Biosensors International Group subsidiary JW Medical Systems (JWMS) has completed the patient enrollment in Credit II, a randomized controlled trial (RCT) involving the Excel II coronary stent.
The Credit II trial recently completed the enrollment of 432 patients in China, according to Biosensors.
JWMS CEO Simon Li said: "JWMS has been a leader in the Chinese drug eluting stent market for many years. The Excel II stent will continue that legacy, based on solid clinical evidence from studies such as Credit."
Part of the Excel family of biodegradable polymer drug-eluting stents (BP-DES), the Excel II stent features an abluminal coating of sirolimus combined with an optimized PLA biodegradable polymer.
Credit II has been designed to compare Excel I and II coronary stents, with a primary endpoint of late lumen loss at nine months.
The trial is part of the Chinese EXCEL II clinical trial program, which enrolled around 1100 patients in three trials across 40 centers, while Excel II’s First in Man (FIM) study, Credit I, started enrollment in March 2013 and has completed one year follow-up.
Principal investigator of the study, China’s ShenYang PLA General Hospital’s Dr Yaling Han said: "The first generation Excel stent demonstrated excellent safety and efficacy. Based on that experience and the preliminary results of the Credit FIM trial, we expect even better long term safety and efficacy results from Excel II."