The SQUID Trial for the Embolization of the Middle Mening... | NCT04410146

Label	Type	Description	Intervention Names
SQUID	Experimental	Embolization of the Middle Meningeal Artery (MMA)	Device: SQUID Embolization Device: SQUID Embolization and Surgical Evacuation
No Embolization	Active Comparator	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 Other: Standard Medical Management

Name	Type	Description	Arm Group Labels	Other Names
SQUID Embolization	Device	Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent	SQUID

Measure	Description	Time Frame
Primary Effectiveness Endpoint-Number of Participants With Treatment Failure	Treatment failure as defined by the occurrence of any of the following events: Residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention. Re-operation (after index procedure) or surgical rescue within 180-days of intervention. 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	Major disabling stroke or any death within 30-days from intervention.	Within 30-days from intervention

Measure	Description	Time Frame
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.	Through 1-year visit
mRS Shift Analysis at 180-day Visit

Measure	Description	Time Frame
mRS ≤ 2 (Binary)	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Name	Affiliation	Role
David Fiorella, MD, PhD	Stony Brook University Medical Center	Principal Investigator
Adam Arthur, MD, MPH	Semmes-Murphy Neurologic and Spine Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Barrow Neurological Institute		Phoenix	Arizona	85013	United States
Carondolet St. Joseph's

PubMed Identifier	Type	Citation	Retractions
39565980	Derived	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.

ID	Title	Description
FG000	Treatment Group (SQUID)	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 1, 2023	Feb 26, 2026

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Primary Effectiveness Endpoint-Number of Participants With Treatment Failure

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

Residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention.
Re-operation (after index procedure) or surgical rescue within 180-days of intervention.
Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause within 180-days of intervention.

Analysis population 117 in Treatment and 123 in Control

Posted

Count of Participants

Participants

On 180-day from intervention

ID	Title	Description
OG000	Treatment Group	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Units	Counts
Participants	OG000117 OG001123

Title

Denominators

Categories

Title	Measurements
Treatment failure	OG00019 OG00147
No treatment Failure	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		P- value		0.0010		Odds Ratio (OR)	0.36			2-Sided	95	0.20	0.65					Other

Primary

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.

Participants included in the Safety population were analyzed according to the treatment received, regardless of randomization assignment. Ultimately, the Safety analysis population consisted of 144 participants who received SQUID and 166 participants who did not receive SQUID.

Posted

Count of Participants

Participants

Within 30-days from intervention

ID	Title	Description
OG000	Treatment Group (Embolization With SQUID)	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group (No Embolization)	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Units	Counts

Secondary

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.

Posted

Count of Participants

Participants

Through 1-year visit

ID	Title	Description
OG000	Treatment Group (Total)	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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

Units	Counts
Participants	OG000

Secondary

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

No significant disability
Slight disability
Moderate disability
Moderately severe disability
Severe disability
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.

Posted

Number

participants

180-day from intervention

ID	Title	Description
OG000	Treatment Group (Embolization With SQUID)	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Units

Other Pre-specified

mRS ≤ 2 (Binary)

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.

No. of participants with mRS score of ≤ 2

Posted

Count of Participants

Participants

180 days

ID	Title	Description
OG000	Treatment Group	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Other Pre-specified

Global Neurocognitive Performance

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).

Posted

Mean

Standard Deviation

T-Score

Baseline and 180 Days

ID	Title	Description
OG000	Treatment Group	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Units	Counts
Participants

Other Pre-specified

EQ-5D-5L (Including EQ-VAS) Visual Analogue Scale

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).

Posted

Mean

Standard Deviation

units on a scale

180-day change from Baseline

ID	Title	Description
OG000	Treatment Group	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Units	Counts
Participants	OG000

Other Pre-specified

EQ-5D-5L Index

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)

Posted

Mean

Standard Deviation

score on a scale

180 day change from Baseline

ID	Title	Description
OG000	Treatment Group	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Units	Counts
Participants

Other Pre-specified

Hospital Days

The number of days (mean) in hospital from baseline through 180 days.

Posted

Mean

Standard Deviation

days

Through 180 days

ID	Title	Description
OG000	Treatment Group	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Units	Counts
Participants	OG000

Other Pre-specified

NIHSS

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

Participants with available data were analyzed- mITT Population

Posted

Mean

Standard Deviation

score on a scale

90-day Change from Baseline

ID	Title	Description
OG000	Treatment Group	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Other Pre-specified

Intensive Care Unit (ICU) Days

The total number of ICU days from baseline through 180 days.

Posted

Mean

Standard Deviation

Days

180 days

ID	Title	Description
OG000	Treatment Group	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Units	Counts
Participants	OG000

Other Pre-specified

Imaging Core Lab Assessments (cSDH Thickness and Midline Shift)

Core Lab Analysis of CT/MRI Images. The thickness of the cSDH was documented separately for the left and right sides.

mITT Population

Posted

Mean

Standard Deviation

180 days Change from Baseline

ID	Title	Description
OG000	Treatment Group	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
OG001	Control Group	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0010 events0 affected166 at risk
Cardiac failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
Cardio-respiratory arrest	Cardiac disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0011 events1 affected166 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Bundle branch block left	Cardiac disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Retinal detachment	Eye disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Umbilical hernia, obstructive	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0010 events0 affected166 at risk
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
Gatrointestinal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0010 events0 affected166 at risk
Haematemesis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Ileus paralytic	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0011 events1 affected166 at risk
Small intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0010 events0 affected166 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0010 events0 affected166 at risk
Chest pain	General disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Death	General disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected166 at risk
Hepatic cirrhosis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Bacteraemia	Infections and infestations	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
COVID-19	Infections and infestations	Systematic Assessment	EG0002 events2 affected144 at risk EG0010 events0 affected166 at risk
COVID-19 pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Cholecystitis infective	Infections and infestations	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Osteomyelitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Pneumonia aspiration	Infections and infestations	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected166 at risk
Periorbital cellulitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Perirectal abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0007 events6 affected144 at risk EG0013 events3 affected166 at risk
Pneumonia escherichia	Infections and infestations	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Pneumonia klebsiella	Infections and infestations	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Septic shock	Infections and infestations	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events3 affected166 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Brain herniation	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Cardiac function disturbance postoperative	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Drain site complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected144 at risk EG0015 events5 affected166 at risk
Craniofacial fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Ligament injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Overdose	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Pneumocephalus	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
Procedural complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events3 affected166 at risk
Road traffic accident	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Surgical procedure repeated	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected166 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG00018 events16 affected144 at risk EG00139 events36 affected166 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Computerised tomogram head abnormal	Investigations	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Alcoholic ketoacidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected166 at risk
Hypernatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Hypervolaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0010 events0 affected166 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Bell's palsy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Brain injury	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Brain compression	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Carotid artery occlusion	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Carotid artery stenosis	Nervous system disorders	Systematic Assessment	EG0002 events1 affected144 at risk EG0010 events0 affected166 at risk
Cerebral infarction	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Cerebral artery occlusion	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Cerebrovascular accident	Nervous system disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0011 events1 affected166 at risk
Cerebrovascular disorder	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Dysarthria	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected166 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected166 at risk
Simple partial seizures	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Generalised tonic-clonic seizure	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Haemorrhage intracranial	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0013 events3 affected166 at risk
Hydrocephalus	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Hemiparesis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Aphasia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Nervous system disorder	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Ischaemic stroke	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
Lacunar infarction	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Lethargy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Migraine	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Neurological symptom	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
Hypertensive urgency	Vascular disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
Partial seizures	Nervous system disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Seizure	Nervous system disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0011 events1 affected166 at risk
Status epilepticus	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Peripheral artery thrombosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0003 events3 affected144 at risk EG0011 events1 affected166 at risk
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
VIth nerve paralysis	Nervous system disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Confusional state	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0011 events1 affected166 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Mental status changes	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0010 events0 affected166 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0014 events3 affected166 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected144 at risk EG0011 events1 affected166 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected166 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected166 at risk
Aortic valve incompetence	Cardiac disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected166 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected166 at risk

ID	Term
D020200	Hematoma, Subdural, Chronic
D046648	Hematoma, Subdural, Intracranial

ID	Term
D006408	Hematoma, Subdural
D020198	Intracranial Hemorrhage, Traumatic
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006406	Hematoma
D006470	Hemorrhage
D014947	Wounds and Injuries

ID	Title	Description
BG000	Treatment Group (Embolization With SQUID)	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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
BG001	Control Group (No Embolization)	Standard Medical Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Group (SQUID)	Embolization of the Middle Meningeal Artery (MMA) SQUID Embolization: Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent 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	13	144	61	144	35	144
EG001	Control Group (No Embolization)	Standard Management Surgical Evacuation: Surgical evacuation of the sub-dural hematoma Other: Medical Management: Standard	12	166	72	166	20	166