News | September 24, 2013

First Patient Enrolled in Gore SCAFFOLD Clinical Study for Carotid Stenting

Pivotal multicenter investigational study begins at Medical University of South Carolina (MUSC), evaluating safety and efficacy of Gore Carotid Stent

Gore Carotid Stenting SCAFFOLD Clinical Trial Stroke Treatment Cath Lab

September 24, 2013 — W. L. Gore & Associates has enrolled the first patient in its Gore 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, M.D., and his team at the Medical University of South Carolina in Charleston.

“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 stabilization benefits, and along with bound heparin may provide advantages for improved patient outcomes.”

The Gore SCAFFOLD clinical study is a multicenter, single-arm, prospective study comparing the Gore Carotid Stent to a performance goal developed from carotid endarterectomy (CEA) outcomes. The investigational study will include up to 50 sites in the United States and will enroll approximately 312 patients. Co-principal investigators are Peter Schneider, M.D., Kaiser Permanente Medical Center, Honolulu, Hawaii; and William Gray, M.D., Columbia University Medical Center.

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 maximized 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 stabilization 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 utilize bound heparin.

“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,” said Ben Beckstead, Ph.D., associate with the Gore Medical Division Peripheral Interventional Business.

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