Trials / Recruiting
RecruitingNCT06726928
SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- Sponsor
- Acandis GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
As there is currently no specifically developed and approved stent on the market for the treatment of symptomatic sinus stenosis, stenting has so far been performed with stents intended for carotid stenosis or peripheral treatment, which leads to considerable limitations. Because of stiff delivery systems (6F or bigger) progression inside the venous sinus is sometimes difficult. Furthermore, the length of such devices is often insufficient to cover the entire pathological segment and more than one device needs to be implanted in an overlaying manor (telescoping), which is accompanied with higher complication risks. The objective of the study is to prove the efficacy and clinical safety of the new dedicated SiREX Stent with optimized technical features (smaller delivery system, longer lengths, reduced radial force), specially developed for the treatment of venous sinus stenosis. Pulsatile tinnitus is expected to disappear immediately after treatment with a stable effect during time.
Conditions
- Treatment of Symptomatic Lateral Sinus Stenosis
- Treatment of Pulsatile Tinnitus Due tu Sinus Stenosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sinus Stenting | Stenting of symptomatic sinus stenosis |
Timeline
- Start date
- 2025-09-01
- Primary completion
- 2027-01-01
- Completion
- 2029-01-01
- First posted
- 2024-12-10
- Last updated
- 2025-09-04
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06726928. Inclusion in this directory is not an endorsement.