Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)
Completed · Not applicable
Conditions studied: Carotid Stenosis, Carotid Artery Diseases
In brief
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.
Key facts
- Study ID
- NCT05845710
- Run by
- Contego Medical, Inc.
- People needed
- 178
- Starts
- 2023-10-05
- Expected to finish
- 2025-08-12
- Last updated by the study team
- 2026-03-06
Who can join
Age: 20 and older, up to 82. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Hackensack University Medical Center — Hackensack, 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
Full record on ClinicalTrials.gov
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