MedTrace Logo

Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)

NCT05845710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2026-03-06

No results posted yet for this study

Summary

The PERFORMANCE III study is a prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the treatment of carotid artery stenosis in subjects at elevated risk for carotid endarterectomy (CEA).

Eligible patients greater than or equal to 20 years of age and less than or equal to 82 years of age, are those who have been diagnosed with either de-novo atherosclerotic or post CEA restenotic lesion(s) in the internal carotid arteries (ICA) or at the carotid bifurcation with greater than or equal to 50% stenosis if symptomatic or greater than or equal to 70% stenosis if asymptomatic.

Conditions

  • Carotid Stenosis
  • Carotid Artery Diseases

Interventions

DEVICE

Neuroguard IEP Direct System

carotid artery stenting, direct access with blood flow redirection

Sponsors & Collaborators

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • CardioMed Device Consultants, LLC

    collaborator INDUSTRY

  • Advance Research Associates

    collaborator OTHER

  • iMedNet

    collaborator UNKNOWN

  • AG Mednet

    collaborator UNKNOWN

  • Contego Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Sean Lyden, MD · The Cleveland Clinic

  • D. Christopher Metzger, MD · OhioHealth Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2025-08-12
Completion
2025-08-12
FDA Device
Yes

Countries

  • United States
  • France

Study Locations

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 NCT05845710 on ClinicalTrials.gov