Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation

NCT05723926 | Recruiting DMC FDA Device

• 1 other identifier: CL-500
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). This randomized control trial aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke vs. only OAC.

Conditions

Atrial Fibrillation; Oral Anticoagulation; Stroke; Implant

Keywords

Filter; Ischemic stroke; NOAC; LVO

Outcome Measures

Primary Outcomes (3)

• Large vessel occlusion strokes (efficacy)

  assessed by MRI/CTA

  44 months

• Serious device or procedure related complications (safety)

  Defined as any carotid filter or procedure related complication (excluding ischemic stroke) that results in death) or major disability, or that requires endovascular stenting or surgical correction.

  44 months

• ISTH (International Society on Thrombosis and Haemostasis) major bleeding occurring during OAC + clopidogrel intake.

  44 months

Secondary Outcomes (1)

• Ischemic stroke (efficacy)

  68 months

Study Arms (2)

Vine Filter and oral anticoagulant

EXPERIMENTAL

Participants randomized to the intervention will undergo implantation of bilateral carotid filters and OAC therapy. In addition, participants will receive additional single antiplatelet therapy with OAC for 6 months.

Device: Vine Filter

Usual Care (oral anticoagulant only)

NO INTERVENTION

Participants randomized to control will not receive carotid filter implants but will receive usual care including OAC, throughout the course of the study.

Interventions

Vine Filter DEVICE

The Vine filters are designed to be implanted in the common carotid arteries in order to capture emboli coming from the heart or great vessels, before they can enter the anterior intracranial circulation. The filter is deployed percutaneously using a 22G needle under ultrasound guidance.

Also known as: Vine Embolic Protection System

Vine Filter and oral anticoagulant

Eligibility Criteria

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

You may qualify if:

• Documented history of clinical AF
• History of ischemic (i.e. non-hemorrhagic) stroke including symptoms of stroke resolving within 24 hours with positive neuro-imaging, meeting one of the following criteria:
• Group 1: Patient was on OAC at time of index stroke, with index stroke occurring \< 6 week from enrollment Group 2: Patient was not on OAC at time of stroke, with index stroke occurring \< 6 weeks from enrollment Group 3: Patient was on OAC at time of index stroke, with index stroke occurring 6 to 52 weeks from enrollment
• Planned use of a Vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC) for the duration of the trial
• Patient able to tolerate single antiplatelet therapy in addition to oral anticoagulation for 6 months, in the opinion of the investigator
• Bilateral ultrasound or angiogram demonstrating all of the following:
• Inner common carotid artery diameter range: ≥5.3 mm and ≤8.8 mm
• Accessibility: up to 40 mm from skin to common carotid artery center
• Implantation segment free of any atherosclerotic disease
• Absence of carotid dissection or pre-existing stent(s) in common carotid artery
• Absence of ≥50% stenosis of the internal carotid arteries as seen on ultrasound or angiography (CTA, MRA or DSA)
• i. For ultrasound, calculate the percentage of carotid stenosis using the Society of Radiologists in Ultrasound Consensus Criteria for Carotid Stenosis, where ≥50% stenosis is defined by internal carotid artery peak systolic velocity of ≥125 cm/sec, internal/common carotid peak systolic velocity ratio of 2 or more and end diastolic velocity of ≥40 cm/sec, or evidence of near occlusion.
• ii. For angiography, calculate the percentage of carotid stenosis using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria (\[D - N\]/D x 100, where N is the luminal diameter at the site of maximal narrowing and D is the diameter of normal distal internal carotid artery beyond the bulb where the artery walls are parallel.
• Provision of informed consent

You may not qualify if:

• Contraindication to oral anticoagulation (e.g. history of intracranial hemorrhage, known hereditary or acquired coagulation disorders, or recurrent major bleeding)
• Contraindication to additional single antiplatelet therapy for 6 months from randomization
• Previously documented 50% or greater stenosis, or high-risk plaque in the opinion of the investigator, of the common carotid, internal carotid, subclavian, vertebral, or intracranial arteries that has not been treated with a revascularization procedure (i.e. stent or angioplasty)
• Visualized active (acute/subacute) cervical or intracranial arterial thrombus (i.e. free-floating) on computed tomography (CT), magnetic resonance (MR), or digital subtraction (DS) angiography that is at risk of causing additional stroke/brain injury
• Previously documented aneurysm of the internal carotid artery or its branches (i.e. ophthalmic, posterior communicating, anterior choroidal, anterior cerebral and middle cerebral arteries) that is 6 mm or greater in diameter.
• Prior surgery or radiation of the neck at the implantation segment
• Pre-existing percutaneous left atrial appendage occlusion device that was implanted after most recent ischemic stroke
• Planned left atrial appendage occlusion procedure
• Female who is pregnant or non-postmenopausal female who is not willing to use an effective method of birth control during duration of the trial
• Overt systemic infection
• Known sensitivity to nickel or titanium metals, or their alloys
• Active participation in another investigational drug or device treatment trial
• 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 trial

Sponsors & Collaborators

• Javelin Medical: lead
• World Health Research Institute: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Canada, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Ischemic Stroke

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

Study Officials

• Stuart Connolly, MD, FRCPC

  Population Health Research Institute, McMaster University

  PRINCIPAL INVESTIGATOR

• Ashkan Shoamanesh, MD, FRCPC

  Population Health Research Institute, McMaster University

  PRINCIPAL INVESTIGATOR

• Alexander P Benz, MD MSc

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Vivek Y Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sagit Broder, MSc

CONTACT

+972587112116; sagit@javelinmed.com

Jessica Tyrwhitt

CONTACT

jessica.tyrwhitt@worldhealthresearch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, open-label, blinded endpoint evaluation

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 13, 2023
• Study Start: January 9, 2026
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): October 20, 2030
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CA (1)