PROTECT Continued Access Post Marketing Surveillance Trial (PROTECT-CA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00846846
First received: February 18, 2009
Last updated: July 1, 2014
Last verified: July 2014
Results First Received: May 30, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease, Autosomal Dominant, 1
Intervention: Device: Endeavor® 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
1018 patients were enrolled from February 2009 until November 2009 in 48 participating hospitals in USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were excluded from participation if they did not meet inclusion/exclusion criteria.

Reporting Groups
  Description
Endeavor® Zotarolimus Eluting Coronary Stent System

Endeavor® Zotarolimus Eluting Coronary Stent System >

> Endeavor® Zotarolimus Eluting Coronary Stent System: Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation


Participant Flow:   Overall Study
    Endeavor® Zotarolimus Eluting Coronary Stent System  
STARTED     1018  
COMPLETED     943 [1]
NOT COMPLETED     75  
Death                 56  
Withdrawal by Subject                 19  
[1] Study ongoing but not recruiting participants.



  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
Endeavor® Zotarolimus Eluting Coronary Stent System Endeavor® Zotarolimus Eluting Coronary Stent Implantation in a patient population requiring stent implantation.

Baseline Measures
    Endeavor® Zotarolimus Eluting Coronary Stent System  
Number of Participants  
[units: participants]
  1018  
Age  
[units: Years]
Mean ( Full Range )
  63.16  
  ( 31 to 90 )  
Gender  
[units: participants]
 
Female     274  
Male     744  
Region of Enrollment  
[units: participants]
 
United States     1018  



  Outcome Measures
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1.  Primary:   To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation   [ Time Frame: 3 years ]

2.  Secondary:   Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.   [ Time Frame: 3 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 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: Lisa Bousquette, Director Clinical Research Coronary and Renal Denervation
Organization: Medtronic Cardiovascular
e-mail: lisa.r.bousquette@medtronic.com


No publications provided


Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00846846     History of Changes
Other Study ID Numbers: Version 1.0, 29 October 2008
Study First Received: February 18, 2009
Results First Received: May 30, 2014
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board