[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551949":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":25,"responsibleParty":43,"collaborators":25,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":25,"enrollmentInfo":56,"targetDuration":25,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":72,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":25},{"fullName":5,"class":6},"University of Puerto Rico","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Endovascular Embolization","EXPERIMENTAL","Embolization of the middle meningeal artery",[13],"Procedure: Embolization of the middle meningeal artery",{"label":15,"type":16,"description":17,"interventionNames":18},"Surgical Evacuation of Hematoma","ACTIVE_COMPARATOR","Burr hole or craniotomy",[19],"Procedure: Surgical Evacuation via burr hole or craniotomy",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Embolization of the middle meningeal artery ipsilateral to the chronic subdural hematoma is performed infusing embolic polyvinyl alcohol (PVA) microparticles.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[15],[31,32],"Burr hole","Craniotomy",[34],{"name":35,"affiliation":5,"role":36},"Juan M Ramos Acevedo, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":25,"email":42},"Maria M Garcia Perez","CONTACT","939-417-4432","dra.garcia.neurosx@gmail.com",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Juan M. Ramos Acevedo","Principal Investigator","100551949","puerto-rico-embolization-of-the-middle-meningeal-artery-for-the-treatment-of-chronic-subdural-hematoma-trial-premma-100551949",false,"NCT06466733","Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)","PREMMA","Inclusion Criteria:\n\n* Age ≥ 21\n* Speak and understand Spanish or English\n* Resident of Puerto Rico\n* Glasgow coma scale ≥ 14\u002F15\n* Presence of cSDH on non-contrast computed tomography (NCCT) or magnetic resonance imaging (MRI)\n* Neurological indication for treatment of cSDH (Markwalder scale ≤ 2)\n* No previous surgical or endovascular treatment for symptomatic cSDH\n* Signed informed consent for participation in the study by the patient or legally authorized representative\n\nExclusion Criteria:\n\n* Acute subdural hematoma\n* Focal, non-hemispheric localization of cSDH\n* 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\n* Imaging evidence of skull fracture over the subdural hematoma\n* Presence of any cerebrospinal fluid (CSF) shunt\n* Imaging evidence of midline shift ≥ 10 mm\n* Imaging evidence of basal cistern effacement\n* Imaging evidence of dilatation of lateral ventricles\n* Imaging evidence of uncal herniation\n* Modified Rankin scale ≥ 3 before developing symptoms associated with cSDH\n* Contraindications for angiography (i.e., complex anatomy or kidney failure)\n* Comorbidity making follow-up impossible\n* Pregnancy\n* Vulnerable patients, including homeless patients, incarcerated patients, and mentally ill patients without appropriate medical decision-making proxies that the physician believes are incapable of appropriately assessing the risks of the procedure\n* Absence of medical insurance","ALL","21 Years",{"count":57,"type":58},658,"ESTIMATED","INTERVENTIONAL",[61],"NA","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.",[64],"Chronic Subdural Hematoma",[66,11,67,68,69,70,71],"Chronic subdural hematoma","Surgical evacuation","Hemorrhage","Intracranial hemorrhage","Cerebrovascular disease","Chronic disease","NOT_YET_RECRUITING","2025-05-02",{"date":75,"type":76},"2025-05-07","ACTUAL",{"date":78,"type":58},"2025-05",{"date":80,"type":58},"2032-07",{"name":45,"class":6}]