An interventional study of cerebral venous stenting in Pulsatile Tinnitus, sponsored by V-Flow 21. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by V-Flow 21 · Not applicable, Interventional, and Treatment
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.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →This is the only study on the registry with V-Flow 21 as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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.
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 \< 8 g/dl. 4 Chronic renal failure Creatinine > 1.6 mg/dl 5 History of stroke or (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 (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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: cerebral venous stenting
VivaStent - cerebral venous stenting
Major adverse events
Major adverse events, procedure or device related, defined as any of the following through 3 months FU: * Bleeding related to the target vein * Thrombosis at the target lesion site * New neurological deficit * Death
Time frame: 3 months
Feasibility of the VivaStent device and procedure
Ability to implant the stent at the target site, and demonstrate its patency at the end of the procedure by pressure gradient on catheter manometry and/or visually by digital subtraction venography
Time frame: End of procedure
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Aug 2027, 16 months after the start.
Of 151 interventional studies with no phase under Tinnitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 16 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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