Silk Road Medical Completes Key Study on Carotid Artery Treatment

Silk Road Medical ((SILK)) announced an update on their ongoing clinical study.

Silk Road Medical has recently completed a clinical study titled ‘Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease,’ also known as the ROADSTER 3 Study. The study aims to evaluate the real-world application of the ENROUTE Transcarotid Stent and Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy, highlighting its significance for patient care and treatment efficacy.

The intervention tested in this study is the Transcarotid Artery Revascularization (TCAR) procedure. This involves carotid artery revascularization using the FDA-cleared ENROUTE Transcarotid Neuroprotection System and the FDA-approved ENROUTE Transcarotid Stent, designed to improve patient outcomes by reducing the risk of stroke during carotid artery procedures.

The study was observational in design, focusing on a case-only model with a prospective time perspective. It was an open-label, single-arm, multi-center study conducted across 30-60 sites in the United States, enrolling up to 400 patients who required carotid artery revascularization.

The study began on September 1, 2022, and was recently completed, with the last update submitted on July 27, 2025. These dates are crucial as they mark the timeline for data collection and analysis, providing a framework for understanding the study’s progress and outcomes.

This update may have significant market implications, potentially boosting Silk Road Medical’s stock performance and investor confidence due to the successful completion of the study. The results could also impact the competitive landscape, influencing other companies in the carotid artery treatment market.

The ROADSTER 3 Study is now complete, with further details available on the ClinicalTrials portal.