SiREX stent to treat pulsatile tinnitus from narrowed lateral venous sinus
Official title: SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis
Run by Acandis GmbH · NCT06726928 · Data updated 2026-11-12
This study will try a dedicated SiREX stent to stop disabling pulsatile tinnitus in adults whose symptoms come from a narrowed lateral venous sinus.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | Acandis GmbH Industry-sponsored |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | September 2025 |
| Main results expected | January 2027 |
| Study ends | January 2029 |
| Registry record updated | September 4, 2025 |
| Trial ID | NCT06726928 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with disabling venous-type pulsatile tinnitus lasting more than three months, a lateral sinus stenosis visible on venous imaging, the required trans-sinus pressure gradient, a dominant or codominant affected sinus, and who request treatment and consent to the SiREX stent are ideal candidates.
✕Probably not a fit
Patients whose tinnitus is non-pulsatile or not caused by lateral sinus stenosis, or who have an insufficient trans-sinus pressure gradient, are unlikely to benefit from this stent.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study implants a purpose-designed SiREX stent into the lateral venous sinus of adults with disabling pulsatile tinnitus related to a visible stenosis. Patients are selected by imaging and an intraprocedural venous pressure gradient threshold, and the stent uses a smaller delivery system, longer lengths, and reduced radial force compared with off-label carotid/peripheral devices. The main outcomes are rapid symptom change and device safety, with clinical and imaging follow-up after the procedure. The protocol targets patients who have had symptoms for more than three months and who consent to receive the SiREX device.
Why it matters
Potential benefit: If successful, the SiREX stent could rapidly eliminate or reduce pulsatile tinnitus while lowering procedural difficulties and complication risk compared with using off-label stents.
How similar studies have gone: Off-label venous sinus stenting using carotid or peripheral stents has produced symptom relief in prior case series, but a dedicated stent like SiREX represents a novel, specifically designed device for this indication.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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Hôpital Lariboisière
Paris, France Recruiting
Study contacts
- Study coordinator: Anna Gold
- Email: info@acandis.com
- Phone: +49 7231 155000
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.