search
Back to results

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

Primary Purpose

Atrial Fibrillation, Stroke

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vine™ Embolic Protection System
Sponsored by
Javelin Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring AF, Stroke, Filter, Emboli, Carotid, OAC

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 two years
  • 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
  • History of intracerebral hemorrhage (ICH) and/or hemorrhagic stroke
  • Event of stroke/TIA in the past 14 days

Sites / Locations

  • OLV Ziekenhuis
  • ZNA Stuivenberg
  • Na Homolce Hospital
  • Alfried-Krupp Krankenhaus Rüttenscheid
  • Cardio Vasculäres Centrum Frankfurt
  • Cardioangiologisches Centrum Bethanien
  • General Hospital of Athens "Hippokrateio"
  • Laiko Hospital
  • University General Hospital of Larisa
  • European Interbalkan Medical Center
  • Gottsegen György Hungarian Institute of Cardiology
  • Carmel
  • Shaari Tzedek
  • Rabin Medical Center (RMC)
  • Poria
  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Pracownia Hemodynamiki Serca
  • Hospital Universitario Ramon y Cajal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vine™ Filter + OAC

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications
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

Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications.
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
Number of properly positioned implants
proper implant position in each common carotid artery (CCA)
Number of participants that had disabling strokes
Disabling stroke
Number of Implantation success
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
Number of properly positioned implants
Proper implant position in each CCA
Number of observed thrombi on the device
Thrombus on implant detected by ultrasound imaging
Number of death cases
Death
Number of strokes (any kind)
Total number of strokes

Full Information

First Posted
March 21, 2019
Last Updated
December 11, 2022
Sponsor
Javelin Medical
Collaborators
Genae
search

1. Study Identification

Unique Protocol Identification Number
NCT03892824
Brief Title
Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants
Acronym
CAPTURE2
Official Title
Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
November 24, 2023 (Anticipated)
Study Completion Date
October 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Javelin Medical
Collaborators
Genae

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the safety and performance 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
Keywords
AF, Stroke, Filter, Emboli, Carotid, OAC

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vine™ Filter + OAC
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Vine™ Embolic Protection System
Intervention Description
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 Measure Information:
Title
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications
Description
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
Time Frame
30 days from implantation procedure
Secondary Outcome Measure Information:
Title
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications.
Description
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
Time Frame
one and two years from implantation procedure
Title
Number of properly positioned implants
Description
proper implant position in each common carotid artery (CCA)
Time Frame
30 days from implantation procedure
Title
Number of participants that had disabling strokes
Description
Disabling stroke
Time Frame
30 days, one and two years from implantation procedure
Title
Number of Implantation success
Description
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
Time Frame
immediately after the procedure
Title
Number of properly positioned implants
Description
Proper implant position in each CCA
Time Frame
one and two years from implantation procedure
Title
Number of observed thrombi on the device
Description
Thrombus on implant detected by ultrasound imaging
Time Frame
30 days, one and two years from implantation procedure
Title
Number of death cases
Description
Death
Time Frame
one and two years from implantation procedure
Title
Number of strokes (any kind)
Description
Total number of strokes
Time Frame
one and two years from implantation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 two years 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 History of intracerebral hemorrhage (ICH) and/or hemorrhagic stroke Event of stroke/TIA in the past 14 days
Facility Information:
Facility Name
OLV Ziekenhuis
City
Aalst
Country
Belgium
Facility Name
ZNA Stuivenberg
City
Antwerp
Country
Belgium
Facility Name
Na Homolce Hospital
City
Prague
Country
Czechia
Facility Name
Alfried-Krupp Krankenhaus Rüttenscheid
City
Essen
ZIP/Postal Code
45131
Country
Germany
Facility Name
Cardio Vasculäres Centrum Frankfurt
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Cardioangiologisches Centrum Bethanien
City
Frankfurt
Country
Germany
Facility Name
General Hospital of Athens "Hippokrateio"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Laiko Hospital
City
Athen
Country
Greece
Facility Name
University General Hospital of Larisa
City
Larissa
Country
Greece
Facility Name
European Interbalkan Medical Center
City
Thessaloníki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Gottsegen György Hungarian Institute of Cardiology
City
Budapest
Country
Hungary
Facility Name
Carmel
City
Haifa
Country
Israel
Facility Name
Shaari Tzedek
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Rabin Medical Center (RMC)
City
Petah tikva
Country
Israel
Facility Name
Poria
City
Tiberias
ZIP/Postal Code
1520800
Country
Israel
Facility Name
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Pracownia Hemodynamiki Serca
City
Poznań
Country
Poland
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs