Wounds and Injuries Clinical Trial
— OTEMACSOfficial 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.
Status | Recruiting |
Enrollment | 440 |
Est. completion date | September 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 115 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu de Montpellier - Gui de Chauliac | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence rate in the Experimental group vs. the Control group | Within 90 days | ||
Secondary | Mortality rates at discharge | Within 7 days | ||
Secondary | Major disabling stroke at discharge | Within 7 days | ||
Secondary | Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs) | Through 24 hours (-6/+24 hours) post endovascular treatment | ||
Secondary | Rate of recurrence of CSDH requiring revision surgery (in surgical group) or surgical rescue (in non-surgical group) | Within 90 days | ||
Secondary | Change in hematoma volume (HV) in the Experimental group vs. the Control group | At 90 days | ||
Secondary | Shift on the modified Rankin Scale (mRS) score in the Experimental group vs. the Control group | At 90 days | ||
Secondary | Proportion of patients with good functional outcome, defined as mRS 0-2 | At 90 days | ||
Secondary | Proportion of patients with favorable functional outcome, defined as mRS 0-3 | At 90 days | ||
Secondary | Degree of disability (shift on the mRS combining scores of 5 and 6) | At 90 days | ||
Secondary | Distribution of utility weighted mRS (UW mRS) | At 90 days | ||
Secondary | Quality of life assessed by the EuroQol (Quality of life) EQ-5D scale | At 90 days | ||
Secondary | Quality of life assessed by the Barthel Index | At 90 days | ||
Secondary | Length of hospital stay for neurosurgery. | within 90 days | ||
Secondary | Incidence of all-cause mortality | At 90 days |
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