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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507559
Recruitment Status : Completed
First Posted : July 26, 2007
Results First Posted : May 27, 2016
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Abdominal Aortic Aneurysms (AAA)
Intervention: Device: Aptus Endovascular AAA Repair System

  Participant Flow

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
AAA Repair System Aptus Endovascular AAA Repair System: EVAR

Participant Flow:   Overall Study
    AAA Repair System
STARTED   155 

  Baseline Characteristics

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
AAA Repair System Aptus Endovascular AAA Repair System: EVAR

Baseline Measures
   AAA Repair System 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 73  (8) 
[Units: Participants]
Female   10 
Male   145 
Region of Enrollment 
[Units: Participants]
United States   155 

  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

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

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

Responsible Party: Medtronic Endovascular Identifier: NCT00507559     History of Changes
Other Study ID Numbers: 2007-01
First Submitted: July 24, 2007
First Posted: July 26, 2007
Results First Submitted: April 21, 2016
Results First Posted: May 27, 2016
Last Update Posted: November 22, 2016