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

NCT ID: NCT06181994

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-05

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Chronic subdural hematoma (cSDH) is a prevalent neurosurgical condition marked by the accumulation of blood in the subarachnoid space. Primarily affecting elderly individuals, cSDH is associated with significant morbidity and mortality rates. Current standard treatments for cSDH involve surgical evacuation through burr hole craniotomy or twist-drill craniotomy; however, recent research has illuminated the potential significance of the middle meningeal artery (MMA) in cSDH pathogenesis, suggesting an innovative minimally invasive treatment avenue. The investigator team is attempting to determine whether MMA embolization has demonstrated a favorable safety profile with a low incidence of treatment-related complications.

Conditions

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Chronic Subdural Hematoma

Keywords

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Middle meningeal artery embolization Endovascular Embolization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Geisinger Clinic

OTHER

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role collaborator

Henri Mondor University Hospital

OTHER

Sponsor Role collaborator

Ospedale Policlinico San Martino

OTHER

Sponsor Role collaborator

Ospedale San Raffaele

OTHER

Sponsor Role collaborator

Lehigh Valley Hospital

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

New York University

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

Sisters of Mercy University Hospital

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role collaborator

Sutter Health

OTHER

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role collaborator

Westchester Medical Center

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Altschul, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Muhammed Amir Essibayi, MD

Role: CONTACT

Phone: 347-908-1889

Email: [email protected]

Facility Contacts

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Muhammed Amir Essibayi, MD

Role: primary

David Altschul, MD

Role: backup

Other Identifiers

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2023-15327

Identifier Type: -

Identifier Source: org_study_id