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Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT05845710

Public ClinicalTrials.gov record NCT05845710. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 10:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Protection Against Emboli During caRotid Artery Stenting Using a Neuroguard IEP® Direct 3-in-1 Delivery System Comprised oF a pOst-dilation Balloon, integRated eMbolic Filter, and A Novel Carotid stEnt - the PERFORMANCE III Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05845710
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Contego Medical, Inc.
Industry
Enrollment
178 participants

Conditions and interventions

Eligibility (public fields only)

Age range
20 Years to 82 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 5, 2023 (Actual)
Primary completion
Aug 12, 2025 (Actual)
Completion
Aug 12, 2025 (Actual)
Last update posted
Mar 6, 2026

2023 – 2025

United States locations

U.S. sites
30
U.S. states
17
U.S. cities
28
Facility City State ZIP Site status
Honor Health Scottsdale Arizona 85258 —
Hartford Hospital Hartford Connecticut 06102 —
MedStar Washington Hospital Center Washington D.C. District of Columbia 20010 —
Manatee Memorial Hospital Bradenton Florida 34208 —
Delray Medical Center Delray Beach Florida 33484 —
Mount Sinai Vascular Institute Miami Beach Florida 33140 —
AdventHealth Orlando Orlando Florida 32803 —
Indiana University Methodist Hospital Indianapolis Indiana 46202 —
Southcoast Health New Bedford Massachusetts 02720 —
McLaren Center for Research and Innovation Bay City Michigan 48708 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
University at Buffalo Neurosurgery - Jacobs Institute Buffalo New York 14203 —
Sisters of Charity Hospital Buffalo New York 14214 —
Northwell Health Lake Success New York 11042 —
Mount Sinai Medical Center New York New York 10029 —
UNC Hospital Chapel Hill North Carolina 27514 —
Atrium Health - Sanger Heart and Vascular Charlotte North Carolina 28204 —
North Carolina Heart and Vascular Research Raleigh North Carolina 27607 —
TriHealth (Bethesda North Hospital) Cincinnati Ohio 45242 —
Cleveland Clinic Cleveland Ohio 44195 —
OhioHealth Research Institute Columbus Ohio 43214 —
St. Francis Hospital Tulsa Oklahoma 74136 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
Medical University of South Carolina Charleston South Carolina 29425 —
Prisma Health Greenville South Carolina 29615 —
Vanderbilt University Nashville Tennessee 37232-5545 —
St. David's Healthcare Austin Texas 78756 —
Baylor Scott and White Research Institute Dallas Texas 75246 —
UT Southwestern Medical Center Dallas Texas 75390 —
Sentara Norfolk General Hospital Norfolk Virginia 23507 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05845710, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 6, 2026 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05845710 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →