NCT06726928 SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis

Eligibility & Interventions

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This trial targets 78 participants in total. It began in 2025-09 with a primary completion date of 2027-01.

Brief Summary

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

Inclusion Criteria: * • 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 * Exclusion of other cause (excepted dehiscence of the lateral sinus related to the stenosis) of PT on MRI and on the temporal bone CT * Stenosis located on a dominant or codominant lateral sinus * Stenosis associated with a venous gradient of at least 3 mm Hg under general anesthesia (GA) in the absence of sinus dehiscence, or 2 mm Hg under GA if there is sinus dehiscence in a mastoid cell * Patients asking for the treatment of her/his pulsatile tinnitus * Patients accepting to receive the SiREX® Stent (instead of a carotid stent) * Written informed consent Exclusion Criteria: * 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 * Any contraindication for treatment according to Instructions for Use: * 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. * Patients in whom treatment with antiplatelet agents and/or anticoagulants is contraindicated. * Patients with an acute subarachnoid haemorrhage. * Patients with an active bacterial infection. * Patients who are hypersensitive to nickel-titanium. * Pregnant or breastfeeding woman * Subject is participating in another clinical study * Patients with a life-threatening event in the last 6 months * Patients with a life expectancy under 12 months * Known, severe comorbidities, which will likely influence carrying out of the follow-up visits (cancer, alcohol/drug abuse or dementia)

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