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SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries (SYNTAX)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Boston Scientific Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
Cardialysis BV
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00114972
First received: June 20, 2005
Last updated: May 27, 2010
Last verified: May 2010
Results First Received: March 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
Procedure: Coronary Artery Bypass Surgery

  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
CABG Coronary Artery By-pass Graft (CABG)
PCI With DES Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)

Participant Flow:   Overall Study
    CABG   PCI With DES
STARTED   897   903 
COMPLETED   849   891 
NOT COMPLETED   48   12 
Withdrawal by Subject                40                7 
Lost to Follow-up                8                5 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Primary Clinical Endpoint of 12-Month Binary MACCE.   [ Time Frame: 12 months post enrollment ]

2.  Primary:   12-month Composite Safety Endpoint.   [ Time Frame: 12 months after enrollment ]

3.  Primary:   Repeat Revascularization (PCI and/or CABG).   [ Time Frame: 12 Months post enrollment ]

4.  Secondary:   Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.   [ Time Frame: 1 month after procedure and 6 months, 3 years, and 5 years post allocation ]

5.  Secondary:   Individual Components of MACCE at 1 Month Post-procedure.   [ Time Frame: 1 month after procedure ]

6.  Secondary:   Individual Components of MACCE at 6 Months Post-allocation.   [ Time Frame: 6 months post allocation ]

7.  Secondary:   Individual Components of MACCE at 1 Year Post-allocation.   [ Time Frame: 1 year post allocation ]

8.  Secondary:   Freedom From MACCE and Its Components at 1 Year Post-allocation.   [ Time Frame: 1 year post allocation ]

9.  Secondary:   Freedom From MACCE and Its Components at 3 Years Post-allocation   [ Time Frame: 3 years post allocation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Freedom From MACCE and Its Components at 5 Years Post-allocation   [ Time Frame: 5 years post allocation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation   [ Time Frame: 1 month after procedure and 6 months, 1, 3 and 5 years post allocation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Secondary:   Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation   [ Time Frame: 1 year, 3 and 5 years post allocation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Secondary:   The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible)   [ Time Frame: 5 Years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events
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Time Frame 1 year
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
CABG Coronary Artery By-pass Graft (CABG)
PCI With DES Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)

Other Adverse Events
    CABG   PCI With DES
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   509/897 (56.74%)   405/903 (44.85%) 
Blood and lymphatic system disorders     
Anaemia * 1     
# participants affected / at risk   104/897 (11.59%)   23/903 (2.55%) 
# events   109   24 
Cardiac disorders     
Angina pectoris * 1     
# participants affected / at risk   26/897 (2.90%)   61/903 (6.76%) 
# events   28   70 
Atrial fibrillation * 1     
# participants affected / at risk   123/897 (13.71%)   25/903 (2.77%) 
# events   129   28 
General disorders     
All other Adverse Events * 1 [3]     
# participants affected / at risk   509/897 (56.74%)   405/903 (44.85%) 
# events   1099   854 
Infections and infestations     
Wound infection * 1     
# participants affected / at risk   56/897 (6.24%)   2/903 (0.22%) 
# events   58   2 
Injury, poisoning and procedural complications     
Incision site complication * 1     
# participants affected / at risk   47/897 (5.24%)   3/903 (0.33%) 
# events   52   3 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1     
# participants affected / at risk   54/897 (6.02%)   2/903 (0.22%) 
# events   55   2 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (8.0)
[3] Total of all other adverse events with an occurrence below the 5% treshold.



  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