The Onyxâ„¢ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (NCT04742920) | Clinical Trial Compass
TerminatedNot Applicable
The Onyxâ„¢ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma
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.
France247 participantsStarted 2021-10-12
Plain-language 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). 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.
Who can participate
Age range18 Years – 115 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Onyxâ„¢.
* Female who is known to be pregnant or lactating at time of admission.
* Patient presenting severe or fatal co-morbidities or Life expectancy …
What they're measuring
1
Recurrence rate in the Experimental group vs. the Control group