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The trial is taking place at:
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Prisma Health | Upstate Greenville Memorial Cardiac Research

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

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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

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

Trial contacts and locations

49

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Central trial contact

Medtronic Neurovascular Clinical Affairs

Data sourced from clinicaltrials.gov

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