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Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

NCT03892824 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-02-20

No results posted yet for this study

Summary

This study will assess the safety and performance of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries

Conditions

Interventions

DEVICE

Vine™ Embolic Protection System

The system includes the implant and the Vine™ Inserter (inserter) manufactured by Javelin Medical LTD (Israel). The inserter comprises a Motor Unit and a Needle Unit ("Needle Unit") available in two sizes. The system is operable when the Needle Unit is loaded with the implant (labeled "Loaded Needle Unit") and connected to the Motor Unit. A flag indicating the needle orientation is attached to the needle luer. The implant is automatically deployed from the needle upon activation of the operating button.

Sponsors & Collaborators

  • Genae

    collaborator INDUSTRY

  • Javelin Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2024-10-24
Completion
2027-10-24

Countries

  • Belgium
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Israel
  • Poland
  • Spain

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 NCT03892824 on ClinicalTrials.gov