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ACTIVE NOT RECRUITING
NCT03892824
NA

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

Sponsor: Javelin Medical

View on ClinicalTrials.gov

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

Official title: Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2019-04-15

Completion Date

2027-10-24

Last Updated

2025-02-20

Healthy Volunteers

No

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.

Locations (17)

OLV Ziekenhuis

Aalst, Belgium

ZNA Stuivenberg

Antwerp, Belgium

Na Homolce Hospital

Prague, Czechia

Alfried-Krupp Krankenhaus Rüttenscheid

Essen, Germany

Cardio Vasculäres Centrum Frankfurt

Frankfurt, Germany

Cardioangiologisches Centrum Bethanien

Frankfurt, Germany

General Hospital of Athens "Hippokrateio"

Athens, Greece

Laiko Hospital

Athens, Greece

University General Hospital of Larisa

Larissa, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Gottsegen György Hungarian Institute of Cardiology

Budapest, Hungary

Carmel

Haifa, Israel

Shaari Tzedek

Jerusalem, Israel

Rabin Medical Center (RMC)

Petah Tikva, Israel

Poria

Tiberias, Israel

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

Poznan, Poland

Hospital Universitario Ramon y Cajal

Madrid, Spain