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

NCT04201132 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2024-06-06

No results posted yet for this study

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).

Conditions

  • Carotid Artery Stenosis
  • Carotid Artery Diseases
  • Carotid Stenosis

Interventions

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

Sponsors & Collaborators

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Advance Research Associates

    collaborator OTHER

  • CardioMed Device Consultants, LLC

    collaborator INDUSTRY

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Medidata Solutions

    collaborator INDUSTRY

  • Contego Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • William A Gray, MD · Main Line Health

  • Ralf Langhoff, MD · Sankt Gertrauden Krankenhaus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2023-10-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States
  • Bulgaria
  • Germany
  • Italy
  • North Macedonia
  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04201132 on ClinicalTrials.gov