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VALIANT CAPTIVIA Post-market Registry (VCOUS)

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ClinicalTrials.gov Identifier: NCT01181947
Recruitment Status : Terminated (CIP was amended to include long-term FU but, not all sites accepted it so the nr. of pts participating in the extended FU will be small.)
First Posted : August 13, 2010
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Aortic Aneurysm, Thoracic Device: TEVAR

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 Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study
Study Start Date : February 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
patients undergoing TEVAR
Those with a thoracic aortic aneurysm/dissection
 Device: TEVAR
Thoracic endovascular aneurysm repair
Other Name: Valiant Captivia stent graft system


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Success [ Time Frame: at 30 days, 12 months, 24 months and 36 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.

  2. 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


Secondary Outcome Measures :
  1. SAE [ Time Frame: through 12 months ]
    Serious Adverse Events (SAE)

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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).

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181947


Locations
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Austria
Medical University of Innsbruck
Innsbruck, Austria, 6020
Germany
Klinikum der J.W.Goethe-Universitat
Frankfurt am Main, Germany, D-60590
Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
Frankfurt am Main, Germany, D-60590
Medizinische Hochschule Hannover
Hannover, Germany, 30625
St Franziskus Hospital GmbH
Muenster, Germany, 48145
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, Germany, 93049
Universitatsklinikum Ulm
Ulm, Germany, D-89075
Italy
Polyclinic Hospital S.Orsola - Malpighi
Bologna, Italy, 40138
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435EM
Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain, 47005
Turkey
Baskent University Ankara Hospital
Ankara, Turkey, 06490
Dokuz Eylul University
Izmir, Turkey
Ege University Hospital
Izmir, Turkey
United Kingdom
St George's Hospital
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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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 Clínico 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. Universitatsklinikum 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: Robin Heijmen, Dr. St. Antonius Ziekenhuis
Principal Investigator: Mustafa Parildar, Prof. Ege University Hospital
Principal Investigator: Fatih Boyvat, Prof. Baskent University Ankara Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01181947    
Other Study ID Numbers: MDTEV20112009
First Posted: August 13, 2010    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015
Last Verified: January 2015
Keywords provided by Medtronic Endovascular:
Stent graft
thoracic aorta
dissection
aneurysm
 TEVAR
VALIANT
CAPTIVIA
endovascular
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases