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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Venous stenting

    Device

    venous stenting associated to antiaggregation protocol

  • Standard of care

    Other intervention

    observation: no treatment

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: venous stentingExperimental treatment 1 intervention
Group B: no treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cognard's classification grade

Cognard's classification status : from type I (Anterograde drainage into venous sinus) to Type V (Drainage into the spinal perimedullary veins)

Time frame
Month 6

Secondary outcomes

1

THI score

THI (Tinnitus Handicap Inventory) score (based on 100 points scale from Grade 1 (\<16 points) Slight or no handicap to Grade 5 (\>=78 points) Catastrophic handicap)

Time frame
Baseline, Month 6, Month 12, Month 24
2

modified Rankin Scale

mRS Neurological score (from 0 - No symptoms at all to 6 - Death)

Time frame
Baseline, Month 6
3

Rate of stent thrombosis

Rate of stent thrombosis

Time frame
Month 6, Month 12, Month 24
4

unsuccessful stent deployment

Rate of unsuccessful stent deployment

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

French Ministry of Social Affairs and Health

Collaborator