Silk Road Medical today announced a post-market study to evaluate the transcarotid artery revascularization (TCAR) system in the treatment of standard surgical risk patients with carotid artery disease.
The ROADSTER 3 study will fulfill 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.
This prospective, multicenter, 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 enrollment 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, MD, from Allina Health Minneapolis Heart Institute, Minneapolis. “I am 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.”