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New treatment option for Pulsatile Tinnitus
Official title Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment
ClinicalTrials.gov ID: NCT05679271
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.