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
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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 |
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Aortic Aneurysm, Thoracic | Device: TEVAR |
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Use of controls
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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
- 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.
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Number of investigation sites and study duration
- 15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects.
- There will be no minimum nor maximum number of enrolled subjects per investigation site.
- 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 |
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 |

Group/Cohort | Intervention/treatment |
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patients undergoing TEVAR
Those with a thoracic aortic aneurysm/dissection
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Device: TEVAR
Thoracic endovascular aneurysm repair
Other Name: Valiant Captivia stent graft system |
- 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.
- 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
- SAE [ Time Frame: through 12 months ]Serious Adverse Events (SAE)
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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).
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

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
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 |
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 |
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 |
Stent graft thoracic aorta dissection aneurysm |
TEVAR VALIANT CAPTIVIA endovascular |
Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |