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New treatment option for Treatment of Symptomatic Lateral Sinus Stenosis
Official title SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis
ClinicalTrials.gov ID: NCT06726928
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Patients in whom treatment with antiplatelet agents and/or anticoagulants is contraindicated.
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.