RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population (R-Int)

This study has been completed.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00752128
First received: September 12, 2008
Last updated: April 18, 2013
Last verified: April 2013
Results First Received: October 31, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Coronary Artery Disease
Cardiovascular Diseases
Intervention: Device: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System

  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: August 28, 2008 > End recruitment: March 19, 2009

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
Resolute Drug-Eluting Stent No text entered.

Participant Flow:   Overall Study
    Resolute Drug-Eluting Stent  
STARTED     2349  
COMPLETED     2345  
NOT COMPLETED     4  
Withdrawal by Subject                 4  



  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
Resolute Drug-Eluting Stent No text entered.

Baseline Measures
    Resolute Drug-Eluting Stent  
Number of Participants  
[units: participants]
  2349  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1260  
>=65 years     1089  
Age  
[units: years]
Mean ± Standard Deviation
  63.5  ± 11.2  
Gender  
[units: participants]
 
Female     521  
Male     1828  
Region of Enrollment  
[units: participants]
 
Europe     2118  
India     174  
Argentina     17  
South Africa     40  



  Outcome Measures
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1.  Primary:   Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)   [ Time Frame: 12 Months ]

2.  Secondary:   Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition   [ Time Frame: 12 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
The data collection in this registry was limited to the collection of MACE (death, myocardial infarction (Q- and non-Q-wave), emergent cardiac bypass surgery and TLR) and stent thrombosis events.


  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: Marianne Wanten
Organization: Medtronic Bakken Research Center B.V.
phone: +3143356 ext 6815
e-mail: marianne.wanten@medtronic.com


No publications provided by Medtronic Vascular

Publications automatically indexed to this study:

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00752128     History of Changes
Other Study ID Numbers: IP091
Study First Received: September 12, 2008
Results First Received: October 31, 2011
Last Updated: April 18, 2013
Health Authority: Argentina: Human Research Bioethics Committee
Belgium: Institutional Review Board
Estonia: Institutional Review Board
Finland: Ethics Committee
Germany: Ethics Commission
Greece: Ethics Committee
India: Institutional Review Board
Netherlands: Independent Ethics Committee
Portugal: Ethics Committee
South Africa: Human Research Ethics Committee
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee