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SYNTAX

Objective: Compare PCI with TAXUS® Express2™ stent vs. CABG in patients with de novo three-vessel disease (3VD) or left main (LM) disease (isolated or in combination with 1, 2, or 3VD
Stent: TAXUS Express2
Purpose: Demonstrate non-inferiority of TAXUS Express2 PCI vs. CABG for 3VD or LM
Design: Prospective, multicenter clinical trial with all-comers design. Randomized for those patients deemed eligible for both PCI and CABG. Nested registries (CABG only or PCI only) for patients judged suitable for only one treatment modality.
Lesion: de novo three-vessel disease (3VD) or left main (LM) disease (isolated or in combination with 1, 2, or 3VD)
Control: Coronary artery bypass graft (CABG) surgery
Release Kinetics: Slow Release (SR)
Primary Endpoint: 1-year MACCE rate (death, MI, repeat PCI, stroke)
Location and Sites: Europe and United States, 81 sites
Status: Enrolling
Number of Patients: Up to 4600 (1800 randomized) planned
Principal Investigators: Patrick Serruys, MD, Thoraxcenter-Erasmus, Rotterdam Friedrich Mohr, MD, University of Leipzig, Germany
*The safety and effectiveness of the TAXUS Express2 Stent have not been established in patients with coronary artery reference diameter less than 2.5 mm or greater than 3.75 mm or in diabetics or patients with left main or three vessel disease or multiple overlapping stents in lesions longer than 28 mm.
Caution: Investigational device. Limited by United States law to investigational use.