VivaStent: a stent procedure to help pulsatile tinnitus
Official title: Evaluation of the Safety and Feasibility of the VivaStent in Patients With Pulsatile Tinnitus Secondary to Ipsilateral Transverse-sigmoid Stenosis - The VivaStent Feasibility Study
Run by V-Flow 21 · NCT07515781 · Data updated 2026-11-12
A stent-based procedure is being tested to see if it can relieve severe pulsatile tinnitus in adults with significant transverse-sigmoid sinus narrowing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | V-Flow 21 Industry-sponsored |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | April 8, 2026 |
| Main results expected | August 2027 |
| Study ends | April 2028 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT07515781 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with unilateral pulsatile tinnitus for at least 1 year, severe tinnitus (grade 4-5 on THI), and significant transverse-sigmoid sinus stenosis with a ≥5 mm Hg pressure gradient who are candidates for transverse-sigmoid sinus stenting.
✕Probably not a fit
Patients without significant stenosis, those without the required pressure gradient, or those with exclusion conditions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This feasibility study tests whether deploying a VivaStent in the transverse-sigmoid sinus can reduce pulsatile tinnitus in adults who have a pronounced stenosis and a measurable pressure gradient. Participants undergo baseline assessments, imaging, and neurological exams before the procedure, followed by venous angiography to confirm eligibility and stent placement if criteria are met. The trial collects clinical data, imaging, and tinnitus-related questionnaires before and after the procedure to explore safety and potential symptom improvement. It is conducted at a single center and is designed to gauge feasibility and signal of benefit for this approach.
Why it matters
Potential benefit: If successful, participants may experience relief from pulsatile tinnitus and improved quality of life.
How similar studies have gone: Previous studies in similar venous sinus stenting approaches have shown varying levels of symptom improvement, with this being a feasibility evaluation in a new context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1 Male or female ≥ 18 years of age at the time of screening. 2 An adult patient, experiencing pulsatile unilateral tinnitus for at least 1-year, which resolves with ipsilateral neck compression. 3 The patient suffers severe debilitating venous pulsatile tinnitus grade 4 or 5 according to the Tinnitus Handicap Inventory (Newman et al., 1996) 4 The patient has ≥50% stenosis of transverse-sigmoid sinus on the ipsilateral side to the pulsatile tinnitus, as identified by CTV or MRV. 5 The patient is a candidate for transverse-sigmoid sinuses stenting procedure using an off-label stent. 6 The patient is willing to sign an informed consent and participate in the study. 7 Intra-procedural criteria:Venographic confirmation of significant transverse-sigmoid sinus stenosis on the ipsilateral side of the pulsatile tinnitus. • Pressure gradient ≥ 5 mm Hg, as measured by catheter manometry. Exclusion Criteria: * 1 Presence of Dural Arteriovenous Fistula (AVF), cerebral vascular lesions, malformation, or aneurysm that can explain the pulsatile tinnitus on CTV or MRV. 2 Transverse-sigmoid sinus vessel size \<5 mm or \>10 mm. 3 Anemia, defined as Hb \< 8 g/dl. 4 Chronic renal failure Creatinine \> 1.6 mg/dl 5 History of stroke or transient ischemic attack (TIA). 6 History of severe carotid atherosclerotic disease. 7 History of AF or other stroke risk factors. 8 History of coagulopathy, hypercoagulability, deep vein thrombosis or pulmonary embolism. 9 History of severe chronic obstructive pulmonary disease (COPD) or other severe respiratory disease. 10 History of heart failure, dilated cardiomyopathy, or congenital heart conditions. 11 Pregnant (confirmed by a pregnancy test) or lactating woman 12 Otologic disorders, such as chronic hearing loss, or other ENT disorders that can cause tinnitus. 13 Allergic to iodinated contrast material despite premedication, or to Nitinol. 14 Contra-indication to aspirin, clopidogrel or other anticoagulants. 15 Protected adults, such as person subject to legal protection, person deprived of liberty, and person unable to express his consent. 16 Participating in another medical device or drug study.
Where it's running
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De Rotchild
Paris, France Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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BosSTENT implantation for pulse-synchronous tinnitus from venous sinus narrowing
This trial will try a new stent called BosSTENT to reduce severe pulse-synchronous tinnitus in adults whose symptoms are caused by narrowing of the cerebral venous sinus and improve when the jugular vein is compressed.
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Venous stenting for treating pulsatile tinnitus caused by low-grade dural arteriovenous fistulae
This study is testing if a new treatment called venous stenting can help people with pulsatile tinnitus caused by certain blood vessel issues feel better compared to standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.