Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)
- Conditions
- Carotid Artery DiseasesCarotid Stenosis
- Interventions
- Device: Neuroguard IEP Direct System
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 229
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neuroguard IEP Direct System Neuroguard IEP Direct System 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.
- 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 (31)
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
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
University at Buffalo Neurosurgery - Jacobs Institute
🇺🇸Buffalo, New York, United States
Sisters of Charity Hospital
🇺🇸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