Not Yet RecruitingNot Applicable

VivaStent Feasibility Study

15 participantsStarted 2026-04

Plain-language summary

Subjects are enrolled in the study following signature of the Informed Consent Form and confirmation of eligibility criteria. During the screening/baseline phase, demographic and clinical data, medical history, concomitant medications, available imaging (contrast-enhanced CTV or MRV), and THI and HIT-6 questionnaires are collected. Pre-procedural medication are initiated one week prior to the procedure, in accordance with standard medical practice. Subjects are admitted prior to the procedure according to local practice. Required laboratory tests, neurological assessments (modified Rankin Scale and NIHSS), and confirmation of informed consent are completed prior to any study-specific procedures. The index procedure includes cerebral venography with confirmation of a significant transverse-sigmoid sinus stenosis and a pressure gradient greater than 5 mmHg. Following confirmation of procedural eligibility and appropriate vessel measurements, the VivaStent is deployed. Post-deployment venography and pressure measurements are performed to assess stent patency and hemodynamic outcome. Procedural data, administered medications, and adverse events are recorded. Following the procedure, subjects are hospitalized for observation as per local protocol. Prior to hospital discharge (or at Day 7 post-procedure, whichever occurs first), the THI questionnaire, concomitant medications, and adverse events are documented. Follow-up visits are conducted at 1 month, 3 months, and 12 months post-procedure. Each visit includes assessment of THI and HIT-6 questionnaires, documentation of concomitant medications and adverse events. Contrast-enhanced CTV or MRV is performed at the 3-month and 12-month visits to evaluate stent position and patency. Subject exit from the study is defined as completion of follow-up, subject withdrawal, investigator-initiated withdrawal, loss to follow-up, or death.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Major adverse events

Timeframe: 3 months

Trial details

NCT IDNCT07515781

SponsorV-Flow 21

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08

View on ClinicalTrials.gov More Pulsatile Tinnitus trials