Study Results
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View full resultsBasic Information
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TERMINATED
100 participants
OBSERVATIONAL
2010-02-28
2013-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients undergoing TEVAR
Those with a thoracic aortic aneurysm/dissection
TEVAR
Thoracic endovascular aneurysm repair
Interventions
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TEVAR
Thoracic endovascular aneurysm repair
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Participation in concurrent interventional trial which may confound study results
* Prior implantation of a thoracic stent graft
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Giovanni Torsello, Prof.
Role: PRINCIPAL_INVESTIGATOR
St Franziskus Hospital GmbH
Rosella Fattori, Prof.
Role: PRINCIPAL_INVESTIGATOR
Policlinico S.Orsola Malpighi
Carlos Vaquero Puerta, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario de Valladolid
Matthew Thompson, Prof.
Role: PRINCIPAL_INVESTIGATOR
St. George's Hospital
Werner Jaschke, Prof.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Innsbruck
Yigit Goktay, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dokuz Eylul University
Karl Heinz Orend, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitatsklinikum Ulm
Omke Teebken, Prof.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Thomas Schmitz-Rixen, Prof.
Role: PRINCIPAL_INVESTIGATOR
Klinikum der J.W.Goethe-Universitat
Markus Steinbauer, Dr.
Role: PRINCIPAL_INVESTIGATOR
Krankenhaus Barmherzige Bruder Regensburg
Stephan Zangos, Dr.
Role: PRINCIPAL_INVESTIGATOR
Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
Joep Teijink, Dr.
Role: PRINCIPAL_INVESTIGATOR
Catharina Ziekenhuis
Robin Heijmen, Dr.
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Hospital
Mustafa Parildar, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ege University Hospital
Fatih Boyvat, Prof.
Role: PRINCIPAL_INVESTIGATOR
Baskent University Ankara Hospital
Locations
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Medical University of Innsbruck
Innsbruck, , Austria
Klinikum der J.W.Goethe-Universitat
Frankfurt am Main, , Germany
Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
Frankfurt am Main, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
St Franziskus Hospital GmbH
Münster, , Germany
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Polyclinic Hospital S.Orsola - Malpighi
Bologna, , Italy
Catharina Ziekenhuis
Eindhoven, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Baskent University Ankara Hospital
Ankara, , Turkey (Türkiye)
Dokuz Eylul University
Izmir, , Turkey (Türkiye)
Ege University Hospital
Izmir, , Turkey (Türkiye)
St George's Hospital
London, , United Kingdom
Countries
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References
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Heijmen RH, Thompson MM, Fattori R, Goktay Y, Teebken OE, Orend KH. Valiant thoracic stent-graft deployed with the new captivia delivery system: procedural and 30-day results of the Valiant Captivia registry. J Endovasc Ther. 2012 Apr;19(2):213-25. doi: 10.1583/11-3652MR.1.
Other Identifiers
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MDTEV20112009
Identifier Type: -
Identifier Source: org_study_id
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