Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries. (ENDEAVORSVS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00609947
First received: January 25, 2008
Last updated: January 26, 2015
Last verified: January 2015
Results First Received: June 5, 2013  
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
Intervention: Device: Endeavor Zotarolimus-Eluting Coronary Stent

  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
Subjects were recruited by local and regional medical centers from December 21, 2007 through November 22, 2010.

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 and fall into the category of per protocol small vessel stenting - 2.25mm, 2.5mm and 2.75mm - single or multi-vessel (Rev K).

Reporting Groups
  Description
Endeavor Zotarolimus-Eluting Coronary Stent Zotarolimus-eltuing stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach

Participant Flow:   Overall Study
    Endeavor Zotarolimus-Eluting Coronary Stent  
STARTED     241  
COMPLETED     240 [1]
NOT COMPLETED     1  
Death                 1  
[1] One death due to automobile accident.



  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 Zotarolimus-eluting stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach

Baseline Measures
    Endeavor Zotarolimus-Eluting Coronary Stent  
Number of Participants  
[units: participants]
  241  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     231  
>=65 years     10  
Age  
[units: years]
Mean ± Standard Deviation
  63.5  ± 10.1  
Gender  
[units: participants]
 
Female     85  
Male     156  
Region of Enrollment  
[units: participants]
 
United States     241  



  Outcome Measures
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1.  Primary:   In-segment Percent Diameter Stenosis at 8 Months Post-procedure   [ Time Frame: 8 months post-procedure ]

2.  Primary:   Major Adverse Cardiac Events (MACE) Rate   [ Time Frame: 12 months post-procedure ]


  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: Lynda Chaplin - Study Manager
Organization: Medtronic CardioVascular
phone: (707) 543-5459
e-mail: lynda.chaplin@medtronic.com


No publications provided


Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00609947     History of Changes
Other Study ID Numbers: IP057
Study First Received: January 25, 2008
Results First Received: June 5, 2013
Last Updated: January 26, 2015
Health Authority: United States: Food and Drug Administration