Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)

NCT06181994 | Recruiting

• 1 other identifier: 2023-15327
• Study Type: observational
• Target: 5,000
• Locations: 3 countries
• Sites: 19

Brief Summary

This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.

Conditions

Chronic Subdural Hematoma

Keywords

Middle meningeal artery embolization; Endovascular Embolization

Outcome Measures

Primary Outcomes (2)

• Reaccumulation of Hematoma

  The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported

  Within 1 month post MMAE

• Rescue surgical evacuation

  The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported

  Between 1-3 months post MMAE

Secondary Outcomes (17)

• Reaccumulation of Hematoma

  Between 1-3 months post MMAE

• Reaccumulation of Hematoma

  Between 3-6 months post MMAE

• Reaccumulation of Hematoma

  Between 6-12 months post MMAE

• Reaccumulation of Hematoma

  Between 12-24 months post MMAE

• Clinical Outcome at Follow-up Clinical outcome at follow-up

  Upon study discharge, 1-4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic subdural hematoma

You may qualify if:

• Consecutive adult patients (18 yrs. of age or older)
• Endovascular embolization of middle meningeal artery using any embolization material:
• PVA particles; Onyx, nBCA glue; dimethyl sulfoxide, microcoils, PVA with microcoils

You may not qualify if:

• Endovascular embolization of middle meningeal artery using any other embolization material

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Geisinger Clinic: collaborator
• Heidelberg University: collaborator
• Henri Mondor University Hospital: collaborator
• Ospedale Policlinico San Martino: collaborator
• Ospedale San Raffaele: collaborator
• Lehigh Valley Hospital: collaborator
• Mayo Clinic: collaborator
• Medical University of South Carolina: collaborator
• New York University: collaborator
• Oregon Health and Science University: collaborator
• Sisters of Mercy University Hospital: collaborator
• Unity Health Toronto: collaborator
• Sutter Health: collaborator
• University of Iowa: collaborator
• Thomas Jefferson University: collaborator
• University Health Network, Toronto: collaborator
• University Hospital, Bordeaux: collaborator
• University of Alabama at Birmingham: collaborator
• University of South Florida: collaborator
• University of Washington: collaborator
• Cornell University: collaborator
• Westchester Medical Center: collaborator

Study Sites (19)

Baptist Health South Florida, Inc.

Coral Gables, Florida, 33143, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

COMPLETED

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

RECRUITING

University of Illinois Chicago

Chicago, Illinois, 60607, United States

COMPLETED

University of Chicago Medicine

Chicago, Illinois, 60637, United States

RECRUITING

The University of Iowa

Iowa City, Iowa, 52242, United States

COMPLETED

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center (BIDMC)/Harvard Medical School

Boston, Massachusetts, 02215, United States

RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

COMPLETED

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Geisinger Health

Danville, Pennsylvania, 17822, United States

COMPLETED

Thomas Jefferson University

Philadelphia, Pennsylvania, 19144, United States

RECRUITING

UTHealth Houston

Houston, Texas, 77030, United States

COMPLETED

HCA Houston Healthcare Kingwood

Kingwood, Texas, 77339, United States

COMPLETED

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

Unity Health Toronto

Toronto, Ontario, M5C 2T2, Canada

COMPLETED

University of Toronto

Toronto, Ontario, M5S 1A1, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

COMPLETED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• David Altschul, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammed Amir Essibayi, MD

CONTACT

347-908-1889; muhammedamir.essibayi@einsteinmed.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 26, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); AU (1); CA (3)