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Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants
Sponsor: Javelin Medical
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
Conditions
Interventions
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