[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491449":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"venous stenting","EXPERIMENTAL","Venous stenting associated to antiaggregation protocol:\n\nVenous stenting: venous approach can be performed via femoral, brachial or jugular puncture. Autoexpansible stent should delivered at the level of the fistulous sinus. If distal access catheter is wide enough, stent can be delivered directly through it. After partial deployment of the stent, Labbe vein's flow may be restricted. If necessary, several stents can be used in the same procedure to cover the whole length of fistulous sinus area. After stent deployment, ballon angioplasty is compulsory and must be performed using a ballon of equivalent size to the stent. The procedure ends after stent deployment and angiographic arterial post-op controls.\n\nAntiaggregation protocol: aspirin (160mg for 3 months) + clopidogrel (75mg\u002Fd 5 days before stenting and 75mg\u002Fd for 1 month after stenting) OR ticagrelor (180mg 2h before stenting and 90mg twice a day for 1 month) in case of clopidogrel platelet resistance.",[13],"Device: Venous stenting",{"label":15,"type":16,"description":17,"interventionNames":18},"no treatment","ACTIVE_COMPARATOR","standard care (no treatment)",[19],"Other: Standard of care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Venous stenting","venous stenting associated to antiaggregation protocol",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard of care","observation: no treatment",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xavier BARREAU, MD","CONTACT","+33 556 79 56 04","xavier.barreau@chu-bordeaux.fr",[38],{"facility":39,"status":40,"city":41,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"CHU Bordeaux","RECRUITING","Bordeaux","France","FR",{"type":45,"coordinates":46},"Point",[47,48],-0.58046,44.84124,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":53,"phoneExt":26,"email":36},"Xavier Barreau, MD","33556795604",{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[57],{"name":58,"class":59},"French Ministry of Social Affairs and Health","UNKNOWN","100491449","dural-sinus-stenting-of-low-grade-dural-arteriovenous-fistulae-davf-for-pulsatile-tinnitus-treatment-100491449",false,"NCT05679271","Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment","Intracranial Dural Arteriovenous Fistula Related Pulsatile Tinnitus . Endovascular Treatment by Venous Stenting : An Efficacy Study","INVENT","Inclusion Criteria:\n\n* Patient presenting invalidating pulsatile tinnitus\n* Patient presenting with PT anatomically correlated with a DAVF\n* Type I or IIa DAVF on digital subtraction angiography (DSA), according to Cognard's classification.\n* DAVF located on sigmoid , lateral or posterior longitudinal sinus.\n* Fistula length compatible with use of up to two stents\n* Highly effective contraception for women of childbearing potential, maintained during research procedures\n* Affiliated or beneficiary of health insurance\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patient with DAVF not eligible for endovascular treatment .\n* DAVF classification of IIb or more according to Cognard's classification.\n* DAVF with severe sinus stenosis or occlusion judged as nor eligible for sinus stenting.\n* DAVF showing evidence of recent (inferior to 3 months) thrombophlebitis at the site of fistulous dural sinus.\n* Patient with DAVF previously treated with surgery or radiotherapy.\n* Patient with multiple DAVF\n* Controlateral sinus aplasia or occlusion\n* Patient presenting contra-indication to the use of LEA according to the instructions For Use.\n* Patient participating in another clinical study evaluating another medical device,\n* Any condition or any situation that would prohibit the patient from coming to the investigational center for the follow-up as recommended by the study protocol at 6 months.\n* Patient with any known allergy to heparin, acetylsalicylic acid, Coumadin , Warfarin or other antiplatelet medications\n* Patient has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.\n* Patient has had an Intracranial hemorrhage and\u002For subarachnoid hemorrhage in the past 30 days prior to the study procedure\n* Known serious sensitivity to radiographic contrast agents.\n* Known sensitivity to nickel, titanium metals, or their alloys\n* Known renal failure as defined by a serum creatinine \\> 2.5 mg\u002Fdl (or 220 μmol\u002Fl) or glomerular filtration rate (GFR) \\\u003C 30.\n* Patient who has a contraindication to MRI or angiography for whatever reason\n* Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period\n* Patient unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent\n* Patient under legal protection","ALL","18 Years",{"count":71,"type":72},48,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this randomized trial to assess the angiographic efficacy of venous stenting in dural arteriovenous fistulae (DAVF) via improvment on Cognard's Classification as compared to no intervention at 6 months Participants belonging to experimental group will be treated using venous stenting. DAVF will be assessed by angiography at 6 months follow-up. Participants belonging to control group will be followed accordingly to standard of care (no treatment). After 6 months, control group patients can be treated by any means accordinlgly to standard of care.",[78],"Pulsatile Tinnitus",[80,81,82],"Dural arteriovenous fistulae","Pulsatile tinnitus","Venous Stenting","2025-02-07",{"date":85,"type":86},"2025-02-11","ACTUAL",{"date":88,"type":86},"2024-08-22",{"date":90,"type":72},"2027-12",{"name":5,"class":6},1]