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Neuroguard IEP Direct System for Carotid Stenosis (PERFORMANCEIII Trial)

N/A
Recruiting
Led By D. Christopher Metzger, MD
Research Sponsored by Contego Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of the study procedure
Awards & highlights

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.

Eligible Conditions
  • Carotid Stenosis
  • Carotid Artery Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of Major Adverse Events (MAE)
Secondary outcome measures
Acute Success
Blood Transfusion
Procedure Success
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neuroguard IEP Direct SystemExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Advance Research AssociatesOTHER
4 Previous Clinical Trials
611 Total Patients Enrolled
1 Trials studying Carotid Stenosis
305 Patients Enrolled for Carotid Stenosis
Yale Cardiovascular Research GroupOTHER
9 Previous Clinical Trials
3,231 Total Patients Enrolled
1 Trials studying Carotid Stenosis
305 Patients Enrolled for Carotid Stenosis
CardioMed Device Consultants, LLCIndustry Sponsor
5 Previous Clinical Trials
962 Total Patients Enrolled
1 Trials studying Carotid Stenosis
305 Patients Enrolled for Carotid Stenosis
~35 spots leftby Dec 2024
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