Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments polymer-based paclitaxel-eluting taxus express2-sr stent, coronary artery bypass surgery
Phase phase 3
Sponsor Boston Scientific Corporation
Collaborator Cardialysis BV
Start date March 2005
End date April 2008
Trial size 1800 participants
Trial identifier NCT00114972, 90169394, S2024

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
polymer-based paclitaxel-eluting taxus express2-sr stent Percutaneous coronary intervention
Drug Eluting Stent
(Active Comparator)
Coronary Artery Bypass Graft
coronary artery bypass surgery Coronary artery disease
Coronary Artery Bypass Surgery

Primary Outcomes

Measure
Primary Clinical Endpoint of 12-Month Binary MACCE.
time frame: 12 months post enrollment
12-month Composite Safety Endpoint.
time frame: 12 months after enrollment
Repeat Revascularization (PCI and/or CABG).
time frame: 12 Months post enrollment

Secondary Outcomes

Measure
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
Individual Components of MACCE at 1 Month Post-procedure.
time frame: 1 month after procedure
Individual Components of MACCE at 6 Months Post-allocation.
time frame: 6 months post allocation
Individual Components of MACCE at 1 Year Post-allocation.
time frame: 1 year post allocation
Freedom From MACCE and Its Components at 1 Year Post-allocation.
time frame: 1 year post allocation
Freedom From MACCE and Its Components at 3 Years Post-allocation
time frame: 3 years post allocation
Freedom From MACCE and Its Components at 5 Years Post-allocation
time frame: 5 years post allocation
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
Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation
time frame: 1 year, 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)
time frame: 5 Years

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery
Principal investigator Patrick W. Serruys, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.