Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma

Completed · Not applicable

Conditions studied: Chronic Subdural Hematoma

In brief

Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach has been attempted with the goal of eliminating the arterial supply to the vascularized membrane. The investigators have recently presented the first known case series of MMA embolization as upfront treatment for cSDH in lieu of surgical evacuation (publication pending). Five patients underwent successful embolization of the MMA with subsequent reduction in size or complete resolution of cSDH with no peri-procedural complications. The purpose of this study will be to evaluate the safety and efficacy of MMA embolization compared to traditional surgical management for symptomatic, chronic, and medically refractory SDH. MMA embolization is an established procedure used routinely for treatment of tumors or vascular malformations; this study investigates the use of an established procedure for a new disease. The investigators hypothesize that MMA embolization will afford a particularly fragile patient population an alternative to invasive and morbid neurosurgical intervention.

Key facts

Study ID

NCT03307395

Run by

Weill Medical College of Cornell University

People needed

6

Starts

2017-10-31

Expected to finish

2018-07-30

Last updated by the study team

2021-03-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age must be greater or equal to 18 years of age.
• Subjects must have a diagnosis of chronic or acute-on-chronic subdural hematoma based on brain imaging, as documented by an independent radiologist.
• One or more symptoms attributable to chronic SDH including headache, cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
• In the opinion of the site investigator or the subject's referring physician, the subject has failed conservative management.

You may not qualify if…

• The subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment.
• Any requirement for urgent surgical evacuation is necessary.
• Life expectancy is less than 6 months in the opinion of the subject's primary physician.
• Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram.
• Acute subdural hematomas.
• Pregnancy

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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