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Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis — PERFORMANCE  

Carotid Artery Stenosis Clinical Trial

Official title:
Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter, and a Novel Carotid Stent (PERFORMANCE 1 Trial)

Clinical Trial Summary

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. The PERFORMANCE I study is a multi-center, prospective, single arm open label study to evaluate the safety and feasibility of the Neuroguard IEP System for the treatment of carotid artery stenosis. The primary endpoint will be the proportion of patients with Major Adverse Events (MAE) reported within 30 days from the index procedure. The primary objective of the PERFORMANCE I study is to evaluate the safety and feasibility of the Neuroguard IEP Carotid Stent System when used in patients with clinically significant carotid artery stenosis requiring revascularization.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04142541
Study type Interventional
Source Contego Medical, Inc.
Contact
Status Completed
Phase N/A
Start date February 28, 2018
Completion date February 17, 2020
View Details
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