[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07715656":3,"trial-entities:NCT07715656":103,"trial-summary:NCT07715656":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":50,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":15,"eligibility_criteria":66,"std_ages":73,"locations":76,"central_contacts":92,"overall_officials":97,"references":101,"see_also_links":102},"NCT07715656","20253018","Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas","Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas: A Randomized Controlled Trial.","RECRUITING","2027-06-30","2026-03","2026-07-20","2025-04-09","Lahey Clinic","OTHER",false,"This is a pragmatic, prospective, multicenter, randomized controlled trial with intention to treat analysis. In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH).","This study will enroll up to 400 subjects who will be randomized to receive either unilateral or bilateral coil MMA embolization. The study will assess the effect of the procedures on hematoma size and patient functional outcomes over 1 to 3 months of follow-up.",[19],"Chronic Subdural Hematoma",[21,22,23,24,25],"cSDH","Chronic subdural hematoma","Coils","Embolization","eMMA","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},400,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","embolization therapy Bilateral","In the bilateral approach, both middle meningeal arteries are accessed and embolized using coils, regardless of hematoma location. Imaging guidance is used throughout the procedure to ensure proper coil placement, and post-procedure imaging confirms that both vessels are fully occluded.",[39,40],"Medical Management","Surgical",{"type":35,"name":42,"description":43,"armGroupLabels":44},"embolization therapy Unilateral","In the unilateral approach, the middle meningeal artery (MMA) on the side of the hematoma is accessed via a catheter and occluded using coils under imaging guidance. The procedure targets only the affected side, and follow-up imaging is used to confirm successful embolization and vessel occlusion.",[39,40],[46],{"measure":47,"description":48,"timeFrame":49},"Change in cSDH Maximum thickness From Baseline on Non-contrast Head CT","Change in maximum hematoma thickness (mm) and Volume (mL) measured on non-contrast head CT compared with baseline. Measurements will be performed using standardized imaging review.","Baseline, 1 month (3-6 weeks), and 3 months (10-14 weeks)",[51,55,59],{"measure":52,"description":53,"timeFrame":54},"Number of Participants Requiring Additional surgical Intervention","Number of participants requiring additional surgical treatment after randomization, including initial surgical evacuation in the medical management cohort or repeat hematoma evacuation in the surgical cohort.","Through 3 months",{"measure":56,"description":57,"timeFrame":58},"Change from Baseline in Modified Rankin scale (mRS) Score","Functional outcome measured using the Modified Rankin Scale (range 0-6). change from baseline will be reported.","Baseline, 1 month, and 3 months",{"measure":60,"description":61,"timeFrame":62},"Number of participants with Procedure-related Serious Adverse Events","Number of participants experiencing procedure related adverse events, including but not limited to ischemic stroke, intracranial hemorrhage, arterial dissection, vessel perforation, access-site complications requiring intervention, or death.","through 3 months after embolization","ALL","18 Years",null,{"inclusion":67,"exclusion":70,"raw_text":72},[68,69],"Midline shift \\\u003C 10mm and hematoma thickness \\> 10 mm as measured on coronal imaging perpendicular to the skull.","No focal deficit related to the chronic subdural hematoma requiring surgical intervention",[71],"Candidates will be excluded from participation if ANY of the following apply:","Inclusion Criteria:\n\nCandidates for this study must meet ALL of the following criteria:\n\n1. Subject is 18 years of age or older.\n2. Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms.\n3. Pre-randomization modified Rankin Score (mRS) ≤3\n\n   a. Surgical Cohort: Assessment should reflect the subject's condition just prior to undergoing surgery. Assessment may be performed post-surgery using pre-surgical data.\n4. Subdural Hematoma Size\n\n   Medical Management Cohort:\n   * Midline shift \\\u003C 10mm and hematoma thickness \\> 10 mm as measured on coronal imaging perpendicular to the skull.\n   * No focal deficit related to the chronic subdural hematoma requiring surgical intervention\n\n   Surgical Cohort:\n\n   • No requirement\n5. A CT performed prior to randomization demonstrating stability of the hematoma. Stability is defined as no worsening of midline shift or increase in the size of the cSDH from the screening image that results in new or worsening clinical symptoms.\n6. Patient or designated Legal Authorized Representative, confirms the patient has the mental capacity, willingness and ability to comply with protocol and follow-up requirements\n7. In the opinion of the treating physician, MMA embolization is technically feasible, including evaluation of preoperative CTA, if available, or presence of a foramen spinosum bilaterally.\n\nExclusion Criteria:\n\n* Candidates will be excluded from participation if ANY of the following apply:\n\n  1. Patients presenting with an acute SDH (e.g. patient with presenting with a SDH due to trauma); mixed density is permitted.\n  2. Subject presents with bilateral cSDHs requiring treatment (contralateral cSDH \\\u003C5mm and not requiring treatment is permitted.\n  3. Subject presents with Glasgow Coma Scale \\\u003C 9\n  4. Markwalder assessment \\>4\n  5. cSDH that developed with underlying conditions such as vascular lesions, brain tumor, arachnoid cyst, spontaneous intracranial hypotension, end stage renal disease (ESRD) on hemodialysis, end stage liver disease or other comorbidities causing a coagulopathy\n  6. Prior carotid stent placement that crosses the origin of the External Carotid Artery (ECA) ipsilateral to the subdural hematoma\n  7. Presumed septic embolus, or suspicion of microbial superinfection\n  8. CT or MRI evidence of intra-cranial tumor or mass lesion\n  9. Significant contraindication to angiography (eg. kidney failure).\n  10. Life expectancy of less than 1-year\n  11. Women who are pregnant, lactating, plan on becoming pregnant during the course of the clinical investigation. We routinely do pregnancy tests prior to this procedure, to avoid radiation exposure to the fetus including radiation on follow up CT scans\n  12. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Subjects in observational, natural history, and\u002For epidemiological studies not involving intervention are eligible\n  13. Patient unwilling to follow SOC recommendations (e.g. refuses surgery or lifestyle modifications)",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":78,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":89},"Lahey Hospital & Medical Center","Burlington","Massachusetts","01803","United States",[84],{"name":85,"role":86,"phone":87,"email":88},"Kimberly Silverman","CONTACT","7817443330","Kimberly.Silverman@lahey.org",{"lat":90,"lon":91},42.50482,-71.19561,[93],{"name":94,"role":86,"phone":95,"email":96},"Sandy L Alvarez, MD","7865800186","sandy.l.alvarez@lahey.org",[98],{"name":99,"affiliation":78,"role":100},"Jonathan Pace, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Chronic intracranial subdural hematoma",[],{"nct_id":4,"found":108,"summary":109,"prompt_version":119},true,{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is a randomized controlled trial involving up to 400 participants. You would be randomly assigned to receive either unilateral or bilateral embolization therapy.","completed","Coil Embolization for Chronic Subdural Hematomas","This study is looking at two ways to treat chronic subdural hematomas (cSDH), which are collections of blood on the brain's surface. Researchers want to see if blocking blood flow to the hematoma using coils in one artery (unilateral embolization therapy) is as effective as blocking it in two arteries (bilateral embolization therapy). You could be eligible if you are 18 or older, have a chronic subdural hematoma causing symptoms, and have a modified Rankin Score (mRS) of 3 or less, which measures your level of disability. The main goal is to see how much the hematoma shrinks over 1 to 3 months. The current status of this study is unclear.","You will be followed for 3 months after the treatment to assess changes in hematoma thickness.",111,"You would undergo either a unilateral or bilateral embolization procedure. Your hematoma size and functional outcomes will be checked at baseline, 1 month, and 3 months after the procedure.","Not stated in the trial record.",[],"v2"]