CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 319 enrolled / 319 target
Drug / intervention
SQUID Embolization +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04410146
NCT04410146N/ACompletedMonitor (4.7/mo)Completion was 25mo ago
CompareCT.gov

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

Balt USA·interventional·Posted Jun 1, 2020·Updated Jun 4, 2026

In Brief

A clinical study evaluating SQUID Embolization, SQUID Embolization and Surgical Evacuation, and 2 other interventions for Subdural Hematoma, Chronic. Completed, enrolled 319 participants across 32 sites in 4 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubdural Hematoma, Chronic
CountriesFrance, Germany, Spain, United States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 1, 2020
Enrollment StartNov 1, 2020
Primary CompletionMay 23, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.1 years ago

Arms & Interventions

SQUIDexperimental

Embolization of the Middle Meningeal Artery (MMA)

Device: SQUID EmbolizationDevice: SQUID Embolization and Surgical Evacuation
No Embolizationactive_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 EvacuationOther: Standard Medical Management

Interventions

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

Surgical evacuation of the sub-dural hematoma

Standard Medical Managementother

Standard Medical Management