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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
247
MMA embolization using the Onyx™ non-adhesive liquid embolic agent within 72 hours after randomization in addition to standard management
Procedure : Surgical Management Surgical evacuation of the subdural hematoma Other: Conservative Management Standard medical management: drug treatment and/or observation
CHU de Bordeaux Hôpital Pellegrin
Bordeaux, France
CHU Lyon
Bron, France
CHU de Dijon
Dijon, France
Chu de Montpellier - Gui de Chauliac
Montpellier, France
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
Time frame: Within 90 days
Mortality rates at discharge
Time frame: Within 7 days
Major disabling stroke at discharge
Time frame: Within 7 days
Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs)
Time frame: 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)
Time frame: Within 90 days
Change in hematoma volume (HV) in the Experimental group vs. the Control group
Time frame: At 90 days
Shift on the modified Rankin Scale (mRS) score in the Experimental group vs. the Control group
Time frame: At 90 days
Proportion of patients with good functional outcome, defined as mRS 0-2
Time frame: At 90 days
Proportion of patients with favorable functional outcome, defined as mRS 0-3
Time frame: At 90 days
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CHU de Nîmes
Nîmes, France
CHU de Toulouse Hôpital Pierre Paul Riquet
Toulouse, France
Degree of disability (shift on the mRS combining scores of 5 and 6)
Time frame: At 90 days
Distribution of utility weighted mRS (UW mRS)
Time frame: At 90 days
Quality of life assessed by the EuroQol (Quality of life) EQ-5D scale
Time frame: At 90 days
Quality of life assessed by the Barthel Index
Time frame: At 90 days
Length of hospital stay for neurosurgery.
Time frame: within 90 days
Incidence of all-cause mortality
Time frame: At 90 days