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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcandis GmbH

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

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

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sinus Stenting

    Device

    Stenting of symptomatic sinus stenosis

Treatment groups

78 Participants
are divided into 1 treatment group
Group A: InterventionOther 1 intervention

Trial outcomes

Primary outcomes

1

Disappearance of pulsatile tinnitus at 90 (± 20) days

Disappearance of pulsatile tinnitus at 90 (± 20) days after resolving of the lateral sinus stenosis with SiREX Stent

Time frame
90 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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