Informations générales (source: ClinicalTrials.gov)
The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS) (OTEMACS)
Interventional
N/A
University Hospital, Montpellier (Voir sur ClinicalTrials)
octobre 2021
juillet 2025
05 avril 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Bordeaux Hôpital Pellegrin - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU de Dijon - 69003 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Chu de Montpellier - Gui de Chauliac - 34 295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU de Nîmes - 34090 - Nîmes - France | Contact (sur clinicalTrials) | ||||
| CHU de Toulouse Hôpital Pierre Paul Riquet - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| CHU Lyon - 69677 - Bron - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.
- 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.
- 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