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

NCT07458243 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-05-28

No results posted yet for this study

Summary

The study is a prospective, non-randomized, single-arm, multi-center 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

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07458243 on ClinicalTrials.gov