Clinical study to evaluate RX Herculink Elite Renal Stent System.
The first patient in has been enrolled in the HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety) clinical trial. The trial is designed to evaluate the safety and effectiveness of the investigational RX Herculink Elite Renal Stent System to treat patients with renal artery stenosis (RAS). The first implant was performed by Dr Joaquin Martinez de Arraras, President of Amarillo Heart Clinical Research Institute, Amarillo, TX. The HERCULES trial will enroll up to 202 patients at approximately 50 sites across the US. The primary endpoint of the study is binary restenosis at nine months. Secondary endpoints in the trial will measure changes in blood pressure and the use of hypertensive medication at nine months. Additional analyses in patient follow-up visits out to 36 months will measure major adverse events in patients such as death, surgical removal of the kidney, or embolic events resulting in kidney damage, as well as target lesion revascularization. The RX Herculink Elite Renal Stent System is an .014-inch rapid-exchange renal stent system made of cobalt chromium. “Many patients with high blood pressure and RAS do not respond as well to medication alone as they may to medication plus stenting,” said Martinez de Arraras. “The goal of the HERCULES trial is to evaluate whether renal artery stenting may reduce vessel renarrowing, thereby potentially reducing other risk factors for cardiovascular disease, such as high blood pressure.” To qualify for the HERCULES study, patients must have uncontrolled hypertension that is not responding to treatment with at least two blood pressure medications, and must have at least 60% stenosis or blockage in a renal artery as measured by visual X-ray angiography.