Subdural Hematoma, Chronic
Conditions
Keywords
Meningeal Arteries, Intracranial Subdural Hematoma
Brief 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)
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).
Interventions
DEVICESQUID Embolization
Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent
DEVICESQUID 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
PROCEDURESurgical Evacuation
Surgical evacuation of the sub-dural hematoma
Standard Medical Management
Sponsors
Balt USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neurocognitive battery. Imaging assessment by blinded core laboratory
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint-Number of Participants With Treatment Failure | 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. |
| Primary Safety Endpoint-Number of Participants With Major Disabling Stroke or Any Death Within 30 Days of Intervention | Within 30-days from intervention | Major disabling stroke or any death within 30-days from intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any Investigational Device/MMAE Procedure-related AE/SAE | 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. |
| mRS Shift Analysis at 180-day Visit | 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. |
Countries
France, Germany, Spain, United States
Contacts
PRINCIPAL_INVESTIGATORDavid Fiorella, MD, PhD
Stony Brook University Medical Center
PRINCIPAL_INVESTIGATORAdam Arthur, MD, MPH
Semmes-Murphy Neurologic and Spine Institute
Participant flow
Pre-assignment details
A total of 319 participants were enrolled; 9 were screen failure, resulting in an Intent-to-Treat (ITT) population of 310 participants randomized (1:1) to either SQUID embolization (treatment) or Standard Medical Management (control). If assigned by the treating team to Surgical Management, subjects were either assigned to SQUID Embolization followed by surgery (treatment) or to Surgery only (control).
Baseline characteristics
| Characteristic | — |
|---|---|
| Addiction - Alcohol None/NA | 278 Participants |
| Addiction - Alcohol Ongoing Addiction | 9 Participants |
| Addiction - Alcohol Previous Addiction | 9 Participants |
| Addiction - Drugs/Other Substance Abuse None/NA | 155 Participants |
| Addiction - Drugs/Other Substance Abuse Ongoing Addiction | 8 Participants |
| Addiction - Drugs/Other Substance Abuse Previous Addiction | 2 Participants |
| Age, Continuous | 73.4 Years STANDARD_DEVIATION 11.31 |
| BMI | 26.6 kg/m2 STANDARD_DEVIATION 4.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 238 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 24 Participants |
| Height | 171.7 cm STANDARD_DEVIATION 8.76 |
| Race/Ethnicity, Customized Asian | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants |
| Race/Ethnicity, Customized Native American or Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 57 Participants |
| Race/Ethnicity, Customized White | 108 Participants |
| Region of Enrollment France | 12 Participants |
| Region of Enrollment Germany | 8 Participants |
| Region of Enrollment Spain | 5 Participants |
| Region of Enrollment United States | 133 Participants |
| Sex: Female, Male Female | 119 Participants |
| Sex: Female, Male Male | 94 Participants |
| Smoking History Current Smoker | 14 Participants |
| Smoking History Never Smoked | 101 Participants |
| Smoking History Previous Smoker | 102 Participants |
| Weight | 79.6 kg STANDARD_DEVIATION 17.31 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 144 | 12 / 166 |
| other Total, other adverse events | 35 / 144 | 20 / 166 |
| serious Total, serious adverse events | 61 / 144 | 72 / 166 |
Outcome results
None listed