JW Medical Systems Limited has announced completion of patient enrolment in CREDIT II, the first randomised controlled trial involving the Excel II coronary stent. Excel II is the latest generation in the Excel family of biodegradable polymer drug-eluting stents. The Excel II stent features an abluminal coating of sirolimus combined with an optimised PLA biodegradable polymer, and is deployed from a new delivery system.
CREDIT II compares the Excel I and II coronary stents with a primary endpoint of late lumen loss at nine months. Enrolment of 432 patients in China was recently completed. “I am delighted to have completed patient enrolment in this important trial so quickly”, commented principal investigator Yaling Han, ShenYang PLA General Hospital, ShenYang, China. “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.”
CREDIT II is part of the Chinese Excel II clinical trial programme which has enrolled over 1,100 patients in three trials across 40 centres.
Excel II’s first in man study, CREDIT I, started enrolment in March 2013 and has completed one year follow-up. Treatment with Excel II demonstrated good four-month and 12-month late lumen loss and sustained effectiveness, with rapid endothelialisation. Both optical coherence tomography and angiographic results suggested safety and efficacy with Excel II. CREDIT I results were published in Catheterization and Cardiovascular Interventions earlier this year. A third trial, CREDIT III, is gathering data from a single arm registry that has enrolled 637 patients to date.