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

NCT04402632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-12-11

No results posted yet for this study

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)

Conditions

  • Subdural Hematoma

Interventions

PROCEDURE

Surgical Management

Surgical Evacuation of the Subdural Hematoma (SDH) (Control)

DEVICE

Onyx™ Liquid Embolic System (LES) Embolization

Onyx™ LES Embolization of the Subdural Hematoma (SDH)

OTHER

Observation Only

Medical Management (Control)

DEVICE

Onyx™ Liquid Embolic System (LES) Embolization

Onyx™ LES Embolization of the Subdural Hematoma (SDH)

PROCEDURE

Surgical Management

Surgical Evacuation of the Subdural Hematoma (SDH)

Sponsors & Collaborators

  • Medtronic Neurovascular Clinical Affairs

    lead INDUSTRY

Principal Investigators

  • Jared Knopman, MD · New York-Presbyterian Hospital/Weill Cornell Medical Center

  • Jason Davies, MD · Buffalo General Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2024-12-19
Completion
2025-04-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04402632 on ClinicalTrials.gov