NCT04742920

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 115 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-12
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2021-02-08
• Last updated: 2025-07-15

Locations

6 sites across 1 country: France