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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.