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

Wounds and Injuries Clinical Trial

— OTEMACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04742920
• Other study ID #: RECHMPL20_0362
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: Imad DERRAZ, MD
• Phone: +33 (0)4 67 33 75 32
• Email: i-derraz[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 115 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Chu de Montpellier - Gui de Chauliac	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate in the Experimental group vs. the Control group		Within 90 days
Secondary	Mortality rates at discharge		Within 7 days
Secondary	Major disabling stroke at discharge		Within 7 days
Secondary	Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs)		Through 24 hours (-6/+24 hours) post endovascular treatment
Secondary	Rate of recurrence of CSDH requiring revision surgery (in surgical group) or surgical rescue (in non-surgical group)		Within 90 days
Secondary	Change in hematoma volume (HV) in the Experimental group vs. the Control group		At 90 days
Secondary	Shift on the modified Rankin Scale (mRS) score in the Experimental group vs. the Control group		At 90 days
Secondary	Proportion of patients with good functional outcome, defined as mRS 0-2		At 90 days
Secondary	Proportion of patients with favorable functional outcome, defined as mRS 0-3		At 90 days
Secondary	Degree of disability (shift on the mRS combining scores of 5 and 6)		At 90 days
Secondary	Distribution of utility weighted mRS (UW mRS)		At 90 days
Secondary	Quality of life assessed by the EuroQol (Quality of life) EQ-5D scale		At 90 days
Secondary	Quality of life assessed by the Barthel Index		At 90 days
Secondary	Length of hospital stay for neurosurgery.		within 90 days
Secondary	Incidence of all-cause mortality		At 90 days