Atrial Fibrillation, Stroke
Conditions
Keywords
AF, Stroke, Filter, Emboli, Carotid, OAC
Brief 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
Detailed 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 \> 1.4mm 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
Interventions
DEVICEVine™ 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.
Sponsors
Javelin Medical
Genae
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of properly positioned implants | 30 days from implantation procedure | proper implant position in each common carotid artery (CCA) |
| Number of participants that had disabling strokes | 30 days, one and two years from implantation procedure | Disabling stroke |
| Number of Implantation success | immediately after the procedure | implantation attempt resulting in proper implant position immediately after the procedure without any device/procedure related complication that requires surgery or endovascular treatment for correction, or that results in death or major disability |
| Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications. | one and two years from implantation procedure | * 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 |
| Number of death cases | one and two years from implantation procedure | Death |
| Number of strokes (any kind) | one and two years from implantation procedure | Total number of strokes |
| Number of observed thrombi on the device | 30 days, one and two years from implantation procedure | Thrombus on implant detected by ultrasound imaging |
Countries
Belgium, Czechia, Germany, Greece, Hungary, Israel, Poland, Spain
Outcome results
None listed