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

Further Study Details: 

Primary Outcomes: 12-month MACCE rate. MACCE is defined as:; *all cause death; *cerebrovascular event (such as stroke); *documented myocardial infarction; *repeat revascularization (PCI and/or CABG)
Secondary Outcomes: Overall MACCE rate at 1 month post-procedure and at 6 months, 3 and 5 years post-allocation; Rates of the individual components of MACCE at 1 month post-procedure and at 6 months, 1, 3 and 5 years post-allocation; Freedom from MACCE and its components at 1, 3 and 5 years post-allocation; Quality of life at 1 month post-procedure and at 6 months, 1, 3 and 5 years post-allocation; Cost and cost-effectiveness at 1, 3 and 5 years post-allocation; 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)
Expected Total Enrollment:  1500

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.

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00114972

Jeroen A Kleijne, MSc      +31 (0) 10-206 28 67    jkleijne@cardialysis.nl

Texas
      Medical City Hospital Dallas, Dallas,  Texas,  75230,  United States; Recruiting

Study ID Numbers:  90169394; Not applicable
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 20, 2005
ClinicalTrials.gov Identifier:  NCT00114972
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05