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Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) (OVER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00094575
First received: October 20, 2004
Last updated: February 8, 2016
Last verified: February 2016
Results First Received: September 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Aortic Aneurysm
Interventions: Procedure: Endovascular Repair
Procedure: Standard Open Repair

  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
Endovascular Repair Endovascular Repair
Open Repair Standard Open Repair

Participant Flow:   Overall Study
    Endovascular Repair     Open Repair  
STARTED     444     437  
COMPLETED     298     291  
NOT COMPLETED     146     146  
Death                 146                 146  



  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
Endovascular Repair Endovascular Repair
Open Repair Standard Open Repair
Total Total of all reporting groups

Baseline Measures
    Endovascular Repair     Open Repair     Total  
Number of Participants  
[units: participants]
  444     437     881  
Age  
[units: years]
Mean (Standard Deviation)
  69.6  (7.8)     70.5  (7.8)     70.1  (7.8)  
Gender  
[units: participants]
     
Female     3     2     5  
Male     441     435     876  
Weight in kilograms  
[units: Kilogram]
Mean (Standard Deviation)
  89.9  (16.8)     89.7  (17.8)     89.8  (17.3)  
Body Mass Index [BMI]  
[units: Kg/m^2]
Mean (Standard Deviation)
  28.6  (5.2)     28.7  (5.6)     28.6  (5.4)  
Smoking Status  
[units: Participants]
     
Ever Smoked     428     413     841  
Never Smoked     16     24     40  
Currently Smoking  
[units: Participants]
     
Yes     170     193     363  
No     274     244     518  
Surgical Risk [RAND Score]  
[units: Participants]
     
Low     240     228     468  
Intermediate     169     175     344  
High     31     29     60  
Not Assessed     4     5     9  
Maximum Aneurysm Diameter  
[units: Centimeter]
Mean (Standard Deviation)
  5.7  (.8)     5.7  (1.0)     5.7  (0.9)  



  Outcome Measures
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1.  Primary:   All-cause Mortality   [ Time Frame: Participants were followed for the duration of the study, up to 9 years ]

2.  Secondary:   Secondary Therapeutic Procedures   [ Time Frame: Participants were followed for the duration of the study, up to 9 years ]

3.  Secondary:   SF-36 Mental Component Score (MCS)   [ Time Frame: Outcome was assessed at 6 months and then yearly, up to 9 years ]

4.  Secondary:   SF-36 Physical Component Score (PCS)   [ Time Frame: Outcome was assessed at 6 months and yearly thereafter, up to 9 years ]

5.  Secondary:   SF-36 Physical Component Deaths Included Score (PCTD)   [ Time Frame: Outcome was assessed at 6 months and yearly thereafter, up to 9 years ]

6.  Secondary:   European Quality of Life-5 Dimension (EQ-5D) Index Score   [ Time Frame: Outcome was assessed at 6 months and yearly thereafter, up to 9 years ]

7.  Secondary:   European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale   [ Time Frame: Outcome was assessed at 6 months and yearly thereafter, up to 9 years ]

8.  Secondary:   International Index of Erectile Function (IIEF-5)   [ Time Frame: Outcome was assessed at 6 months and yearly thereafter, up to 9 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: Dr. Frank A. Lederle
Organization: VAMC Minneapolis, MN
phone: 612-725-2158
e-mail: Frank.Lederle@va.gov


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00094575     History of Changes
Other Study ID Numbers: 498
Study First Received: October 20, 2004
Results First Received: September 16, 2013
Last Updated: February 8, 2016
Health Authority: United States: Federal Government