Venous stenting for treating pulsatile tinnitus caused by low-grade dural arteriovenous fistulae
Intracranial Dural Arteriovenous Fistula Related Pulsatile Tinnitus . Endovascular Treatment by Venous Stenting : An Efficacy Study
This study is testing if a new treatment called venous stenting can help people with pulsatile tinnitus caused by certain blood vessel issues feel better compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05679271 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of venous stenting in patients suffering from pulsatile tinnitus linked to low-grade dural arteriovenous fistulae (DAVF). Participants will be randomly assigned to either receive venous stenting or follow standard care without intervention. The primary outcome will be assessed through angiographic evaluation at six months, focusing on improvements in Cognard's Classification. This approach seeks to provide a less invasive alternative to traditional endovascular treatments, potentially alleviating symptoms of pulsatile tinnitus without significant neurological risks.
Who should consider this trial
Good fit: Ideal candidates include patients experiencing debilitating pulsatile tinnitus associated with type I or IIa DAVF.
Not a fit: Patients with high-grade DAVF or those previously treated with surgery or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce or eliminate pulsatile tinnitus symptoms for patients with low-grade DAVF.
How similar studies have performed: While endovascular treatments for high-grade DAVF have been explored, the use of venous stenting for low-grade cases is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux
- CHU Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Xavier BARREAU, MD
- Email: xavier.barreau@chu-bordeaux.fr
- Phone: +33 556 79 56 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.