Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Trea… (NCT05679271) | Clinical Trial Compass
RecruitingNot Applicable
Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment
France48 participantsStarted 2024-08-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
* Patient with any known allergy to heparin, acetylsalicylic acid, Coumadin , Warfarin or ot…