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

The recruitment status of this study is unknown because the information has not been verified recently.
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;   Endpoint Classification: Safety/Efficacy Study;   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


  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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

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

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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Nic Van Dyck / Senior Program Manager
Organization: Boston Scientific
phone: + 31 43 356 8328
e-mail: vandyckn@bsci.com


No publications provided by Boston Scientific Corporation

Publications automatically indexed to this study:


Responsible Party: Nic Van Dyck, Boston Scientific
ClinicalTrials.gov Identifier: NCT00114972     History of Changes
Other Study ID Numbers: S2024, 90169394
Study First Received: June 20, 2005
Results First Received: March 27, 2009
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration