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

 

Atrial fibrillation is a common cardiac arrhythmia and associated with an increased risk of ischemic stroke. Approximately 90% of ischemic strokes in patients with atrial fibrillation involve the anterior circulation, which is supplied by the common carotid arteries. More than 40% of these strokes are associated with large vessel occlusion, often resulting in disability or death. Oral anticoagulation with a vitamin K antagonist or a direct oral anticoagulant reduces the risk of stroke by about two-thirds. However, patients with atrial fibrillation who have experienced a stroke within the past year remain at very high risk of recurrent stroke, despite ongoing oral anticoagulation.

 

The purpose of the INTERCEPT trial is to assess the efficacy and safety of bilateral common carotid filter implantation with the Vine™ Embolic Protection System as an adjunct to oral anticoagulation in patients with atrial fibrillation who have suffered an ischemic stroke within the previous year.

 

Approximately 2,000 patients with atrial fibrillation and a stroke within the previous year will be randomized to either receive or not receive bilateral common carotid filters. All study participants will be treated with oral anticoagulation. Those randomized to receive bilateral common carotid filters will also be given single antiplatelet therapy (clopidogrel) for six months following implantation.

 

The study results will be evaluated after a sufficient number of stroke cases have occurred, which is expected to take about four years. Depending on the outcomes, the study may continue for up to two additional years. The timeline may be adjusted based on how the data develops during the study