Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment

Recruiting now · Not applicable

Conditions studied: Pulsatile Tinnitus

In brief

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.

Key facts

Study ID

NCT05679271

Run by

University Hospital, Bordeaux

People needed

48

Starts

2024-08-22

Expected to finish

2027-12-01

Last updated by the study team

2025-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 other antiplatelet medications
• Patient has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
• Patient has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure
• Known serious sensitivity to radiographic contrast agents.
• Known sensitivity to nickel, titanium metals, or their alloys
• Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) < 30.
• Patient who has a contraindication to MRI or angiography for whatever reason
• Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period
• Patient unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent
• Patient under legal protection

Where it is running

• CHU Bordeaux — Bordeaux, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.