The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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).
Enrollment
Sex
Ages
Volunteers
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.
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
440 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Imad DERRAZ, MD
Data sourced from clinicaltrials.gov
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