Silk Road Medical’s ROADSTER 3 Study: A Long-Term Look at Carotid Revascularization

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 treated with Silk Road Medical’s ENROUTE Transcarotid Stent System and Neuroprotection System. This study is significant as it assesses the effectiveness and safety of these systems in patients at standard risk for adverse events from carotid endarterectomy.

Intervention/Treatment: The study focuses on the Transcarotid Artery Revascularization (TCAR) procedure, which uses the FDA-cleared ENROUTE Transcarotid Neuroprotection System and the FDA-approved ENROUTE Transcarotid Stent. This intervention is designed to revascularize the carotid artery, potentially reducing the risk of stroke in patients with carotid artery disease.

Study Design: This is an observational, case-only, prospective study. It is open-label and single-arm, meaning all participants receive the same treatment without a control group. The primary purpose is to observe long-term outcomes in patients who have undergone the TCAR procedure.

Study Timeline: The study began on July 31, 2024, with its primary completion date yet to be announced. The last update was submitted on June 24, 2025. These dates are crucial for tracking the study’s progress and anticipating when results might influence market dynamics.

Market Implications: The ongoing study could impact Silk Road Medical’s stock performance positively if results demonstrate favorable long-term outcomes, enhancing investor confidence. As the medical device industry is competitive, successful results could position Silk Road Medical favorably against competitors in the carotid revascularization market.

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