Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma (EMBOLISE)

Medtronic

Status: Enrolling

Conditions: Subdural Hematoma

Treatments: Device: Surgical Management + Treatment; Device: Treatment; Other: No Treatment; Procedure: Surgical Management

Study type: Interventional

Funder types: Industry

Identifiers

NCT04402632

MDT19027ONYX

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-morbid Modified Rankin Score ≤3
• Confirmed diagnosis of subacute or chronic subdural hematoma
• Completed informed consent
• Meets criteria for Surgery or Observation Cohort

Exclusion criteria

• Life expectancy <1 year
• Unable to complete follow-up
• Pregnant, lactating, or has a positive pregnancy test at time of admission
• Diagnosed with acute SDH
• Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization
• Pre-randomized Markwalder Grading Scale score ≥ 3
• Unmanaged, uncontrolled bleeding disorders/blood diathesis
• Presumed septic embolus, or suspicion of microbial superinfection
• Known active COVID-19 infection
• CT or MRI evidence of intra-cranial tumor or mass lesion Contraindication to angiography
• Participation in another clinical trial
• Contraindicated for the use of Onyx™ LES
• Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at least 90 days post-randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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600 participants in 4 patient groups

Surgery Cohort: Control Arm

Active Comparator group

Description:

Control

Treatment:

Procedure: Surgical Management

Surgery Cohort: Treatment Arm

Experimental group

Description:

Treatment

Treatment:

Device: Surgical Management + Treatment

Observational Cohort: Control Arm

Active Comparator group

Description:

Control

Treatment:

Other: No Treatment

Observational Cohort: Treatment Arm

Experimental group

Description:

Treatment

Treatment:

Device: Treatment