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

NCT04742920 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2025-07-15

No results posted yet for this study

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

Interventions

DEVICE

Middle Meningeal Artery Embolization

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

PROCEDURE

Standard Management

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Vincent COSTALAT, MD, PhD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
115 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2025-05-28
Completion
2025-05-28

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742920 on ClinicalTrials.gov