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Subdural Hematoma, ChronicSTEMNCT04410146

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

A study testing SQUID Embolization, SQUID Embolization and Surgical Evacuation and Surgical Evacuation in people with Subdural Hematoma, Chronic, run by Balt USA at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Subdural Hematoma, Chronic
What is being tested?
SQUID Embolization, SQUID Embolization and Surgical Evacuation and Surgical Evacuation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
32 sitesin 4 countries
Study dates
1 Nov 2020to 23 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female Subject whose age is ≥ 30 at the time of consent
  • Pre-morbid mRS (Modified Rankin Scale) 0-1 within the previous 12 months
  • cSDH measures ≥ 10 mm in greatest thickness
  • cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift
  • 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))
  • 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
Show all 9Show fewer
  • 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
  • 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
  • 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

Who cannot join

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

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

United States25 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins Medicine

    Baltimore, Maryland, 21287

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Penn State Health Hershey Medical Center

    Hershey, Pennsylvania, 17918

  • Baptist Health

    Jacksonville, Florida, 32207

  • University of Kansas

    Kansas City, Kansas, 66160

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • West Virginia University

    Morgantown, West Virginia, 26506

  • NYU Langone Health

    New York, New York, 10016

  • Nebraska Health

    Omaha, Nebraska, 68106

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Riverside Community Hospital

    Riverside, California, 92501

  • University of Utah

    Salt Lake City, Utah, 84132

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Swedish Cherry Hill

    Seattle, Washington, 98122

  • Stony Brook University

    Stony Brook, New York, 11794

  • Overlook Medical Center

    Summit, New Jersey, 07901

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Los Robles Hospital and Medical Center

    Thousand Oaks, California, 92360

  • Carondolet St. Joseph's

    Tucson, Arizona, 85711

Other trials in United States

France4 sites

  • Chu Cote de Nacre

    Caen, 14000

  • CHU Hopital Bicetre

    Le Kremlin-Bicêtre, 94275

  • Hopital Pitie Salpetriere

    Paris

  • CHU Hopital Maison Blanche

    Reims

Other trials in France

Germany2 sites

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Klinikum Nurnberg Sud

    Nuremberg

Other trials in Germany

Spain1 site

  • Gregorio Maranon Hospital

    Madrid, 28007

Other trials in Spain

About this study

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)

Read the 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).

Being tested
SQUID Embolization, SQUID Embolization and Surgical Evacuation, Surgical Evacuation, Standard Medical Management
Keywords
Meningeal Arteries, Intracranial Subdural Hematoma
Medical subject headings
Hematoma, Subdural, Chronic, Hematoma, Subdural, Intracranial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SQUID EmbolizationDevice

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

  • SQUID Embolization and Surgical EvacuationDevice

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

  • Surgical EvacuationProcedure or surgery

    Surgical evacuation of the sub-dural hematoma

  • Standard Medical ManagementOther

    Standard Medical Management

Study groups in NCT04410146
Study groupRoleWhat they receive
SQUIDExperimentalEmbolization of the Middle Meningeal Artery (MMA)
Receives: Device: SQUID Embolization; Device: SQUID Embolization and Surgical Evacuation
No EmbolizationActive comparatorStandard 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).
Receives: Procedure: Surgical Evacuation; Other: Standard Medical Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Effectiveness Endpoint-Number of Participants With Treatment Failure

    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.

    Measured: On 180-day from intervention

  2. Primary Safety Endpoint-Number of Participants With Major Disabling Stroke or Any Death Within 30 Days of Intervention

    Major disabling stroke or any death within 30-days from intervention.

    Measured: Within 30-days from intervention

Secondary outcomes (2)

  1. Any Investigational Device/MMAE Procedure-related AE/SAE

    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.

    Measured: Through 1-year visit

  2. mRS Shift Analysis at 180-day Visit

    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.

    Measured: 180-day from intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start1 Nov 2020
  3. Primary completion23 May 2024
  4. Study completion23 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04410146
Sponsor's protocol ID
CIP-201912-SQUID
Acronym
STEM
Status last verified
Jun 2026
First submitted
27 May 2020
Last updated
4 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Fiorella D, Monteith SJ, Hanel R, Atchie B, Boo S, McTaggart RA, Zauner A, Tjoumakaris S, Barbier C, Benitez R, Spelle L, Pierot L, Hirsch JA, Froehler M, Arthur AS; STEM Investigators. Embolization of the Middle Meningeal Artery for Chronic Subdural Hematoma. N Engl J Med. 2025 Feb 27;392(9):855-864. doi: 10.1056/NEJMoa2409845. Epub 2024 Nov 20.

    PubMed 39565980

Questions about this trial

What is this clinical trial studying?

A study testing SQUID Embolization, SQUID Embolization and Surgical Evacuation and Surgical Evacuation in people with Subdural Hematoma, Chronic, run by Balt USA at 32 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, France, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint-Number of Participants With Treatment Failure (time frame: On 180-day from intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04410146, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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