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Comparison of Cypher Select and Taxus Express Coronary Stents

2014-08-27 03:42:01 | BioPortfolio

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.

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 conscent.

Exclusion critteria:

- 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-påoints:

- 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 ajudicated by an independent end-point committee

Study Design

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

Conditions

Coronary Artery Disease

Intervention

Percutaneous coronary intervention (PCI)

Status

Completed

Source

Skejby Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:01-0400

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