Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742920
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2021-02-03
Brief Title:
The Onyx Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma OTEMACS
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
The Onyx Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma OTEMACS
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OTEMACS
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 surgicalconservative 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 11 ratio to receive either surgical treatment plus an adjuvant MMA embolization STMMAE 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 11 ratio to MMA embolization MMAE group the Experimental arm or conservative management CM group the Control arm
Eligible symptomatic CSDH patients will be randomly assigned in a 11 ratio to receive either surgical treatment plus an adjuvant MMA embolization STMMAE 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 11 ratio to MMA embolization MMAE group the Experimental arm or conservative management CM group the Control arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None