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

Aarhus University Hospital Skejby

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Angina Pectoris

Treatments: Device: Drug eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT00388934

SORT-OUT II

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,095 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned implantation of drug eluting stent
• Written informed consent

Exclusion criteria

• Planned intervention with other stents than study stents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,095 participants in 2 patient groups

Drug eluting stent (Cypher)

Experimental group

Description:

Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher)

Treatment:

Device: Drug eluting stent

Drug eluting stent (Taxus)

Experimental group

Description:

Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus)

Treatment:

Device: Drug eluting stent