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

Not Applicable

Active, not recruiting

• Conditions: Carotid Artery Diseases; Carotid Stenosis

• Registration Number: NCT05845710
• Lead Sponsor: Contego Medical, Inc.

Brief 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 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.

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.

Study Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-05-06
• Study Start: 2023-10-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-11
• Primary Completion: 2025-08-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite of Major Adverse Events (MAE)	Within 30 days of the study procedure	The primary endpoint is a composite 30-day rate of Major Adverse Events (MAE), defined as the cumulative incidence of all stroke, myocardial infarction (MI) and death within 30 days of the index procedure.

Secondary Outcome Measures

Name	Time	Method
Procedure Success	Procedure	Acute Success and Technical Success in the absence of device related Major Adverse Events (defined as the cumulative incidence of all stroke, myocardial infarction and death) prior to discharge.
Stroke, Death	Within 30 days of the study procedure	Ipsilateral, major and minor stroke, all death, cardiac death, neurological death
Acute Success	Procedure	The ability to insert the Neuroguard IEP Direct System, deliver the stent, and remove the stent delivery catheter.
Technical Success	Procedure	The ability to utilize the accessories provided in the Neuroguard Direct Access Kit to establish flow reversal, defined as visualization of blood in the collection tubing.
Blood Transfusion	Procedure through discharge or within 30 days of the study procedure	Number of subjects requiring blood transfusion from procedure initiation through to discharge.

Trial Locations

Locations (32)

Honor Health; 🇺🇸 Scottsdale, Arizona, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, 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

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