Clinical trial NCT05679271: Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment
Official title: Intracranial Dural Arteriovenous Fistula Related Pulsatile Tinnitus . Endovascular Treatment by Venous Stenting : An Efficacy Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulsatile Tinnitus
Keywords: Dural arteriovenous fistulae
Pulsatile tinnitus
Venous Stenting
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: French Ministry of Social Affairs and Health
First posted: 2023-01-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: DAVF are frequently revealed as a cause of invalidating pulsatile tinnitus (PT). Endovascular treatment (EVT) of DAVF using liquid embolic agent (LEA) is currently performed when an hemorrhagic risk of intracranial hemorrhage is identified (high grade DAVF). PT alone may not be a sufficient condition to offer EVT because procedure-related risks may overcome clinical benefits specifically in case of extended shunts requiring complex procedures. Stenting of dural sinus may represent an alternative to LEA-EVT with a simple and low risk procedure. Thus PT could be cured even in case of low grade DAVF without neurologic risk.

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

Primary outcomes:
measure: Cognard's classification grade
timeFrame: Month 6
Secondary outcomes:
measure: THI score
timeFrame: Baseline, Month 6, Month 12, Month 24
measure: modified Rankin Scale
timeFrame: Baseline, Month 6
measure: Rate of stent thrombosis
timeFrame: Month 6, Month 12, Month 24
measure: unsuccessful stent deployment
timeFrame: Baseline
measure: Concentration troubles
timeFrame: Baseline, Month 6, Month 12, Month 24
measure: Sleep troubles
timeFrame: Baseline, Month 6, Month 12, Month 24
measure: Headaches
timeFrame: Baseline, Month 6
measure: Dizziness
timeFrame: Baseline, Month 6, Month 12, Month 24
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: