Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants (CAPTURE2)

  • STATUS
    Recruiting
  • End date
    Aug 20, 2024
  • participants needed
    100
  • sponsor
    Javelin Medical
Updated on 4 October 2022
stroke
anticoagulants
atrial fibrillation
fibrillation
vitamin k antagonist
ischemic stroke
noac
vitamin k
vascular disease

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

Description

The Vine™ filter (Vine™ or implant) is a permanent carotid filter designed for stroke prevention in AF patients taking OAC at high stroke risk (CHA2DS2-VASc ≤ 4 and stroke history). This patient population accounts for ~20% of the entire AF population, which is ~300K/year in the United State and EU. The implant is designed to exclude emboli > 1.2mm in size from reaching the anterior circulation. In AF patients, approximately 80% of strokes are total or partial anterior circulation strokes caused by occlusions of the main branches of the Circle of Willis, mainly M1-2, and rarely A1-2. The diameter of these branches, in the majority of cases, is > 1.5 mm

Details
Condition Atrial Fibrillation, Stroke
Treatment Vine™ Embolic Protection System
Clinical Study IdentifierNCT03892824
SponsorJavelin Medical
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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