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Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions

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ClinicalTrials.gov Identifier: NCT00232739
Recruitment Status : Completed
First Posted : October 5, 2005
Results First Posted : February 8, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Cordis Corporation

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Device: CYPHER Sirolimus-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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions

Participant Flow:   Overall Study
    2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
STARTED   100 
COMPLETED   91 
NOT COMPLETED   9 



  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
  Description
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions

Baseline Measures
   2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent 
Overall Participants Analyzed 
[Units: Participants]
 100 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   52 
>=65 years   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.4  (9.90) 
Gender 
[Units: Participants]
 
Female   36 
Male   64 
Region of Enrollment 
[Units: Participants]
 
United States   100 
Diabetes Mellitus 
[Units: Participants]
 
Diabetes Mellitus   40 
Without Diabetes Mellitus   60 
History of Myocardial Infarction (MI) 
[Units: Participants]
 
History of MI   33 
Without History of MI   61 
N/A   6 


  Outcome Measures

1.  Primary:   Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure   [ Time Frame: From post-procedure to 6 months ]

2.  Secondary:   Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up   [ Time Frame: From post-procedure to 4 years ]

3.  Secondary:   Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.   [ Time Frame: From post-procedure to 6 months ]

4.  Secondary:   Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.   [ Time Frame: From post-procedure to 6 months ]

5.  Secondary:   Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.   [ Time Frame: From post-procedure to 6 months and 9 months ]

6.  Secondary:   Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.   [ Time Frame: From post-procedure to 6 months and 9 months follow-up ]

7.  Secondary:   Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure   [ Time Frame: From post-procedure to 6 months and 9 months follow-up ]

8.  Secondary:   Average Lumen Volume (mm3) at Post-procedure   [ Time Frame: At Post-procedure ]

9.  Secondary:   Average Stent Obstruction Volume at Post-procedure   [ Time Frame: At post-procedure ]

10.  Secondary:   Average Lumen Volume (mm3) at 6 Months Post-procedure   [ Time Frame: From post-procedure to 6 months ]

11.  Secondary:   Average Stent Obstruction Volume at 6 Months Post-procedure   [ Time Frame: From post-procedure to 6 months ]

12.  Secondary:   Percentage of Participants Who Achieved Lesion Success at Post-procedure   [ Time Frame: At post-procedure ]

13.  Secondary:   Percentage of Participants Who Achieved Device Success at Post-procedure   [ Time Frame: At post-procedure ]

14.  Secondary:   Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge   [ Time Frame: From post-procedure to hospital discharge ]


  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
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  More Information

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.


Results Point of Contact:  
Name/Title: Sidney Cohen, MD PhD, Vice President
Organization: Cordis
phone: 650 614-2726
e-mail: scohen7@its.jnj.com


Publications:

Responsible Party: Sriram Iyer, MD, Lenox Hill Hospital
ClinicalTrials.gov Identifier: NCT00232739     History of Changes
Other Study ID Numbers: P03-6320
First Submitted: October 3, 2005
First Posted: October 5, 2005
Results First Submitted: October 19, 2009
Results First Posted: February 8, 2010
Last Update Posted: March 16, 2010