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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
  Purpose

The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).


Condition Intervention Phase
Coronary Artery Disease
Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
Procedure: Coronary Artery Bypass Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Primary Clinical Endpoint of 12-Month Binary MACCE. [ Time Frame: 12 months post enrollment ] [ Designated as safety issue: Yes ]
    Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).

  • 12-month Composite Safety Endpoint. [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: Yes ]
    Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.

  • Repeat Revascularization (PCI and/or CABG). [ Time Frame: 12 Months post enrollment ] [ Designated as safety issue: Yes ]
    Number of participants with repeat revascularization (PCI and/or CABG).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.

  • Individual Components of MACCE at 1 Month Post-procedure. [ Time Frame: 1 month after procedure ] [ Designated as safety issue: Yes ]
    Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.

  • Individual Components of MACCE at 6 Months Post-allocation. [ Time Frame: 6 months post allocation ] [ Designated as safety issue: Yes ]
    Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.

  • Individual Components of MACCE at 1 Year Post-allocation. [ Time Frame: 1 year post allocation ] [ Designated as safety issue: Yes ]
    Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.

  • Freedom From MACCE and Its Components at 1 Year Post-allocation. [ Time Frame: 1 year post allocation ] [ Designated as safety issue: Yes ]
    Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).

  • Freedom From MACCE and Its Components at 3 Years Post-allocation [ Time Frame: 3 years post allocation ] [ Designated as safety issue: Yes ]
  • Freedom From MACCE and Its Components at 5 Years Post-allocation [ Time Frame: 5 years post allocation ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation [ Time Frame: 1 year, 3 and 5 years post allocation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1800
Study Start Date: March 2005
Estimated Study Completion Date: May 2012
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCI with DES Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
Drug Eluting Stent
Other Names:
  • Percutaneous coronary intervention
  • Paclitaxel eluting stent
  • 3 vessel disease
  • Left main stem
Active Comparator: CABG (coronary artery bypass graft)
Coronary Artery Bypass Graft
Procedure: Coronary Artery Bypass Surgery
Coronary Artery Bypass Surgery
Other Names:
  • Coronary artery disease
  • Coronary artery bypass graft
  • Left Main coronary artery

Detailed Description:

Due to the introduction of drug-eluting stents (DESs) and to improvements in therapy for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) patients, PCI is challenging CABG as the gold standard for treatment of three vessel (3VD) and left main (LM) coronary disease.

SYNTAX is a novel, randomized trial with nested registries comparing PCI with paclitaxel-eluting TAXUS stents to CABG for 3VD and LM patients to evaluate the best treatment for these patients with complex coronary disease.

Patients at participating centers will be evaluated by both a cardiothoracic surgeon and by an interventional cardiologist.

Those patients who are determined to be eligible for treatment by both PCI and CABG will be randomized to receive either PCI with a polymer-based paclitaxel-eluting TAXUS stent or CABG.

Patients who are determined to be unsuitable for treatment by PCI will be treated by CABG and will be entered into a CABG registry to help define the patient population in which stenting continues to be an unacceptable treatment option.

Similarly, patients who are determined to be unsuitable for treatment by CABG will be treated by PCI, using any interventional techniques or devices with or without the use of DES, and entered into a PCI registry to help define the patients for whom CABG is considered inappropriate.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory)
  • De novo lesions with at least 50% stenosis
  • Myocardial ischemia (stable, unstable, silent)

Exclusion Criteria:

  • Prior PCI or CABG
  • Acute myocardial infarction (with creatinine kinase >2x upper limit of normal)
  • Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement)
  • Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed
  • Inability to give informed consent due to mental condition, mental retardation, or language barrier
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114972

  Show 106 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Cardialysis BV
Investigators
Principal Investigator: Patrick W. Serruys, MD, PhD Erasmus University Medical Center Rotterdam
Principal Investigator: Friedrich W Mohr, MD University of Leipzig
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
  More Information

No publications provided by Boston Scientific Corporation

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

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

Keywords provided by Boston Scientific Corporation:
Three-vessel coronary artery disease
Left main coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014