St. Luke's Medical Center (SLMC) - home of the Texas Heart® Institute (THI) - announced today that the first eight patients in Texas have been treated in a multi-center, clinical trial of a new carotid artery stent that can be used as an alternative to surgery, for surgical high-risk patients with potentially stroke-causing carotid artery disease.
In partnership with W. L. Gore & Associates (GORE), physicians at St. Luke’s in affiliation with THI, are participating in the Gore SCAFFOLD clinical trial. This national study compares the outcomes of patients treated with the GORE SCAFFOLD Carotid Stent versus performance data from carotid artery surgery outcomes. The study will include up to 50 centers in the United States, including THI at St. Luke’s, and will enroll approximately 312 patients. The national co-principal investigators are Peter Schneider, MD, Kaiser Permanente Medical Center, Honolulu; and William Gray, MD, Columbia University Medical Center.
“In times of uncertainty regarding optimal treatment for patients with high surgical risks, it’s important to evaluate unique treatment options,” said Dr. Schneider.
“The new Gore device is designed to be flexible, offer plaque retention and stabilization benefits, and along with bound heparin, which may provide advantages for improved patient outcomes,” said Zvonimir Krajcer, MD, Principal Investigator for the SCAFFOLD study at St. Luke’s and Co-Director of Peripheral Vascular Disease Services at THI. Sub-Investigators also participating in the study are Neil Strickman, MD, THI Co-Director of Peripheral Vascular Disease Services and Surendra Jain, MD.
Carotid artery disease is caused by build-up of plaque in the carotid arteries on each side of the neck. These arteries supply the brain with oxygen-rich blood. Stenosis, or narrowing, of these arteries can lead to stroke, the third leading cause of death in the U.S. Historically, the most common treatment for carotid artery disease has been carotid endarterectomy (CEA) a type of surgery performed to remove the plaque from inside the artery. THI surgeons have performed more than 8,000 CEAs to date. THI cardiologists have been studying alternative treatments for carotid disease for more than 15 years and have more performed more than 1,200 carotid stent procedures to date.