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

Primary Purpose

Subdural Hematoma, Chronic

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SQUID Embolization
SQUID Embolization and Surgical Evacuation
Surgical Evacuation
Other: Medical Management
Sponsored by
Balt USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subdural Hematoma, Chronic focused on measuring Meningeal Arteries, Intracranial Subdural Hematoma

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

10. 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 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
  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 participating in another clinical research study
  14. Subject who is unable to complete the required follow-up
  15. Female Subject who is pregnant and/or breastfeeding
  16. Subject who is currently enrolled in another investigational study protocol that could potentially confound the current study endpoints

Sites / Locations

  • Barrow Neurological Institute
  • Carondolet St. Joseph's
  • Riverside Community Hospital
  • Santa Barbara Cottage Hospital
  • Los Robles Hospital and Medical Center
  • Swedish Medical Center
  • Baptist Health
  • Emory University
  • Wellstar Kennestone Hospital
  • University of Kansas
  • Johns Hopkins Medicine
  • Nebraska Health
  • Overlook Medical Center
  • Montefiore Medical Center
  • NYU Langone Health
  • Stony Brook University
  • Geisinger Medical Center
  • Penn State Health Hershey Medical Center
  • Thomas Jefferson University
  • Rhode Island Hospital
  • Methodist University Hospital
  • Baptist Memorial Hospital
  • University of Utah
  • Swedish Cherry Hill
  • West Virginia University
  • Chu Cote de Nacre
  • CHU Hopital Bicetre
  • Hopital Pitie Salpetriere
  • CHU Hopital Maison Blanche
  • Universitätsklinikum Heidelberg
  • Klinikum Nurnberg Sud
  • Gregorio Maranon Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SQUID

No Embolization

Arm Description

Embolization of the Middle Meningeal Artery (MMA)

Standard Management

Outcomes

Primary Outcome Measures

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.
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
Primary Safety Endpoint
Major disabling stroke or any death

Secondary Outcome Measures

mRS (analyzed as shift)
Any investigational device/procedure-related AE/SAE

Full Information

First Posted
May 27, 2020
Last Updated
August 14, 2023
Sponsor
Balt USA
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1. Study Identification

Unique Protocol Identification Number
NCT04410146
Brief Title
The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
Acronym
STEM
Official Title
The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balt USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subdural Hematoma, Chronic
Keywords
Meningeal Arteries, Intracranial Subdural Hematoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neurocognitive battery. Imaging assessment by blinded core laboratory
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SQUID
Arm Type
Experimental
Arm Description
Embolization of the Middle Meningeal Artery (MMA)
Arm Title
No Embolization
Arm Type
Active Comparator
Arm Description
Standard Management
Intervention Type
Device
Intervention Name(s)
SQUID Embolization
Intervention Description
Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent
Intervention Type
Device
Intervention Name(s)
SQUID Embolization and Surgical Evacuation
Intervention Description
Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent and the surgical evacuation of the sub-dural hematoma
Intervention Type
Procedure
Intervention Name(s)
Surgical Evacuation
Intervention Description
Surgical evacuation of the sub-dural hematoma
Intervention Type
Other
Intervention Name(s)
Other: Medical Management
Intervention Description
Standard
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
Treatment failure is defined by the occurrence of residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention.
Time Frame
On 180-day from intervention
Title
Primary Effectiveness Endpoint
Description
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
Time Frame
Within 180-days of intervention
Title
Primary Safety Endpoint
Description
Major disabling stroke or any death
Time Frame
Within 30-days from intervention
Secondary Outcome Measure Information:
Title
mRS (analyzed as shift)
Time Frame
180-day from intervention
Title
Any investigational device/procedure-related AE/SAE
Time Frame
Through 1-year visit
Other Pre-specified Outcome Measures:
Title
mRS (analyzed as shift)
Time Frame
30-day and 1-year from intervention
Title
mRS ≤ 2 (binary)
Time Frame
30-day, 180-days, and 1-year from intervention
Title
Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neuro-cognitive battery HVLT-R, COWAT, Animal Naming, Trail making tests
Time Frame
Baseline, 30-day, 180-day, and 1-year from intervention
Title
EQ-5D-5L (including EQ-VAS)
Time Frame
Baseline vs. 30-day, 180-day, and 1-year from intervention
Title
Hospital Days
Time Frame
Through 1-year visit
Title
Intensive Care Unit (ICU) Days
Time Frame
Through 1-year visit
Title
NIHSS
Time Frame
Baseline vs Discharge and 90-day
Title
CT/MRI
Time Frame
Baseline vs. 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Subject whose age is ≥ 30 at the time of consent Pre-morbid mRS 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Fiorella, MD, PhD
Organizational Affiliation
Stony Brook University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Arthur, MD, MPH
Organizational Affiliation
Semmes-Murphy Neurologic and Spine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Carondolet St. Joseph's
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Riverside Community Hospital
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Los Robles Hospital and Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
92360
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Baptist Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Nebraska Health
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Penn State Health Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17918
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Swedish Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Chu Cote de Nacre
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Hopital Bicetre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Hopital Pitie Salpetriere
City
Paris
Country
France
Facility Name
CHU Hopital Maison Blanche
City
Reims
Country
France
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Klinikum Nurnberg Sud
City
Nurnberg
Country
Germany
Facility Name
Gregorio Maranon Hospital
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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