Status:
TERMINATED
VALIANT CAPTIVIA Post-market Registry
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Aortic Aneurysm, Thoracic
Eligibility:
All Genders
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 ...
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01181947
Start Date
February 1 2010
End Date
August 1 2013
Last Update
November 8 2023
Active Locations (15)
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1
Medical University of Innsbruck
Innsbruck, Austria, 6020
2
Klinikum der J.W.Goethe-Universitat
Frankfurt am Main, Germany, D-60590
3
Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
Frankfurt am Main, Germany, D-60590
4
Medizinische Hochschule Hannover
Hanover, Germany, 30625