Ireland
--:--IST
Recruiting Not applicable

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

NCT05679271 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-08-22
Last updated
2025-02-11

Condition(s) studied

Pulsatile Tinnitus

Investigational drug(s) / intervention(s)

Venous stentingStandard of care

Venous stenting: venous stenting associated to antiaggregation protocol

Standard of care: observation: no treatment

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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. * 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

Primary outcome measure(s)

  • Cognard's classification grade — Month 6
    Cognard's classification status : from type I (Anterograde drainage into venous sinus) to Type V (Drainage into the spinal perimedullary veins)

Trial sites (1)

FacilityCityRegionStatus
CHU Bordeaux Bordeaux France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05679271 on ClinicalTrials.gov ↗ ← All trials in France