Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent (RESOLUTE-AC)

This study has been completed.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00617084
First received: February 4, 2008
Last updated: May 27, 2014
Last verified: May 2014
Results First Received: November 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Coronary Artery Disease
Interventions: Device: Medtronic Endeavor Resolute
Device: Abbott Xience V

  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

Start recruitment: April 30, 2008 > End recruitment: October 28, 2008

> Types of location: medical clinic


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1. Resolute - 12-13 Months Medtronic Resolute - 12-13 Months
2. XIENCE V - 12-13 Months Abbott Xience V - 12-13 Months

Participant Flow:   Overall Study
    1. Resolute - 12-13 Months     2. XIENCE V - 12-13 Months  
STARTED     1140     1152  
COMPLETED     1119     1126  
NOT COMPLETED     21     26  
Withdrawal by Subject                 5                 7  
Missed 12 Months visit                 16                 19  



  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
1. Resolute - 12-13 Months Medtronic Resolute - 12-13 Months
2. XIENCE V - 12-13 Months Abbott Xience V - 12-13 Months
Total Total of all reporting groups

Baseline Measures
    1. Resolute - 12-13 Months     2. XIENCE V - 12-13 Months     Total  
Number of Participants  
[units: participants]
  1140     1152     2292  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     545     563     1108  
>=65 years     595     589     1184  
Age  
[units: years]
Mean ± Standard Deviation
  64.4  ± 10.9     64.2  ± 10.8     64.3  ± 10.9  
Gender  
[units: participants]
     
Female     266     263     529  
Male     874     889     1763  
Region of Enrollment  
[units: participants]
     
Europe     1122     1132     2254  
Middle East     18     20     38  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Target Lesion Failure   [ Time Frame: 12 months ]

2.  Secondary:   In-Stent Percent Diameter Stenosis   [ Time Frame: 13 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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Miraida Weldam
Organization: Medtronic Bakken Research Center B.V.
phone: + 31 43 356 ext 6652
e-mail: miraida.weldam@medtronic.com


No publications provided by Medtronic Vascular

Publications automatically indexed to this study:


Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00617084     History of Changes
Other Study ID Numbers: Version 1.2 - IP090
Study First Received: February 4, 2008
Results First Received: November 22, 2010
Last Updated: May 27, 2014
Health Authority: Belgium: Institutional Review Board
Denmark: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Ireland: Medical Ethics Research Committee
Israel: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration