Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis - Trial NCT04142541
Access comprehensive clinical trial information for NCT04142541 through Pure Global AI's free database. This phase not specified trial is sponsored by Contego Medical, Inc. and is currently Completed. The study focuses on Carotid Artery Stenosis. Target enrollment is 67 participants.
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Study Focus
Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)
Interventional
device
Sponsor & Location
Contego Medical, Inc.
Timeline & Enrollment
N/A
Feb 28, 2018
Feb 17, 2020
Primary Outcome
Major Adverse Event (MAE)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04142541
Device Trial