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

NCT06726928 | Recruiting DMC

• 1 other identifier: RESOLVE
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Treatment of Symptomatic Lateral Sinus Stenosis; Treatment of Pulsatile Tinnitus Due tu Sinus Stenosis

Keywords

Pulsatile Tinnitus; Sinus vein stenosis

Outcome Measures

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

  90 days

Study Arms (1)

Intervention

OTHER

Novel medical device

Device: Sinus Stenting

Interventions

Sinus Stenting DEVICE

Stenting of symptomatic sinus stenosis

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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 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.
• 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)

Sponsors & Collaborators

• Acandis GmbH: lead

Study Sites (1)

Hôpital Lariboisière

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Gold

CONTACT

+49 7231 155000; info@acandis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

FR (1)