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Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting

NCT01783639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-08-07

Study results available
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Summary

The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with embolic protection studies

Conditions

  • Carotid Artery Diseases
  • Stroke

Interventions

PROCEDURE

Carotid Artery Stent

Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices

Sponsors & Collaborators

  • Gardia Medical

    lead INDUSTRY

Principal Investigators

  • Dierk Scheinert, MD · Herzzentrum Leipzig GmbH and Park-Krankenhaus Leipzig

  • Horst Sievert, MD · Cardio Vascular Center Frankfurt

  • Stefan Rohde, MD · Radiologische Klinik, Klinikum Dortmund GmbH

  • Joachim Schofer, MD · Universitäres Herz- und Gefäßzentrum Hamburg

  • Harald Mudra, MD · Städtisches Klinikum München GmbH

  • Marc Bosiers, MD · AZ St-Blasius, Dendermonde

  • Thomas Zeller, MD · Universitaets Herzzentrum, Bad-Krozingen

  • Alberto Cremonesi, MD · Villa Maria Cecilia, Contignola

  • Bernhard Reimers, MD · Mirano Hospital

  • Henrik Schröder, MD · Ihre-Radiologen.de

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-12-31
Completion
2015-04-30

Countries

  • Belgium
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT01783639 on ClinicalTrials.gov