NCT05845710

Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)

Protection Against Emboli During caRotid Artery Stenting Using a Neuroguard IEP® Direct 3-in-1 Delivery System Comprised oF a pOst-dilation Balloon, integRated eMbolic Filter, and A Novel Carotid stEnt - the PERFORMANCE III Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Contego Medical, Inc. · Industry
• Sex: All
• Age: 20 Years – 82 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Carotid Stenosis
• Carotid Artery Diseases

Interventions

Type	Name	Description
DEVICE	Neuroguard IEP Direct System	carotid artery stenting, direct access with blood flow redirection

Timeline

• Start date: 2023-10-05
• Primary completion: 2025-08-12
• Completion: 2025-08-12
• First posted: 2023-05-06
• Last updated: 2026-03-06

Locations

32 sites across 2 countries: United States, France

Regulatory

• FDA-regulated device study