Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Randomized Study Comparing Endeavor With Cypher Stents (PROTECT) (PROTECT)

This study has been completed.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00476957
First received: May 21, 2007
Last updated: November 3, 2014
Last verified: November 2014
Results First Received: September 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Ischemic Heart Disease
Intervention: Device: Stent

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
8709 patients were randomized from May 2007 until December 2008 in 196 participating hospitals in 36 countries across five continents.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
80 patients were excluded because there was no validly signed consent available during monitoring and 2 patients retracted their consent before the procedure, resulting in a total of 8709 patients randomised.

Reporting Groups
  Description
E-ZES

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

C-SES

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation


Participant Flow:   Overall Study
    E-ZES   C-SES
STARTED   4357   4352 
COMPLETED   4181   4159 
NOT COMPLETED   176   193 
Lost to Follow-up                176                193 



  Baseline Characteristics
  Hide 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.
Intention to treat analysis has been used.

Reporting Groups
  Description
E-ZES

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Stent : Stent implantation

C-SES

Cordis Cypher® Sirolimus-eluting Coronary Stent

Stent : Stent implantation

Total Total of all reporting groups

Baseline Measures
   E-ZES   C-SES   Total 
Overall Participants Analyzed 
[Units: Participants]
 4357   4352   8709 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   2428   2468   4896 
>=65 years   1929   1884   3813 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.3  (10.6)   62.1  (10.7)   62.2  (10.6) 
Gender 
[Units: Participants]
     
Female   1017   1044   2061 
Male   3340   3308   6648 
Region of Enrollment 
[Units: Participants]
     
Europe   3180   3179   6359 
South Asia   623   622   1245 
North America   115   115   230 
South America   25   25   50 
Australia   207   207   414 
New Zealand   43   42   85 
Middle East   164   162   326 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent 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
  Hide 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