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

NCT ID: NCT04742920

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2025-05-28

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MMA embolization group

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

Group Type: OTHER

Middle Meningeal Artery Embolization

Intervention Type: DEVICE

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

Control group

Standard (surgical/conservative) Management alone

Group Type: OTHER

Standard Management

Intervention Type: PROCEDURE

Procedure : Surgical Management Surgical evacuation of the subdural hematoma

Other: Conservative Management Standard medical management: drug treatment and/or observation

Interventions

Middle Meningeal Artery Embolization

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

Intervention Type: DEVICE

Standard Management

Procedure : Surgical Management Surgical evacuation of the subdural hematoma

Other: Conservative Management Standard medical management: drug treatment and/or observation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 115 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent COSTALAT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

CHU de Bordeaux Hôpital Pellegrin

Bordeaux, , France

CHU Lyon

Bron, , France

CHU de Dijon

Dijon, , France

Chu de Montpellier - Gui de Chauliac

Montpellier, , France

CHU de Nîmes

Nîmes, , France

CHU de Toulouse Hôpital Pierre Paul Riquet

Toulouse, , France

Countries

France

Other Identifiers

RECHMPL20_0362

Identifier Type: -

Identifier Source: org_study_id