OrbusNeich reported the completion of patient enrolment 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). Patients enrolled in the study were split evenly between the control and test arms.
“Based on its unique design and healing technology, we believe that Genous has the potential to give physicians an additional option for treating patients,” said professor Lu Shuzheng from Anzhen Hospital, principal investigator of the trial. “We are excited to complete enrolment in this study, which may bring further clinical support for the technology’s use in China.”
David Chien, vice chairman of OrbusNeich, added, “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.”
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.
Genous is OrbusNeich’s patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents.
OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases.