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The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)

NCT04410146 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2025-04-30

No results posted yet for this study

Summary

STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH)

Conditions

  • Subdural Hematoma, Chronic

Interventions

DEVICE

SQUID Embolization

Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent

DEVICE

SQUID Embolization and Surgical Evacuation

Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent and the surgical evacuation of the sub-dural hematoma

PROCEDURE

Surgical Evacuation

Surgical evacuation of the sub-dural hematoma

OTHER

Other: Medical Management

Standard

Sponsors & Collaborators

  • Balt USA

    lead INDUSTRY

Principal Investigators

  • David Fiorella, MD, PhD · Stony Brook University Medical Center

  • Adam Arthur, MD, MPH · Semmes-Murphy Neurologic and Spine Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2024-05-23
Completion
2024-05-23
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Spain

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 NCT04410146 on ClinicalTrials.gov