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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Venous stenting
  • Standard of care

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Bordeaux

Lead sponsor

French Ministry of Social Affairs and Health

Collaborator