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

NAActive, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 15, 2019

Primary Completion Date

October 24, 2024

Study Completion Date

October 24, 2027

Conditions
Atrial FibrillationStroke
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."

Trial Locations (17)

11527

"General Hospital of Athens Hippokrateio", Athens

45131

Alfried-Krupp Krankenhaus Rüttenscheid, Essen

57001

European Interbalkan Medical Center, Thessaloniki

60389

Cardio Vasculäres Centrum Frankfurt, Frankfurt

1520800

Poria, Tiberias

9103102

Shaari Tzedek, Jerusalem

Unknown

OLV Ziekenhuis, Aalst

ZNA Stuivenberg, Antwerp

Na Homolce Hospital, Prague

Cardioangiologisches Centrum Bethanien, Frankfurt

Laiko Hospital, Athens

University General Hospital of Larisa, Larissa

Gottsegen György Hungarian Institute of Cardiology, Budapest

Carmel, Haifa

Rabin Medical Center (RMC), Petah Tikva

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Pracownia Hemodynamiki Serca, Poznan

Hospital Universitario Ramon y Cajal, Madrid

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Genae

INDUSTRY

lead

Javelin Medical

INDUSTRY