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

Conditions

• Extracranial Carotid Artery Disease
• TCAR
• Transcarotid Artery Revascularization

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

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 — 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.

Study Details

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.

Key Dates

First listed

Mar 6, 2026

Start date

Aug 19, 2026

Status verified

Sep 2026

Primary completion

May 31, 2028

Completion

Apr 30, 2030

Study Design

Enrollment

5,000 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

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

Central Contacts

• Erin Hammer
  952-356-2730
  [email protected]

Locations (1)

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