VALIANT CAPTIVIA Post-market Registry (VCOUS)

This study has been 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.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01181947
First received: August 10, 2010
Last updated: January 22, 2015
Last verified: January 2015
Results First Received: December 17, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Aortic Aneurysm, Thoracic
Intervention: Device: TEVAR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Patients Undergoing TEVAR

Those with a thoracic aortic aneurysm/dissection >

> TEVAR: Thoracic endovascular aneurysm repair


Participant Flow:   Overall Study
    Patients Undergoing TEVAR  
STARTED     100  
COMPLETED     100  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Patients Undergoing TEVAR

Those with a thoracic aortic aneurysm/dissection >

> TEVAR: Thoracic endovascular aneurysm repair


Baseline Measures
    Patients Undergoing TEVAR  
Number of Participants  
[units: participants]
  100  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     52  
>=65 years     48  
Age  
[units: year]
Median (Full Range)
  65.0   (25 to 87)  
Gender  
[units: participants]
 
Female     19  
Male     81  
Region of Enrollment  
[units: participants]
 
Spain     5  
Turkey     15  
Austria     2  
Netherlands     16  
Germany     24  
United Kingdom     21  
Italy     17  
Native aorta diameter  
[units: mm]
Median (Full Range)
  32   (22 to 42)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Technical Success at Time of Initial Implant   [ Time Frame: intraoperatively ]

2.  Secondary:   SAE   [ Time Frame: through 12 months ]

3.  Primary:   Treatment Success   [ Time Frame: at 30 days, 12 months, 24 months and 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   ACM and ARM   [ Time Frame: at 30 days, 12 months, 24 months and 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Robin Heijmen
Organization: St. Antonius Ziekenhuis
phone: 0031306092047
e-mail: r.heijmen@antoniusziekenhuis.nl


No publications provided by Medtronic Endovascular

Publications automatically indexed to this study:

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01181947     History of Changes
Other Study ID Numbers: MDTEV20112009
Study First Received: August 10, 2010
Results First Received: December 17, 2014
Last Updated: January 22, 2015
Health Authority: Austrian: Ethics Commision
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee