Comparison of Cypher Select and Taxus Express Coronary Stents

Phase 4

Completed

• Conditions: Coronary Artery Disease; Angina Pectoris

• Registration Number: NCT00388934
• Lead Sponsor: Aarhus University Hospital Skejby

Brief 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

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2006-01
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Status Verified: 2007-05
• Study Completion: 2009-01
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2095

Inclusion Criteria

• Planned implantation of drug eluting stent
• Written informed consent

Exclusion Criteria

• Planned intervention with other stents than study stents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)	during 9 months

Secondary Outcome Measures

Name	Time	Method
Total death	after 9 months, 2 and 3 years
Cardiac death	after 9 months, 2 and 3 years
Myocardial infarction	after 9 months, 2 and 3 years
Target vessel revascularisation, target lesion revascularisation, TVF	after 9 months, 2 and 3 years
Stent thrombosis	after 9 months, 2 and 3 years