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.
DAVF are frequently revealed as a cause of invalidating pulsatile tinnitus (PT). Endovascular treatment (EVT) of DAVF using liquid embolic agent (LEA) is currently performed when an hemorrhagic risk of intracranial hemorrhage is identified (high grade DAVF). PT alone may not be a sufficient condition to offer EVT because procedure-related risks may overcome clinical benefits specifically in case of extended shunts requiring complex procedures. Stenting of dural sinus may represent an alternative to LEA-EVT with a simple and low risk procedure. Thus PT could be cured even in case of low grade DAVF without neurologic risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
venous stenting associated to antiaggregation protocol
observation: no treatment
CHU Bordeaux
Bordeaux, France
RECRUITINGCognard's classification grade
Cognard's classification status : from type I (Anterograde drainage into venous sinus) to Type V (Drainage into the spinal perimedullary veins)
Time frame: Month 6
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)
Time frame: Baseline, Month 6, Month 12, Month 24
modified Rankin Scale
mRS Neurological score (from 0 - No symptoms at all to 6 - Death)
Time frame: Baseline, Month 6
Rate of stent thrombosis
Rate of stent thrombosis
Time frame: Month 6, Month 12, Month 24
unsuccessful stent deployment
Rate of unsuccessful stent deployment
Time frame: Baseline
Concentration troubles
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time frame: Baseline, Month 6, Month 12, Month 24
Sleep troubles
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time frame: Baseline, Month 6, Month 12, Month 24
Headaches
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time frame: Baseline, Month 6
Dizziness
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time frame: Baseline, Month 6, Month 12, Month 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.