OrbusNeich has completed patient enrollment in a randomized clinical study of its Genous Bio-engineered R stent at 11 sites in China.
The primary objective of the 180 patient, controlled study is to demonstrate the safety and effectiveness of the Genous Bio-engineered R stent compared to the Medtronic Endeavor Sprint stent in patients 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 after implantation and 270 day angiographic late loss (LL).
OrbusNeich vice chairman David Chien said that this first clinical study of Genous in China is significant in the full development of the technology.
“We look forward to seeing additional clinical support for the use of Genous in challenging cases, such as diabetic patients and those who cannot tolerate a year of dual antiplatelet therapy,” Chien said.
The 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.