Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System

Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System (ENTRUST)

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.