Physicians at University Hospitals Case Medical Center enrolled their first patients in the ROADSTER Study, a global, multicenter clinical trial evaluating a novel, less-invasive procedure to help clear blockages in carotid arteries and prevent strokes.
Every year, more than 300,000 people in the United States are diagnosed with blockages, or plaques in their carotid artery. If left untreated, these blockages can slow or even stop blood flow to the brain, causing a potentially disabling stroke, also known as a "brain attack."
Current treatment options include an open surgery known as carotid endarterectomy (CEA) and a minimally invasive alternative known as carotid artery stenting (CAS). Both procedures have been shown to effectively treat the blockage and reduce a patient's risk of stroke. However, each option has limitations for patients. CEA involves a large incision along the neck and carries a risk of surgical complications. CAS is less invasive, but in some studies, has not been as effective in preventing strokes as CEA.
The ROADSTER trial is investigating the safety and efficacy of the Silk Road System, in high surgical risk patients. The new system is designed to combine the advantages of both CEA and CAS in a procedure called Transcarotid Stenting with Dynamic Flow Reversal, also known as the Silk Road procedure.
Vik Kashyap, MD, Division Chief of Vascular Surgery at UH Case Medical Center's Harrington Heart & Vascular Institute and Professor of Surgery at Case Western Reserve University School of Medicine, is leading the trial for the hospital which was selected as one of 25 centers around the world participating. The trial, which is expected to enroll 140 patients, is intended to support FDA clearance of the Silk Road system in the U.S.
"The potential to treat carotid disease with a less invasive method that potentially offers the same safety profile as traditional surgery is exciting," said Dr. Kashy
|Contact: Mike Ferrari|
University Hospitals Case Medical Center