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Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)
Sponsor: Juan M. Ramos Acevedo
Summary
Puerto Rico Embolization of the Middle Meningeal Artery (PREMMA) trial is a multi-center, parallel, prospective, superiority, randomized controlled trial with concealed allocation comparing reoperation rates and neurological outcomes in patients with chronic subdural hematoma that receive treatment via embolization of the middle meningeal artery versus surgical evacuation via burr hole trephination or craniotomy.
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
658
Start Date
2025-05
Completion Date
2032-07
Last Updated
2025-05-07
Healthy Volunteers
No
Conditions
Interventions
Embolization of the middle meningeal artery
Embolization of the middle meningeal artery ipsilateral to the chronic subdural hematoma is performed infusing embolic polyvinyl alcohol (PVA) microparticles.
Surgical Evacuation via burr hole or craniotomy
The standard of care for chronic subdural hematoma, burr hole or craniotomy are performed ipsilateral to the lesion.