Valor II: The Valiant Thoracic Stent Graft System Clinical Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00413231
First received: December 15, 2006
Last updated: November 25, 2015
Last verified: October 2015
Results First Received: December 23, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Thoracic Aortic Aneurysm
Intervention: Device: Valiant Thoracic Stent Graft 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
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
Valiant Thoracic Stent Graft System Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).

Participant Flow for 3 periods

Period 1:   0 to 30-day Post Treatment
    Valiant Thoracic Stent Graft System  
STARTED     160  
COMPLETED     152  
NOT COMPLETED     8  
Death                 5  
Intend to treat, but not implanted                 3  

Period 2:   30-day to 365-day Post Treatment
    Valiant Thoracic Stent Graft System  
STARTED     152  
COMPLETED     139  
NOT COMPLETED     13  
Death                 13  

Period 3:   365-day to 60-month Post Treatment
    Valiant Thoracic Stent Graft System  
STARTED     139  
COMPLETED     93  
NOT COMPLETED     46  
Death                 36  
Withdrawal by Subject                 5  
Lost to Follow-up                 4  
Exited after surgical conversion                 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.
No text entered.

Reporting Groups
  Description
Valiant Thoracic Stent Graft System Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).

Baseline Measures
    Valiant Thoracic Stent Graft System  
Number of Participants  
[units: participants]
  160  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     26  
>=65 years     134  
Age  
[units: years]
Mean (Standard Deviation)
  72.2  (9.1)  
Gender  
[units: participants]
 
Female     65  
Male     95  
Region of Enrollment  
[units: participants]
 
United States     160  



  Outcome Measures
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1.  Primary:   Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)   [ Time Frame: 0 through 1825 days post treatment ]

2.  Primary:   Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)   [ Time Frame: At 12-month post procedure ]

3.  Primary:   Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >   [ Time Frame: Within 12-months post treatment ]

4.  Secondary:   Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant   [ Time Frame: At implant ]

5.  Secondary:   Percentage of Participants That Experienced Perioperative Mortality   [ Time Frame: Within 30 days post treatment ]

6.  Secondary:   Percentage of Participants That Experienced Paraplegia   [ Time Frame: Within 30 days post treatment ]

7.  Secondary:   Percentage of Participants That Experienced Paraparesis   [ Time Frame: Within 30 days post treatment ]

8.  Secondary:   Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge   [ Time Frame: Within 30 days post treatment ]

9.  Secondary:   Percentage of Participants That Experienced One or More Major Adverse Events   [ Time Frame: Within 30 days post treatment ]

10.  Secondary:   Percentage of Participants That Experienced Aneurysm-related Mortality   [ Time Frame: Within 12 months post treatment ]

11.  Secondary:   Percentage of Participants That Experience Aneurysm Rupture   [ Time Frame: Within 12 months post treatment ]

12.  Secondary:   Percentage of Participants That Experienced Conversion to Open Surgical Repair   [ Time Frame: Within 12 months post treatment ]

13.  Secondary:   Percentage of Participants That Experienced Endoleak(s)   [ Time Frame: At 12 months ]

14.  Secondary:   Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak   [ Time Frame: Between 30 days and 12 months ]

15.  Secondary:   Percentage of Participants That Experienced Stent Graft Migration   [ Time Frame: Within 12 months post treatment ]

16.  Secondary:   Percentage of Participants That Experience Loss of Stent Graft Patency   [ Time Frame: Within 12 months post treatment ]

17.  Secondary:   Percentage of Participants That Experienced One or More Major Adverse Events   [ Time Frame: Within 12 months post treatment ]

18.  Secondary:   Percentage of Participants That Died (All-cause Mortality)   [ Time Frame: 0 through 1825 days post treatment ]

19.  Secondary:   Percentage of Participants That Experienced Aneurysm-related Mortality   [ Time Frame: 0 through 1825 days post treatment ]

20.  Secondary:   Percentage of Participants That Experienced Aneurysm Ruptures   [ Time Frame: 0 through 1825 days post treatment ]

21.  Secondary:   Percentage of Participants That Experienced Conversions to Open Surgical Repair   [ Time Frame: 0 through 1825 days post treatment ]

22.  Secondary:   Percentage of Participants That Experienced Type I Endoleaks   [ Time Frame: 0 through 1825 days post treatment ]

23.  Secondary:   Percentage of Participants That Experienced Type III Endoleaks   [ Time Frame: 0 through 1825 days post treatment ]

24.  Secondary:   Percentage of Participants That Experienced Type IV Endoleaks   [ Time Frame: 0 through 1825 days post treatment ]

25.  Secondary:   Percentage of Participants That Experienced Secondary Endovascular Procedures   [ Time Frame: 0 through 1825 days post treatment ]

26.  Secondary:   Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)   [ Time Frame: 0 through 1825 days post treatment ]

27.  Secondary:   Percentage of Participants That Experienced Loss of Stent Graft Patency   [ Time Frame: 0 through 1825 days post treatment ]


  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
Adverse Events and Serious Adverse Events listed in ClinicalTrials.gov were re-coded, using MedDRA 13.1. To do so, events were reclassified. As a result, data in listings may not match those in Clinical Update reports, SSEDs, or Instructions for Use.


  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: PJ Belmont, Clinical Research Specialist
Organization: Medtronic Vascular, Inc.
phone: 707-480-3025
e-mail: PJ.Belmont@Medtronic.com


No publications provided


Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00413231     History of Changes
Other Study ID Numbers: Investigational Plan #078
Study First Received: December 15, 2006
Results First Received: December 23, 2011
Last Updated: November 25, 2015
Health Authority: United States: Food and Drug Administration