Sep. 27, 2001 LOS ANGELES (Sept. 25, 2001) -- A clinical trial studying the use of radioactive balloons as a means of preventing artery blockages from re-growing in people who have previously been treated with coronary artery stents is underway at Cedars-Sinai Medical Center and other sites nationwide. According to Raj Makkar, M.D., co-director of the Cardiovascular Intervention Center and co-director of the Interventional Cardiology Research Program in the Division of Cardiology at Cedars-Sinai in Los Angeles, the purpose of the trial is to determine whether placing a balloon with a radioactive source in it directly at the site of the blockage reduces or prevents re-growth of scar tissue inside a stent in people with blocked arteries.
A metal tube, or stent, is often placed in the artery to treat blocked arteries, but according to Dr. Makkar, approximately one-fifth of such patients experience re-blockage due to growth of scar tissue inside the stent. "Much like radiation therapy is used to treat many types of tumors to prevent growth, we're now studying the use of radiation at the site of re-stenosis, hoping it will prevent re-growth of scar tissue in arteries as well," he said. The use of radiation to treat coronary arteries is called intracoronary brachytherapy.
The procedure is done in the cardiac catheterization laboratory and starts with the use of a conventional balloon angioplasty using a "regular" balloon to clear the artery. This is followed by inserting a balloon containing BETA radiation film and leaving it at the site of the narrowing for approximately five to seven minutes. Compared to Gamma radiation, BETA radiation is easier to use because it requires less shielding, said Dr. Makkar.
Intracoronary brachytherapy, which received FDA approval in July of this year, may offer an alternative to bypass surgery for some patients who have failed angioplasty. According to Dr. Makkar, it is easy to use and has been studied using other systems in previous clinical trials in the United States involving more than 1000 patients.
To date, Cedars-Sinai has enrolled 14 patients in the multi-center study and hopes to enroll 20 to 30 more. For more information on participating in this study, please call 310-423-3977.
Cedars-Sinai Medical Center is one of the largest nonprofit academic medical centers in the Western United States. For the fifth straight two-year period, Cedars-Sinai has been named Southern California's gold standard in health care in an independent survey. Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of programs and services, as well as breakthrough biomedical research and superlative medical education. The Medical Center ranks among the top seven non-university hospitals in the nation for its research activities.
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