Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
Sponsor: Javelin Medical • ClinicalTrials.gov ID: NCT05723926
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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.
Interventions
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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.
Eligibility criteria
Conditions
Locations
- Mercyhealth Javon Bea Hospital - Riverside — Rockford, Illinois, United States
- Boston University Medical Center — Boston, Massachusetts, United States
- Weill Cornell Medical Center — New York, New York, United States
- Erlanger Medical Center — Chattanooga, Tennessee, United States
- Methodist University Hospital — Memphis, Tennessee, United States
- Baptist Memorial Hospital-Memphis — Memphis, Tennessee, United States
- Universidade Fedeal Do Parana — Curitiba, Brazil
- Hcfmrp-Usp — Monte Alegre, Brazil
- HCPA — Porto Alegre, Brazil
- Hospital São Rafael — Salvador, Brazil
- Hospital de Base de Rio Preto — São José do Rio Preto, Brazil
- NEURORAD — São Paulo, Brazil
- UNIFESP — São Paulo, Brazil
- Hospital Estadual Central de Vitória — Vitória, Brazil
- Hamilton General Hospital — Hamilton, Canada, Canada
- University Hospital — London, Ontario, Canada
- West Georgia Medical Center — Kutaisi, Georgia
- K. Eristavi National Center of Experimental and Clinical Surgery JSC — Tbilisi, Georgia
- LLC Geo Hospitals Tbilsi Multiprofile Medical Center — Tbilisi, Georgia
- Pineo Medical Ecosystem — Tbilisi, Georgia
- Tbilisi State Medical University First University Clinic — Tbilisi, Georgia
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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