Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment
Trial Parameters
Brief Summary
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.
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. * Fistula length compatible with use of up to two stents * 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