An interventional study of Venous stenting and Standard of care in Pulsatile Tinnitus, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
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.
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.
421 studies on the registry are indexed under Tinnitus; 88 are open to participants now.
This study's planned enrollment of 48 is below the median of 59 across 346 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.
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Exclusion Criteria:
Venous stenting associated to antiaggregation protocol: Venous stenting: venous approach can be performed via femoral, brachial or jugular puncture. Autoexpansible stent should delivered at the level of the fistulous sinus. If distal access catheter is wide enough, stent can be delivered directly through it. After partial deployment of the stent, Labbe vein's flow may be restricted. If necessary, several stents can be used in the same procedure to cover the whole length of fistulous sinus area. After stent deployment, ballon angioplasty is compulsory and must be performed using a ballon of equivalent size to the stent. The procedure ends after stent deployment and angiographic arterial post-op controls. Antiaggregation protocol: aspirin (160mg for 3 months) + clopidogrel (75mg/d 5 days before stenting and 75mg/d for 1 month after stenting) OR ticagrelor (180mg 2h before stenting and 90mg twice a day for 1 month) in case of clopidogrel platelet resistance.
Device: Venous stenting
standard care (no treatment)
Other: Standard of care
venous stenting associated to antiaggregation protocol
observation: no treatment
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
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
modified Rankin Scale
mRS Neurological score (from 0 - No symptoms at all to 6 - Death)
Time frame: Baseline, Month 6
Rate of stent thrombosis
Rate of stent thrombosis
Time frame: Month 6, Month 12, Month 24
unsuccessful stent deployment
Rate of unsuccessful stent deployment
Time frame: Baseline
Concentration troubles
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time frame: Baseline, Month 6, Month 12, Month 24
Sleep troubles
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time frame: Baseline, Month 6, Month 12, Month 24
Headaches
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time frame: Baseline, Month 6
Dizziness
Assessment via Visual Analog Scale from 0-no trouble to 10-extreme troubles
Time frame: Baseline, Month 6, Month 12, Month 24
Plan to share: No
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