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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Vine™

• Registration Number: NCT03571789
• Lead Sponsor: Javelin Medical

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 Timeline

• Study Start: 2017-09-12
• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-06-17
• Study First Posted: 2018-06-28
• Primary Completion: 2018-12-13
• Status Verified: 2023-09
• Study Completion: 2023-11-28
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vine™ implantation bilaterally in the common carotid arteries	Vine™	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.

Primary Outcome Measures

Name	Time	Method
Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)	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	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 Outcome Measures

Name	Time	Method
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	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 properly positioned Vine™ in each CCA	within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure	Proper implant position
Number of Successful Delivery and Deployment Attempts	within 4 hours of implantation procedure	Successful Delivery and Deployment Attempts is defined as Proper Vine™ Position

Trial Locations

Locations (4)

OLV Ziekenhuis; 🇧🇪 Aalst, Belgium

ZNA Stuivenberg; 🇧🇪 Antwerp, Belgium

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Sint-Antonius ziekenhuis; 🇳🇱 Nieuwegein, Netherlands