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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03571789
Recruitment Status : Active, not recruiting
First Posted : June 28, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Vine™ Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter, prospective, non-randomized, open-label, first-in-human (FIH) study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : December 13, 2018
Estimated Study Completion Date : November 13, 2019

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs) [ Time Frame: within 3, 6, and 12 months of implantation procedure ]
  2. Number of Successful Delivery and Deployment Attempts [ Time Frame: within 4 hours of implantation procedure ]
    Successful Delivery and Deployment Attempts is defined as Proper Vine™ Position

  3. Number of patients with properly positioned Vine™ in each CCA [ Time Frame: within 3, 6, and 12 months of implantation procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571789


Locations
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Belgium
OLV Ziekenhuis
Aalst, Belgium
ZNA Stuivenberg
Antwerp, Belgium
Czechia
Na Homolce Hospital
Prague, Czechia
Netherlands
Sint-Antonius ziekenhuis
Nieuwegein, Netherlands
Sponsors and Collaborators
Javelin Medical
Investigators
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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

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Responsible Party: Javelin Medical
ClinicalTrials.gov Identifier: NCT03571789     History of Changes
Other Study ID Numbers: CL-150
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Javelin Medical:
AF

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes