[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522065":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":20,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Coil embolization of lumbar vein","EXPERIMENTAL","Subjects with confirmed Nutcracker physiology, retrograde lumbar vein flow, and epidural venous plexus congestion with a high pressure headache will have coil embolization of the lumbar vein.",[13],"Procedure: Coil Embolization of the Lumbar Vein",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Coil Embolization of the Lumbar Vein","Catheter based venography will first confirm Nutcracker physiology with retrograde lumbar vein flow and epidural venous plexus congestion. The lumbar vein will then be coil embolized.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Zlatko Devcic, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Julia Santos","CONTACT","904-953-3280","Santos.Julia@mayo.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":20},"Mayo Clinic Florida","RECRUITING","Jacksonville","Florida","32224","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-81.65565,30.33218,{"lat":44,"lon":43},{"type":24,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Zlatko Devcic","Principal Investigator","100522065","lumbar-vein-embolization-for-chronic-headaches-with-nutcracker-physiology-100522065",false,"NCT06077747","Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology","Lumbar Vein Embolization for the Treatment of Chronic Headache in Patients With Nutcracker Physiology and Retrograde Lumbar Vein Flow With Epidural Venous Plexus Enhancement","Inclusion Criteria:\n\n* Daily headache from onset lasting \\> 3 months.\n* Headache described as pressure sensation.\n* Headache worsened in the Trendelenburg position.\n* Exposed to CSF pressure\u002Fvolume lowering medications.\n* Tried 2 of 4 unless contraindications: acetazolamide, methazolamide, indomethacin SR or spironolactone) or CSF volume removal via LP with positive or neutral response.\n* Failed at least 3 typical headache preventative medications from different classes-antidepressants, antiepileptic, blood pressure medications.\n* MRI demonstrates that Nutcracker physiology is present.\n* Decreased SMA angle, renal vein narrowing, decreased AMD.\n* Retrograde lumbar vein flow and early EVP enhancement.\n* Ability to understand study procedures and to comply with them for the entire length of the study.\n* Negative pregnancy test.\n\nExclusion Criteria:\n\n* Evidence of disc edema.\n* Positive urinalysis for hematuria or proteinuria.\n* Abnormal CBC or CMP.\n* MRI, MRA head and neck and MR venogram with a possible secondary causes of headache including space occupying lesions, Chiari malformation, cerebral vein thrombosis, hydrocephalus, dissection, aneurysm etc.","ALL","18 Years",{"count":59,"type":60},4,"ESTIMATED","INTERVENTIONAL",[63],"NA","The purpose of this research is to gather information on the safety and feasibility of coiling the lumbar vein for the treatment of chronic headaches in patients with Nutcracker physiology and retrograde lumbar vein flow with epidural venous plexus congestion. All patients are extensively evaluated by a headache trained Neurologist confirming high pressure headache refractory to other treatments.",[66,67,68],"Chronic Headache","Nutcracker Phenomenon, Renal","Nutcracker Syndrome, Renal","2025-11-14",{"date":71,"type":72},"2025-11-18","ACTUAL",{"date":74,"type":72},"2024-09-17",{"date":76,"type":60},"2027-09",{"name":5,"class":6},1]