About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Venous stenting
Devicevenous stenting associated to antiaggregation protocol
Standard of care
Other interventionobservation: no treatment
Treatment groups
Trial outcomes
Primary outcomes
Cognard's classification grade
Cognard's classification status : from type I (Anterograde drainage into venous sinus) to Type V (Drainage into the spinal perimedullary veins)
Secondary outcomes
THI score
THI (Tinnitus Handicap Inventory) score (based on 100 points scale from Grade 1 (\<16 points) Slight or no handicap to Grade 5 (\>=78 points) Catastrophic handicap)
modified Rankin Scale
mRS Neurological score (from 0 - No symptoms at all to 6 - Death)
Rate of stent thrombosis
Rate of stent thrombosis
unsuccessful stent deployment
Rate of unsuccessful stent deployment
Sponsors and contacts
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University Hospital, Bordeaux
Lead sponsor
French Ministry of Social Affairs and Health
Collaborator