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

June 2, 2026 updated by: Balt USA
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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study objective is 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
319

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Caen, France, 14000
        • CHU Côte de Nacre
      • Le Kremlin-Bicêtre, France, 94275
        • CHU Hopital Bicetre
      • Paris, France
        • Hopital Pitie Salpetriere
      • Reims, France
        • CHU Hopital Maison Blanche
  • Germany
      • Heidelberg, Germany
        • UniversitatsKlinikum Heidelberg
      • Nuremberg, Germany
        • Klinikum Nurnberg Sud
  • Spain
      • Madrid, Spain, 28007
        • Gregorio Maranon Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
      • Tucson, Arizona, United States, 85711
        • Carondolet St. Joseph's
    • California
      • Riverside, California, United States, 92501
        • Riverside Community Hospital
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage Hospital
      • Thousand Oaks, California, United States, 92360
        • Los Robles Hospital and Medical Center
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Health
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • Nebraska Health
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Overlook Medical Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, United States, 17918
        • Penn State Health Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Cherry Hill
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female Subject whose age is ≥ 30 at the time of consent
  2. Pre-morbid mRS (Modified Rankin Scale) 0-1 within the previous 12 months
  3. cSDH measures ≥ 10 mm in greatest thickness
  4. cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift
  5. Imaging characteristics indicative of chronicity (≥ 50% of the volume of the collection should be isodense or hypodense to normal cortical gray matter on Computed Tomography (CT))
  6. Subject presents with one or more of the following neurological symptoms: headache; cognitive decline; speech difficulty or aphasia; gait impairment or imbalance; focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop); and/or seizure
  7. Subject, or his/her legally authorized representative, understands the nature of the procedure, consents to participation in the study and provides a signed Informed Consent Form
  8. Female Subjects of child-bearing potential must be able to provide a current negative urine pregnancy test and agree to an appropriate method of contraception throughout the trial
  9. Subject is able and willing to return to the investigational site for all follow-up visits (e.g., 30-day, 90-day, 180-day and 1-year), as required per protocol

Exclusion Criteria:

  1. Subject with prior ipsilateral craniotomy or burr hole evacuation of cSDH
  2. Subject with prior Embolization of either MMA
  3. Subject requires (in the opinion of the treating surgeon) a full or mini craniotomy
  4. Subject with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed
  5. Subject with a cSDH with a focal location (confined to the frontal or temporal base or the inter-hemispheric space without cerebral convexity involvement)
  6. cSDH developed due to underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or secondary to a previous craniotomy
  7. Life expectancy of <1 year
  8. Subject who presents with an intracranial mass other than subdural hematoma
  9. Subject who presents with a meningioma with mass effect and/or ≥1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
  10. Subject with serum creatinine level > 3.0 mg/dL at time of enrollment (this will restrict the use of contrast) and not on dialysis
  11. Subject with significant liver function impairment at the time of enrollment
  12. Subject with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
  13. Subject who is currently enrolled in another investigational study protocol that could potentially confound the current study endpoints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SQUID
Embolization of the Middle Meningeal Artery (MMA)
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 of the sub-dural hematoma
Active Comparator: No Embolization

Standard Management

For subjects in the surgery only group (i.e., surgical management but no adjunctive MMAE), the surgical evacuation was to occur within 48 hours of randomization. Surgery included hemorrhage evacuation through one or two burr-holes with irrigation of the hematoma (and the option for placement of a subgaleal or subdural drain) or twist-drill drainage, such as Subdural Evacuating Port System.

Subjects in the non-surgical management alone group were followed by the clinical team and treated as per the standard of care (SOC) established at the institution for the management of cSDH. Standard of care typically included cSDH monitoring, medical intervention to control symptoms, reversal or cessation of anti-coagulant and anti-platelet medications as well as the administration of anti-inflammatory medications (e.g., steroids, statins).
Procedure: Surgical Evacuation
Surgical evacuation of the sub-dural hematoma
Other: Standard Medical Management
Standard Medical Management

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint-Number of Participants With Treatment Failure
Time Frame: On 180-day from intervention

Treatment failure as defined by the occurrence of any of the following events:

  1. Residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention.
  2. Re-operation (after index procedure) or surgical rescue within 180-days of intervention.
  3. Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause within 180-days of intervention.
On 180-day from intervention
Primary Safety Endpoint-Number of Participants With Major Disabling Stroke or Any Death Within 30 Days of Intervention
Time Frame: Within 30-days from intervention
Major disabling stroke or any death within 30-days from intervention.
Within 30-days from intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Any Investigational Device/MMAE Procedure-related AE/SAE
Time Frame: Through 1-year visit
Number of participants with an adverse event (AE) or serious adverse event (SAE) adjudicated as probably or causally related to the investigational device or Middle Meningeal Artery Embolization (MMAE) procedure.
Through 1-year visit
mRS Shift Analysis at 180-day Visit
Time Frame: 180-day from intervention

The modified Rankin Scale (mRS) is an ordinal scale used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death):

0: No symptoms

  1. No significant disability
  2. Slight disability
  3. Moderate disability
  4. Moderately severe disability
  5. Severe disability
  6. Dead The Shift Analysis (also known as an ordinal analysis) evaluates the distribution of mRS scores to identify a general improvement or 'shift' across the entire range of the scale, rather than just comparing 'good' vs. 'poor' outcomes.
180-day from intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mRS ≤ 2 (Binary)
Time Frame: 180 days

The Modified Rankin Scale (mRS) is a clinician-reported measure used to assess the degree of functional disability or dependence in daily activities following a neurological event. This binary outcome dichotomizes the 7-point scale (0-6) into two categories: Favorable Outcome (mRS 0-2) and Unfavorable Outcome (mRS 3-6).

A score of ≤ 2 signifies that the participant is functionally independent and capable of looking after their own affairs without assistance. Results will be reported as the proportion of participants in each treatment arm achieving a score of 0, 1, or 2 at the 180-day follow-up.
180 days
Global Neurocognitive Performance
Time Frame: Baseline and 180 Days
T-scores were used to convert raw data to standardized scale with a mean of 50 and a standard deviation of 10. A higher T-score indicates better cognitive performance (a score near 40 indicates a low average to average range). Global neurocognitive performance was assessed by taking the mean T-score for all individual neurocognitive markers (Hopkins Verbal Learning Tests (HVLT-R), Controlled Oral Word Association Test (COWAT), Animal Naming, and Trail making tests).
Baseline and 180 Days
EQ-5D-5L (Including EQ-VAS) Visual Analogue Scale
Time Frame: 180-day change from Baseline
The EQ VAS is a 20 cm vertical visual analogue scale that records the patient's self-rated health today. It ranges from 0 (Worst health you can imagine) to 100 (Best health you can imagine).
180-day change from Baseline
EQ-5D-5L Index
Time Frame: 180 day change from Baseline
The EQ-5D-5L (EuroQol - 5 Dimension - 5 Level) is a standardized, patient-reported instrument used globally to measure health-related quality of life (HRQoL). It assesses health across 5 dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-with 5 levels of severity. The index score ranges from -0.59 to 1.0, where 1.0 represents 'full health' and 0.0 represents death. A higher score indicates a better health-related quality of life. Change is calculated as (180-Day score minus Baseline score)
180 day change from Baseline
Hospital Days
Time Frame: Through 180 days
The number of days (mean) in hospital from baseline through 180 days.
Through 180 days
NIHSS
Time Frame: 90-day Change from Baseline

The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to objectively quantify the neurological impairment caused by a stroke. It consists of 15 items assessing areas such as level of consciousness, vision, motor function, sensation, and language.

Score Range: Total scores range from 0 to 42. Interpretation: A score of 0 indicates normal function (no symptoms), while higher scores indicate more severe neurological deficit.

This outcome measures the mean change in the total NIHSS score from baseline (at enrollment) to the 90-day follow-up
90-day Change from Baseline
Intensive Care Unit (ICU) Days
Time Frame: 180 days
The total number of ICU days from baseline through 180 days.
180 days
Imaging Core Lab Assessments (cSDH Thickness and Midline Shift)
Time Frame: 180 days Change from Baseline
Core Lab Analysis of CT/MRI Images. The thickness of the cSDH was documented separately for the left and right sides.
180 days Change from Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Balt USA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AXIOM Real Time Metrics
Embo-Flüssigkeiten A.G.
Balt Extrusion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Fiorella, MD, PhD, Stony Brook University Medical Center
  • Principal Investigator: Adam Arthur, MD, MPH, Semmes-Murphy Neurologic and Spine Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP-201912-SQUID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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