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.
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
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Documented AF
* CHA2DS2-VASc score ≥ 4 and history of ischemic stroke (including TIA with positive neuro-imaging)
* No contra-indication for patient to receive an OAC, either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC) for the duration of the study
* Age \> 50 years
* Maximal (systolic) CCA diameter range: ≥ 4.8mm and ≤ 9.8mm
* CCA accessibility: up to 40mm from skin to CCA center, safe approach
* Implantation segment free of atherosclerotic disease as determined by ultrasound imaging
* Patient is able and willing to provide informed consent
Exclusion Criteria:
* Evidence of carotid stenosis \> 30% \[CCA, internal carotid artery (ICA), or external carotid artery (ECA)\]
* Evidence of carotid dissection
* Pre-existing stent(s) in CCA
* Female who is pregnant or who is planning to become pregnant during the course of the study
* Life expectancy of less than two years
* Active systemic infection
* Known sensitivity to nickel or titanium metals, or their alloys
* Known hereditary or acquired coagulation disorders
* Any planned surgical or endovascular treatment within 30 days after the implantation procedure
* A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments\* Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day)
* Active participation in another investigational drug or device treatment study
* Inability to complete all scheduled follow-up
* Any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the study
* History of intracerebral hemorrhage (ICH) and/or hemorrhagic stroke
* Event of stroke/TIA in the past 14 days
Primary outcome measure(s)
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications — 30 days from implantation procedure Major Adverse Events (MAEs) within 30 days of the final index (implantation) procedure, defined as the composite that includes any of the following:
* Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries
* Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation
* Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability
Trial sites (17)
Facility
City
Region
Status
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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