NCT07455747

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 TCAR in patients with extracranial carotid artery disease are inadequately reported.

Detailed description

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.

Conditions

• Extracranial Carotid Artery Disease
• TCAR
• Transcarotid Artery Revascularization

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2030-04-01
• First posted: 2026-03-06
• Last updated: 2026-04-14