Comparison of Cypher Select and Taxus Express Coronary Stents — SORT-OUTII  

Coronary Artery Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT00388934
• Study type: Interventional
• Source: Aarhus University Hospital Skejby
• Status: Completed
• Phase: Phase 4
• Start date: August 2004
• Completion date: January 2009