5,000-Patient registry to test new artery device in Real-World use
NCT ID NCT07455747
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study will follow 5,000 adults with carotid artery disease who receive a treatment called TCAR using the ENROUTE system. The goal is to see how safe and effective the device is in real-world settings, especially for groups not well-studied before. Researchers will track major events like stroke, heart attack, or death within a year of the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 5,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.