Gore has announced that it has enrolled the first patient in its Carotid stent clinical study for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy (SCAFFOLD). The patient was successfully treated by Claudio Schönholz and his team at the Medical University of South Carolina in Charleston, USA.
“The first procedure using the Gore carotid stent was successful and the patient is doing well, having left the hospital the next day. Studies like this will further our understanding of optimal patient outcomes in carotid artery stenosis,” Schönholz said. “The new Gore device is designed to be flexible, offer plaque retention and stabilisation benefits, and along with bound heparin may provide advantages for improved patient outcomes.”
SCAFFOLD is a multicentre, single-arm, prospective study comparing the Gore carotid stent to a performance goal developed from carotid endarterectomy outcomes. The investigational study will include up to 50 sites in the US and will enrol approximately 312 patients. Co-principal investigators are Peter Schneider, Kaiser Permanente Medical Center, Honolulu; and William Gray, Columbia University Medical Center, New York.
“In times of uncertainty regarding optimal treatment for patients with high surgical risks, it is important to evaluate unique treatment options,” said Schneider.
Leveraging more than 35 years of clinical experience with expanded polytetrafluoroethylene (ePTFE), the Gore carotid stent is a next-generation device designed to integrate innovative material to trap arterial plaque against the vessel wall, while yielding maximised flexibility of the stent in order to conform to the often tortuous anatomy of carotid vasculature. The new Gore device combines the flexible properties of a traditional open-cell, nitinol stent design with a 500 micron pore size ePTFE lattice which offers the plaque retention and stabilisation benefits traditionally seen in a closed cell stent design. Additionally, the permanently bound heparin may offer a local advantage seen with other Gore devices that utilise bound heparin.
“Gore is committed to continuing development of innovative solutions for patients in order to improve their quality of life,” said Ben Beckstead, associate with the Gore Medical Division Peripheral Interventional Business. “The Gore SCAFFOLD clinical study will bring us one step closer to a new solution for improving patient outcomes, while simultaneously generating data for consideration of Medicare reimbursement for such procedures.”