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CGUARDIANS III IDE Pivotal Trial

NCT07277296 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-12-11

No results posted yet for this study

Summary

This is a prospective, multi-center, single-arm, pivotal study. The objective of this study is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during Transcarotid Artery Revascularization procedures using the CGuard Prime Carotid Stent System 80 in the treatment of carotid artery stenosis in patients at high risk for complications from CEA.

Conditions

  • Carotid Artery Stenosis

Interventions

DEVICE

SwitchGuardTM NPS

The CGuard Prime™ 80 will be used in conjunction with the SwitchGuard™ NPS for the carotid artery stenting implantation procedure that will be performed by physician investigators experienced with transcarotid artery revascularization.

Sponsors & Collaborators

  • InspireMD

    lead INDUSTRY

Principal Investigators

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

  • Patrick Edward Muck, MD · TriHealth Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-02-01
Completion
2028-02-01
FDA Device
Yes

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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 NCT07277296 on ClinicalTrials.gov