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

Not Applicable

Active, not recruiting

• Conditions: Stroke; Atrial Fibrillation
• Interventions: Device: Vine™ Embolic Protection System

• Registration Number: NCT03892824
• Lead Sponsor: Javelin Medical

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 \> 1.4mm 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

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Study Start: 2019-04-15
• Primary Completion: 2024-10-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Study Completion: 2027-10-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vine™ Filter + OAC	Vine™ Embolic Protection System	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

Primary Outcome Measures

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

Name	Time	Method
Number of participants that had disabling strokes	30 days, one and two years from implantation procedure	Disabling stroke
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications.	one and two years 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
Number of properly positioned implants	one and two years from implantation procedure	Proper implant position in each CCA
Number of death cases	one and two years from implantation procedure	Death
Number of strokes (any kind)	one and two years from implantation procedure	Total number of strokes
Number of Implantation success	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
Number of observed thrombi on the device	30 days, one and two years from implantation procedure	Thrombus on implant detected by ultrasound imaging

Trial Locations

Locations (17)

OLV Ziekenhuis; 🇧🇪 Aalst, Belgium

ZNA Stuivenberg; 🇧🇪 Antwerp, Belgium

Laiko Hospital; 🇬🇷 Athen, Greece

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Pracownia Hemodynamiki Serca; 🇵🇱 Poznań, Poland

Rabin Medical Center (RMC); 🇮🇱 Petah tikva, Israel

Poria; 🇮🇱 Tiberias, Israel

Gottsegen György Hungarian Institute of Cardiology; 🇭🇺 Budapest, Hungary

General Hospital of Athens "Hippokrateio"; 🇬🇷 Athens, Greece

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt, Germany

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Carmel; 🇮🇱 Haifa, Israel

Cardio Vasculäres Centrum Frankfurt; 🇩🇪 Frankfurt, Germany

Alfried-Krupp Krankenhaus Rüttenscheid; 🇩🇪 Essen, Germany

European Interbalkan Medical Center; 🇬🇷 Thessaloníki, Greece

University General Hospital of Larisa; 🇬🇷 Larissa, Greece

Shaari Tzedek; 🇮🇱 Jerusalem, Israel