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The Pivotal Study of the Aptus Endovascular AAA Repair System (STAPLE-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00507559
First received: July 24, 2007
Last updated: April 21, 2016
Last verified: April 2016
Results First Received: April 21, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Abdominal Aortic Aneurysms (AAA)
Intervention: Device: Aptus Endovascular AAA Repair 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
AAA Repair System Aptus Endovascular AAA Repair System: EVAR

Participant Flow:   Overall Study
    AAA Repair System  
STARTED     155  
COMPLETED     84  
NOT COMPLETED     71  



  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
AAA Repair System Aptus Endovascular AAA Repair System: EVAR

Baseline Measures
    AAA Repair System  
Number of Participants  
[units: participants]
  155  
Age  
[units: years]
Mean (Standard Deviation)
  73  (8)  
Gender  
[units: participants]
 
Female     10  
Male     145  
Region of Enrollment  
[units: participants]
 
United States     155  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effectiveness: Composite Success Rate   [ Time Frame: 12 months ]

2.  Primary:   Safety: MAE (Major Adverse Event)   [ Time Frame: 30 days ]

3.  Secondary:   Safety: SAE (Serious Adverse Event)   [ Time Frame: 5 years ]

4.  Secondary:   Effectiveness: Surgical Conversion   [ Time Frame: 12 months ]

5.  Secondary:   Effectiveness: Aneurysm Rupture   [ Time Frame: 12 months ]

6.  Secondary:   Effectiveness: Aneurysm Change   [ Time Frame: 12 months ]

7.  Secondary:   Effectiveness: EndoStaple Stent/Fracture   [ Time Frame: 12 months ]

8.  Secondary:   Effectiveness: Prosthesis Migration   [ Time Frame: 12 months ]

9.  Secondary:   Effectiveness: Type I Endoleak and Type III Endoleak   [ Time Frame: 12 months ]

10.  Secondary:   Effectiveness: Thrombosis   [ Time Frame: 5 years ]


  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: Kristin Schwartz
Organization: Medtronic Endovascular
phone: (763) 514-4000
e-mail: kristin.schwartz@medtronic.com



Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00507559     History of Changes
Other Study ID Numbers: 2007-01
Study First Received: July 24, 2007
Results First Received: April 21, 2016
Last Updated: April 21, 2016
Health Authority: United States: Food and Drug Administration