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

NCT ID: NCT03892824

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2027-10-24

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

Conditions

Atrial Fibrillation; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Vine™ Embolic Protection System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genae

INDUSTRY

Sponsor Role: collaborator

Javelin Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OLV Ziekenhuis

Aalst, , Belgium

ZNA Stuivenberg

Antwerp, , Belgium

Na Homolce Hospital

Prague, , Czechia

Alfried-Krupp Krankenhaus Rüttenscheid

Essen, , Germany

Cardio Vasculäres Centrum Frankfurt

Frankfurt, , Germany

Cardioangiologisches Centrum Bethanien

Frankfurt, , Germany

General Hospital of Athens "Hippokrateio"

Athens, , Greece

Laiko Hospital

Athens, , Greece

University General Hospital of Larisa

Larissa, , Greece

European Interbalkan Medical Center

Thessaloniki, , Greece

Gottsegen György Hungarian Institute of Cardiology

Budapest, , Hungary

Carmel

Haifa, , Israel

Shaari Tzedek

Jerusalem, , Israel

Rabin Medical Center (RMC)

Petah Tikva, , Israel

Poria

Tiberias, , Israel

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

Poznan, , Poland

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Countries

Belgium; Czechia; Germany; Greece; Hungary; Israel; Poland; Spain

Other Identifiers

CL-326

Identifier Type: -

Identifier Source: org_study_id