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

NCT06466733 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 658

Last updated 2025-05-07

No results posted yet for this study

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.

Conditions

  • Chronic Subdural Hematoma

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.

Sponsors & Collaborators

  • Juan M. Ramos Acevedo

    lead OTHER

Principal Investigators

  • Juan M Ramos Acevedo, MD · University of Puerto Rico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2031-07-31
Completion
2032-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06466733 on ClinicalTrials.gov