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

NCT05845710 | Completed DMC FDA Device

• 1 other identifier: CSP-1997
• Study Type: interventional
• Target: 178
• Locations: 2 countries
• Sites: 32

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 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

Keywords

carotid artery stent

Outcome Measures

Primary Outcomes (1)

• Composite of Major Adverse Events (MAE)

  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.

  Within 30 days of the study procedure

Secondary Outcomes (5)

• Acute Success

  Procedure

• Technical Success

  Procedure

• Procedure Success

  Procedure

• Blood Transfusion

  Procedure through discharge or within 30 days of the study procedure

• Stroke, Death

  Within 30 days of the study procedure

Study Arms (1)

Neuroguard IEP Direct System

EXPERIMENTAL

The Neuroguard IEP® 3-in-1 Direct Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP Direct System) is a combination self-expanding carotid artery stent, nitinol embolic protection filter, and post-dilation balloon. Neuroguard IEP Direct System is used with the Neuroguard Direct Access Kit which includes the Flow Redirection System.

Device: Neuroguard IEP Direct System

Interventions

Neuroguard IEP Direct System DEVICE

carotid artery stenting, direct access with blood flow redirection

Neuroguard IEP Direct System

Eligibility Criteria

• Age: 20 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 20 or ≤ 82 years of age.
• 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.
• 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.
• 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).
• Subject is diagnosed with either:
• 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
• Asymptomatic carotid stenosis ≥ 70% as determined by angiography, CTA, or duplex ultrasound.
• Subject has a lesion located in the internal carotid artery (ICA) and/or common carotid artery (CCA).
• Subject has a modified Rankin Scale of ≤ 2 at the time of procedure.
• Females of child-bearing potential have a negative pregnancy test within 24 hours prior to the index procedure.
• Subject is willing and able to take dual anti platelet therapy for a minimum of 30 days following the index procedure.
• Subject meets at least one physiologic or one anatomic high-risk criteria.
• Anatomic High-Risk Conditions for CEA
• \. Target lesion at or above C2 (level of jaw). 2. Prior head and neck surgery in the region of the carotid artery. 3. Tracheostomy or tracheostoma. 4. Surgically inaccessible lesion or hostile neck which the investigator deems safe for direct carotid access including but not limited to:
• Prior neck irradiation

You may not qualify if:

• Life expectancy of less than one year in the opinion of the investigator at the time of enrollment.
• Currently requiring an organ transplantation.
• An evolving acute stroke
• 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.
• Deep being thrombosis (DVT) or pulmonary embolism (PE) treated within the past 12 months.
• Recently (\< 60 days) implanted heart valve.
• 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.
• History of chronic atrial flutter or chronic atrial fibrillation.
• Anticoagulation with Phenprocoumon (Marcumar®), warfarin, direct thrombin inhibitors, or anti-Xa agents within 14 days of the index procedure.
• Subject with a known hypercoaguable state.
• Acute febrile illness (temperature ≥ 100.4°F or 38°C) or active infection.
• Subject with a SARS-CoV-2/COVID-19 infection within 21 days prior to the index procedure.
• Acute myocardial infarction \< 30 days prior to index procedure.
• Any major surgical procedure (i.e., intraabdominal or intrathoracic surgery or any surgery / interventional procedure involving cardiac or vascular system) 30 days prior to or within 30 days following the index procedure.
• History of disabling stroke with substantial residual disability (modified Rankin score ≥ 3).

Sponsors & Collaborators

• Yale Cardiovascular Research Group: collaborator
• iMedNet: collaborator
• Contego Medical, Inc.: lead
• CardioMed Device Consultants, LLC: collaborator
• Advance Research Associates: collaborator
• AG Mednet: collaborator

Study Sites (32)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Mount Sinai Vascular Institute

Miami Beach, Florida, 33140, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Indiana University Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Southcoast Health

New Bedford, Massachusetts, 02720, United States

Location

McLaren Center for Research and Innovation

Bay City, Michigan, 48708, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University at Buffalo Neurosurgery - Jacobs Institute

Buffalo, New York, 14203, United States

Location

Sisters of Charity Hospital

Buffalo, New York, 14214, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

UNC Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Atrium Health - Sanger Heart and Vascular

Charlotte, North Carolina, 28204, United States

Location

North Carolina Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

TriHealth (Bethesda North Hospital)

Cincinnati, Ohio, 45242, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health

Greenville, South Carolina, 29615, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-5545, United States

Location

St. David's Healthcare

Austin, Texas, 78756, United States

Location

Baylor Scott and White Research Institute

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

GH Paris St. Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sean Lyden, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• D. Christopher Metzger, MD

  OhioHealth Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: October 5, 2023
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

FR (2); US (30)