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Cardiothoracic and Vascular Surgeons, in Collaboration with Heart Hospital of Austin, First in Texas to Enroll and Treat Patients In Global Clinical Trial for New Carotid Artery Treatment

October 3, 2013

New Procedure Designed to Allow Physicians to Open Blocked Carotid Arteries Safely and Less Invasively

AUSTIN, Texas, Oct. 3, 2013 /PRNewswire/ — On Sept. 12, 2013, physicians with Cardiothoracic and Vascular Surgeons 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(TM)( )System for the treatment of carotid artery disease. Mazin I. Foteh, M.D., a vascular surgeon with Cardiothoracic and Vascular Surgeons and principal investigator for the trial, performed the first procedure in Texas at Heart Hospital of Austin.

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 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, 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,” Dr. 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,” Dr. 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 a European study, called 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.

The carotid arteries are a pair of blood vessels in the neck that carry blood from the heart to the head and brain. These vessels can become narrowed or blocked by a build up of plaque called a stenosis. A stenosis may lead to a stroke, which happens when blood flow to a part of the brain is stopped. If blood flow is stopped for longer than a few seconds, the brain cannot get blood and oxygen. Brain cells can die, causing permanent damage.

Media Contacts:
Erin Ochoa or Kristin Marcum
Elizabeth Christian & Associates Public Relations
512.472.9599

SOURCE Heart Hospital of Austin


Source: PR Newswire