The OMEGA Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01419171
First received: August 16, 2011
Last updated: August 27, 2014
Last verified: August 2014
Results First Received: July 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Atherosclerosis
Coronary Artery Disease
Intervention: Device: OMEGA™ Monorail Coronary 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
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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
OMEGA™ Monorail Coronary Stent System OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.

Participant Flow:   Overall Study
    OMEGA™ Monorail Coronary Stent System  
STARTED     328  
COMPLETED     328  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
OMEGA™ Monorail Coronary Stent System OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.

Baseline Measures
    OMEGA™ Monorail Coronary Stent System  
Number of Participants  
[units: participants]
  328  
Age  
[units: years]
Mean ± Standard Deviation
  65.46  ± 11.23  
Gender  
[units: participants]
 
Female     106  
Male     222  
Race/Ethnicity, Customized  
[units: participants]
 
Black, of African heritage     9  
Caucasian     254  
Hispanic or Latino     2  
Other     2  
Not disclosed     61  
Region of Enrollment  
[units: participants]
 
France     55  
United States     104  
Spain     39  
Belgium     37  
Netherlands     39  
Latvia     23  
Germany     31  
Cardiac History [1]
[units: participants]
 
Previous Myocardial Infarction     96  
History of CABG     15  
History of PCI     95  
History of CHF     21  
Stable Angina     182  
Unstable Angina     111  
Silent Ischemia     54  
Cardiac Risk Factors [1]
[units: participants]
 
Smoking, Ever     211  
Medically Treated Diabetes     57  
Hyperlipidemia Requiring Medication     230  
Hypertension Requiring Medication     243  
Family History of CAD     131  
Lesion Characteristics: Target Lesion Vessel [1]
[units: participants]
 
Left Anterior Descending Artery     112  
Circumflex Artery     79  
Right Coronary Artery     137  
Lesion Characteristic: Lesion Location [1]
[units: Lesions]
 
Proximal     122  
Mid     155  
Distal     37  
Ostial     14  
Lesion Characteristic: Lesion Length [1]
[units: Lesions]
 
Less than 10 mm     123  
10 to 20 mm     172  
Greater than 20 mm     32  
Lesion Characteristics [1]
[units: Lesions]
 
Tortuosity, Any     32  
Thrombus     4  
Calcification, Any     111  
Ulcer     21  
Aneurysm     7  
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow [1]
[units: Lesions]
 
0 (no perfusion)     0  
1 (penetration with minimal perfusion)     2  
2 (partial perfusion)     6  
3 (complete perfusion)     319  
Lesion Characteristics by Quantitative Cornary Angiography  
[units: Millimeters]
Mean ± Standard Deviation
 
Reference Vessel Diameter     2.77  ± 0.53  
Minimum Lumen Diameter     0.9  ± 0.38  
Lesion Length     12.49  ± 5.15  
Lesion Characteristic: Percent Diameter Stenosis by QCA  
[units: Percent]
Mean ± Standard Deviation
  67.41  ± 11.34  
[1] Note: A single participant could potentially experience multiple categories listed below.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   9-month Target Lesion Failure (TLF) Rate   [ Time Frame: Nine Month ]

2.  Secondary:   12 Month Target Lesion Revascularization (TLR) Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

3.  Secondary:   12 Month Target Vessel Revascularization (TVR) Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

4.  Secondary:   12 Month Target Vessel Failure (TVF) Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

5.  Secondary:   12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

6.  Secondary:   12 Month Cardiac Death Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

7.  Secondary:   12 Month Non-cardiac Death Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

8.  Secondary:   12 Month All Death Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

9.  Secondary:   12 Month Cardiac Death or MI Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

10.  Secondary:   12 Month All Death or MI Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

11.  Secondary:   12 Month All Death/MI/TVR Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

12.  Secondary:   12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months ]

13.  Secondary:   Periprocedural Endpoints: Technical Success Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]

14.  Secondary:   Clinical Procedural Success Rate   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ]


  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
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  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Peter Maurer, Director Clinical Trials
Organization: Peter Maurer, Director Clinical Trials
phone: 508-683-6678
e-mail: Peter.Maurer@bsci.com


No publications provided


Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01419171     History of Changes
Other Study ID Numbers: S2215
Study First Received: August 16, 2011
Results First Received: July 24, 2014
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration