Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson and Johnson, S.A.
ClinicalTrials.gov Identifier:
NCT00968019
First received: August 27, 2009
Last updated: March 5, 2013
Last verified: March 2013
Results First Received: January 15, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Coronary Arteriosclerosis
Intervention: Device: Presillion 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
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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
Treated With Presillion Stent Patients treated with the Presillion stent in up to two de novo coronary artery lesions

Participant Flow:   Overall Study
    Treated With Presillion Stent  
STARTED     318  
COMPLETED     303  
NOT COMPLETED     15  



  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
Treated With Presillion Stent Patients treated with the Presillion stent in up to two de novo coronary artery lesions

Baseline Measures
    Treated With Presillion Stent  
Number of Participants  
[units: participants]
  318  
Age  
[units: years]
Mean ± Standard Deviation
  65.5  ± 12.4  
Gender  
[units: participants]
 
Female     70  
Male     248  
Region of Enrollment  
[units: participants]
 
Portugal     56  
Spain     262  



  Outcome Measures
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1.  Primary:   Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))   [ Time Frame: at 12 months follow-up ]

2.  Secondary:   Device Success   [ Time Frame: Peri-procedure up to discharge ]

3.  Secondary:   Lesion Success   [ Time Frame: Peri-procedure up to discharge ]

4.  Secondary:   Procedural Success   [ Time Frame: Peri-procedure up to discharge ]

5.  Secondary:   Clinically Driven TLR   [ Time Frame: Up to 30 days ]

6.  Secondary:   Clinically Driven TVR   [ Time Frame: Up to 30 days ]

7.  Secondary:   Target Vessel Failure   [ Time Frame: Up to 30 days ]

8.  Secondary:   Myocardial Infarction   [ Time Frame: Up to 30 days ]

9.  Secondary:   Major Bleeding   [ Time Frame: Up to 30 days ]

10.  Secondary:   Stroke   [ Time Frame: Up to 30 days ]

11.  Secondary:   Stent Thrombosis   [ Time Frame: Up to 30 days ]

12.  Secondary:   Clinically Driven TLR   [ Time Frame: up to 12 months ]

13.  Secondary:   Clinically Driven TVR   [ Time Frame: Up to 12 months ]

14.  Secondary:   Target Vessel Failure   [ Time Frame: Up to 12 months ]

15.  Secondary:   Myocardial Infarction   [ Time Frame: Up to 12 months ]

16.  Secondary:   Major Bleeding   [ Time Frame: Up to 12 months ]

17.  Secondary:   Stent Thrombosis   [ Time Frame: Up to 12 months ]

18.  Secondary:   Stroke   [ Time Frame: Up to 12 months ]


  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
since the difference with the performance goal is this large; the possibility of underreporting of adverse events is something that needs to be considered.


  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: Mayda Lopez-Belmonte, PhD
Organization: Johnson and Johnson Medical Iberia
phone: +34 91 7228481
e-mail: tlopezbe@its.jnj.com


No publications provided


Responsible Party: Johnson and Johnson, S.A.
ClinicalTrials.gov Identifier: NCT00968019     History of Changes
Other Study ID Numbers: 08-CR-001
Study First Received: August 27, 2009
Results First Received: January 15, 2013
Last Updated: March 5, 2013
Health Authority: Spain: Ethics Committee
Portugal: Ethics Committee for Clinical Research