[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615347":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":31,"centralContacts":41,"locations":50,"responsibleParty":69,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":10,"enrollmentInfo":86,"targetDuration":89,"studyType":90,"phases":10,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with cSDH",null,"All participants enrolled will be treated with the Balt coils.\n\n1. MMA embolization: Utilize Balt Coils as stand-alone with or without other embolics treatment.\n2. MMA embolization: Utilize Balt Coils in combination with or without embolics in surgical or bedside evacuation, such as:\n\n   1. MMA embolization in combination with Balt coils post-surgical debridement, or\n   2. MMA embolization using Balt coils alone, pre- or post-surgical debridement.",[13,14],"Device: Balt coils: (Balt USA, LLC)","Procedure: MMA embolization",[16,26],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Balt coils: (Balt USA, LLC)","MMA embolization utilizing Balt Coils",[9],[22,23,24,25],"Optima","OptiMax","OptiBlock","Optima series line extensions",{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"PROCEDURE","MMA embolization","surgical or bedside evacuation\n\npre or post-surgical debridement",[9],[32,35,38],{"name":33,"affiliation":5,"role":34},"Christopher Kellner","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Benjamin Yim","John Muir Health",{"name":39,"affiliation":40,"role":34},"Alexander Coon","Carondelet Neurological Institute",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"Sukaina Davdani","CONTACT","(212) 241-2524","Sukaina.Davdani@mountsinai.org",{"name":48,"role":44,"phone":45,"phoneExt":10,"email":49},"Sydney Edwards","Sydney.Edwards@mountsinai.org",[51],{"facility":52,"status":53,"city":54,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Mount Sinai Hospital","RECRUITING","New York","10029","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-74.00597,40.71427,{"lat":62,"lon":61},[65,66,68],{"name":43,"role":44,"phone":10,"phoneExt":10,"email":46},{"name":48,"role":44,"phone":10,"phoneExt":10,"email":67},"sydney.edwards@mountsinai.org",{"name":33,"role":34,"phone":10,"phoneExt":10,"email":10},{"type":34,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Christopher P Kellner","Associate Professor",[73,74],{"name":37,"class":6},{"name":40,"class":75},"UNKNOWN","100615347","chronic-subdural-hematoma-embolization-with-detachable-coils-100615347",false,"NCT07291427","Chronic Subdural Hematoma Embolization With Detachable Coils","Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils","SEED","Inclusion criteria:\n\n* Age ≥ 18\n* Patients experiencing unilateral or bilateral non-acute subdural hematoma confirmed by CT imaging. Acute on Chronic or mixed density hematoma allowed.\n* A clinical decision has been made to use coiling and\u002For embolics as treatment, with or without surgical debridement, independently as per standard of care and prior to enrollment in the study.\n* Signed informed consent obtained by patient or Legal Authorized Representative (LAR)\n\nExclusion criteria:\n\n* Primary acute SDH\n* Prior MMAE in target territory\n* Premorbid mRS \\> 3\n* Common carotid stenosis \\>70% or prior carotid stent placement\n* Significant medical contraindication to angiography (kidney failure\u002Fdisease)\n* Anatomical variations that would make MMA embolization difficult or unsafe\n* Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints\n* Pregnancy\n* Life expectancy ≤ 1 year","ALL","18 Years",{"count":87,"type":88},150,"ESTIMATED","180 Days","OBSERVATIONAL","This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH).",[93],"Chronic Subdural Hemorrhage (cSDH)",[95,96,97],"Subdural hemorrhage","Coils","Middle meningeal artery","2026-07-23",{"date":100,"type":101},"2026-07-24","ACTUAL",{"date":103,"type":101},"2026-06-02",{"date":105,"type":88},"2028-09-01",{"name":5,"class":6},1]