Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00715884
First received: July 11, 2008
Last updated: December 17, 2013
Last verified: December 2013
Results First Received: February 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Coronary Artery Disease
Coronary Atherosclerosis
Interventions: Device: CYPHER® ELITE™ Sirolimus-Eluting Stent System
Device: CYPHER® Bx VELOCITY® Sirolimus-eluting 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
No text entered.

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
ELITE™ CYPHER® ELITE™ Sirolimus-Eluting Stent System.
CYPHER® CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System

Participant Flow:   Overall Study
    ELITE™     CYPHER®  
STARTED     452     226  
COMPLETED     444     225  
NOT COMPLETED     8     1  



  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
ELITE™ CYPHER® ELITE™ Sirolimus-Eluting Stent System.
CYPHER® CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
Total Total of all reporting groups

Baseline Measures
    ELITE™     CYPHER®     Total  
Number of Participants  
[units: participants]
  452     226     678  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     252     137     389  
>=65 years     200     89     289  
Age  
[units: years]
Mean ± Standard Deviation
  63.1  ± 10.5     62.2  ± 10.5     62.8  ± 10.5  
Gender  
[units: participants]
     
Female     138     74     212  
Male     314     152     466  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     21     4     25  
Not Hispanic or Latino     421     218     639  
Unknown or Not Reported     10     4     14  
Region of Enrollment  
[units: participants]
     
United States     452     226     678  
Race  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     11     3     14  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     33     20     53  
White     403     203     606  
Other     3     0     3  
Patients with History of Previous Percutaneous Coronary Intervention (PCI)  
[units: participants]
     
History of Previous PCI     145     69     214  
Without History of Previous PCI     307     157     464  
Patients with History of Previous Coronary Artery Bypass Graft (CABG)  
[units: participants]
     
History of Previous CABG     48     21     69  
Without History of Previous CABG     404     205     609  
Patients with Family History of Coronary Artery (CAD)  
[units: participants]
     
Family History of Coronary Artery (CAD)     255     137     392  
Without Family History of Coronary Artery (CAD)     197     89     286  
Patients with History of Hyperlipidemia  
[units: participants]
     
History of Hyperlipidemia     388     188     576  
Without History of Hyperlipidemia     64     38     102  
Patients with History of Hypertension  
[units: participants]
     
History of Hypertension     360     178     538  
Without History of Hypertension     92     48     140  
Patients with History of Diabetes Mellitus  
[units: participants]
     
History of Diabetes Mellitus     144     69     213  
Without History of Diabetes Mellitus     308     157     465  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Experienced Target Lesion Failure (TLF)   [ Time Frame: 12-months post-procedure ]

2.  Secondary:   Percentage of Lesion Success   [ Time Frame: At procedure ]

3.  Secondary:   Percentage of Device Success - Protocol Definition   [ Time Frame: At procedure ]

4.  Secondary:   Percentage of Device Success - All CYPHER® Stents Included   [ Time Frame: At procedure ]

5.  Secondary:   Percentage of Participants Who Achieved Procedure Success   [ Time Frame: At procedure during hospital stay ]

6.  Secondary:   Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)   [ Time Frame: 12 months post-procedure ]

7.  Secondary:   Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)   [ Time Frame: 12 months post procedure ]

8.  Secondary:   Percentage of Participants Who Experienced Target Vessel Failure (TVF)   [ Time Frame: 12 months post procedure ]

9.  Secondary:   Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)   [ Time Frame: 12 months post procedure ]

10.  Secondary:   Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)   [ Time Frame: 12 months post procedure ]

11.  Secondary:   Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)   [ Time Frame: 12 months post procedure ]

12.  Secondary:   Percentage of Participants Who Experienced Bleeding Complications   [ Time Frame: 12 months post procedure ]

13.  Secondary:   Percentage of Participants Who Died   [ Time Frame: 12 months post procedure ]

14.  Secondary:   Percentage of Participants Who Experienced Any Myocardial Infarction (MI)   [ Time Frame: 12 months post procedure ]

15.  Secondary:   Percentage of Participants Who Experienced Stroke   [ Time Frame: 12 months post procedure ]

16.  Secondary:   Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)   [ Time Frame: 12 months post procedure ]

17.  Secondary:   Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)   [ Time Frame: 12 months post procedure ]

18.  Secondary:   Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)   [ Time Frame: 0-30 days post-procedure ]

19.  Secondary:   Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)   [ Time Frame: 31-360 days post-procedure ]


  Serious Adverse Events


  Other Adverse 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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
The study was terminated early by the Sponsor for business reasons. Hence the data was under powered for hypothesis testing. No definitive conclusions can be made from this data.  


Results Point of Contact:  
Name/Title: Amy Orlick, Associate Director Clinical Research
Organization: Cordis
phone: 908-541-4347
e-mail: AOrlick@its.jnj.com


No publications provided


Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00715884     History of Changes
Other Study ID Numbers: P07-6330
Study First Received: July 11, 2008
Results First Received: February 25, 2011
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration