The VIRTUE Post Marketing Surveillance Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01213589
First received: October 1, 2010
Last updated: October 21, 2013
Last verified: October 2013
Results First Received: October 21, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Aortic Dissection

  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
Enrollment of study patients in the Registry began in the medical clinics on 5 December 2006 and was completed on 26 August 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No subject got excluded after enrollment

Reporting Groups
  Description
Acute Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
Sub-acute Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
Chronic Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.

Participant Flow:   Overall Study
    Acute     Sub-acute     Chronic  
STARTED     50     24     26  
COMPLETED     37     19     18  
NOT COMPLETED     13     5     8  



  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
Acute Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
Sub-acute Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
Chronic Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Total Total of all reporting groups

Baseline Measures
    Acute     Sub-acute     Chronic     Total  
Number of Participants  
[units: participants]
  50     24     26     100  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     25     18     19     62  
>=65 years     25     6     7     38  
Age  
[units: years]
Mean ± Standard Deviation
  63.2  ± 14.1     59.7  ± 11.0     58.8  ± 10.9     61.2  ± 12.7  
Gender  
[units: participants]
       
Female     12     6     6     24  
Male     38     18     20     76  
Region of Enrollment  
[units: participants]
       
Europe     50     24     26     100  



  Outcome Measures
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1.  Primary:   Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure   [ Time Frame: 12 months post-procedure ]

2.  Secondary:   Safety   [ Time Frame: 30 days or at discharge, 3/6/12/24/36 months ]

3.  Secondary:   Efficacy/Performance   [ Time Frame: 30 days or at discharge, 3/6/12/24/36 months ]

4.  Secondary:   Freedom of Re-intervention   [ Time Frame: 30 days or at discharge, 3/6/12/24/36 months ]

5.  Secondary:   Freedom From Disease-, Procedure- or Device-related Major Complications   [ Time Frame: through 36 months ]

6.  Secondary:   Freedom From Disease-, Procedure-, or Device-related Severe Complications   [ Time Frame: through 36 months ]

7.  Secondary:   Clinical Success   [ Time Frame: through 36 months ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Richard Jonkers, PhD
Organization: Medtronic
phone: 800-217-1617 ext 3727
e-mail: richard.jonkers@medtronic.com


Publications of Results:

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01213589     History of Changes
Other Study ID Numbers: MDTVIRTUE001
Study First Received: October 1, 2010
Results First Received: October 21, 2013
Last Updated: October 21, 2013
Health Authority: Belgium: Ethics Committee
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee
Switzerland: Ethikkommission
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee