The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma

NCT04742920 | Terminated DMC

• 1 other identifier: RECHMPL20_0362
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 6

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.

Conditions

Hematoma, Subdural, Chronic; Brain Diseases; Central Nervous System Diseases; Wounds and Injuries

Keywords

Chronic Subdural Hematoma; Middle Meningeal Artery; Embolization

Outcome Measures

Primary Outcomes (1)

• Recurrence rate in the Experimental group vs. the Control group

  The recurrence of CSDH is defined by: * radiological remaining of the hematoma with thickness \> 10 mm in the ipsilateral subdural space with or without any clinical presentation at 90 days (+/- 14 days) after the randomization OR * revision surgery (in surgical group) / surgical rescue (non-surgical group) for hematoma reaccumulation (as assessed

  Within 90 days

Secondary Outcomes (14)

• Mortality rates at discharge

  Within 7 days

• Major disabling stroke at discharge

  Within 7 days

• Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs)

  Through 24 hours (-6/+24 hours) post endovascular treatment

• Rate of recurrence of CSDH requiring revision surgery (in surgical group) or surgical rescue (in non-surgical group)

  Within 90 days

• Change in hematoma volume (HV) in the Experimental group vs. the Control group

  At 90 days

Study Arms (2)

MMA embolization group

OTHER

MMA embolization procedure with Onyx™ in addition to standard (surgical/conservative) management

Device: Middle Meningeal Artery Embolization

Control group

OTHER

Standard (surgical/conservative) Management alone

Procedure: Standard Management

Interventions

Middle Meningeal Artery Embolization DEVICE

MMA embolization using the Onyx™ non-adhesive liquid embolic agent within 72 hours after randomization in addition to standard management

MMA embolization group

Standard Management PROCEDURE

Procedure : Surgical Management Surgical evacuation of the subdural hematoma Other: Conservative Management Standard medical management: drug treatment and/or observation

Control group

Eligibility Criteria

• Age: 18 Years - 115 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (6)

CHU de Bordeaux Hôpital Pellegrin

Bordeaux, France

Location

CHU Lyon

Bron, 69677, France

Location

CHU de Dijon

Dijon, 69003, France

Location

Chu de Montpellier - Gui de Chauliac

Montpellier, 34 295, France

Location

CHU de Nîmes

Nîmes, 34090, France

Location

CHU de Toulouse Hôpital Pierre Paul Riquet

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Brain Diseases; Central Nervous System Diseases; Wounds and Injuries

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage

Study Officials

• Vincent COSTALAT, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: October 12, 2021
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)