NCT07458243

Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-10-31
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2026-03-09
• Last updated: 2026-04-13

Regulatory

• FDA-regulated device study