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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Documented AF
  2. CHA2DS2-VASc score ≥ 4 and history of ischemic stroke (including TIA with positive neuro-imaging)
  3. 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
  4. Age > 50 years
  5. Maximal (systolic) CCA diameter range: ≥ 4.8mm and ≤ 9.8mm
  6. CCA accessibility: up to 40mm from skin to CCA center, safe approach
  7. Implantation segment free of atherosclerotic disease as determined by ultrasound imaging
  8. Patient is able and willing to provide informed consent

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA)]
  2. Evidence of carotid dissection
  3. Pre-existing stent(s) in CCA
  4. Female who is pregnant or who is planning to become pregnant during the course of the study
  5. Life expectancy of less than two years
  6. Active systemic infection
  7. Known sensitivity to nickel or titanium metals, or their alloys
  8. Known hereditary or acquired coagulation disorders
  9. Any planned surgical or endovascular treatment within 30 days after the implantation procedure
  10. 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)
  11. Active participation in another investigational drug or device treatment study
  12. Inability to complete all scheduled follow-up
  13. 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
  14. History of intracerebral hemorrhage (ICH) and/or hemorrhagic stroke
  15. Event of stroke/TIA in the past 14 days

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition
Atrial Fibrillation,Stroke
Age (in years)
50+
Phase
NA
Participants needed
100
Est. Completion Date
Oct 24, 2027
Treatment type
INTERVENTIONAL

Sponsor
Javelin Medical
ClinicalTrials.gov identifier
NCT03892824
Study number
CL-326

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