Treatment of Symptomatic Lateral Sinus StenosisRESOLVENCT06726928
SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis
A study testing Sinus Stenting in people with Treatment of Symptomatic Lateral Sinus Stenosis and Treatment of Pulsatile Tinnitus Due tu Sinus Stenosis, run by Acandis GmbH at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Symptomatic Lateral Sinus Stenosis, Treatment of Pulsatile Tinnitus Due tu Sinus Stenosis
- What is being tested?
- Sinus Stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
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- 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
Who cannot join
- 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 the procedure.
- Patients in whom treatment with antiplatelet agents and/or anticoagulants is contraindicated.
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Lariboisière
Paris, 75010
Emmanuel Houdart, Prof, + 33 (0)1 49 95 61 35, emmanuel.houdart@lrb.aphp.fr
About this study
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
Read the 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
- Being tested
- Sinus Stenting
- Keywords
- Pulsatile Tinnitus, Sinus vein stenosis
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus StentingDevice
Stenting of symptomatic sinus stenosis
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Novel medical device Receives: Device: Sinus Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study startSep 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Symptomatic Lateral Sinus StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acandis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726928
- Sponsor's protocol ID
- RESOLVE
- Acronym
- RESOLVE
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis
- ClinicalTrials.gov ID
- NCT06726928
- Acronym / sponsor ID
- RESOLVE / RESOLVE
- Conditions
- Treatment of Symptomatic Lateral Sinus Stenosis, Treatment of Pulsatile Tinnitus Due tu Sinus Stenosis
- Keywords
- Pulsatile Tinnitus, Sinus vein stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Acandis GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Device: Sinus StentingNovel medical device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Patient ≥ 18 years old
Key exclusion criteria (14 listed)
- 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:
- Pregnant or breastfeeding woman
- Subject is participating in another clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinus StentingStenting of symptomatic sinus stenosis | Device | Intervention |
Primary outcome
Disappearance of pulsatile tinnitus at 90 (± 20) days
Time frame: 90 days
Disappearance of pulsatile tinnitus at 90 (± 20) days after resolving of the lateral sinus stenosis with SiREX Stent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinus Stenting in people with Treatment of Symptomatic Lateral Sinus Stenosis and Treatment of Pulsatile Tinnitus Due tu Sinus Stenosis, run by Acandis GmbH at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Gold (+49 7231 155000, info@acandis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disappearance of pulsatile tinnitus at 90 (± 20) days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.