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

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ClinicalTrials.gov Identifier: NCT03571789
Recruitment Status : Active, not recruiting
First Posted : June 28, 2018
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Javelin Medical

Tracking Information
First Submitted Date  ICMJE May 30, 2018
First Posted Date  ICMJE June 28, 2018
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE September 12, 2017
Actual Primary Completion Date December 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2020)
  • Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs) [ Time Frame: 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 Successful Delivery and Deployment Attempts [ Time Frame: within 4 hours of implantation procedure ]
    Successful Delivery and Deployment Attempts is defined as Proper Vine™ Position
  • Number of patients with properly positioned Vine™ in each CCA [ Time Frame: within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure ]
    Proper implant position
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2018)
  • 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 ]
  • 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
  • Number of patients with properly positioned Vine™ in each CCA [ Time Frame: within 3, 6, and 12 months of implantation procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients
Official Title  ICMJE Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE 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

Study Arms  ICMJE 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.
Intervention: Device: Vine™
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 12, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2018)
30
Estimated Study Completion Date  ICMJE November 13, 2022
Actual Primary Completion Date December 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czechia,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03571789
Other Study ID Numbers  ICMJE CL-150
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Javelin Medical
Study Sponsor  ICMJE Javelin Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Javelin Medical
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP