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

Subdural Hematoma, Chronic Clinical Trial

— STEM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04410146
• Other study ID #: CIP-201912-SQUID
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Balt USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: May 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

1. Male or female Subject whose age is = 30 at the time of consent

2. Pre-morbid mRS 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

Related Conditions & MeSH terms

• Hematoma
• Hematoma, Subdural, Chronic
• Subdural Hematoma, Chronic

Intervention

Device:
• 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

Procedure:
• Surgical Evacuation
Surgical evacuation of the sub-dural hematoma

Other:
• Other: Medical Management
Standard

Locations

Country	Name	City	State
France	Chu Cote de Nacre	Caen
France	CHU Hopital Bicetre	Le Kremlin-Bicêtre
France	Hopital Pitie Salpetriere	Paris
France	CHU Hopital Maison Blanche	Reims
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Klinikum Nurnberg Sud	Nurnberg
Spain	Gregorio Maranon Hospital	Madrid
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins Medicine	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Swedish Medical Center	Englewood	Colorado
United States	Penn State Health Hershey Medical Center	Hershey	Pennsylvania
United States	Baptist Health	Jacksonville	Florida
United States	University of Kansas	Kansas City	Kansas
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Methodist University Hospital	Memphis	Tennessee
United States	West Virginia University	Morgantown	West Virginia
United States	NYU Langone Health	New York	New York
United States	Nebraska Health	Omaha	Nebraska
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Riverside Community Hospital	Riverside	California
United States	University of Utah	Salt Lake City	Utah
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Swedish Cherry Hill	Seattle	Washington
United States	Stony Brook University	Stony Brook	New York
United States	Overlook Medical Center	Summit	New Jersey
United States	Los Robles Hospital and Medical Center	Thousand Oaks	California
United States	Carondolet St. Joseph's	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Balt USA

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mRS (analyzed as shift)		30-day and 1-year from intervention
Other	mRS = 2 (binary)		30-day, 180-days, and 1-year from intervention
Other	Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neuro-cognitive battery HVLT-R, COWAT, Animal Naming, Trail making tests		Baseline, 30-day, 180-day, and 1-year from intervention
Other	EQ-5D-5L (including EQ-VAS)		Baseline vs. 30-day, 180-day, and 1-year from intervention
Other	Hospital Days		Through 1-year visit
Other	Intensive Care Unit (ICU) Days		Through 1-year visit
Other	NIHSS		Baseline vs Discharge and 90-day
Other	CT/MRI		Baseline vs. 180 days
Primary	Primary Effectiveness Endpoint	Treatment failure is defined by the occurrence of residual or re-accumulation of the SDH (=10 mm) on 180-day scan from intervention.	On 180-day from intervention
Primary	Primary Effectiveness Endpoint	Treatment failure is defined by the occurrence of any of the following events: Re-operation (after index procedure) or surgical rescue; Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause	Within 180-days of intervention
Primary	Primary Safety Endpoint	Major disabling stroke or any death	Within 30-days from intervention
Secondary	mRS (analyzed as shift)		180-day from intervention
Secondary	Any investigational device/procedure-related AE/SAE		Through 1-year visit