At the 4 centers, 25 patients were enrolled: age 71±9 years, CHA2DS2-VASc = 4.4±1.0, prior embolism in 48%. Procedure success was 92% (23/25 patients); one patient had unilateral deployment. There were no device/procedure-related MAEs; minor puncture site hematomas/edema occurred in 5/25 (20%). After 6 months mean follow-up, in situthrombus was not observed. The filter captured emboli in 4 patients (1 bilateral, 4 unilateral), none developed symptoms. In all patients, the thrombi dissolved with subcutaneous heparin. In 1 patient, 2 minor strokes involving non-CCA territory strokes occurred.
Conclusion of the trial was that permanent carotid filter placement for stroke prophylaxis is technically feasible and safe. Monitoring was performed by a contract clinical research organization (genae; Antwerp, Belgium).