Silk Road Medical announces final results for ROADSTER-2 study
Silk Road Medical announced final results for the company's ROADSTER-2 post-marketing study evaluating real world use of the ENROUTE Neuroprotection and Stent Systems in TransCarotid Artery Revascularization procedures. The study demonstrated compelling patient outcomes with low stroke and combined stroke and death rates of 0.6% and 0.8%, respectively, in 632 high surgical risk patients enrolled across 42 sites. 70% of patients enrolled in the study were from physicians new to TCAR. Designed as a follow-on study to the pivotal ROADSTER trial, ROADSTER-2 is a prospective, multi-center study designed to assess the real-world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the TCAR procedure. The study met its primary endpoint of procedural success, defined as acute device and technical success in the absence of stroke, death or myocardial infarction at 30 days, at 97.9%. Significant findings from the study showed TCAR to have low rates of 30-day major adverse events. In addition, ROADSTER-2 showed lower rates of acute and permanent cranial nerve injury than is typically observed for patients receiving carotid endarterectomy, the current standard of care.