NCT07455747 Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System
| NCT ID | NCT07455747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Scientific Corporation |
| Condition | Extracranial Carotid Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2026-08-19 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2026-08-19 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Angela H Martin, MD
PRINCIPAL INVESTIGATOR
Evansville Surgical Associates
Frequently Asked Questions
Who can join the NCT07455747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Extracranial Carotid Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07455747 currently recruiting?
Yes, NCT07455747 is actively recruiting participants. Contact the research team at Erin.Hammer@bsci.com for enrollment information.
Where is the NCT07455747 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT07455747 clinical trial?
NCT07455747 is sponsored by Boston Scientific Corporation. The principal investigator is Angela H Martin, MD at Evansville Surgical Associates. The trial plans to enroll 5,000 participants.