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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00609947
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : January 26, 2015
Last Update Posted : February 9, 2015
Information provided by (Responsible Party):
Medtronic Vascular

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Device: Endeavor Zotarolimus-Eluting Coronary Stent

  Participant Flow

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
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] 
Death                1 
[1] One death due to automobile accident.

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   231 
>=65 years   10 
[Units: Years]
Mean (Standard Deviation)
 63.5  (10.1) 
[Units: Participants]
Female   85 
Male   156 
Region of Enrollment 
[Units: Participants]
United States   241 

  Outcome Measures

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

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
No text entered.

  More Information

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

Responsible Party: Medtronic Vascular Identifier: NCT00609947     History of Changes
Other Study ID Numbers: IP057
First Submitted: January 25, 2008
First Posted: February 7, 2008
Results First Submitted: June 5, 2013
Results First Posted: January 26, 2015
Last Update Posted: February 9, 2015