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. Kashyap. "Our goal is to treat the blockage with as little procedural risk as possible so that our patients can return to full and productive lives."
The innovative procedure draws upon proven surgical techniques to protect the brain from stroke risk during carotid stenting. It allows physicians to deliver a stent directly from the neck, offering a potentially safer delivery route than the groin, which is typically used in CAS procedures. Another unique aspect of the system is the ability to temporarily reverse blood flow during the procedure to ensure the patient's brain is fully protected at all times. The Silk Road procedure is minimally invasive and can be performed using local anesthesia.
In a European study (PROOF) performed last year, the Silk Road procedure demonstrated encouraging results. In a population of 75 patients, the results closely matched the outcomes demonstrated in numerous CEA studies and were better than the stroke outcomes reported in several CAS studies. The PROOF study also used a sensitive imaging test to determine how well the Silk Road System protected the brain from tiny plaque debris that can be displaced during CEA and CAS treatment and lodge in the brain. The imaging analysis indicated that the Silk Road system provided impressive neuroprotection, with a very low rate of localized brain injury.
"This procedure is first-of-its-kind in combining the safety advantages of traditional surgery with the more patient-friendly advantages of stenting," said Dr. Kashyap. "The reason we treat the neck is to prevent stroke but the biggest risk of the traditional procedures was causing a stroke during the operation from plaque breaking off and getting to the brain. This device significantly minimizes that risk and potentially could lead us to finding a new treatment alternative."
The study is funded by Silk Road Medical, developers of the transcarotid stenting with dynamic flow reversal system.
About University Hospitals
University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our health system is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. University Hospitals Case Medical Center is the 2012 recipient of the American Hospital Association – McKesson Quest for Quality Prize for its leadership and innovation in quality improvement and safety. For more information, go to http://www.uhhospitals.org
About the Silk Road System
The Silk Road procedure includes a combination direct carotid access sheath and dynamic flow reversal circuit (the Silk Road System) and a carotid stent. After a tiny incision is made at the neckline, the physician inserts a small tube, called a sheath, into the carotid artery. The sheath is connected to a device that temporarily re-directs blood flow away from the brain. Reversing the blood flow allows a physician to place a stent inside the blockage without risk of plaque breaking off and traveling up toward the brain. After the stent is placed successfully, flow reversal is turned off and blood flow resumes in its normal direction. Typically, the Silk Road procedure is performed under local anesthesia and significantly minimizes recovery time and scarring for the patient. Silk Road Medical is a private company based in Sunnyvale, California.