Middle Meningeal Artery Embolization in Patients With Chronic Subdural Hematoma

ConditionsMiddle Meningeal Artery Embolization Chronic Subdural Hematomas

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Acute subdural hematoma or acute-on-chronic SDH where the acute component is the primary pathology.

Acute and severe neurological deterioration.

Intracranial tumors.

Intracranial infections.

Trial design

Design model

Single group

Treatments tested in this trial

middle meningeal artery embolization
Procedure/Surgery
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.

Treatment groups

35 Participants

are divided into 1 treatment group

Group A: Embolization of middle meningeal arteryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

six months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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