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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: September 12, 2014
Last verified: September 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 
Overall Participants Analyzed 
[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 
[1] Note: A single participant could potentially experience multiple categories listed below.
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 
[1] Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristics: Target Lesion Vessel [1] 
[Units: Participants]
 
Left Anterior Descending Artery   112 
Circumflex Artery   79 
Right Coronary Artery   137 
[1] Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristic: Lesion Location [1] 
[Units: Lesions]
 
Proximal   122 
Mid   155 
Distal   37 
Ostial   14 
[1] Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristic: Lesion Length [1] 
[Units: Lesions]
 
Less than 10 mm   123 
10 to 20 mm   172 
Greater than 20 mm   32 
[1] Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristics [1] 
[Units: Lesions]
 
Tortuosity, Any   32 
Thrombus   4 
Calcification, Any   111 
Ulcer   21 
Aneurysm   7 
[1] Note: A single participant could potentially experience multiple categories listed below.
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 
[1] Note: A single participant could potentially experience multiple categories listed below.
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) 


  Outcome Measures
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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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: September 12, 2014
Health Authority: United States: Food and Drug Administration