NCT07806552

Brief Summary

Primary : to evaluate the efficacy of MMAE on resolution and recurrence of hematoma in patients with CSDH. Secondary : evaluate the effect of MMAE on functional outcome, radiological changes, the need to repeat surgery, duration of hospital stay, time for hematoma to resolve.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Sep 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Feb 2029

First Submitted

Initial submission to the registry

August 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

August 30, 2026

Last Update Submit

September 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrence Requiring Additional Surgical Intervention

    Composite outcome defined as recurrence of chronic subdural hematoma requiring repeat surgical intervention within 6 months. Recurrence may be identified by radiological enlargement or reaccumulation of the hematoma on CT associated with recurrent or worsening neurological symptoms leading to reoperation.

    six months

Study Arms (1)

Embolization of middle meningeal artery

EXPERIMENTAL
Procedure: middle meningeal artery embolization

Interventions

Middle meningeal artery (MMA) embolization is a minimally invasive endovascular procedure designed to treat chronic subdural hematomas by blocking blood flow to the MMA, preventing recurrent bleeding. Under local or general anesthesia, a catheter is inserted through a micro-puncture in the femoral or radial artery and navigated up to the external carotid system into the MMA under real-time fluoroscopic (X-ray) guidance. Angiography is performed to map the arterial anatomy and identify any dangerous anastomoses with the ophthalmic or internal carotid arteries. Once positioned safely, an embolic agent such as liquid embolic systems (e.g., Onyx, n-BCA), liquid-suspended microparticles (PVA), or microcoils is injected into the anterior and posterior branches of the MMA. This occludes the fragile, hypervascular membranes driving the hematoma, allowing the body to naturally reabsorb the collected blood and reducing the need for open surgical evacuation.

Embolization of middle meningeal artery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any age.
  • Radiologically confirmed chronic subdural hematoma (CSDH) on CT or MRI either Unilateral or Bilateral CSDH.
  • Patients considered suitable for standard surgical treatment of CSDH.
  • First presentation or recurrent CSDH requiring treatment.

You may not qualify if:

  • Acute subdural hematoma or acute-on-chronic SDH where the acute component is the primary pathology.
  • Acute and severe neurological deterioration.
  • Subdural hematomas secondary to:
  • Intracranial tumors.
  • Intracranial infections.
  • Contraindications to angiography or embolization (for the MMAE group), such as:
  • Severe contrast allergy.
  • Untreatable coagulopathy.
  • Severe renal failure precluding contrast administration
  • Severe tortuosity or anatomical variations of the external carotid artery/MMA making catheterization unfeasible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • https://doi.org/10.1016/j.clineuro.2024.108323

    BACKGROUND
  • https://doi.org/10.1212/CPJ.0000000000200501

    BACKGROUND
  • https://doi.org/10.1227/neu.0000000000002505

    BACKGROUND
  • https://doi.org/10.20452/jmr.2025.20007

    BACKGROUND
  • https://doi.org/10.1016/j.jns.2025.123469

    BACKGROUND
  • https://doi.org/10.1159/000543041

    BACKGROUND
  • https://doi.org/10.3389/fsurg.2025.1623619

    BACKGROUND
  • https://doi.org/10.1080/01616412.2025.2592857

    BACKGROUND
  • https://doi.org/10.1016/j.clineuro.2025.109128

    BACKGROUND
  • Liu J, Ni W, Zuo Q, Yang H, Peng Y, Lin Z, Li Z, Wang J, Zhen Y, Luo J, Lin Y, Chen J, Hua X, Lu H, Zhong M, Liu M, Zhang J, Wang Y, Wan J, Li Y, Li T, Mao G, Zhao W, Gao L, Li C, Chen E, Cheng X, Zhang P, Wang Z, Chen L, Zhang Y, Tian B, Shen F, Lei Y, Wu Y, Li Y, Duan G, Xu L, Lv N, Yu J, Xu X, Du Z, Zhang H, Hu J, Li Z, Yuan Q, Zhou Y, Wu G, Zhang L, Gao C, Dai D, Wu X, Zhang Y, Jiang H, Zhao R, Su J, Xu Y, Ospel JM, Majoie CBLM, Goyal M, Li Q, Yang P, Gu Y, Mao Y; MAGIC-MT Investigators. Middle Meningeal Artery Embolization for Nonacute Subdural Hematoma. N Engl J Med. 2024 Nov 21;391(20):1901-1912. doi: 10.1056/NEJMoa2401201.

    PMID: 39565989BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, SubduralIntracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematomaHemorrhageWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 30, 2026

First Posted

September 8, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

February 28, 2029

Last Updated

September 8, 2026

Record last verified: 2026-09