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Clinical Trials in Germany / NCT03892824
Active, not recruiting Not applicable

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

NCT03892824 · tracked via the Priya Life Science Germany tracker
Sponsor
Javelin Medical
Phase
Not applicable
Started
2019-04-15
Last updated
2026-08-12

Condition(s) studied

Atrial FibrillationStroke

Investigational drug(s) / intervention(s)

Vine™ Embolic Protection System

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)

Trial sites (17)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT03892824 on ClinicalTrials.gov ↗ ← All trials in Germany