Comparison of Cypher Select and Taxus Express Coronary Stents

Coronary Artery Disease Clinical Trial

— SORT-OUTII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388934
• Other study ID #: SORT-OUT II
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2006
• Last updated: July 29, 2013
• Start date: August 2004
• Est. completion date: January 2009

Study information

• Verified date: May 2007
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2095
• Est. completion date: January 2009
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned implantation of drug eluting stent

• Written informed consent

Exclusion Criteria:

• Planned intervention with other stents than study stents

Study Design

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

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Drug eluting stent
percutaneous intervention with implantation of drug eluting coronary stent

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Odense University Hospital, University of Aarhus, University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)		during 9 months	Yes
Secondary	Total death		after 9 months, 2 and 3 years	Yes
Secondary	Cardiac death		after 9 months, 2 and 3 years	Yes
Secondary	Myocardial infarction		after 9 months, 2 and 3 years	Yes
Secondary	Target vessel revascularisation, target lesion revascularisation, TVF		after 9 months, 2 and 3 years	Yes
Secondary	Stent thrombosis		after 9 months, 2 and 3 years	Yes