Boston Scientific Corporation
The ENTRUST registry's objective is to collect real-world data (RWD) and health economic data on the ENROUTE™ Transcarotid Neuroprotection System (ENROUTE™ Transcarotid NPS), including populations in which outcomes of Transcarotid Artery Revascularization (TCAR) in patients with extracranial carotid artery disease are inadequately reported.
A global prospective, single-arm, non-randomized, open-label, observational/non-interventional, multi-center registry to collect Real-World Data for TCAR procedure, including health economic data.
Inclusion Criteria: * Patient is ≥ 18 years of age\* * Written informed consent (patient data-release form) * Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease and specified in the Registry Enrollment Guide(s). * Refer to the Registry Enrollment Guide for details on enrollment restrictions based on patient age Exclusion Criteria: * Life expectancy of \< 1 year or patient is unlikely to derive net clinical benefit from carotid revascularization. * Patient has primary,…
ENROUTE™ Transcarotid NPS AND ENROUTE™ Transcarotid Stent System. Additionally, ENROUTE™ Transcarotid NPS AND any commercially available Boston Scientific stent marketed for treatment of carotid artery disease may be added upon commercial availability.
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