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

Launched by ACANDIS GMBH · Dec 5, 2024

Keywords

ClinConnect Summary

The SiREX-Stent clinical trial is investigating a new treatment option for people experiencing disabling pulsatile tinnitus caused by a condition known as lateral sinus stenosis. Pulsatile tinnitus is a type of ringing in the ears that is often linked to blood flow issues. The trial aims to determine how effective and safe the SiREX stent is for relieving these symptoms in patients who have had this condition for more than three months. Participants will need to be at least 18 years old and must have specific signs of lateral sinus stenosis confirmed by imaging tests.

If you or a loved one is suffering from this type of tinnitus and are interested in participating, you should know that you must be willing to receive the stent treatment and provide written consent. However, certain individuals won't be eligible, including those with non-pulsatile tinnitus or specific health conditions that would complicate treatment. The trial is not yet recruiting, so there will be more information available soon about how to get involved. This study is important as it could provide new insights into effective treatments for a condition that can significantly impact quality of life.

Gender

ALL

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)