PRECLINICAL EVALUATION OF THE VASCULAR EFFECTS OF REJUVENATE® COBALT CHROMIUM CORONARY STENT SYSTEM IMPLANTED IN THE PORCINE CORONARY IN STENT RESTENOSIS MODEL

Abstract

Objectives: The main objective of the study was to evaluate the implantation, safety, and vascular tissue effects of REJUVENATE® Cobalt Chromium Bare Metal Stent in the Porcine Coronary Restenosis model at short, mid and long-term follow up. Methodology: A total of 18 REJUVENATE® bare metal stents (CoCr, 95 µm strut thickness) were implanted into the coronary arteries (RCA, LCX and LAD) of the six pigs. Throughout the study period, stent patency, vascular response, percent stenosis, late lumen loss and performance of stent were evaluated by angiography, optical coherence tomography (OCT), and Histopathology (includes both Histopathology and histomorphometry) at 30, 90, and 180 days and compared with the results of control Bare Metal Stent Coflexus®. The mean, variance and standard deviation was analyzed using SPSS software. Results: OCT and QCA analysis demonstrated two cases of binary restenosis at 30 days follow-up and two at 90 days follow-up (33%). The mean area stenosed for Rejuvenate® was 34% as compared to 24% of Coflexus® and at 180 days follow up, it decreased to 21%. The histopathology analysis demonstrated favorable safety with acceptable levels of neointimal formation, with decreased levels of inflammation and complete endothelialization in 180 days. Conclusion: This study proved the potential safety of REJUVENATE® in porcine model and supports that this stent can move forward for the human trials.