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Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants (CAPTURE2)

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ClinicalTrials.gov Identifier: NCT03892824
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Genae
Information provided by (Responsible Party):
Javelin Medical

Brief Summary:
This study will assess the safety of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Device: Vine™ Embolic Protection System Not Applicable

Detailed Description:
The Vine™ filter (Vine™ or implant) is a permanent carotid filter designed for stroke prevention in AF patients taking OAC at high stroke risk (CHA2DS2-VASc ≤ 4 and stroke history). This patient population accounts for ~20% of the entire AF population, which is ~300K/year in the United State and EU. The implant is designed to exclude emboli > 1.2mm in size from reaching the anterior circulation. In AF patients, approximately 80% of strokes are total or partial anterior circulation strokes caused by occlusions of the main branches of the Circle of Willis, mainly M1-2, and rarely A1-2. The diameter of these branches, in the majority of cases, is > 1.5 mm

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vine™ Filter + OAC
Vine™ Filter in each common carotid artery (CCA) with oral anticoagulant treatment (either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC)) for the duration of the study
Device: Vine™ Embolic Protection System
The system includes the implant and the Vine™ Inserter (inserter) manufactured by Javelin Medical LTD (Israel). The inserter comprises a Motor Unit and a Needle Unit ("Needle Unit") available in two sizes. The system is operable when the Needle Unit is loaded with the implant (labeled "Loaded Needle Unit") and connected to the Motor Unit. A flag indicating the needle orientation is attached to the needle luer. The implant is automatically deployed from the needle upon activation of the operating button.




Primary Outcome Measures :
  1. Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications [ Time Frame: 30 days from implantation procedure ]

    Major Adverse Events (MAEs) within 30 days of the final index (implantation) procedure, defined as the composite that includes any of the following:

    • Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries
    • Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation
    • Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability


Secondary Outcome Measures :
  1. Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications. [ Time Frame: one year from implantation procedure ]
    • Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries
    • Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation
    • Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability

  2. Number of properly positioned implants [ Time Frame: 30 days from implantation procedure ]
    proper implant position in each common carotid artery (CCA)

  3. Number of participants that had disabling strokes [ Time Frame: 30 days and one year from implantation procedure ]
    Disabling stroke

  4. Number of Implantation success [ Time Frame: immediately after the procedure ]
    implantation attempt resulting in proper implant position immediately after the procedure without any device/procedure related complication that requires surgery or endovascular treatment for correction, or that results in death or major disability

  5. Number of properly positioned implants [ Time Frame: one year from implantation procedure ]
    Proper implant position in each CCA

  6. Number of observed thrombi on the device [ Time Frame: 30 days and one year from implantation procedure ]
    Thrombus on implant detected by ultrasound imaging

  7. Number of death cases [ Time Frame: one year from implantation procedure ]
    Death

  8. Number of strokes (any kind) [ Time Frame: one year from implantation procedure ]
    Total number of strokes



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:

  • Documented AF
  • CHA2DS2-VASc score ≥ 4 and history of ischemic stroke (including TIA with positive neuro-imaging)
  • No contra-indication for patient to receive an OAC, either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC) for the duration of the study
  • Age > 50 years
  • Maximal (systolic) CCA diameter range: ≥ 4.8mm and ≤ 9.8mm
  • CCA accessibility: up to 40mm from skin to CCA center, safe approach
  • Implantation segment free of atherosclerotic disease as determined by ultrasound imaging
  • Patient is able and willing to provide informed consent

Exclusion Criteria:

  • Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA)]
  • Evidence of carotid dissection
  • Pre-existing stent(s) in CCA
  • Female who is pregnant or who is planning to become pregnant during the course of the study
  • Life expectancy of less than one 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 treatment within 30 days after the implantation 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
  • Inability to complete all scheduled follow-up
  • Any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient'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): NCT03892824


Contacts
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Contact: Sagit Broder, M.Sc 972-4-7701267 ext 206 sagit@javelinmed.com
Contact: maria Berson, B.Sc 972-4-7701270 ext 209 Maria@javelinmed.com

Locations
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Belgium
OLV Ziekenhuis Recruiting
Aalst, Belgium
Contact: Tom De Potter, M.D       tom.de.potter@olvz-aalst.be   
Contact: Hedwig Batjoens       Hedwig.Batjoens@OLVZ-aalst.be   
ZNA Stuivenberg Recruiting
Antwerp, Belgium
Contact: Stefan Verheye, M.D       stefan.verheye@gmail.com   
Czechia
Na Homolce Hospital Recruiting
Prague, Czechia
Contact: Petr Neuzil, M.D.       Petr.Neuzil@homolka.cz   
Contact: Petr Moucka       Petr.Moucka@homolka.cz   
Germany
Alfried-Krupp Krankenhaus Rüttenscheid Not yet recruiting
Essen, Germany, 45131
Contact: Ronald Veltkamp, M.D       roland.veltkamp@krupp-krankenhaus.de   
Cardio Vasculäres Centrum Frankfurt Not yet recruiting
Frankfurt, Germany, 60389
Contact: Horst Sievert, M.D       horst@sievert.md   
Contact: Sabine deBruijn       s.debruijn@cvcfrankfurt.de   
Cardioangiologisches Centrum Bethanien Not yet recruiting
Frankfurt, Germany
Contact: Boris Schmidt, M.D       b.schmidt@ccb.de   
Greece
General Hospital of Athens "Hippokrateio" Not yet recruiting
Athens, Greece, 11527
Contact: Konstantinos Toutouzas, M.D       ktoutouz@gmail.com   
European Interbalkan Medical Center Not yet recruiting
Thessaloníki, Greece, 57001
Contact: Apostolos Tzikas, M.D       aptzikas@yahoo.com   
Hungary
Gottsegen György Hungarian Institute of Cardiology Recruiting
Budapest, Hungary
Contact: Geza Fontos, M.D       geza.fontos@kardio.hu   
Contact: Orsolya Nagy       zs.nagyorsi@gmail.com   
Israel
Soroka Not yet recruiting
Be'er Sheva, Israel
Contact: Motti Haim, M.D       MotiH@clalit.org.il   
Carmel Not yet recruiting
Haifa, Israel
Contact: Ofer Galili, M.D       offerga@clalit.org.il   
Contact: Ariela Goldberg       arielago1@clslit.org.il   
Shaari Tzedek Not yet recruiting
Jerusalem, Israel, 9103102
Contact: Yaron Almagor, M.D       almagor@szmc.org.il   
Contact: Michel Glikson       mglikson@szmc.org.il   
Poria Not yet recruiting
Tiberias, Israel, 1520800
Contact: Ibrahim Marai, M.D       imarai@poria.health.gov.il   
Contact: Jana Etkin       JEtkin@poria.health.gov.il   
Spain
Hospital Universitario Ramon y Cajal Not yet recruiting
Madrid, Spain
Contact: Jaime Masjuan, M.D       jaime.masjuan@gmail.com   
Sponsors and Collaborators
Javelin Medical
Genae

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Responsible Party: Javelin Medical
ClinicalTrials.gov Identifier: NCT03892824     History of Changes
Other Study ID Numbers: CL-326
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
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

Keywords provided by Javelin Medical:
AF
Stroke
Filter
Emboli
Carotid
OAC

Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Anticoagulants