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Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease

Carotid Artery Diseases Clinical Trial

Official title:
Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease. The ROADSTER 3 Study

Clinical Trial Summary

The study objective is to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy

Clinical Trial Description

This is an open label, single arm, multi-center post-approval study for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and who are eligible for treatment using the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System. The study will enroll a maximum of 400 patients treated per protocol at 30-60 sites in the United States. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05365490
Study type Observational
Source Silk Road Medical
Contact Dipti Sahoo
Phone 669-271-0501
Email dsahoo@silkroadmed.com
Status Recruiting
Phase
Start date September 1, 2022
Completion date May 2025
View Details
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