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

This study has been completed.
Sponsor:
Collaborators:
University of Aarhus
University of Copenhagen
Odense University Hospital
Information provided by:
Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00388934
First received: October 16, 2006
Last updated: July 29, 2013
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Angina Pectoris
Device: Drug eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF) [ Time Frame: during 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total death [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]
  • Target vessel revascularisation, target lesion revascularisation, TVF [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 2095
Study Start Date: August 2004
Study Completion Date: January 2009
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • DES
  • Cypher
  • Taxus
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:
  • DES
  • Cypher
  • Taxus

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned implantation of drug eluting stent
  • Written informed consent

Exclusion Criteria:

  • Planned intervention with other stents than study stents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388934

Sponsors and Collaborators
Aarhus University Hospital Skejby
University of Aarhus
University of Copenhagen
Odense University Hospital
Investigators
Principal Investigator: Anders Galloe, MD Gentofte Hospital, Copenhagen
  More Information

No publications provided by Aarhus University Hospital Skejby

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Cardiology B, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT00388934     History of Changes
Other Study ID Numbers: SORT-OUT II
Study First Received: October 16, 2006
Last Updated: July 29, 2013
Health Authority: Denmark: National Board of Health

Keywords provided by Aarhus University Hospital Skejby:
Percutaneous coronary intervention
Angina pectoris
Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014