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NCT05845710 · ClinicalTrials.gov registry record · NA
Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)
A NA study of Carotid Stenosis and Carotid Artery Diseases, sponsored by Contego Medical.
- Completed
- Registry status
- NA
- Development phase
- 178
- Enrollment target
- 20
- Study locations
NCT05845710 is a NA study of Carotid Stenosis and Carotid Artery Diseases that has completed, run by Contego Medical. The registered enrollment target is 178 participants, below the 584-participant average among 11 other Carotid Stenosis trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT05845710, a NA study of Carotid Stenosis and Carotid Artery Diseases, has completed, sponsored by Contego Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 178 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DEVICE Neuroguard IEP Direct System
Study Locations (20)
Florida
- Manatee Memorial Hospital - Bradenton
- Delray Medical Center - Delray Beach
- Mount Sinai Vascular Institute - Miami Beach
- AdventHealth Orlando - Orlando
New York
- University at Buffalo Neurosurgery - Jacobs Institute - Buffalo
- Sisters of Charity Hospital - Buffalo
- Northwell Health - Lake Success
- Mount Sinai Medical Center - New York
North Carolina
- UNC Hospital - Chapel Hill
- Atrium Health - Sanger Heart and Vascular - Charlotte
- North Carolina Heart and Vascular Research - Raleigh
Ohio
- TriHealth (Bethesda North Hospital) - Cincinnati
- Cleveland Clinic - Cleveland
Arizona
- Honor Health - Scottsdale
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Indiana
- Indiana University Methodist Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2023-10-05 |
| Est. Completion | 2025-08-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05845710
The ClinicalTrials.gov registry entry for NCT05845710 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 584-participant average among 11 other Carotid Stenosis trials with a reported enrollment target (70% lower). The listed sponsor is Contego Medical, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Carotid Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Neuroguard IEP Direct System is the first listed.
NCT05845710 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05845710 about?
NCT05845710 is a clinical study titled "Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)". 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 th...
What is the current status of trial NCT05845710?
This trial is currently completed. It is a NA study. The enrollment target is 178 participants. The study started on 2023-10-05. Estimated completion is 2025-08-12.
What conditions does trial NCT05845710 study?
This clinical trial studies the following conditions: Carotid Stenosis, Carotid Artery Diseases.
What interventions are being tested in trial NCT05845710?
The interventions under investigation include: Neuroguard IEP Direct System (DEVICE).
Who is sponsoring clinical trial NCT05845710?
This trial is sponsored by Contego Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05845710 being conducted?
This trial has 20 study locations across Arizona, Connecticut, District of Columbia, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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