FOR IMMEDIATE RELEASE
New Procedure Designed to Help Safely Open Blocked Carotid Arteries Less Invasively
September 17, 2013 – Austin, Texas – Cardiothoracic and Vascular Surgeons is the first in Texas to enroll patients 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. Dr. Mazin Foteh and Dr. Jeffrey Apple, board-certified vascular surgeons, performed the procedure on two patients.
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 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.
Cardiothoracic and Vascular Surgeons was selected as one of 25 centers around the world participating in the trial, which is expected to enroll 140 patients. The trial 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 potentially offers the same safety profile as traditional surgery is exciting. 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,” Dr. Apple said.
In a European study (PROOF) performed last year, the Silk Road procedure demonstrated very 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.
“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. Foteh, ROADSTER investigator with Cardiothoracic and Vascular Surgeons. “We are proud to contribute to this important research and potentially find a new treatment alternative.”