NCT07515781

VivaStent Feasibility Study

Evaluation of the Safety and Feasibility of the VivaStent in Patients With Pulsatile Tinnitus Secondary to Ipsilateral Transverse-sigmoid Stenosis - The VivaStent Feasibility Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: V-Flow 21 · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulsatile Tinnitus

Interventions

Type	Name	Description
DEVICE	cerebral venous stenting	VivaStent - cerebral venous stenting

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-08-01
• Completion: 2028-04-01
• First posted: 2026-04-07
• Last updated: 2026-04-07