Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury (RESCUE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01092767
First received: March 16, 2010
Last updated: February 13, 2014
Last verified: January 2014
Results First Received: February 13, 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: Blunt Thoracic Aortic Injury
Intervention: Device: Valiant Thoracic Stent Graft with 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
A total of 25 investigational sites were activated and allowed to enroll in the RESCUE study in the US and Canada. A total of 50 subjects were enrolled at 20 of the 25 activated investigational sites, with the first enrollment on April 14, 2010 and the final enrollment on January 17, 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All 50 subjects enrolled were implanted with the device (Valiant Thoracic Stent Graft with the Captivia Delivery System ).

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     45  
NOT COMPLETED     5  



  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 With the Captivia Delivery System No text entered.

Baseline Measures
    Valiant Thoracic Stent Graft With the Captivia Delivery System  
Number of Participants  
[units: participants]
  50  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     43  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation
  40.7  ± 17.4  
Gender  
[units: participants]
 
Female     12  
Male     38  
Region of Enrollment  
[units: participants]
 
United States     48  
Canada     2  



  Outcome Measures

1.  Primary:   All-cause Mortality Within 30-days of the Index Procedure   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Kalyan Obalampalli
Organization: Medtronic, Inc
phone: 7075413158
e-mail: kalyan.obalampalli@medtronic.com


No publications provided by Medtronic Endovascular

Publications automatically indexed to this study:

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01092767     History of Changes
Other Study ID Numbers: Investigational Plan #117
Study First Received: March 16, 2010
Results First Received: February 13, 2014
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration