Safety and Efficacy of Valiant Mona LSA Stent Graft System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01839695
First received: April 11, 2013
Last updated: October 24, 2014
Last verified: September 2014
Results First Received: October 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Thoracic Aortic Aneurysms
Intervention: Device: Valiant Mona LSA 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
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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 Mona LSA Stent Graft System

TEVAR procedure using Medtronic Stent Graft >

> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device


Participant Flow:   Overall Study
    Valiant Mona LSA Stent Graft System  
STARTED     9  
COMPLETED     9  
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.
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Reporting Groups
  Description
Valiant Mona LSA Stent Graft System

TEVAR procedure using Medtronic Stent Graft >

> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device


Baseline Measures
    Valiant Mona LSA Stent Graft System  
Number of Participants  
[units: participants]
  9  
Age  
[units: years]
Mean ± Standard Deviation
  72.89  ± 7.61  
Gender  
[units: participants]
 
Female     6  
Male     3  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     5  
More than one race     0  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     7  
United Kingdom     2  



  Outcome Measures
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1.  Primary:   Primary Safety Observation   [ Time Frame: 1 month ]

2.  Primary:   Primary Effectiveness Observation   [ Time Frame: 1 month ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Anna Busman, Sr. Clinical Research Specialist
Organization: Medtronic Vascular
phone: 707-591-7633
e-mail: rs.medtroniccardiovascularclinicaltrials@medtronic.com


No publications provided


Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01839695     History of Changes
Other Study ID Numbers: 10086370DOCRev1C
Study First Received: April 11, 2013
Results First Received: October 24, 2014
Last Updated: October 24, 2014
Health Authority: United States: Food and Drug Administration