Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hem… (NCT06466733) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)
658 participantsStarted 2025-05
Plain-language 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.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 21
* Speak and understand Spanish or English
* Resident of Puerto Rico
* Glasgow coma scale ≥ 14/15
* Presence of cSDH on non-contrast computed tomography (NCCT) or magnetic resonance imaging (MRI)
* Neurological indication for treatment of cSDH (Markwalder scale ≤ 2)
* No previous surgical or endovascular treatment for symptomatic cSDH
* Signed informed consent for participation in the study by the patient or legally authorized representative
Exclusion Criteria:
* Acute subdural hematoma
* Focal, non-hemispheric localization of cSDH
* Evidence of other lesions associated with cSDH, such as neoplasms, vascular lesions, or additional epidural, subarachnoid, or parenchymal hemorrhage on non-contrast computed tomography or magnetic resonance imaging
* Imaging evidence of skull fracture over the subdural hematoma
* Presence of any cerebrospinal fluid (CSF) shunt
* Imaging evidence of midline shift ≥ 10 mm
* Imaging evidence of basal cistern effacement
* Imaging evidence of dilatation of lateral ventricles
* Imaging evidence of uncal herniation
* Modified Rankin scale ≥ 3 before developing symptoms associated with cSDH
* Contraindications for angiography (i.e., complex anatomy or kidney failure)
* Comorbidity making follow-up impossible
* Pregnancy
* Vulnerable patients, including homeless patients, incarcerated patients, and mentally ill patients without appropriate medical decision-making proxies that the physician believes are incapable of appropr…