Silk Road Medical Enroute System Will Be Evaluated in Postmarket ROADSTER 3 Study of TCAR for Standard-Risk Patients

June 15, 2022—Silk Road Medical, Inc. announced a prospective study to evaluate the company’s TCAR system for transcarotid artery revascularization in the treatment of standard surgical risk patients with carotid artery disease.

According to the company, the postmarket ROADSTER 3 study will fulfill the FDA’s condition of approval for the recent expansion of labeling for the Silk Road Enroute transcarotid stent system, which now includes patients at high and standard risk of complications from carotid endarterectomy (CEA).

TCAR with the company’s Enroute transcarotid stent is intended to be used in patients at high risk and standard risk for complications from CEA, in conjunction with the Enroute transcarotid neuroprotection system during the procedure.

Silk Road Medical advised that ROADSTER 3 is a prospective, multicenter, single-arm study designed to assess the real-world treatment of standard surgical risk patients with carotid artery disease using TCAR. The study targets a maximum enrollment of 400 patients across approximately 50 sites. The study’s primary endpoints include a composite of major adverse events (death, stroke, or myocardial infarction) through 30 days postprocedure, plus ipsilateral stroke from day 31 to 365 postprocedure. The incidence of cranial nerve injury within 30 days postprocedure is a key secondary endpoint.

The study is led by co-National Principal Investigators Marc L. Schermerhorn, MD, who is Chief, Division of Vascular and Endovascular Surgery at Beth Israel Deaconess Medical Center in Boston, Massachusetts; Meghan Dermody, MD, who is Chief, Division of Vascular Surgery at Lancaster General Hospital in Lancaster, Pennsylvania; and Jeffrey Jim, who is Chief of Vascular and Endovascular Surgery at Allina Health Minneapolis Heart Institute in Minneapolis, Minnesota.

“This study is providing physicians with the unique opportunity to participate in a first-ever prospective study to demonstrate the safety and efficacy of TCAR among the standard surgical risk patient population,” commented Dr. Jim in Silk Road Medical’s press release. “I’m honored to be included as Principal Investigator and eagerly await clinical results that will help expand a less invasive treatment option for carotid patients regardless of their surgical risk.”