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 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, recurrent or metastatic malignancy and does not have independent assessment of life expectancy of ≥5 years performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.

The intended population for the ENTRUST Registry are real-world patients who are treated with ENROUTE™ Transcarotid NPS in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease. Efforts will be made to include study centers with varied patient populations in order to enroll populations previously not represented in carotid artery disease trials.