Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients

Study Overview
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Brief Summary
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Vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. The procedure is performed without general anesthesia and takes minutes. The safety, feasibility and tolerability of Vine™ will be evaluated. Patients who are eligible will receive Vine™ and will be followed-up for a year after device implantation.

Detailed Description
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CAPTURE is a prospective, single-arm, multicenter trial, designed to evaluate the safety, feasibility and tolerability of the Vine™ permanent carotid filter. The trial will enroll up to 30 patients, and will be conducted in up to five sites worldwide. All enrolled patients will be invited for non-invasive follow-up tests and clinical evaluations according to the study protocol.

Official Title
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Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Vine™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Atrial fibrillation (AF): documented persistent or permanent CHA2DS2-VASc score ≥ 4 Age > 50 Unsuitable for oral anticoagulation therapy (OAC), defined as contraindicated for OAC, patient refusing OAC, or physician is reluctant to prescribe OAC Maximal (systolic) CCA diameter range: ≥ 5.3mm and ≤ 9.8mm CCA accessibility: up to 60mm from skin to CCA center, safe approach Patient is willing to provide informed consent Patient is willing to complete all scheduled follow-up Exclusion Criteria: Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA) Evidence of any atherosclerotic disease in CCA above the clavicles Evidence of carotid dissection Pre-existing stent(s) in CCA Contraindicated or allergic to antiplatelet therapy, or any medication required during the study Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure Female who is pregnant or who is planning to become pregnant during the course of the study Life expectancy of less than 1 year Active systemic infection Known sensitivity to nickel or titanium metals, or their alloys Known hereditary or acquired coagulation disorders Any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index 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 Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Multicenter, prospective, non-randomized, open-label, first-in-human (FIH) study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vine™ implantation bilaterally in the common carotid arteries<br>Vine™ is a permanent carotid filter made from a single nitinol wire. It is configured to capture emboli exceeding 1.2mm in size, which originate in the heart and large arteries below the neck. Vine™ has a helical structure, with leading and supporting coils interposed by a filter section. | Device: Vine™<br>* The Vine™ is made of a super-elastic nitinol wire comprises a helix that resides within the CCA lumen and a linear stem that traverses the CCA wall. The helix includes three segments: supporting coils, filter, and leading coils. The device is available in sizes of 6.0mm - 10.0mm (in 0.5mm intervals) to accommodate individual CCA diameters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs) | Major Adverse Events (MAEs) are defined as: Death Major and minor strokes Major bleeding Common carotid artery (CCA) stenosis > 70% Vine™ migration CCA thrombus Any complications in the CCA requiring endovascular treatment or surgery | 30 days from implantation procedure | 
| Number of patients with Procedure Success | Procedure Success is defined as Proper Vine™ Position in each CCA Proper Vine™ Position is defined as: Supporting coil in contact with artery walls No migration No fracture No Vine™ coils or portions thereof visible outside the arterial lumen No entangled or overlapping coils | 30 days from implantation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs) | Death Major and minor strokes Major bleeding Common carotid artery (CCA) stenosis > 70% Vine™ migration CCA thrombus Any complications in the CCA requiring endovascular treatment or surgery | within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure | 
| Number of Successful Delivery and Deployment Attempts | Successful Delivery and Deployment Attempts is defined as Proper Vine™ Position | within 4 hours of implantation procedure | 
| Number of patients with properly positioned Vine™ in each CCA | Proper implant position | within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AF