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Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00833924
First received: January 30, 2009
Last updated: February 9, 2016
Last verified: February 2016
Results First Received: December 18, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Abdominal Aortic Aneurysms
Iliac Aneurysms
Aorto-iliac Aneurysms
Intervention: Device: Zenith(R) Low Profile AAA Endovascular Graft

  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
Zenith® Low Profile AAA Endovascular Graft The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.

Participant Flow:   Overall Study
    Zenith® Low Profile AAA Endovascular Graft
STARTED   120 
30-day   120 
12-month   113 
COMPLETED   11 
NOT COMPLETED   109 
Death                21 
Conversion                2 
Lost to Follow-up                2 
Withdrawal by Subject                13 
In study follow-up                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
Zenith® Low Profile AAA Endovascular Graft The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.

Baseline Measures
   Zenith® Low Profile AAA Endovascular Graft 
Overall Participants Analyzed 
[Units: Participants]
 120 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.8  (8.7) 
Gender 
[Units: Participants]
 
Female   16 
Male   104 


  Outcome Measures
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1.  Primary:   Patients With Major Adverse Events (MAE)   [ Time Frame: 30-day ]

2.  Primary:   Patients With Device Failures   [ Time Frame: 12-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 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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Scott Snyder, PhD, Director of Clinical Science & Biostatistics
Organization: Cook Research Incorporated
phone: 765-463-7537
e-mail: SSnyder@medinst.com



Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00833924     History of Changes
Other Study ID Numbers: 08-013
370016
Study First Received: January 30, 2009
Results First Received: December 18, 2015
Last Updated: February 9, 2016
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Canada: Health Canada