Recruiting

MMAE

Sponsor:

Montefiore Medical Center

Code:

NCT06181994

Conditions

Chronic Subdural Hematoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06181994

Start date

Dec 5, 2023

Status verified date

Jan, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Reaccumulation of Hematoma [ Time Frame: Within 1 month post MMAE ]
  • Rescue surgical evacuation [ Time Frame: Between 1-3 months post MMAE ]

Central Contacts and Locations

Central contacts

Muhammed Amir Essibayi, MD

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

Locations

Baptist Health South Florida, Inc.

Recruiting

Coral Gables, Florida, United States, 33143

Contacts

Italo Linfante, MD

786-596-1825ItaloL@baptisthealth.net

Orlando Regional Medical Center

Recruiting

Orlando, Florida, United States, 32806

Contacts

Paul Foreman, MD

321-841-7550paul.foreman@orlandohealth.com

University of Chicago Medicine

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Tareq Kass-Hout, MD

773-702-6222tkasshout@bsd.uchicago.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Aman Patel, MD

617-643-5547abpatel@mgh.harvard.edu

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

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christopher S Ogilvy, MD

617-632-7246mrotondo@bidmc.harvard.edu

Lahey Hospital and Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Timo Krings, MD, PhD, MSc

781-744-3330Timo.Krings@lahey.org

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Muhammed Amir Essibayi, MD

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

David Altschul, MD

718-920-7498daltschu@montefiore.org

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19144

Contacts

Pascal M Jabbour, MD

215-955-7000pascal.jabbour@jefferson.edu

University of Toronto

Recruiting

Toronto, Ontario, Canada, M5S 1A1

Contacts

Pascal J Mosimann, MD, PD

416-603-5800pascal.mosimann@uhn.ca

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Middle meningeal artery embolization
  • Endovascular Embolization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-01-07.