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

Primary Purpose

Coronary Artery Disease, Angina Pectoris

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Drug eluting stent
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous coronary intervention, Angina pectoris, Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Planned implantation of drug eluting stent
  • Written informed consent

Exclusion Criteria:

  • Planned intervention with other stents than study stents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Drug eluting stent (Cypher)

    Drug eluting stent (Taxus)

    Arm Description

    Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher)

    Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus)

    Outcomes

    Primary Outcome Measures

    MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)

    Secondary Outcome Measures

    Total death
    Cardiac death
    Myocardial infarction
    Target vessel revascularisation, target lesion revascularisation, TVF
    Stent thrombosis

    Full Information

    First Posted
    October 16, 2006
    Last Updated
    July 29, 2013
    Sponsor
    Aarhus University Hospital Skejby
    Collaborators
    University of Aarhus, University of Copenhagen, Odense University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00388934
    Brief Title
    Comparison of Cypher Select and Taxus Express Coronary Stents
    Acronym
    SORT-OUTII
    Official Title
    Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2004 (undefined)
    Primary Completion Date
    January 2006 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Aarhus University Hospital Skejby
    Collaborators
    University of Aarhus, University of Copenhagen, Odense University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Angina Pectoris
    Keywords
    Percutaneous coronary intervention, Angina pectoris, Stent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2095 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Drug eluting stent (Cypher)
    Arm Type
    Experimental
    Arm Description
    Percutaneous coronary intervention with implantation of drug eluting coronary stent (Cypher)
    Arm Title
    Drug eluting stent (Taxus)
    Arm Type
    Experimental
    Arm Description
    Percutaneous coronary intervention with implantation of drug eluting coronary stent (Taxus)
    Intervention Type
    Device
    Intervention Name(s)
    Drug eluting stent
    Other Intervention Name(s)
    DES, Cypher, Taxus
    Intervention Description
    percutaneous intervention with implantation of drug eluting coronary stent
    Primary Outcome Measure Information:
    Title
    MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)
    Time Frame
    during 9 months
    Secondary Outcome Measure Information:
    Title
    Total death
    Time Frame
    after 9 months, 2 and 3 years
    Title
    Cardiac death
    Time Frame
    after 9 months, 2 and 3 years
    Title
    Myocardial infarction
    Time Frame
    after 9 months, 2 and 3 years
    Title
    Target vessel revascularisation, target lesion revascularisation, TVF
    Time Frame
    after 9 months, 2 and 3 years
    Title
    Stent thrombosis
    Time Frame
    after 9 months, 2 and 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Planned implantation of drug eluting stent Written informed consent Exclusion Criteria: Planned intervention with other stents than study stents
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anders Galloe, MD
    Organizational Affiliation
    Gentofte Hospital, Copenhagen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28183505
    Citation
    Galloe AM, Kelbaek H, Thuesen L, Hansen HS, Ravkilde J, Hansen PR, Christiansen EH, Abildgaard U, Stephansen G, Lassen JF, Engstrom T, Jensen JS, Jeppesen JL, Bligaard N; SORT OUT II Investigators. 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents. J Am Coll Cardiol. 2017 Feb 14;69(6):616-624. doi: 10.1016/j.jacc.2016.11.055.
    Results Reference
    derived
    PubMed Identifier
    18230778
    Citation
    Galloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamaki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrom SZ, Stephansen GB, Lassen JF; SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008 Jan 30;299(4):409-16. doi: 10.1001/jama.299.4.409.
    Results Reference
    derived

    Learn more about this trial

    Comparison of Cypher Select and Taxus Express Coronary Stents

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