Recruiting

ENROUTE™ Transcarotid NPS

Sponsor:

Boston Scientific Corporation

Code:

NCT07455747

Conditions

Extracranial Carotid Artery Disease

TCAR

Transcarotid Artery Revascularization

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Extracranial Carotid Artery Disease

TCAR

Transcarotid Artery Revascularization

Study ID

NCT07455747

Start date

Aug 19, 2026

Status verified date

Sep, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Clinical Cohort

All enrolled patients are included in the Clinical Cohort. Patients will complete assessments per standard of care through 12-months in North America.

Extended Clinical Cohort

Patients who elect to be followed through 36 months are included in the Extended Clinical Cohort. Patients will complete assessments per standard of care through 36-months in North America.

Interventions

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

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 outcome measure

  • Major Adverse Events [ Time Frame: within 30 days (death, stroke, or MI); within 31-365 days (ipsilateral stroke) ]

Central Contacts and Locations

Central contacts

Erin Hammer

952-356-2730Erin.Hammer@bsci.com

Locations

St. Luke's Episcopal-Presbyterian Hospital

Recruiting

St Louis, Missouri, United States, 63141

More Information

Sponsor

Boston Scientific Corporation

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • Carotid Artery Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Boston Scientific Corporation on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.