Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06726928

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

Led by Acandis GmbH · Updated on 2025-09-04

78

Participants Needed

1

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years old or older
  • Disabling pulsatile tinnitus lasting more than three months
  • Pulsatile tinnitus is interrupted by compression of the same side jugular vein
  • Lateral sinus stenosis visible on venous MRA or venous angio CT
  • Other causes of pulsatile tinnitus excluded on MRI and temporal bone CT except lateral sinus dehiscence related to stenosis
  • Stenosis located on a dominant or codominant lateral sinus
  • Pressure gradient of at least 3 mm Hg under general anesthesia if no sinus dehiscence, or at least 2 mm Hg if sinus dehiscence present
  • Patient requests treatment of their pulsatile tinnitus
  • Patient agrees to receive the SiREX Stent instead of a carotid stent
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Pulsatile tinnitus that is non-pulsatile or unrelated to lateral sinus stenosis
  • Stenosis with pressure gradient less than 2 mm Hg without associated lateral sinus dehiscence
  • Contraindications for treatment per Instructions for Use, including:
    • Venous vessel size outside stent range
    • Anatomic morphology unsuitable for endovascular treatment due to severe vessel tortuosity or stenosis
    • No pre-treatment with antiplatelet agents before procedure
    • Contraindication to antiplatelet and/or anticoagulant therapy
    • Acute subarachnoid hemorrhage
    • Active bacterial infection
    • Hypersensitivity to nickel-titanium
  • Pregnant or breastfeeding women
  • Participation in another clinical study
  • Life-threatening event in the last 6 months
  • Life expectancy under 12 months
  • Severe comorbidities likely to prevent follow-up visits (e.g., cancer, substance abuse, dementia)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hôpital Lariboisière

Paris, France, 75010

Actively Recruiting

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Research Team

A

Anna Gold

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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