Status:
COMPLETED
Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 investig...
Detailed Description
The purpose of this study will be to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical management for symptomatic, chronic, and medically ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03307395
Start Date
October 31 2017
End Date
July 30 2018
Last Update
March 4 2021
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10065