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VALIANT CAPTIVIA Post-market Registry

NCT01181947 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-11-08

Study results available
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Summary

The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October 1st, 2009.

The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections.

The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market approval.

Conditions

  • Aortic Aneurysm, Thoracic

Interventions

DEVICE

TEVAR

Thoracic endovascular aneurysm repair

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Giovanni Torsello, Prof. · St Franziskus Hospital GmbH

  • Rosella Fattori, Prof. · Policlinico S.Orsola Malpighi

  • Carlos Vaquero Puerta, Dr. · Hospital Clínico Universitario de Valladolid

  • Matthew Thompson, Prof. · St. George's Hospital

  • Werner Jaschke, Prof. · Medical University of Innsbruck

  • Yigit Goktay, Prof. · Dokuz Eylul University

  • Karl Heinz Orend, Prof. · Universitatsklinikum Ulm

  • Omke Teebken, Prof. · Hannover Medical School

  • Thomas Schmitz-Rixen, Prof. · Klinikum der J.W.Goethe-Universitat

  • Markus Steinbauer, Dr. · Krankenhaus Barmherzige Bruder Regensburg

  • Stephan Zangos, Dr. · Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie

  • Joep Teijink, Dr. · Catharina Ziekenhuis

  • Robin Heijmen, Dr. · St. Antonius Hospital

  • Mustafa Parildar, Prof. · Ege University Hospital

  • Fatih Boyvat, Prof. · Baskent University Ankara Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-03-31
Completion
2013-08-31

Countries

  • Austria
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

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 NCT01181947 on ClinicalTrials.gov