Comparison of Cypher Select and Taxus Express Coronary Stents

Study Overview
=================
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

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

Conditions
-----------------
Coronary Artery Disease, Angina Pectoris

Intervention / Treatment
-----------------
* Device: Drug eluting stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned implantation of drug eluting stent Written informed consent Exclusion Criteria: Planned intervention with other stents than study stents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug eluting stent (Cypher)<br>Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher) | Device: Drug eluting stent<br>* percutaneous intervention with implantation of drug eluting coronary stent<br>* Other names: Taxus;|
| Experimental: Drug eluting stent (Taxus)<br>Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus) | Device: Drug eluting stent<br>* percutaneous intervention with implantation of drug eluting coronary stent<br>* Other names: Taxus;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF) |  | during 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous coronary intervention, Angina pectoris, Stent