CINCINNATI, OH (FOX19) - Physicians at The Christ Hospital are the first in the U.S. to implant the OMEGA bare metal stent as part of a clinical trial.
This trial, sponsored by Boston Scientific, will test the OMEGA Platinum Chromium Bare-Metal Coronary Stent System for safety and efficacy in the treatment of coronary artery disease. An 68-year-old man from Harrison, Ohio, the first U.S. patient in the study, is doing well after being treated by Dr. Dean Kereiakes, principal investigator for the study and medical director of The Lindner Center for Research and Education and The Christ Hospital Heart and Vascular Center.
"The Christ Hospital was a major research participant for both the first FDA-approved bare metal and drug-eluting stints," said Kereiakes. "Although drug-eluting stents currently dominate the market, there are certain patients with coronary artery disease who are not candidates for this type of treatment. We are testing the new alloy and design of the OMEGA bare metal coronary stent for improved deliverability and functionality as an alternative for these patients."
Stents coated in medication to treat coronary artery disease are often placed in the artery to prevent new blockages, commonly resulting from the buildup of plaque in the arteries that deliver blood to the heart. However, drug-eluting stents may not be the most appropriate treatment for specific patients.
The OMEGA bare metal stent is composed of a new platinum chromium alloy designed to enhance flexibility, strength and visibility. In the U.S. and at participating clinical sites, the OMEGA Stent System is part of Boston Scientific's Platinum Chromium Stent series and an investigational device not available for sale.
This trial will enroll 328 patients at 40 sites in the U.S. and Europe. Patients will undergo clinical follow-up at 30 days, nine months and one year after the procedure. The study covers the cost of the investigational device. All other medical costs are the responsibility of the patient, and are typically covered by Medicare or private insurance.
For more information about enrolling in this trial, please call the Lindner Research Center at (513) 585-1777.