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

NCT03892824 | Active Not Recruiting DMC

• 1 other identifier: CL-326
• Study Type: interventional
• Target: 100
• Locations: 8 countries
• Sites: 17

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

Conditions

Atrial Fibrillation; Stroke

Keywords

AF; Stroke; Filter; Emboli; Carotid; OAC

Outcome Measures

Primary Outcomes (1)

• 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

  30 days from implantation procedure

Secondary Outcomes (8)

• Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications.

  one and two years from implantation procedure

• Number of properly positioned implants

  30 days from implantation procedure

• Number of participants that had disabling strokes

  30 days, one and two years from implantation procedure

• Number of Implantation success

  immediately after the procedure

• Number of properly positioned implants

  one and two years from implantation procedure

Study Arms (1)

Vine™ Filter + OAC

EXPERIMENTAL

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

Interventions

Vine™ Embolic Protection System DEVICE

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.

Vine™ Filter + OAC

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Javelin Medical: lead
• Genae: collaborator

Study Sites (17)

OLV Ziekenhuis

Aalst, Belgium

Location

ZNA Stuivenberg

Antwerp, Belgium

Location

Na Homolce Hospital

Prague, Czechia

Location

Alfried-Krupp Krankenhaus Rüttenscheid

Essen, 45131, Germany

Location

Cardio Vasculäres Centrum Frankfurt

Frankfurt, 60389, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, Germany

Location

General Hospital of Athens "Hippokrateio"

Athens, 11527, Greece

Location

Laiko Hospital

Athens, Greece

Location

University General Hospital of Larisa

Larissa, Greece

Location

European Interbalkan Medical Center

Thessaloniki, 57001, Greece

Location

Gottsegen György Hungarian Institute of Cardiology

Budapest, Hungary

Location

Carmel

Haifa, Israel

Location

Shaari Tzedek

Jerusalem, 9103102, Israel

Location

Rabin Medical Center (RMC)

Petah Tikva, Israel

Location

Poria

Tiberias, 1520800, Israel

Location

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Pracownia Hemodynamiki Serca

Poznan, Poland

Location

Hospital Universitario Ramon y Cajal

Madrid, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Embolism

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Embolism and Thrombosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 27, 2019
• Study Start: April 15, 2019
• Primary Completion: October 24, 2024
• Study Completion (Estimated): October 24, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); PL (1); IL (4); GR (4); CZ (1); HU (1); BE (2); DE (3)