Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 4
- Primary Endpoint
- Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Atrial fibrillation (AF): documented persistent or permanent
- •CHA2DS2-VASc score ≥ 4
- •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
Arms & Interventions
Vine™ implantation bilaterally in the common carotid arteries
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.
Intervention: Vine™ (Device)
Outcomes
Primary Outcomes
Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)
Time Frame: 30 days from implantation procedure
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
Number of patients with Procedure Success
Time Frame: 30 days from implantation procedure
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
Secondary Outcomes
- Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)(within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure)
- Number of patients with properly positioned Vine™ in each CCA(within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure)
- Number of Successful Delivery and Deployment Attempts(within 4 hours of implantation procedure)