Text Size

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:
Skejby Hospital
ClinicalTrials.gov Identifier:
NCT00388934
First received: October 16, 2006
Last updated: March 26, 2010
Last verified: May 2007
History of Changes
  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
 Procedure: Percutaneous coronary intervention (PCI)
 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:

U.S. FDA Resources

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:
  • MACE (cardiac death, MI, TVR, TLR, 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 ]
  • MI [ Time Frame: after 9 months, 2 and 3 years ] [ Designated as safety issue: Yes ]
  • TVL, TVR, 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: Cypher
Percutan intervention with Implantation of coronary stent
 Procedure: Percutaneous coronary intervention (PCI)
Implantation of coronary stent
Other Names:
  • PCI
  • PTCA
Experimental: Taxus
Implantation of coronary stent
 Procedure: Percutaneous coronary intervention (PCI)
Implantation of coronary stent
Other Names:
  • PCI
  • PTCA

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 conscent.

Exclusion critteria:

  • 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-påoints:

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

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

No publications provided by Skejby Hospital

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: March 26, 2010
Health Authority: Denmark: National Board of Health

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

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

ClinicalTrials.gov processed this record on May 19, 2013