Clinical trial NCT04742920: The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma
Official title: The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hematoma, Subdural, Chronic
Brain Diseases
Central Nervous System Diseases
Wounds and Injuries
Keywords: Chronic Subdural Hematoma
Middle Meningeal Artery
Embolization
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 115
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence rate in the Experimental group vs. the Control group
timeFrame: Within 90 days
Secondary outcomes:
measure: Mortality rates at discharge
timeFrame: Within 7 days
measure: Major disabling stroke at discharge
timeFrame: Within 7 days
measure: Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs)
timeFrame: Through 24 hours (-6/+24 hours) post endovascular treatment
measure: Rate of recurrence of CSDH requiring revision surgery (in surgical group) or surgical rescue (in non-surgical group)
timeFrame: Within 90 days
measure: Change in hematoma volume (HV) in the Experimental group vs. the Control group
timeFrame: At 90 days
measure: Shift on the modified Rankin Scale (mRS) score in the Experimental group vs. the Control group
timeFrame: At 90 days
measure: Proportion of patients with good functional outcome, defined as mRS 0-2
timeFrame: At 90 days
measure: Proportion of patients with favorable functional outcome, defined as mRS 0-3
timeFrame: At 90 days
measure: Degree of disability (shift on the mRS combining scores of 5 and 6)
timeFrame: At 90 days
measure: Distribution of utility weighted mRS (UW mRS)
timeFrame: At 90 days
measure: Quality of life assessed by the EuroQol (Quality of life) EQ-5D scale
timeFrame: At 90 days
measure: Quality of life assessed by the Barthel Index
timeFrame: At 90 days
measure: Length of hospital stay for neurosurgery.
timeFrame: within 90 days
measure: Incidence of all-cause mortality
timeFrame: At 90 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux Hôpital Pellegrin
city: Bron
country: France
facility: CHU Lyon
city: Dijon
country: France
facility: CHU de Dijon
city: Montpellier
country: France
facility: Chu de Montpellier - Gui de Chauliac
city: Nîmes
country: France
facility: CHU de Nîmes
city: Toulouse
country: France
facility: CHU de Toulouse Hôpital Pierre Paul Riquet
Study officials:
affiliation: University Hospital, Montpellier
name: Vincent COSTALAT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: