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A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach

NCT06653387 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-31

No results posted yet for this study

Summary

The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.

Conditions

  • Carotid Artery Diseases

Interventions

DEVICE

CGuard Prime 80cm stent system

This study is single arm looking at the technical success of the CGuard Prime 80cm stent system when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • TriHealth Inc.

    collaborator OTHER

  • NAMSA

    collaborator OTHER

  • InspireMD

    lead INDUSTRY

Principal Investigators

  • Patrick J. Geraghty, MD · Washington University School of Medicine

  • Patrick E. Muck, MD · TriHealth Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2026-11-20
Completion
2027-11-20
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06653387 on ClinicalTrials.gov