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Promising treatment for blocked leg arteries.

In March, a landmark clinical trial evaluating a drug-coated stent for peripheral arterial disease (PAD) received its first patient. The disease, which affects more than 10 million Americans each year, often goes undiagnosed, according to the American Heart Association.

PAD affects blood vessels that lead from the heart to other areas of the body, such as the legs, feet, and kidneys. When blood vessels become blocked due to fatty deposit buildup, blood circulation becomes restricted. Untreated, PAD can lead to pain when walking and potential gangrene and amputation.

The trial at Stanford University Medical Center is the first in the U.S. to test whether drug-eluting stents, which have demonstrated positive benefits in treating patients with coronary artery disease (CAD), could offer similar benefits in treating arteries outside the heart. The stent is a small metal device that acts like a scaffold to help prop open blocked arteries. All too often, however, arteries become blocked again as scar tissue forms around the implanted stent. To prevent return of blockage, the stent is coated with paclitaxel to potentially reduce the risk of renarrowing of the artery.

"We already know the benefits of drug-coated stents for the treatment of coronary artery disease," said Michael Dake, M.D., the principal investigator of the multicenter study. "We're hoping to translate that success to the peripheral circulation, especially in the legs, where blockages can be disabling."

Researchers plan to enroll 60 patients in the pilot study, which is being conducted in 10 U.S. medical facilities. Recruitment is expected to be complete by the end of 2005; an expanded trial is planned pending FDA review of initial results.

The stent was made by Cook, Inc., a large Indiana medical-device manufacturer that is sponsoring the clinical trial.

Eligible participants who have crampy calf pain after walking, relieved by rest, will be tested to see if they have a blockage in the superficial femoral artery--the most common cause of such pain and the target of this clinical trial. Those interested in participating can learn more about enrollment by contacting the research coordinators of Stanford's Division of Interventional Radiology at 650-725-9810.
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Title Annotation:Medical Update; a clinical trial to check if drug-coated stent can help in treatment of peripheral arterial disease
Publication:Indiana Business Magazine
Geographic Code:1USA
Date:Jul 1, 2005
Words:353
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