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NCT07455747Recruiting

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

Boston Scientific Corporation

Start Date

8/19/2026

Completion Date

4/1/2030

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease

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Conditions

Extracranial Carotid Artery DiseaseTCARTranscarotid Artery Revascularization

Locations

St. Luke's Episcopal-Presbyterian Hospital

St Louis, Missouri 63141

United States