[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dheeraj Gandhi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100648907","phase-1-intra-arterial-bevacizumab-as-an-adjunct-to-middle-meningeal-artery-embolization-for-chronic-subdural-hematoma-100648907",false,"NCT07729098","Intra-Arterial Bevacizumab as an Adjunct to Middle Meningeal Artery Embolization for Chronic Subdural Hematoma","Safety And Efficacy of Intra-aRterial BEV (IA-BEV) as an Adjunctive Treatment During Middle Meningeal Artery Embolization (MMAE) in Non-Surgical Chronic Subdural Hematoma (cSDH) Patients","SAFER-MMAE","Inclusion Criteria:\n\n* Age 18-85 years\n* Scheduled to undergo MMAE as standard of care for cSDH, no concurrent surgical evacuation planned (prior surgery for the target cSDH allowed if ≥14 days elapsed)\n* Radiographically confirmed cSDH meeting specified unilateral\u002Fbilateral density criteria\n* cSDH volume 20-100 cc\n* Midline shift \\\u003C8 mm\n* Markwalder Grade 1 or 2\n* Subject or LAR able to provide written informed consent\n\nExclusion Criteria:\n\n* Requires immediate\u002Furgent surgical evacuation\n* Prior large craniotomy, membranectomy, or MMAE for the current target cSDH\n* Life expectancy \\\u003C1 year\n* Uncontrolled bleeding disorder (INR \\>1.7, aPTT \\>35s, platelets \\\u003C100,000\u002FμL)\n* Concurrent intracranial hemorrhage outside the target subdural space\n* Persistent neurological deficit from another acute\u002Fchronic neurological condition\n* Pregnancy or lactation\n* Known\u002Fsuspected intracranial neoplasm or mass lesion\n* Active alcohol\u002Fsubstance use disorder within 12 months\n* Baseline mRS ≥3\n* Uncontrolled severe hypertension (SBP \\>220 or DBP \\>120, or IV antihypertensive need within 24h pre-procedure)\n* Thromboembolic event within 6 months (DVT, PE, TIA, stroke)\n* Contraindication to VTE prophylaxis\n* eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² or acute kidney injury at screening\n* Known hypersensitivity to bevacizumab or its components","ALL","18 Years","85 Years",{"count":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1, open-label, single-center, dose-escalation study evaluating the safety and tolerability of intra-arterial bevacizumab (IA-BEV) given as an adjunct to middle meningeal artery embolization (MMAE) in adults with non-surgical chronic subdural hematoma (cSDH). Up to 18 participants who are already scheduled to undergo MMAE as standard of care will receive a single dose of bevacizumab, delivered directly into the middle meningeal artery immediately before embolization, during the same procedure. Three dose levels (2.0, 3.5, and 5.0 mg\u002Fkg) will be tested using a standard 3+3 dose-escalation design to identify the maximum tolerated dose. The study will also collect imaging and blood biomarker data to help understand which patients may benefit most from this combined treatment approach.",[28],"Chronic Subdural Hematoma",[30,31,32,33],"bevacizumab","middle meningeal artery embolization","intra-arterial chemotherapy","VEGF","NOT_YET_RECRUITING","2026-07-22",{"date":37,"type":38},"2026-07-27","ACTUAL",{"date":40,"type":22},"2027-01-01",{"date":42,"type":22},"2029-06-01",{"name":44,"class":45},"Dheeraj Gandhi","OTHER",""]