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SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Boston Scientific Corporation
Cardialysis BV
Information provided by: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00114972
  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 Express-SR Stent
Procedure: Coronary Artery Bypass Surgery
Phase III

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 12-month MACCE rate. MACCE is defined as:all cause death,cerebrovascular event(such as stroke,)documented myocardial infarction, and [ Time Frame: 1 year after enrollment ] [ Designated as safety issue: Yes ]
  • repeat revascularization (PCI and/or CABG) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall MACCE rate at 1 month post-procedure and at 6 months, 3 and 5 years post-allocation [ Time Frame: 1 month after procedure and 6 months, 3 and 5 years post allocation ] [ Designated as safety issue: Yes ]
  • Rates of the individual components of MACCE 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, 3 and 5 years post allocation ] [ Designated as safety issue: Yes ]
  • Freedom from MACCE and its components at 1, 3 and 5 years post-allocation [ Time Frame: 1 year and 3 and 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: April 2012
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Device: Polymer-based Paclitaxel-Eluting TAXUS Express-SR Stent
Drug Eluting Stent
2: Active Comparator Procedure: Coronary Artery Bypass Surgery
Coronary Artery Bypass Surgery

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

Locations
United States, Texas
Medical City Hospital Dallas
Dallas, Texas, United States, 75230
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: Xavier Lefebvre, PhD Boston Scientific Corporation
  More Information

Responsible Party: Boston Scientific ( Nic Van Dyck )
Study ID Numbers: 90169394, S2024
Study First Received: June 20, 2005
Last Updated: February 5, 2008
ClinicalTrials.gov Identifier: NCT00114972  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Paclitaxel
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009