Mar. 14, 2001 Cardiologists at Rush-Presbyterian-St. Luke's Medical Center in Chicago have begun treating patients with a new catheterization procedure that might eliminate restenosis in arteries previously clogged from scarring or arteriosclerosis.
Joseph O'Connor, a 49-year old retired Teamster from Tinley Park, Ill., has had three angioplasties and one bypass surgery. He is one of the first patients to receive the new catheterization procedure and is hopeful this is the last procedure he receives for awhile.
"I'm hoping this procedure eliminates the need for to visit a hospital every four months and that I can have a normal quality of life," O'Connor said.
Using a device that incorporates radiation into the balloon that is used in the angioplasty, Rush interventional cardiologists Gary Schaer, MD and Jeffery Snell, MD, have now begun treating patients in the BRITE II (Beta Radiation to Reduce In-Stent Restenosis) Trial. BRITE II is a prospective, randomized, double-blinded placebo controlled clinical study testing Radiance Corp. RDX™ for the treatment of in-stent restenosis. Rush is one of 40 medical centers involved in the trial and the only hospital in Chicago.
"This radiation device is the second generation of catheterization procedures using radiation to prevent reclosing, or restenosis," said Schaer, who is director of the Cardiac Catheterization Laboratories at Rush. Rush also participated in the clinical trials for the Beta Cath system, which showed a 66 percent reduction in restenosis.
"While Beta Cath was very successful in preventing reclosing of diseased or scarred arteries, we feel that the preliminary data on the Coronary Radiation Delivery System is very promising," said Dr. Snell, interventional cardiologist at Rush.
The BRITE II protocol is designed to enroll 480 patients at approximately 40 centers worldwide treating in-stent coronary blockages up to 45mm in length in artery diameters of 2.25mm to 4.0mm. Unlike the Beta Cath trial which was only open to patients who had previous angioplasties, BRITE II will allow those patients who have had either an angioplasty or a vein bypass surgery to enroll Results from the preliminary BRITE Trial, a Phase I study with the RDX System, showed a 0% restenosis rate for in-stent restenosis with six-month follow-up in 27 patients.
"This may be lowest restenosis rate ever reported in a trial for the treatment of in-stent restenosis," said Schaer.
During angioplasty, a cardiologist threads a balloon catheter through the femoral artery - accessed in the thigh - to the coronary artery in the heart. Once the catheter is positioned at the site of the blockage, the balloon is expanded, pressing plaque against the artery wall to open the artery and restore blood flow.
More than 13 million people in the United States have been diagnosed with coronary artery disease, the leading cause of death in this country. This year alone, an estimated 1.8 million patients will undergo procedures such as coronary bypass surgery and balloon angioplasty to reopen their arteries.
Rush-Presbyterian-St. Luke's Medical Center includes the 809-bed Presbyterian-St. Luke's Hospital; 154-bed Johnston R. Bowman Health Center for the Elderly; Rush University (Rush Medical College, College of Nursing, College of Health Sciences and Graduate College); and seven Rush Institutes providing diagnosis, treatment and research into leading health problems. The medical center is the tertiary hub of the Rush System for Health, a comprehensive healthcare system capable of serving about two million people.
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