Actively Recruiting
Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
Led by Javelin Medical · Updated on 2026-04-09
2000
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
Sponsors
J
Javelin Medical
Lead Sponsor
W
World Health Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented history of clinical atrial fibrillation
- History of ischemic (non-hemorrhagic) stroke with symptoms resolving within 24 hours and positive neuro-imaging
- Index stroke occurred less than 6 weeks before enrollment if on oral anticoagulation at time of stroke
- Index stroke occurred less than 6 weeks before enrollment if not on oral anticoagulation at time of stroke
- Index stroke occurred 6 to 52 weeks before enrollment if on oral anticoagulation at time of stroke
- Planned use of Vitamin K antagonist or direct oral anticoagulant for the trial duration
- Ability to tolerate single antiplatelet therapy alongside oral anticoagulation for 6 months, per investigator
- Bilateral ultrasound or angiogram showing common carotid artery diameter between 5.3 mm and 8.8 mm
- Implantation site free of atherosclerotic disease and no carotid dissection or existing stent
- Less than 50% stenosis of internal carotid arteries on imaging
- Provision of informed consent
You will not qualify if you...
- Contraindication to oral anticoagulation (e.g., history of intracranial hemorrhage, coagulation disorders, or recurrent major bleeding)
- Contraindication to additional single antiplatelet therapy for 6 months
- Untreated 50% or greater stenosis or high-risk plaque in relevant arteries
- Active cervical or intracranial arterial thrombus at risk of causing additional stroke
- Internal carotid artery aneurysm 6 mm or larger
- Prior neck surgery or radiation at implantation site
- Existing percutaneous left atrial appendage occlusion device implanted after recent stroke
- Planned left atrial appendage occlusion procedure
- Female who is pregnant or non-postmenopausal and unwilling to use birth control during trial
- Overt systemic infection
- Known allergy to nickel, titanium, or their alloys
- Participation in another investigational drug or device trial
- Any other condition that may affect patient safety or trial completion as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hamilton General Hospital
Hamilton, Canada, Canada
Actively Recruiting
Research Team
S
Sagit Broder, MSc
CONTACT
J
Jessica Tyrwhitt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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