Silk Road Medical has announced enrolment of the first patient in ROADSTER 3, which the company claims is the the first prospective, multicentre, single-arm study to assess real-world treatment of standard surgical risk patients with carotid artery disease using transcarotid artery revascularisation (TCAR). The procedure was performed by Animesh Rathore at Sentara Norfolk General Hospital in Norfolk, USA.
ROADSTER 3 is a post-approval study designed to prospectively evaluate real-world use of TCAR among standard surgical risk patients and will enrol a maximum of 400 per protocol patients across up to 60 sites. The primary endpoints include a hierarchical composite of major adverse events (death, stroke, or myocardial infarction) through 30 days post-procedure, plus ipsilateral stroke from day 31 to 365 post-procedure. The incidence of cranial nerve injury within 30 days post-procedure is a key secondary endpoint. With the enrolment of the first patient, the launch of the ROADSTER 3 study achieves the first of a series of milestones set forth by the US Food and Drug Administration (FDA)’s post-approval requirements.
“The successful enrolment of the first patient in ROADSTER 3 by Dr Rathore and the team at Sentara Norfolk General Hospital represents a significant milestone in our efforts to extend the body of clinical evidence supporting TCAR in this expanded patient population,” said Erica Rogers, president and chief executive officer of Silk Road Medical. “Our goal with the study is to confirm the safety and efficacy of TCAR in a prospective real-world standard surgical risk patient population to firmly establish this less invasive treatment option for all carotid stenosis patients.”
“Positive outcomes in high surgical risk patients treated with TCAR have been well documented over the years,” said Rasesh M Shah, site principal investigator at Sentara Norfolk General Hospital for the ROADSTER 3 study. “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 am honoured to be participating in this first ever study to collect prospective data on the treatment of a recently approved patient population using TCAR.”