Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Carotid Stenosis and Carotid Artery Diseases, sponsored by Contego Medical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT05845710 record still lists
NCT05845710 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 11 other Carotid Stenosis trials with a reported enrollment target (70% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Carotid Stenosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05845710's enrollment target sits among peer trials
178 5th of 11 higher than 7 of 11 other Carotid Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carotid Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients
ACTIVE NOT RECRUITING · NA
-
Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System
ACTIVE NOT RECRUITING · NA
-
Transcutaneous ARFI Ultrasound for Differentiating Carotid Plaque With High Stroke Risk
ACTIVE NOT RECRUITING · NA
-
Remote Ischemic Preconditioning for Carotid Endarterectomy
COMPLETED · NA
-
Symptomatic Carotid Outcomes Registry
ACTIVE NOT RECRUITING
-
Cost-Effectiveness of a Specialized Ultrasound Instrument to Diagnose Carotid Stenosis as a Way to Reduce the Risk of Stroke
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03642002 · 178 participants · NA
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
- NCT04227847 · 178 participants · Phase 1
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
- NCT04855214 · 178 participants
Evaluating the Experience of Upper Limb Prosthesis Use
- NCT05391126 · 178 participants · NA
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI