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

Stroke Clinical Trial

— CAPTURE2  

Official title:

Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03892824
• Other study ID #: CL-326
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: October 24, 2024

Study information

• Verified date: January 2024
• Source: Javelin Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 24, 2024
• Est. primary completion date: November 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis	Aalst
Belgium	ZNA Stuivenberg	Antwerp
Czechia	Na Homolce Hospital	Prague
Germany	Alfried-Krupp Krankenhaus Rüttenscheid	Essen
Germany	Cardio Vasculäres Centrum Frankfurt	Frankfurt
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt
Greece	Laiko Hospital	Athen
Greece	General Hospital of Athens "Hippokrateio"	Athens
Greece	University General Hospital of Larisa	Larissa
Greece	European Interbalkan Medical Center	Thessaloníki
Hungary	Gottsegen György Hungarian Institute of Cardiology	Budapest
Israel	Carmel	Haifa
Israel	Shaari Tzedek	Jerusalem
Israel	Rabin Medical Center (RMC)	Petah tikva
Israel	Poria	Tiberias
Poland	Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Pracownia Hemodynamiki Serca	Poznan
Spain	Hospital Universitario Ramon y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Javelin Medical	Genae

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	one and two years from implantation procedure
Secondary	Number of properly positioned implants	proper implant position in each common carotid artery (CCA)	30 days from implantation procedure
Secondary	Number of participants that had disabling strokes	Disabling stroke	30 days, one and two years from implantation procedure
Secondary	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	immediately after the procedure
Secondary	Number of properly positioned implants	Proper implant position in each CCA	one and two years from implantation procedure
Secondary	Number of observed thrombi on the device	Thrombus on implant detected by ultrasound imaging	30 days, one and two years from implantation procedure
Secondary	Number of death cases	Death	one and two years from implantation procedure
Secondary	Number of strokes (any kind)	Total number of strokes	one and two years from implantation procedure