Comparison of Cypher Select and Taxus Express Coronary Stents

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00388934

Acronym

SORT-OUTII

Enrollment

2095

Registered

2006-10-17

Start date

2004-08-31

Completion date

2009-01-31

Last updated

2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Coronary Artery Disease

Keywords

Percutaneous coronary intervention, Angina pectoris, Stent

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

Interventions

DEVICEDrug eluting stent

percutaneous intervention with implantation of drug eluting coronary stent

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Planned implantation of drug eluting stent * Written informed consent

Exclusion criteria

* Planned intervention with other stents than study stents

Design outcomes

Primary

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

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026