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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

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

18 Years - 115 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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

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

v-costalat@chu-montpellier.fr

First Name & Middle Initial & Last Name & Degree

Imad DERRAZ

i-derraz@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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