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Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00875563
First received: February 19, 2009
Last updated: March 7, 2016
Last verified: March 2016
Results First Received: June 30, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Abdominal Aortic Aneurysms
Aorto-iliac Aneurysms
Juxtarenal Aneurysms
Intervention: Device: Zenith(R) Fenestrated 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
No text entered.

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® Fenestrated AAA Endovascular Graft The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair

Participant Flow:   Overall Study
    Zenith® Fenestrated AAA Endovascular Graft  
STARTED     42  
COMPLETED     18  
NOT COMPLETED     24  
Death                 4  
Withdrawal by Subject                 7  
No long-term (3-5 year) consent                 6  
Still be eligible for follow-up                 7  



  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
Zenith® Fenestrated AAA Endovascular Graft The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair

Baseline Measures
    Zenith® Fenestrated AAA Endovascular Graft  
Number of Participants  
[units: participants]
  42  
Age  
[units: years]
Mean (Standard Deviation)
  75.3  (7.4)  
Gender  
[units: participants]
 
Female     9  
Male     33  



  Outcome Measures

1.  Primary:   Number of Participants With Treatment Success   [ Time Frame: 6 months ]


  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: NCT00875563     History of Changes
Other Study ID Numbers: 04-541
370015, FNCT
Study First Received: February 19, 2009
Results First Received: June 30, 2015
Last Updated: March 7, 2016
Health Authority: United States: Food and Drug Administration