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RECRUITING
NCT05723926
NA

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

Sponsor: Javelin Medical

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2026-01-09

Completion Date

2030-10-20

Last Updated

2026-06-09

Healthy Volunteers

No

Interventions

DEVICE

Vine Filter

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.

Locations (7)

Mercyhealth Javon Bea Hospital - Riverside

Rockford, Illinois, 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

Hamilton General Hospital

Hamilton, Canada, Canada

University Hospital

London, Ontario, Canada