Silk Road Medical today announced a post-market study to evaluate the transcarotid artery revascularisation (TCAR) system in the treatment of standard surgical risk patients with carotid artery disease.
The ROADSTER 3 study will fulfil the US Food and Drug Administration’s (FDA) condition of approval for the recent expansion of labelling for Silk Road’s Enroute transcarotid stent system, which now includes patients at high and standard risk of complications from carotid endarterectomy (CEA) as of May 2022.
“ROADSTER 3 presents a significant opportunity to further build on the substantial clinical evidence supporting TCAR,” said Erica Rogers, president and CEO of Silk Road. “Strong clinical evidence has always been the backbone of our strategy to drive adoption, and to ensure every eligible patient has access to a less invasive treatment option.”
This prospective, multicentre, single-arm study is designed to assess the real-world treatment of standard surgical risk patients with carotid artery disease using TCAR, targeting a maximum enrolment of 400 patients across approximately 50 sites. Primary endpoints include a 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.
“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,” said co-national principal investigator Jeffrey Jim (Allina Health Minneapolis Heart Institute, Minneapolis, USA). “I am honoured 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.”
Jim is set to be joined by co-national principal investigators of the study, Marc Schermerhorn (Beth Israel Deaconess Medical Center, Boston, USA) and Meghan Dermody (Lancaster General Hospital, Lancaster, USA).