INTERCEPT Trial
Carotid Implants for PreveNtion of STrokE ReCurrEnce from Large Vessel Occlusion in Atrial Fibrillation Patients Treated with Oral Anticoagulation
Introducing Vine™ Embolic Protection System
INTERCEPT is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial evaluating the Vine™ Embolic Protection System (carotid filter and inserter) in patients with atrial fibrillation (AF) and ischemic stroke within the previous year. Approximately 2,000 participants will be randomized 1:1 to receive either bilateral carotid filters in addition to oral anticoagulation or oral anticoagulation alone, across up to 300 sites in up to 30 countries.
Objective
Primary Objective:
To evaluate in AF patients with ischemic stroke within the previous year whether bilateral carotid filters in addition to oral anticoagulation (OAC), compared to oral anticoagulation alone, reduce the risk of anterior circulation ischemic stroke due to large vessel occlusion (LVO).
​​​
​
​​
​
Secondary Objectives:​​
​
-
To determine whether bilateral carotid filters reduce total ischemic stroke
-
To evaluate the safety of the study intervention, including serious device- or procedure-related complications and ISTH major bleeding during the first 6 months after randomization
-
To assess functional outcomes and health-related quality of life using validated tools such as the modified Rankin Scale (mRS), EQ-5D-5L, and SAGEA
Principal Investigator
Dr. Ashkan Shoamenesh
Principal-Investigator
McMaster University
237 Barton Street East
Hamilton, Ontario, L8L 2X2 Canada
​
Principal Investigator
Dr. Alexander Benz
Principal-Investigator
McMaster University
237 Barton Street East
Hamilton, Ontario, L8L 2X2 Canada
​