Enrollment Begins in SCAFFOLD Study for Gore Carotid Stent

September 12, 2013—Gore & Associates (Flagstaff, AZ) announced commencement of enrollment in SCAFFOLD, the Gore Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events from Carotid Endarterectomy.

According to the company, the multicenter, single-arm, prospective SCAFFOLD study is 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 United States and will enroll approximately 312 patients. Coprincipal investigators are Peter Schneider, MD, of Kaiser Permanente Medical Center in Honolulu, Hawaii, and William Gray, MD, of Columbia University Medical Center in New York, New York.

“In times of uncertainty regarding optimal treatment for patients with high surgical risks, it is important to evaluate unique treatment options,” commented Dr. Schneider in Gore's press release.

Claudio Schönholz, MD, and his team at the Medical University of South Carolina in Charleston, South Carolina, successfully treated the first patient. In Gore's press release, Dr. Schönholz commented, “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. 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.”

Gore stated that its carotid stent design leverages the company's 35 years of clinical experience with expanded polytetrafluoroethylene; the carotid stent is a next-generation device designed to integrate the company's 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 the carotid vasculature. The new Gore device combines the flexible properties of a traditional open-cell nitinol stent design with a 500-µm pore size expanded polytetrafluoroethylene 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, noted the company.