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NOT YET RECRUITING
NCT06466733
NA

Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)

Sponsor: Juan M. Ramos Acevedo

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

PROCEDURE

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.