Loading clinical trials...

Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III) | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT05845710•Contego Medical, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

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 adverse events following carotid endarterectomy (CEA). The Neuroguard IEP Direct System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath. Eligible patients greater than or equal to 20 years of age and less than or equal to 80 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. Symptomatic subjects are defined as having stroke or transient ischemic attack (TIA) in the ipsilateral hemisphere supplied by the target vessel carotid lesion or ipsilateral transient monocular blindness (amaurosis fugax) within 180 days prior to the index procedure. Subjects will be followed for 30 days post index procedure with additional follow up for subjects having a stroke or cranial nerve injury.

Eligibility

Age

20 - 82 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 20 or ≤ 82 years of age.
•2. Subject is willing and capable of complying with and understands all study protocol requirements, including the specified follow-up visits, and can be contacted by telephone.
•3. Subject has signed a written informed consent form that has been approved by the local governing Institutional Review Board (IRB) of the respective clinical site.
•4. Subject is diagnosed with carotid artery stenosis treatable with carotid artery stenting via direct carotid access and is considered a high operative risk for carotid endarterectomy (CEA).
•5. Subject is diagnosed with either:
•1. Symptomatic carotid stenosis ≥ 50% as determined by angiography, CTA, or duplex ultrasound. Symptomatic is defined as having stroke, transient ischemic attack (TIA) in the ipsilateral hemisphere supplied by the target vessel carotid lesion or ipsilateral transient monocular blindness (amaurosis fugax) within 180 days prior to the procedure; or
•2. Asymptomatic carotid stenosis ≥ 70% as determined by angiography, CTA, or duplex ultrasound.
•6. Subject has a lesion located in the internal carotid artery (ICA) and/or common carotid artery (CCA).
•7. Subject has a modified Rankin Scale of ≤ 2 at the time of procedure.
•8. Females of child-bearing potential have a negative pregnancy test within 24 hours prior to the index procedure.
+25 more criteria

Exclusion Criteria

•1. Life expectancy of less than one year in the opinion of the investigator at the time of enrollment.
•2. Currently requiring an organ transplantation.
•3. An evolving acute stroke
•4. Anticipated or existing potential sources of emboli including left ventricular aneurysm, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area \< 1.0 cm2), endocarditis, moderate to severe mitral stenosis, known previously symptomatic patent foramen ovale (PFO), left atrial thrombus, any intracardiac mass.
•5. Deep being thrombosis (DVT) or pulmonary embolism (PE) treated within the past 12 months.
•6. Recently (\< 60 days) implanted heart valve.
•7. Subject has experienced any episode of paroxysmal atrial fibrillation or atrial flutter within the past 6 months or has a history of paroxysmal atrial fibrillation or atrial flutter requiring chronic anticoagulation.
•8. History of chronic atrial flutter or chronic atrial fibrillation.
•9. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, direct thrombin inhibitors, or anti-Xa agents within 14 days of the index procedure.
•10. Subject with a known hypercoaguable state.
+38 more criteria

Locations (32)

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

Key Dates

Start Date

October 5, 2023

Primary Completion Date

August 12, 2025

Completion Date

August 12, 2025

Last Updated

March 6, 2026

Enrollment

178

ACTUAL participants

Conditions

Carotid StenosisCarotid Artery Diseases

Interventions

Neuroguard IEP Direct System

DEVICE

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

NCT07322913

Carotid Artery DiseasesAortic Diseases+1 more

View study

RECRUITINGNA

Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis

NCT07412249

Carotid Stenosis

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis

Residual Stenosis and Restenosis Following Carotid Endarterectomy With Primary Closure, A Prospective Tracking Study

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

Change of Hemodynamics and Cerebral Functions After Carotid Artery Revascularization

Comprehensive Assessment of Atherosclerotic Ischemic Stroke Risk and Development of a Prediction Model