OrbusNeich has reported that the first patient has been enrolled in its randomized clinical trial of the Genous Bio-engineered R stent in China.
The multicenter, randomised, controlled study will enroll 180 patients split evenly between the control and test arms at 11 sites countrywide. The primary study objective is to demonstrate the safety and effectiveness of the Genous Bio-engineered R stent as compared to the Medtronic Endeavor Sprint stent.
The study population will consist of patients ages 18 to 75 with symptoms of angina or myocardial ischemia. The primary endpoints are difference in Major Adverse Cardiac Event (MACE) rates between the two groups at 12 months, following implant and 270 day angiographic Late Loss (LL).
Secondary endpoints include all-cause and cardiac mortality, myocardial infarction, in-stent thrombosis, MACE rates at 30, 60, 90, 180 and 270 days, as well as clinically driven target lesion revascularization (TLR), target vessel revascularization (TVR) and target lesion failure (TLF) rates at 30, 60, 90, 180, 270 and 360 days.
Lu Shuzheng, professor of Anzhen Hospital and principal investigator of the trial, said: “We believe that the Genous Bio-engineered R stent will provide a treatment option to patients who present challenging cases with standard drug eluting stents.”
Al Novak, chairman and CEO of OrbusNeich, said: “We are excited to take the Genous Bio-engineered R stent into this pivotal trial in China. We expect that clinical data from this study will show positive benefits for patients, including those who often encounter challenges with today’s drug eluting stents.”