Silk Road Medical Begins ROADSTER 3 Postapproval Study of TCAR System in Patients at Standard Surgical Risk

September 7, 2022—Silk Road Medical, Inc. announced enrollment of the first patient in the ROADSTER 3 postapproval study of the company’s system for transcarotid artery revascularization (TCAR) of patients at standard surgical risk with carotid artery disease in real-world treatment.

The procedure was performed by Animesh Rathore, MD, at Sentara Norfolk General Hospital in Norfolk, Virginia. With the enrollment of the first patient, the launch of the ROADSTER 3 study achieves the first of a series of milestones set forth by the FDA’s postapproval requirements, noted the company.

According to the company, ROADSTER 3 is a prospective, multicenter, single-arm study that will enroll a maximum of 400 per-protocol patients at up to 60 sites.

The primary endpoints of the study include a hierarchical composite of major adverse events (death, stroke, or myocardial infarction) through 30-days postprocedure, plus ipsilateral stroke from day 31 to 365 postprocedure. A key secondary endpoint is the incidence of cranial nerve injury within 30 days postprocedure.

Rasesh M. Shah, MD, who is site Principal Investigator at Sentara Norfolk General Hospital for the ROADSTER 3 study, commented in the company’s press release, “Positive outcomes in high-surgical-risk patients treated with TCAR have been well documented over the years. A study to confirm the efficacy of TCAR in the treatment of standard-surgical-risk patients is incredibly valuable as the physician community looks to improve its overall approach to treating carotid patients, independent of their surgical risk. I’m honored to be participating in this first-ever study to collect prospective data on the treatment of a recently approved patient population using TCAR.”

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

Silk Road Medical announced FDA approval of the expanded indications for TCAR to include patients at standard risk on May 2, 2022. On June 15, the company announced the plans for ROADSTER 3.

The ROADSTER 3 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.