Abbott (Abbott Park, Illinois) in late September reported enrollment of the first patient in its HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety), a U.S. study to evaluate the safety/efficacy of its RX Herculink Elite Renal Stent System to treat patients with renal artery stenosis (RAS)

RAS is characterized by fatty plaque buildup in the kidney arteries that .can lead to kidney failure and dialysis, a risk factor for cardiovascular disease, and is often discovered as the source of uncontrolled high blood pressure.

The first implant was performed by Joaquin Martinez de Arraras, MD, president of Amarillo Heart Clinical Research Institute (Amarillo, Texas).

The RX Herculink Elite Renal Stent System is an .014-inch rapid-exchange (single-operator) system made of cobalt chromium, easier to see under X-ray than stainless steel.

Abbott pointed to estimates that renal artery stenosis affects about 5 million people in the U.S., most often in men in the 50-to-70 age range.

"Many patients with high blood pressure and renal artery stenosis do not respond as well to medication alone as they may to medication plus stenting," said de Arraras.

He said that HERCULES will evaluate the abiliy of renal artery stenting to reduce vessel renarrowing, thus reducing renal disease and the risk factors for cardiovascular disease.

The HERCULES trial will enroll up to 202 patients at approximately 50 sites across the United States.

The primary endpoint is binary restenosis at nine months; secondary endpoints are 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 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 (TLR).

To qualify for the HERCULES study, patients must have uncontrolled hypertension not responding to treatment with at least two blood pressure medications, and at least 60% stenosis or in a renal artery as measured by X-ray angiography.

Chuck Foltz, VP, Abbott Vascular (Santa Clara, California) said that with HERCULES "we can continue to expand our understanding of vascular disease and how to deliver the best treatments for patients."

Abbott is conducting the HERCULES trial to seek FDA approval for use of Herculink to treat renal artery stenosis.