a 1:1 ratio, to receive either surgical treatment plus an adjuvant MMA embolization (ST+MMAE group; the Experimental arm) or surgical treatment alone (ST group; the Control arm).
Eligible symptomatic nonsurgically treated patients with CSDH will be randomized, in a 1:1 ratio, to MMA embolization (MMAE group; the Experimental arm) or conservative management (CM group; the Control arm).
- Conditions
- Hematoma, Subdural, Chronic, Brain Diseases, Central Nervous System Diseases, Wounds and Injuries
- Being tested
- Middle Meningeal Artery Embolization, Standard Management
- Keywords
- Chronic Subdural Hematoma, Middle Meningeal Artery, Embolization
- Medical subject headings
- Hematoma, Subdural, Chronic, Brain Diseases, Central Nervous System Diseases, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle Meningeal Artery EmbolizationDevice
MMA embolization using the Onyx™ non-adhesive liquid embolic agent within 72 hours after randomization in addition to standard management
Standard ManagementProcedure or surgery
Procedure : Surgical Management Surgical evacuation of the subdural hematoma
Other: Conservative Management Standard medical management: drug treatment and/or observation
| Study group | Role | What they receive |
|---|---|---|
| MMA embolization group | Other | MMA embolization procedure with Onyx™ in addition to standard (surgical/conservative) management Receives: Device: Middle Meningeal Artery Embolization |
| Control group | Other | Standard (surgical/conservative) Management alone Receives: Procedure: Standard Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate in the Experimental group vs. the Control group
The recurrence of CSDH is defined by:
- radiological remaining of the hematoma with thickness > 10 mm in the ipsilateral subdural space with or without any clinical presentation at 90 days (+/- 14 days) after the randomization OR
- revision surgery (in surgical group) / surgical rescue (non-surgical group) for hematoma reaccumulation (as assessed
Measured: Within 90 days
Secondary outcomes (14)
Mortality rates at discharge
Measured: Within 7 days
Major disabling stroke at discharge
Measured: Within 7 days
Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs)
Measured: Through 24 hours (-6/+24 hours) post endovascular treatment
Rate of recurrence of CSDH requiring revision surgery (in surgical group) or surgical rescue (in non-surgical group)
Measured: Within 90 days
Change in hematoma volume (HV) in the Experimental group vs. the Control group
Measured: At 90 days
Shift on the modified Rankin Scale (mRS) score in the Experimental group vs. the Control group
Measured: At 90 days
Proportion of patients with good functional outcome, defined as mRS 0-2
Measured: At 90 days
Proportion of patients with favorable functional outcome, defined as mRS 0-3
Measured: At 90 days
Degree of disability (shift on the mRS combining scores of 5 and 6)
Measured: At 90 days
Distribution of utility weighted mRS (UW mRS)
Measured: At 90 days
Quality of life assessed by the EuroQol (Quality of life) EQ-5D scale
Measured: At 90 days
Quality of life assessed by the Barthel Index
Measured: At 90 days
Length of hospital stay for neurosurgery.
Measured: within 90 days
Incidence of all-cause mortality
Measured: At 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start12 Oct 2021
- Primary completion28 May 2025
- Study completion28 May 2025
Why it stopped: The DSMB recommended to stop the study after the interim analysis, as the results shown a superiority of the embolization arm. 247 patient were finally enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematoma, Subdural, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent COSTALAT, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742920
- Sponsor's protocol ID
- RECHMPL20_0362
- Acronym
- OTEMACS
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2021
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)
- ClinicalTrials.gov ID
- NCT04742920
- Acronym / sponsor ID
- OTEMACS / RECHMPL20_0362
- Conditions
- Hematoma, Subdural, Chronic, Brain Diseases, Central Nervous System Diseases, Wounds and Injuries
- Keywords
- Chronic Subdural Hematoma, Middle Meningeal Artery, Embolization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The DSMB recommended to stop the study after the interim analysis, as the results shown a superiority of the embolization arm. 247 patient were finally enrolled.
- Enrolment
- 247 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 8 Feb 2021 (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.
Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach might increase the likelihood of resolution and might prevent reaccumulation of Chronic Subdural Hematoma (CSDH). The purpose of the OTEMACS Trial is to assess the safety and effect on recurrence rate and functional outcome of endovascular treatment in patients with CSDH.
Detailed description
The OTEMACS study is a prospective, multicenter clinical trial with randomized treatment allocation, open label treatment and blinded endpoint evaluation (PROBE), designed to demonstrate that MMA embolization via a minimally invasive endovascular approach combined with standard (surgical/conservative) management is superior to standard management alone, in reducing the rate of CSDH-related surgical interventions and the recurrence rate in patient with CSDH at 90 days.
Eligible symptomatic CSDH patients will be randomly assigned, in a 1:1 ratio, to receive either surgical treatment plus an adjuvant MMA embolization (ST+MMAE group; the Experimental arm) or surgical treatment alone (ST group; the Control arm).
Eligible symptomatic nonsurgically treated patients with CSDH will be randomized, in a 1:1 ratio, to MMA embolization (MMAE group; the Experimental arm) or conservative management (CM group; the Control arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMA embolization group | Other | Device: Middle Meningeal Artery EmbolizationMMA embolization procedure with Onyx™ in addition to standard (surgical/conservative) management |
| Control group | Other | Procedure: Standard ManagementStandard (surgical/conservative) Management alone |
Who may qualify
- Ages
- 18 to 115 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is ≥ 18 years old at inclusion (no upper age limit).
- CSDH confirmed on cranial imaging (e.g. CT/magnetic resonance imaging [MRI]), as documented by a radiologist.
- One or more symptoms attributable to CSDH including headache, cognitive impairment, gait instability, seizure, mild focal neurologic deficit, speech disturbance, or decreased consciousness.
- No significant pre-morbid disability (baseline mRS score ≤3).
- Decision of conventional therapy (neurosurgeon blinded to the randomization group)
Key exclusion criteria (12 listed)
- CSDH developing with underlying conditions: vascular lesions, brain tumor, arachnoid cyst, or spontaneous intracranial hypotension.
- CSDH that have a focal location (confined to the frontal or temporal base or the interhemispheric space without cerebral convexity involvement), is 10 mm or less in thickness, or have no mass effect (cortical flattening or midline shifting).
- Known absence of vascular access or any local cause prohibiting femoral catheterization.
- Known contrast or endovascular or anesthetic product allergy or contraindications.
- Any contraindications to the use of the Onyx™.
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 EmbolizationMMA embolization using the Onyx™ non-adhesive liquid embolic agent within 72 hours after randomization in addition to standard management | Device | MMA embolization group |
| Standard ManagementProcedure : Surgical Management Surgical evacuation of the subdural hematoma Other: Conservative Management Standard medical management: drug treatment and/or observation | Procedure or surgery | Control group |
Primary outcome
Recurrence rate in the Experimental group vs. the Control group
Time frame: Within 90 days
The recurrence of CSDH is defined by: * radiological remaining of the hematoma with thickness > 10 mm in the ipsilateral subdural space with or without any clinical presentation at 90 days (+/- 14 days) after the randomization OR * revision surgery (in surgical group) / surgical rescue (non-surgical group) for hematoma reaccumulation (as assessed
14 secondary outcomes
Mortality rates at discharge
Time frame: Within 7 days
Major disabling stroke at discharge
Time frame: Within 7 days
Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs)
Time frame: Through 24 hours (-6/+24 hours) post endovascular treatment
Rate of recurrence of CSDH requiring revision surgery (in surgical group) or surgical rescue (in non-surgical group)
Time frame: Within 90 days
Change in hematoma volume (HV) in the Experimental group vs. the Control group
Time frame: At 90 days
Shift on the modified Rankin Scale (mRS) score in the Experimental group vs. the Control group
Time frame: At 90 days
Proportion of patients with good functional outcome, defined as mRS 0-2
Time frame: At 90 days
Proportion of patients with favorable functional outcome, defined as mRS 0-3
Time frame: At 90 days
Degree of disability (shift on the mRS combining scores of 5 and 6)
Time frame: At 90 days
Distribution of utility weighted mRS (UW mRS)
Time frame: At 90 days
Quality of life assessed by the EuroQol (Quality of life) EQ-5D scale
Time frame: At 90 days
Quality of life assessed by the Barthel Index
Time frame: At 90 days
Length of hospital stay for neurosurgery.
Time frame: within 90 days
Incidence of all-cause mortality
Time frame: At 90 days
Results and safety
The study was stopped early (reason given: The DSMB recommended to stop the study after the interim analysis, as the results shown a superiority of the embolization arm. 247 patient were finally enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Vincent COSTALAT, MD, PhD principal investigator
University Hospital, Montpellier
6 sites 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 Embolization and Standard Management in people with Hematoma, Subdural, Chronic and Brain Diseases, run by University Hospital, Montpellier at 6 sites in France.
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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
The study was stopped early (reason given: The DSMB recommended to stop the study after the interim analysis, as the results shown a superiority of the embolization arm. 247 patient were finally enrolled.). Results are not available in the source record.
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 rate in the Experimental group vs. the Control group (time frame: Within 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.