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Completed

NCT Number: NCT00388934

Comparison of Cypher Select and Taxus Express Coronary Stents

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Planned implantation of drug eluting stent
  • Written informed consent

Exclusion criteria

  • Planned intervention with other stents than study stents

Treatment and study plan

Drug eluting stent

Device

percutaneous intervention with implantation of drug eluting coronary stent

Other names: DES, Cypher, Taxus

Primary outcomes

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

    Time frame: during 9 months

Secondary outcomes

  1. Total death

    Time frame: after 9 months, 2 and 3 years

  2. Cardiac death

    Time frame: after 9 months, 2 and 3 years

  3. Myocardial infarction

    Time frame: after 9 months, 2 and 3 years

  4. Target vessel revascularisation, target lesion revascularisation, TVF

    Time frame: after 9 months, 2 and 3 years

  5. Stent thrombosis

    Time frame: after 9 months, 2 and 3 years

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Odense University Hospital
  • University of Aarhus
  • University of Copenhagen

Registry information

Official study title

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

Acronym: SORT-OUTII

Important dates

Study start
2004
Primary completion
2006
Study completion
2009
First posted
Oct 17, 2006
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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