Enrollment Completed in Pivotal ROADSTER Trial for Silk Road's Enroute CAS Device

July 16, 2014—Silk Road Medical, Inc. announced the completion of enrollment in the pivotal ROADSTER study of the company’s Enroute transcarotid neuroprotection system (NPS). The Enroute NPS is designed to protect the brain from a stroke during carotid angioplasty and stenting via a mechanism to divert debris by temporarily reversing blood flow. 

According to the company, the ROADSTER trial is studying the treatment of carotid stenosis by placing a stent via direct access to the common carotid artery. The Silk Road procedure is designed to reduce the surgical risks of carotid endarterectomy that include nerve damage, bleeding, scarring, and infection. 

Data from the trial will be used to support US Food and Drug Administration 510(k) clearance of the Enroute transcarotid NPS as well as premarket approval of the Enroute transcarotid stent system. The company advised that the Enroute NPS is limited by law to investigational use in the United States. The Enroute transcarotid stent system is not currently available in the United States. Both the Enroute transcarotid NPS and stent system have been granted European CE Mark approval.

In the company’s press release, Richard Cambria, MD, commented, “Historically, there has not been a safe and effective minimally invasive procedure that could hold up to the clinical outcomes established by carotid endarterectomy. This new procedure may be it.”

Dr. Cambria serves as the national coprincipal investigator for the ROADSTER trial. He is Chief of the Division of Vascular and Endovascular Surgery at Massachusetts General Hospital and the Robert R. Linton, MD, Professor of Vascular and Endovascular Surgery at the Harvard Medical School. Dr. Cambria advised that the ROADSTER results from his center will be announced at the Veith symposium in November in New York.

Christopher Kwolek, MD, Director of the Vascular and Endovascular training program at Massachusetts General Hospital and Chief of Vascular Surgery at Newton Wellesley Hospital in Massachusetts, is also national coprincipal investigator for the ROADSTER trial. Dr. Kwolek commented in Silk Road’s announcement, “The ROADSTER trial included an elite, multidisciplinary group of physicians across the United States and Europe with vast experience in treating carotid disease. Similar to important endovascular innovations in aortic aneurysms and peripheral arterial disease, this new minimally invasive procedure will be an important step forward in the treatment of carotid artery disease for the vascular specialist.”