Below-Knee Stent Trial Approved

A clinical trial will investigate the use of minimally invasive stent placement to treat severe peripheral arterial disease (PAD) below the knee

The study will be the first in the United States to evaluate the Xpert expandable nitinol stent in the blood vessels below the knee. The stent is manufactured by Abbott Vascular (Abbott Park, Il, USA) and is currently cleared in the United States for treating blockages in the biliary ducts that carry digestive enzymes from the liver. The self-expanding stent is a tiny cylinder made of metal mesh that is guided into place by a catheter through the blood vessels to the site of the blockage under x-ray guidance. The stent is deployed through the catheter and expanded to prop open the diseased artery.

"The Xpert stent is particularly appropriate for this trial because it is the only self-expanding stent that comes in a variety of sizes small enough to treat the blood vessels below the knee,” said principal investigator Dr. James Joye of El Camino Hospital (Mountain View, CA, USA), which will be among the sites participating in the study. The study is also important because it is one of only a very few independent, physician-sponsored efforts.”

The trial is sponsored by VIVA Physicians Inc. (VPI, Rosemont, IL, USA), a multi-disciplinary group of independent doctors who are nationally known experts in the diagnosis and management of peripheral vascular diseases and who have joined together to advance education in vascular medicine and support research and innovative treatment options. VPI set the protocol, applied for the investigational device exemption (IDE), and is responsible for data collection, evaluation, and reporting of the Xpert stent study, called XCELL.



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