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

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Jan 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients suffering from pulsatile tinnitus, a condition where individuals hear a rhythmic sound in their ears, often matching their heartbeat. The trial is testing whether placing a stent (a small tube) in the affected veins of the brain can help improve this condition compared to no treatment at all. Participants will be randomly assigned to either receive the stenting procedure or continue with standard care for six months, after which their progress will be evaluated through imaging tests.

To be eligible for this trial, patients must have significant pulsatile tinnitus linked to a specific type of blood vessel abnormality in the brain, known as a dural arteriovenous fistula (DAVF). This trial is open to adults aged 65 to 74 who meet specific criteria, such as not having had previous treatments for their condition and not having other serious medical issues. If you join the study, you will be closely monitored for six months to see how well the treatment works and whether it improves your symptoms. Additionally, if you are in the control group, you will have the option for treatment after the six-month period if needed.

Gender

ALL

Eligibility criteria

• 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 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