MedTrace Logo

VivaStent Feasibility Study

NCT07515781 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-21

No results posted yet for this study

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

DEVICE

cerebral venous stenting

VivaStent - cerebral venous stenting

Sponsors & Collaborators

  • V-Flow 21

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2027-08-31
Completion
2028-04-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07515781 on ClinicalTrials.gov