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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Vine™

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • OLV Ziekenhuis
  • Antwerp, Belgium
    • ZNA Stuivenberg
• Czechia
  • Prague, Czechia
    • Na Homolce Hospital
• Netherlands
  • Nieuwegein, Netherlands
    • Sint-Antonius ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Atrial fibrillation (AF): documented persistent or permanent
2. CHA2DS2-VASc score ≥ 4
3. Age > 50
4. Unsuitable for oral anticoagulation therapy (OAC), defined as contraindicated for OAC, patient refusing OAC, or physician is reluctant to prescribe OAC
5. Maximal (systolic) CCA diameter range: ≥ 5.3mm and ≤ 9.8mm
6. CCA accessibility: up to 60mm from skin to CCA center, safe approach
7. Patient is willing to provide informed consent
8. Patient is willing to complete all scheduled follow-up

Exclusion Criteria:

1. Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA)
2. Evidence of any atherosclerotic disease in CCA above the clavicles
3. Evidence of carotid dissection
4. Pre-existing stent(s) in CCA
5. Contraindicated or allergic to antiplatelet therapy, or any medication required during the study
6. Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure
7. Female who is pregnant or who is planning to become pregnant during the course of the study
8. Life expectancy of less than 1 year
9. Active systemic infection
10. Known sensitivity to nickel or titanium metals, or their alloys
11. Known hereditary or acquired coagulation disorders
12. Any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index procedure
13. A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
14. 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)
15. Active participation in another investigational drug or device treatment study
16. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Vine™; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Javelin Medical
• Investigators: Principal Investigator: Petr Neuzil, MD, Na Homolca Hospital; Principal Investigator: Jan Van der Heijden, MD, St. Antonius Hospital; Principal Investigator: Tom De Potter, MD, OLV Ziekenhuis; Principal Investigator: Stefan Verheye, MD, ZNA Stuivenberg

Publications and helpful links

General Publications

• Reddy VY, Neuzil P, de Potter T, van der Heyden J, Tromp SC, Rensing B, Jiresova E, Dujka L, Lekesova V. Permanent Percutaneous Carotid Artery Filter to Prevent Stroke in Atrial Fibrillation Patients: The CAPTURE Trial. J Am Coll Cardiol. 2019 Aug 20;74(7):829-839. doi: 10.1016/j.jacc.2019.04.035. Epub 2019 May 11. Erratum In: J Am Coll Cardiol. 2019 Aug 20;74(7):1013-1014. doi: 10.1016/j.jacc.2019.07.025.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): December 13, 2018
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: June 17, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: AF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CL-150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No