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Carotid Artery Treatment

Michigan Vascular Center / McLaren Flint

Among The First To Enroll In Global Clinical Trial For New Carotid Artery Treatment

New Procedure Designed to Help Safely Open Blocked Carotid Arteries Less Invasively

Physicians at Michigan Vascular Center image
Physicians at Michigan Vascular Center/ McLaren Flint enrolled their 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 in high surgical risk patients. Vascular surgeons, Robert Molnar, MD and Russell Becker, DO, performed the procedure.

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. The 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 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.

Michigan Vascular Center 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," said Dr. Molnar, ROADSTER investigator at Michigan Vascular Center.

"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 (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 neuroprotection, with a very low rate of localized brain injury.

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.