Silk Road Medical’s ROADSTER 3 Study Update: Long-Term Outcomes in Focus

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

Study Overview: The ROADSTER 3 Extended Follow-up Sub-Study, officially titled ‘Long-Term Follow-up Study of ROADSTER 3 Patients,’ aims to evaluate the long-term outcomes of participants from the ROADSTER 3 study. These participants were treated with the ENROUTE Transcarotid Stent System (TSS) and the ENROUTE Transcarotid Neuroprotection System (NPS). This study is significant as it seeks to provide insights into the long-term safety and efficacy of these interventions for patients at standard risk for adverse events from carotid endarterectomy.

Intervention/Treatment: The intervention being tested is the Transcarotid Artery Revascularization (TCAR) procedure. This involves carotid artery revascularization using the FDA-cleared ENROUTE Transcarotid NPS and the FDA-approved ENROUTE Transcarotid Stent, aimed at reducing the risk of stroke in patients with carotid artery disease.

Study Design: This is an observational study with a case-only model and a prospective time perspective. It is an open-label, single-arm, multi-center post-market study focusing on patients who underwent carotid revascularization with the specified systems.

Study Timeline: The study began on July 31, 2024, with the primary completion and estimated completion dates yet to be announced. The last update was submitted on July 27, 2025. These dates are crucial for tracking the study’s progress and any emerging data that could impact clinical practices and market dynamics.

Market Implications: This study update could influence Silk Road Medical’s stock performance positively, as successful long-term outcomes may enhance investor confidence and market positioning. It could also impact the competitive landscape, as other companies in the carotid revascularization market may need to respond to the findings.

The study is ongoing, and further details are available on the ClinicalTrials portal.