The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS) (OTEMACS)
Primary Purpose
Hematoma, Subdural, Chronic, Brain Diseases, Central Nervous System Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Middle Meningeal Artery Embolization
Standard Management
Sponsored by
About this trial
This is an interventional treatment trial for Hematoma, Subdural, Chronic focused on measuring Chronic Subdural Hematoma, Middle Meningeal Artery, Embolization
Eligibility Criteria
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
Sites / Locations
- Chu de Montpellier - Gui de ChauliacRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
MMA embolization group
Control group
Arm Description
MMA embolization procedure with Onyx™ in addition to standard (surgical/conservative) management
Standard (surgical/conservative) Management alone
Outcomes
Primary Outcome Measures
Recurrence rate in the Experimental group vs. the Control group
Secondary Outcome Measures
Mortality rates at discharge
Major disabling stroke at discharge
Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs)
Rate of recurrence of CSDH requiring revision surgery (in surgical group) or surgical rescue (in non-surgical group)
Change in hematoma volume (HV) in the Experimental group vs. the Control group
Shift on the modified Rankin Scale (mRS) score in the Experimental group vs. the Control group
Proportion of patients with good functional outcome, defined as mRS 0-2
Proportion of patients with favorable functional outcome, defined as mRS 0-3
Degree of disability (shift on the mRS combining scores of 5 and 6)
Distribution of utility weighted mRS (UW mRS)
Quality of life assessed by the EuroQol (Quality of life) EQ-5D scale
Quality of life assessed by the Barthel Index
Length of hospital stay for neurosurgery.
Incidence of all-cause mortality
Full Information
NCT ID
NCT04742920
First Posted
February 3, 2021
Last Updated
April 4, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT04742920
Brief Title
The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)
Acronym
OTEMACS
Official Title
The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 (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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematoma, Subdural, Chronic, Brain Diseases, Central Nervous System Diseases, Wounds and Injuries
Keywords
Chronic Subdural Hematoma, Middle Meningeal Artery, Embolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MMA embolization group
Arm Type
Other
Arm Description
MMA embolization procedure with Onyx™ in addition to standard (surgical/conservative) management
Arm Title
Control group
Arm Type
Other
Arm Description
Standard (surgical/conservative) Management alone
Intervention Type
Device
Intervention Name(s)
Middle Meningeal Artery Embolization
Intervention Description
MMA embolization using the Onyx™ non-adhesive liquid embolic agent within 72 hours after randomization in addition to standard management
Intervention Type
Procedure
Intervention Name(s)
Standard Management
Intervention Description
Procedure : Surgical Management Surgical evacuation of the subdural hematoma
Other: Conservative Management Standard medical management: drug treatment and/or observation
Primary Outcome Measure Information:
Title
Recurrence rate in the Experimental group vs. the Control group
Time Frame
Within 90 days
Secondary Outcome Measure Information:
Title
Mortality rates at discharge
Time Frame
Within 7 days
Title
Major disabling stroke at discharge
Time Frame
Within 7 days
Title
Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs)
Time Frame
Through 24 hours (-6/+24 hours) post endovascular treatment
Title
Rate of recurrence of CSDH requiring revision surgery (in surgical group) or surgical rescue (in non-surgical group)
Time Frame
Within 90 days
Title
Change in hematoma volume (HV) in the Experimental group vs. the Control group
Time Frame
At 90 days
Title
Shift on the modified Rankin Scale (mRS) score in the Experimental group vs. the Control group
Time Frame
At 90 days
Title
Proportion of patients with good functional outcome, defined as mRS 0-2
Time Frame
At 90 days
Title
Proportion of patients with favorable functional outcome, defined as mRS 0-3
Time Frame
At 90 days
Title
Degree of disability (shift on the mRS combining scores of 5 and 6)
Time Frame
At 90 days
Title
Distribution of utility weighted mRS (UW mRS)
Time Frame
At 90 days
Title
Quality of life assessed by the EuroQol (Quality of life) EQ-5D scale
Time Frame
At 90 days
Title
Quality of life assessed by the Barthel Index
Time Frame
At 90 days
Title
Length of hospital stay for neurosurgery.
Time Frame
within 90 days
Title
Incidence of all-cause mortality
Time Frame
At 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
115 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imad DERRAZ, MD
Phone
+33 (0)4 67 33 75 32
Email
i-derraz@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent COSTALAT, MD, PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Montpellier - Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34 295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent COSTALAT
Email
v-costalat@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Imad DERRAZ
Email
i-derraz@chu-montpellier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)
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