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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
25
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
OLV Ziekenhuis
Aalst, Belgium
ZNA Stuivenberg
Antwerp, Belgium
Na Homolce Hospital
Prague, Czechia
Sint-Antonius ziekenhuis
Nieuwegein, Netherlands
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
Time frame: 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
Time frame: 30 days from implantation procedure
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
Time frame: 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
Time frame: within 4 hours of implantation procedure
Number of patients with properly positioned Vine™ in each CCA
Proper implant position
Time frame: within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure
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