VALIANT CAPTIVIA Post-market Registry (VCOUS)

January 26, 2023 updated by: Medtronic Cardiovascular

VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

  1. Use of controls

    1. This study is a post-market registry without using a control. All analyses will be descriptive in nature and no statistical comparisons are planned.

      Sample size

    2. There is no sample size calculation since this is not a hypothesis driven study; VALIANT CAPTIVIA has recruited 100 subjects and will follow these subjects through for approximately 36 months.

  2. Number of investigation sites and study duration

    1. 15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects.
    2. There will be no minimum nor maximum number of enrolled subjects per investigation site.
    3. The sites' compliance with the clinical investigation plan will be assessed on an ongoing basis. In case of serious non-compliance, the sponsor may decide to stop subject enrolment in a site based on the assessment.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medical University of Innsbruck
  • Germany
      • Frankfurt am Main, Germany, D-60590
        • Klinikum der J.W.Goethe-Universitat
      • Frankfurt am Main, Germany, D-60590
        • Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Muenster, Germany, 48145
        • St Franziskus Hospital GmbH
      • Regensburg, Germany, 93049
        • Krankenhaus Barmherzige Bruder Regensburg
      • Ulm, Germany, D-89075
        • Universitätsklinikum Ulm
  • Italy
      • Bologna, Italy, 40138
        • Polyclinic Hospital S.Orsola - Malpighi
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
      • Nieuwegein, Netherlands, 3435EM
        • St. Antonius Ziekenhuis
  • Spain
      • Valladolid, Spain, 47005
        • Hospital Clinico Universitario de Valladolid
  • Turkey
      • Ankara, Turkey, 06490
        • Baskent University Ankara Hospital
      • Izmir, Turkey
        • Ege University Hospital
      • Izmir, Turkey
        • Dokuz Eylul University
  • United Kingdom
      • London, United Kingdom, SW17 0QT
        • St George's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The Valiant Thoracic Stent Graft with the Captivia Delivery System is indicated for treatment of diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The Valiant Thoracic Stent Graft is indicated for exclusion of the aneurysm, the false lumen or site of rupture and restoration of blood flow through the stent graft lumen. The device is intended for use in subjects who are candidates for conventional surgical repair, and in subjects who are not candidates for conventional surgical repair due to pre-existing risk factors.

Study enrolment is open to subjects who in the opinion of the investigator are candidates for endovascular TAA repair with the Valiant Captivia Thoracic Stent Graft System according to the instructions for use (IFU).

Description

Inclusion criteria

  • Age ≥ 18 years or minimum age as required by local regulations
  • Indication for surgical repair of thoracic aortic aneurysms and/or thoracic aortic dissections with an thoracic endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Valiant Captivia Thoracic Stent Graft System
  • Signed consent form ('Patient informed consent form' or 'Patient Data Release Authorization Form')
  • Intention to implant the Valiant Captivia Thoracic Stent Graft System or having implanted the system within the last 3 months before subject enrollment
  • Willingness and ability to comply with the CIP

Exclusion criteria

  • High probability of non-adherence to physician's follow-up requirements
  • Participation in concurrent interventional trial which may confound study results
  • Prior implantation of a thoracic stent graft

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients undergoing TEVAR
Those with a thoracic aortic aneurysm/dissection
Device: TEVAR
Thoracic endovascular aneurysm repair
Other Names:
  • Valiant Captivia stent graft system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success at Time of Initial Implant
Time Frame: intraoperatively
Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system
intraoperatively
Treatment Success
Time Frame: at 12 months

technical success and freedom from

  • TAA diameter increase of stented segment (>5mm compared to 1 mo),
  • Types I/III endoleak,
  • Aneurysm rupture,
  • Conversion to open surgery,
  • Stent graft occlusion,
  • Stent graft migration resulting in SAE or secondary intervention.
at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAE
Time Frame: through 12 months
Serious Adverse Events (SAE)
through 12 months
ACM and ARM
Time Frame: at 30 days, 12 months, 24 months and 36 months
All-cause (ACM), Aneurysm related (ARM) and dissection related mortality
at 30 days, 12 months, 24 months and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

  • Principal Investigator: Giovanni Torsello, Prof., St Franziskus Hospital GmbH
  • Principal Investigator: Rosella Fattori, Prof., Policlinico S.Orsola Malpighi
  • Principal Investigator: Carlos Vaquero Puerta, Dr., Hospital Clinico Universitario de Valladolid
  • Principal Investigator: Matthew Thompson, Prof., St. George's Hospital
  • Principal Investigator: Werner Jaschke, Prof., Medical University of Innsbruck
  • Principal Investigator: Yigit Goktay, Prof., Dokuz Eylul University
  • Principal Investigator: Karl Heinz Orend, Prof., Universitätsklinikum Ulm
  • Principal Investigator: Omke Teebken, Prof., Hannover Medical School
  • Principal Investigator: Thomas Schmitz-Rixen, Prof., Klinikum der J.W.Goethe-Universitat
  • Principal Investigator: Markus Steinbauer, Dr., Krankenhaus Barmherzige Bruder Regensburg
  • Principal Investigator: Stephan Zangos, Dr., Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
  • Principal Investigator: Joep Teijink, Dr., Catharina Ziekenhuis
  • Principal Investigator: Mustafa Parildar, Prof., Ege University Hospital
  • Principal Investigator: Fatih Boyvat, Prof., Baskent University Ankara Hospital
  • Principal Investigator: Robin Heijmen, Dr., St. Antonius Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 12, 2010

First Posted (Estimated)

August 13, 2010

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDTEV20112009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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