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Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients

NCT03571789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-02-20

No results posted yet for this study

Summary

Vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. The procedure is performed without general anesthesia and takes minutes. The safety, feasibility and tolerability of Vine™ will be evaluated. Patients who are eligible will receive Vine™ and will be followed-up for a year after device implantation.

Conditions

Interventions

DEVICE

Vine™

The Vine™ is made of a super-elastic nitinol wire comprises a helix that resides within the CCA lumen and a linear stem that traverses the CCA wall. The helix includes three segments: supporting coils, filter, and leading coils. The device is available in sizes of 6.0mm - 10.0mm (in 0.5mm intervals) to accommodate individual CCA diameters

Sponsors & Collaborators

  • Javelin Medical

    lead INDUSTRY

Principal Investigators

  • Petr Neuzil, MD · Na Homolca Hospital

  • Jan Van der Heijden, MD · St. Antonius Hospital

  • Tom De Potter, MD · OLV Ziekenhuis

  • Stefan Verheye, MD · ZNA Stuivenberg

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2018-12-13
Completion
2023-11-28

Countries

  • Belgium
  • Czechia
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT03571789 on ClinicalTrials.gov