Venous stenting for treating pulsatile tinnitus caused by low-grade dural arteriovenous fistulae

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Bordeaux
  Bordeaux, France Recruiting

Study contacts

• Study coordinator: Xavier BARREAU, MD
• Email: xavier.barreau@chu-bordeaux.fr
• Phone: +33 556 79 56 04

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VivaStent: a stent procedure to help pulsatile tinnitus

  A stent-based procedure is being tested to see if it can relieve severe pulsatile tinnitus in adults with significant transverse-sigmoid sinus narrowing.

  Recruiting V-Flow 21 · Paris · NCT07515781

• BosSTENT implantation for pulse-synchronous tinnitus from venous sinus narrowing

  This trial will try a new stent called BosSTENT to reduce severe pulse-synchronous tinnitus in adults whose symptoms are caused by narrowing of the cerebral venous sinus and improve when the jugular vein is compressed.

  Recruiting at 5 sites Sonorous NV, Inc · Ottawa, Canada and 5 other locations · NCT07070089

• Glaucoma and Brain Changes: How Brain Structure and Size See What Glaucoma Is Doing

  This study tests whether glaucoma is linked to broader brain changes by comparing brain MRI and eye health over time in people with glaucoma and matched controls.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT07802769

• Who’s at high risk after RCC surgery? Real-world clues from French registry

  This study looks at real-world data from French RCC patients who had local or high-risk locally advanced disease to see how they do after surgery and how doctors decide on adjuvant treatment.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT07753343

• Prediction score for death or lung transplant in emphysema caused by alpha-1 antitrypsin deficiency

  This study tests a new prediction tool to identify people with emphysema due to alpha-1-antitrypsin deficiency who are at high risk of death or needing a lung transplant.

  Recruiting at 4 sites University Hospital, Bordeaux · Bron and 3 other locations · NCT07715617

• Frailty score predicts quality of life after emergency heart surgery in people 75 and older

  This study tests whether a preoperative frailty score can predict quality of life one year after emergency heart surgery in patients aged 75 and up.

  Recruiting University Hospital, Bordeaux · Bordeaux, France · NCT07677319

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.