Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment (INVENT)
Pulsatile Tinnitus
About this trial
This is an interventional treatment trial for Pulsatile Tinnitus focused on measuring Dural arteriovenous fistulae, Pulsatile tinnitus, Venous Stenting
Eligibility Criteria
Inclusion Criteria: Patient presenting invalidating pulsatile tinnitus Patient presenting with PT anatomically correlated with a DAVF Type I or IIa DAVF on digital subtraction angiography (DSA), according to Cognard's classification. DAVF located on sigmoid , lateral or posterior longitudinal sinus. Highly effective contraception for women of childbearing potential, maintained during research procedures Affiliated or beneficiary of health insurance Signed informed consent Exclusion Criteria: Patient with DAVF not eligible for endovascular treatment . DAVF classification of IIb or more according to Cognard's classification. DAVF with severe sinus stenosis or occlusion judged as nor eligible for sinus stenting. DAVF showing evidence of recent (inferior to 3 months) thrombophlebitis at the site of fistulous dural sinus. Patient with DAVF previously treated with surgery or radiotherapy. Patient with multiple DAVF Controlateral sinus aplasia or occlusion Patient presenting contra-indication to the use of LEA according to the instructions For Use. Patient participating in another clinical study evaluating another medical device, 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. Patient with any known allergy to heparin, acetylsalicylic acid, Coumadin , Warfarin or other antiplatelet medications Patient has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure. Patient has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure Known serious sensitivity to radiographic contrast agents. Known sensitivity to nickel, titanium metals, or their alloys Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) < 30. Patient who has a contraindication to MRI or angiography for whatever reason Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period Patient unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent Patient under legal protection
Sites / Locations
- CHU Bordeaux
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
venous stenting
no treatment
Venous stenting associated to antiaggregation protocol: Venous 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. Antiaggregation protocol: aspirin (160mg for 3 months) + clopidogrel (75mg/d 5 days before stenting and 75mg/d 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.
standard care (no treatment)