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NCT Number: NCT07455747

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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.

Primary outcomes

  1. Major Adverse Events

    Time frame: within 30 days (death, stroke, or MI); within 31-365 days (ipsilateral stroke)

    Major Adverse Events (MAEs) defined as a composite outcome including any death, stroke, or myocardial infarction (MI) within 30 days of the index procedure and ipsilateral stroke within 31 days to 365 days of the index procedure. No pre-specified endpoints or formal tests of hypotheses are proposed. Analyses will be performed for exploratory purposes.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Hammer

CONTACT

[email protected]

952-356-2730

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: ENTRUST

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Mar 6, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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