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

NCT03571789 | Completed DMC

• 1 other identifier: CL-150
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 4

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.

Conditions

Atrial Fibrillation

Keywords

AF

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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 Successful Delivery and Deployment Attempts

  within 4 hours 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

Study Arms (1)

Vine™ implantation bilaterally in the common carotid arteries

EXPERIMENTAL

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™

Interventions

Vine™ DEVICE

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

Vine™ implantation bilaterally in the common carotid arteries

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Javelin Medical: lead

Study Sites (4)

OLV Ziekenhuis

Aalst, Belgium

Location

ZNA Stuivenberg

Antwerp, Belgium

Location

Na Homolce Hospital

Prague, Czechia

Location

Sint-Antonius ziekenhuis

Nieuwegein, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 31085320 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, prospective, non-randomized, open-label, first-in-human (FIH) study

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 28, 2018
• Study Start: September 12, 2017
• Primary Completion: December 13, 2018
• Study Completion: November 28, 2023
• Last Updated: February 20, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); CZ (1); NL (1)