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

STATUS

Recruiting
End date

Aug 20, 2024
participants needed

100
sponsor

Javelin Medical

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Updated on 4 October 2022

See if I qualify

stroke

anticoagulants

atrial fibrillation

fibrillation

vitamin k antagonist

ischemic stroke

noac

vitamin k

vascular disease

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 > 1.2mm 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

Details

Condition	Atrial Fibrillation, Stroke
Treatment	Vine™ Embolic Protection System
Clinical Study Identifier	NCT03892824
Sponsor	Javelin Medical
Last Modified on	4 October 2022

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Eligibility		Yes	No	Not Sure
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

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