October 4, 2013 — On Sept. 12, physicians with Cardiothoracic and Vascular Surgeons, Texas at the Heart Hospital of Austin, enrolled and successfully treated the first patient in the Roadster study, a global, multicenter clinical trial evaluating the safety and efficacy of the Silk Road System for the treatment of carotid artery disease. Mazin I. Foteh, M.D., a vascular surgeon and principal investigator for the trial, performed the first procedure.
Every year, more than 300,000 people in the United States are diagnosed with blockages, or plaque, in their carotid artery. If left untreated, these blockages can slow or stop blood flow to the brain, causing a potentially disabling stroke.
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, it has not been as effective in preventing strokes as CEA.
The Roadster trial is investigating a new system 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. This procedure incorporates proven surgical techniques to protect the brain from stroke risk during carotid stenting. It allows physicians to deliver a stent directly from the neck, potentially offering a safer delivery route than the groin, which is typically used in CAS procedures. Another unique aspect of the system is the ability to temporarily reduce blood flow during the procedure, which is intended to continuously protect the brain during the intervention. The Silk Road procedure is minimally invasive and can be performed using local anesthesia.
"This procedure is the first of its kind in combining the safety advantages of traditional surgery with the more patient-friendly advantages of stenting," Foteh said. "We are proud to contribute to this important research and potentially find a new treatment alternative."
The Silk Road procedure includes a combination of 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 redirects 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. The Silk Road procedure can significantly minimize recovery time and scarring for the patient.
Cardiothoracic and Vascular Surgeons was selected to be among 25 centers around the world to participate in this trial. The trial, which is expected to enroll a total of 140 patients, is intended to support FDA clearance of the Silk Road System in the United States.
"The potential to treat carotid disease with a less invasive method that is potentially as safe as traditional surgery is exciting," Foteh said. "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."
In the European PROOF study 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 protection with a very low rate of localized brain injury.
For more information, visit: www.silkroadmedical.com/clinical-trials/roadster