August 19, 2020
Early Outcomes Reported From Postmarket ROADSTER 2 Study of Silk Road Medical’s Enroute TCAR Devices
August 19, 2020—Silk Road Medical, Inc. announced that early outcomes from the ROADSTER 2 postmarket study of transcarotid artery revascularization (TCAR) have been published by Vikram S. Kashyap, MD, et al in Stroke (2020;51:2620-2629).
ROADSTER 2 is a prospective multicenter study designed to assess the real-world usage of Silk Road Medical’s Enroute transcarotid stent when used with the company’s Enroute transcarotid neuroprotection system by physicians of varying experience with the TCAR procedure. The study enrolled 692 patients at high surgical risk in the FDA analysis population across 43 sites, of whom 62% were treated by physicians new to TCAR.
According to the company, the study findings demonstrate that TCAR in patients with significant carotid artery disease results in low stroke and combined stroke and death rates that are comparable to carotid endarterectomy (CEA). In addition, ROADSTER 2 showed lower rates of acute and persistent cranial nerve injury than what is typically observed for patients receiving CEA.
Dr. Kashyap, who is Chief of Vascular Surgery and Endovascular Therapy at the Harrington Heart and Vascular Institute, University Hospitals Case Medical Center in Cleveland, Ohio, serves as the National Co-Principal Investigator of ROADSTER 2.
“The peer-reviewed publication of these data in Stroke reinforces the effectiveness of TCAR as an optimal treatment option for patients with carotid artery disease and high surgical risk factors,” commented Dr. Kashyap in the company’s announcement. “TCAR continues to show a low stroke and death rate with lower rates of cranial nerve injury compared to CEA, which we believe will further instill physician confidence and adoption.”