NCT04201132

Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System

Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1 Delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter and a Novel Carotid Stent - the PERFORMANCE II Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Contego Medical, Inc. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA).

Detailed description

The Neuroguard IEP 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 must be between 20 and 80 years of age and diagnosed with either de-novo atherosclerotic or post CEA restenotic lesion(s) in the internal carotid arteries (ICA) or at the carotid bifurcation with ≥50% stenosis if symptomatic), or, ≥80% stenosis if asymptomatic (both defined by angiography using NASCET methodology). Symptomatic patients are defined as having stroke or TIA ipsilateral to the carotid lesion within 180 days of the procedure within the hemisphere supplied by the target vessel. Enrolled subjects will be followed at 30 days, 6 months, 12 months, 24 months and 36 months.

Conditions

• Carotid Artery Stenosis
• Carotid Artery Diseases
• Carotid Stenosis

Interventions

Type	Name	Description
DEVICE	Carotid artery stenting with Neuroguard IEP System	Carotid artery stenting (treatment) with the Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection

Timeline

• Start date: 2020-06-12
• Primary completion: 2023-10-31
• Completion: 2025-12-01
• First posted: 2019-12-17
• Last updated: 2024-06-06

Locations

38 sites across 6 countries: United States, Bulgaria, Germany, Italy, North Macedonia, Slovenia

Regulatory

• FDA-regulated device study