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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;   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 
Overall Participants Analyzed 
[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
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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


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


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