NCT00388934

Comparison of Cypher Select and Taxus Express Coronary Stents

Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,095 (actual)
• Sponsor: Aarhus University Hospital Skejby · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease.

Detailed description

Design: * Randomized open multicentre trial. Patients: * 1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation. Inclusion criteria: * Patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation. * Signed informed consent. Exclusion criteria: * Participation in other stent studies. Randomization: * Implantation of Taxus Express og Cypher Select stents. Primary end-point: * Combined end-point of cardiac death, new revascularization (PCI or CABG) or myocardial infarction after nine months. Secondary end-points: * Total death after nine months * Cardiac death after nine months * Myocardial infarction after nine months * Index vessel myocardial infarction after nine months * Target lesion revascularization * Target vessel revascularization * Stent thrombosis after nine months End-point evaluation: * End-points will be adjudicated by an independent end-point committee

Conditions

• Coronary Artery Disease
• Angina Pectoris

Interventions

Type	Name	Description
DEVICE	Drug eluting stent	percutaneous intervention with implantation of drug eluting coronary stent

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-01-01
• Completion: 2009-01-01
• First posted: 2006-10-17
• Last updated: 2013-07-30