VALIANT CAPTIVIA Post-market Registry (VCOUS)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study|
- Treatment success [ Time Frame: at 30 days, 12 months, 24 months and 36 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 0 days (assessed intraoperatively). ] [ Designated as safety issue: No ]Successful delivery and deployment of the stent graft (assessed intraoperatively).
- SADE, SAE or TO [ Time Frame: through 30 days, 12 months, 24 months and 36 months ] [ Designated as safety issue: Yes ](Serious) Adverse Device Effects (SADE) Technical Observations (TO) Serious Adverse Events (SAE)
- ACM and ARM [ Time Frame: at 30 days, 12 months, 24 months and 36 months ] [ Designated as safety issue: Yes ]All-cause (ACM), Aneurysm related (ARM) and dissection related mortality
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||August 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
patients undergoing TEVAR
Those with a thoracic aortic aneurysm/dissection
Thoracic endovascular aneurysm repair
Other Name: Valiant Captivia stent graft system
Use of controls
This study is a post-market registry without using a control. All analyses will be descriptive in nature and no statistical comparisons are planned.
- 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.
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.
|Medical University of Innsbruck|
|Innsbruck, Austria, 6020|
|Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie|
|Frankfurt am Main, Germany, D-60590|
|Klinikum der J.W.Goethe-Universitat|
|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|
|Ulm, Germany, D-89075|
|Polyclinic Hospital S.Orsola - Malpighi|
|Bologna, Italy, 40138|
|Eindhoven, Netherlands, 5623 EJ|
|St. Antonius Ziekenhuis|
|Nieuwegein, Netherlands, 3435EM|
|Hospital Clinico Universitario de Valladolid|
|Valladolid, Spain, 47005|
|Baskent University Ankara Hospital|
|Ankara, Turkey, 06490|
|Ege University Hospital|
|Dokuz Eylul University|
|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 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 Eylül 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|