Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis
Stopped early · Not applicable
Conditions studied: Tinnitus, Pulsatile Tinnitus, Venous Sinus Stenosis, Dural Sinus Stenosis
In brief
There have been few published studies that examine the efficacy and safety of endovascular treatments on patients with pulsatile tinnitus with venous stenosis. Despite the limited experience with venous sinus stenting to treat pulsatile tinnitus, preliminary results show that venous sinus stenting could represent a viable alternative for refractory pulsatile tinnitus patients with venous sinus stenosis. The purpose of this study is to evaluate the safety and efficacy of this procedure in a controlled fashion, using strict inclusion and exclusion criteria, and long-term clinical and imaging follow-up. The investigators hope to provide robust data regarding the safety and efficacy of venous sinus stenting for patients with pulsatile tinnitus.
Key facts
- Study ID
- NCT02734576
- Run by
- Weill Medical College of Cornell University
- People needed
- 10
- Starts
- 2017-01-24
- Expected to finish
- 2020-03-01
- Last updated by the study team
- 2021-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Severe or catastrophic venous pulsatile tinnitus defined as Grades 4 or 5 on Tinnitus Handicap Inventory
- 50% or more stenosis of the lateral venous sinus on Magnetic Resonance Venogram (MRV) or Computed Tomographic Venogram (CTV_, ipsilateral to the side of more severe tinnitus
- Failure of conservative or non-surgical therapies (including sound therapy, sound masking, hearing aids, tinnitus retraining (desensitization) therapy. Failure is defined as Grades 4 or 5 on the Tinnitus Handicap Inventory despite prior treatments that have lasted for at least 3 months.
You may not qualify if…
- Non-pulsatile tinnitus
- Contra-indication to iodinated contrast
- Contra-indication to antiplatelet therapy
- Contra-indication to general anesthesia
- Pregnancy or plans for immediate pregnancy
Where it is running
- New York Presbyterian Hospital/ Weill Cornell Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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