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Prevention study for Atrial Fibrillation
Official title Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
ClinicalTrials.gov ID: NCT05723926
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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:
You likely can't join if
- Contraindication to oral anticoagulation (e.g. history of intracranial hemorrhage, known hereditary or acquired coagulation disorders, or recurrent...
- 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...
- Visualized active (acute/subacute) cervical or intracranial arterial thrombus (i.e. free-floating) on computed tomography (CT), magnetic resonance...
- Previously documented aneurysm of the internal carotid artery or its branches (i.e. ophthalmic, posterior communicating, anterior choroidal, anterior...
- Prior surgery or radiation of the neck at the implantation segment
See the full eligibility criteria
- 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...
- 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...
- Provision of informed consent
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rockford, Illinois, United States
- New York, New York, United States
- Chattanooga, Tennessee, United States
- Memphis, Tennessee, United States
- Hamilton, Canada, Canada
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rockford, Illinois, United States; New York, New York, United States; Chattanooga, Tennessee, United States; Memphis, Tennessee, United States; Hamilton, Canada, Canada; London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.