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Clinical Trials/NCT04402632
NCT04402632CompletedNot Applicable

A Study of the Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)

Medtronic Neurovascular Clinical Affairs98 sites in 1 country600 target enrollmentStarted: October 27, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
600
Locations
98
Primary Endpoint
Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline

Time Frame: 90 days post-procedure

Secondary Outcomes

  • Safety: Incidence of procedure-related serious adverse events(30 days post-procedure)
  • Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score(90 days post-procedure)
  • Safety: Incidence of neurological death(90 days and 180 days post-procedure)
  • Safety: Incidence of device-related adverse events(90 days and 180 days post-procedure)
  • Effectiveness: Change in hematoma thickness per CT/MRI imaging(90 days post-procedure)
  • Safety: Incidence of device-related serious adverse events(30 days post-procedure)
  • Effectiveness: Incidence of hospital readmissions(90 days post-procedure)
  • Effectiveness: Change in hematoma volume based on CT/MRI imaging(90 days post-procedure)
  • Effectiveness: Change in midline shift based on CT/MRI imaging(90 days post-procedure)

Investigators

Sponsor
Medtronic Neurovascular Clinical Affairs
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (98)

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