Silk Road Medical’s ROADSTER 3 Study: A Promising Update for Long-Term Outcomes

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 who were treated with the ENROUTE Transcarotid Stent System (TSS) and ENROUTE Transcarotid Neuroprotection System (NPS). This study is significant as it assesses the effectiveness and safety of these interventions in patients at standard risk for adverse events from carotid endarterectomy.

Intervention/Treatment: The study focuses on the Transcarotid Artery Revascularization (TCAR) procedure, which involves carotid artery revascularization using the FDA-cleared ENROUTE Transcarotid NPS and the FDA-approved ENROUTE Transcarotid Stent. These interventions are designed to minimize the risk of stroke during carotid artery procedures.

Study Design: This is an observational, case-only, prospective study. It is open-label and single-arm, meaning all participants receive the same treatment, and there is no blinding involved. The primary purpose is to observe long-term outcomes in a real-world setting.

Study Timeline: The study began on July 31, 2024, with its primary completion and estimated completion dates yet to be announced. The last update was submitted on June 24, 2025. These dates are crucial as they guide investors on the study’s progress and potential upcoming results.

Market Implications: This study update could positively influence Silk Road Medical’s stock performance by demonstrating the long-term efficacy and safety of its products. Positive results may enhance investor confidence and market position, especially in comparison to competitors in the carotid intervention market.

The study is currently ongoing, with further details available on the ClinicalTrials portal.