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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• • 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

Locations
Other Locations
France
Hôpital Lariboisière
RECRUITING
Paris
Contact Information
Primary
Anna Gold
info@acandis.com
+49 7231 155000
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2029-01
Participants
Target number of participants: 78
Treatments
Other: Intervention
Novel medical device
Related Therapeutic Areas
Sponsors
Leads: Acandis GmbH

This content was sourced from clinicaltrials.gov