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NOT YET RECRUITING
NCT07458243

Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

The study is a prospective, non-randomized, single-arm, multi-center post-market registry. To confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese population

Official title: A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-10-31

Completion Date

2027-09-30

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DEVICE

transcarotid artery revascularization

The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below: * Adequate femoral venous access * Common carotid artery reference diameter of at least 6 mm * Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography.