Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
Status unconfirmed · Not applicable
Conditions studied: Chronic Subdural Hematoma
In brief
Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.
Key facts
- Study ID
- NCT04095819
- Run by
- Atlantic Health System
- People needed
- 50
- Starts
- 2019-06-19
- Expected to finish
- 2022-04-19
- Last updated by the study team
- 2019-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 or older
- Participant or Surrogate must be English speaking
- Subjects must have a diagnosis of chronic or acute-on subdural hematoma based on brain imaging, as documented by an
- One or more symptoms attributable to chronic SDH including headache cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
- In opinion of 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
- Health insurance doesn't cover MMA embolization or performing Surgeon and follow up visits are considered out of network.
- Pregnancy
Where it is running
- Overlook Medical Center — Summit, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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