SiREX stent to treat pulsatile tinnitus from narrowed lateral venous sinus
SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Acandis GmbH Industry-sponsored |
| Locations | 1 site (Paris) |
| Trial ID | NCT06726928 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris
- Hôpital Lariboisière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Anna Gold
- Email: info@acandis.com
- Phone: +49 7231 155000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.