Silk Road Medical ((SILK)) announced an update on their ongoing clinical study.
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Silk Road Medical is conducting the ROADSTER 3 Study, officially titled ‘Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease.’ This study aims to evaluate the real-world application of the ENROUTE Transcarotid Stent and Neuroprotection System in patients at standard risk for complications from carotid endarterectomy. The significance lies in its potential to offer a safer alternative for carotid revascularization.
The intervention being tested is the Transcarotid Artery Revascularization (TCAR) procedure, which uses the FDA-cleared ENROUTE Transcarotid Neuroprotection System and the FDA-approved ENROUTE Transcarotid Stent. This procedure is intended to treat carotid artery disease by revascularizing the artery while minimizing the risk of stroke during the procedure.
The study is observational, focusing on a single group of standard-risk patients requiring carotid intervention. It is designed as a prospective case-only study, meaning it observes outcomes in patients who receive the TCAR procedure without a comparison group or blinding.
The study began on September 1, 2022, with an estimated completion date of June 24, 2025. The primary completion date is not specified, but the last update was submitted in June 2025, indicating ongoing progress and adjustments.
This study update could potentially influence Silk Road Medical’s stock performance positively if the results demonstrate safety and efficacy, enhancing investor confidence. Competitors in the carotid revascularization market may feel pressure to innovate or improve their offerings in response.
The ROADSTER 3 Study is currently active but not recruiting, with further details available on the ClinicalTrials portal.