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NCT04142541

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

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)
Contego Medical, Inc.·ClinicalTrials.gov·device·Device trialCompleted
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Study focus
Disease/Condition
Carotid Artery Stenosis
Drug/Device/Intervention
Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Contego Medical, Inc.
Location
Berlin,Frankfurt,Hamburg,Leipzig,Cotignola,Naples, Germany,Italy
Timeline & enrollment
Phase
N/A
Start date
Feb 28, 2018
End date
Feb 17, 2020
Enrollment
67 participants
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
Occlusion and stenosis of carotid arteryCarotid artery syndrome (hemispheric)Injury of carotid arteryAneurysm and dissection of carotid arteryOcclusion and stenosis of vertebral artery
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04142541
Type
Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.