Clinical trialNCT05845710CompletedInterventional

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

SponsorContego Medical, Inc.Enrollment178Carotid Artery DiseasesCarotid Stenosis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

D. Christopher Metzger, MD
OhioHealth Research Institute
Principal Investigator
clinicaltrials.gov ↗
Sean Lyden, MD
The Cleveland Clinic
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

32 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

France

Hopital Marie Lannelongue
Le Plessis-Robinson, France
Gh Paris St. Joseph
Paris, France

United States

Honor Health
Scottsdale, Arizona, United States
Hartford Hospital
Hartford, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
Mount Sinai Vascular Institute
Miami Beach, Florida, United States
Adventhealth Orlando
Orlando, Florida, United States
Indiana University Methodist Hospital
Indianapolis, Indiana, United States
Southcoast Health
New Bedford, Massachusetts, United States
Mclaren Center for Research and Innovation
Bay City, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Sisters of Charity Hospital
Buffalo, New York, United States
University at Buffalo Neurosurgery - Jacobs Institute
Buffalo, New York, United States
Northwell Health
Lake Success, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Unc Hospital
Chapel Hill, North Carolina, United States
Atrium Health - Sanger Heart and Vascular
Charlotte, North Carolina, United States
North Carolina Heart and Vascular Research
Raleigh, North Carolina, United States
Trihealth (bethesda North Hospital)
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohiohealth Research Institute
Columbus, Ohio, United States
St. Francis Hospital
Tulsa, Oklahoma, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
St. David'S Healthcare
Austin, Texas, United States
Baylor Scott and White Research Institute
Dallas, Texas, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 5 Oct 2023
Primary completion: 12 Aug 2025
Completion: 12 Aug 2025
Last update posted: 6 Mar 2026
Registered enrollment: 178
Registry id: NCT05845710

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.