Intracranial Dural Arteriovenous Fistula Related Pulsatile Tinnitus . Endovascular Treatment by Venous Stenting : An Efficacy Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Cognard's classification grade
Overview
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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.
Outcomes
Primary Outcomes
Cognard's classification grade
Time Frame: Month 6
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(Baseline, Month 6, Month 12, Month 24)
- Rate of stent thrombosis(Month 6, Month 12, Month 24)
- Headaches(Baseline, Month 6)
- modified Rankin Scale(Baseline, Month 6)
- unsuccessful stent deployment(Baseline)
- Concentration troubles(Baseline, Month 6, Month 12, Month 24)
- Sleep troubles(Baseline, Month 6, Month 12, Month 24)
- Dizziness(Baseline, Month 6, Month 12, Month 24)