About this trial
The purpose of the study is to assess the efficacy, safety and the clinical benefit of the SiREX stent for the treatment of disabling pulsatile tinnitus due to stenosis of lateral sinus.
The study will enrol patients suffering from pulsatile tinnitus related to a lateral sinus stenosis lasting more than three months, and who want to be treated with lateral sinus stenting
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Patient ≥ 18 years old
Disabling pulsatile tinnitus lasting for more than three months
Venous type: pulsatile tinnitus is interrupted by ipsilateral jugular vein compression
Lateral sinus stenosis visible on venous MRA or venous angio CT
Disqualifiers
Non-pulsatile tinnitus or pulsatile tinnitus unrelated to lateral sinus stenosis
Stenosis with gradient < 2 mm Hg in the absence of associated lateral sinus dehiscence
Patients in whom the size of the venous vessel section to be treated does not lie within the range indicated for the stent.
Patients for whom angiography shows that the anatomic morphology is not suitable for endovascular treatment due to severe vessel tortuosity or stenosis.Patients who were not pre-treated with antiplatelet agents prior to the procedure.
Trial design
Single group
Treatments tested in this trial
Sinus Stenting
DeviceStenting of symptomatic sinus stenosis
Treatment groups
Trial outcomes
Primary outcomes
Disappearance of pulsatile tinnitus at 90 (± 20) days
Disappearance of pulsatile tinnitus at 90 (± 20) days after resolving of the lateral sinus stenosis with SiREX Stent
Sponsors and contacts
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