Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01114724
First received: April 26, 2010
Last updated: May 30, 2014
Last verified: January 2014
Results First Received: May 30, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Aortic Dissection
Intervention: Device: Valiant Thoracic Stent Graft will the Captivia Delivery System

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Valiant Thoracic Stent Graft With the Captivia Delivery System Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device

Participant Flow:   Overall Study
    Valiant Thoracic Stent Graft With the Captivia Delivery System  
STARTED     50  
COMPLETED     40  
NOT COMPLETED     10  
Death                 8  
Lost to Follow-up                 1  
Withdrawal by Subject                 1  



  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.
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Reporting Groups
  Description
Valiant Thoracic Stent Graft With the Captivia Delivery System Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device

Baseline Measures
    Valiant Thoracic Stent Graft With the Captivia Delivery System  
Number of Participants  
[units: participants]
  50  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     37  
>=65 years     12  
Age  
[units: years]
Mean ± Standard Deviation
  57.2  ± 12.9  
Gender  
[units: participants]
 
Female     10  
Male     40  
Region of Enrollment  
[units: participants]
 
United States     50  



  Outcome Measures
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1.  Primary:   All Cause Mortality.   [ Time Frame: Up to 30 days after the stent graft implant. ]

2.  Secondary:   All-cause Mortality   [ Time Frame: at 12 months ]

3.  Secondary:   Subjects With Successful Delivery and Deployment of the Device.   [ Time Frame: At implant. ]

4.  Secondary:   Subjects With Coverage of Primary Tear   [ Time Frame: At implant ]

5.  Secondary:   Aortic Rupture   [ Time Frame: Within 30 days ]

6.  Secondary:   Aortic Rupture   [ Time Frame: Within 12 months ]

7.  Secondary:   Subjects With Secondary Endovascular Procedures   [ Time Frame: Through12 months ]

8.  Secondary:   Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment   [ Time Frame: At 6 months ]

9.  Secondary:   Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment   [ Time Frame: At 12 months ]

10.  Secondary:   Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft   [ Time Frame: at 6 months ]

11.  Secondary:   Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft   [ Time Frame: at 12 months ]

12.  Secondary:   Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft   [ Time Frame: at 6 months ]

13.  Secondary:   Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft   [ Time Frame: at 12 months ]

14.  Secondary:   Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.   [ Time Frame: at 30 days ]

15.  Secondary:   Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.   [ Time Frame: at 12 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 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: Kalyan Obalampalli
Organization: Medtronic Inc
phone: 7075413158
e-mail: kalyan.obalampalli@medtronic.com


No publications provided


Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01114724     History of Changes
Other Study ID Numbers: IP # 118
Study First Received: April 26, 2010
Results First Received: May 30, 2014
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration