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

July 29, 2013 updated by: Aarhus University Hospital Skejby

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

2095

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Planned implantation of drug eluting stent
  • Written informed consent

Exclusion Criteria:

  • Planned intervention with other stents than study stents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug eluting stent (Cypher)
Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher)
Device: Drug eluting stent
percutaneous intervention with implantation of drug eluting coronary stent
Other Names:
  • Taxus
  • DES
  • Cypher
Experimental: Drug eluting stent (Taxus)
Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus)
Device: Drug eluting stent
percutaneous intervention with implantation of drug eluting coronary stent
Other Names:
  • Taxus
  • DES
  • Cypher

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Total death
Time Frame: after 9 months, 2 and 3 years
after 9 months, 2 and 3 years
Cardiac death
Time Frame: after 9 months, 2 and 3 years
after 9 months, 2 and 3 years
Myocardial infarction
Time Frame: after 9 months, 2 and 3 years
after 9 months, 2 and 3 years
Target vessel revascularisation, target lesion revascularisation, TVF
Time Frame: after 9 months, 2 and 3 years
after 9 months, 2 and 3 years
Stent thrombosis
Time Frame: after 9 months, 2 and 3 years
after 9 months, 2 and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Collaborators

Odense University Hospital
University of Copenhagen
University of Aarhus

Investigators

  • Principal Investigator: Anders Galloe, MD, Gentofte Hospital, Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SORT-OUT II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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