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Completed

NCT Number: NCT00552877

The SOURT OUT IV TRIAL

In a randomized study the Xience V coroary artery stent may be non inferior to the Cypher Select+ coronary stents in the treatment of unselected patients with coronary artery disease.

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Key information

Conditions

Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Atherosclerosis Coronary Disease Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Dept. of Cardiology

Odense, 5000, Denmark

About this study

2 Purpose In a randomized study to compare the Cypher Select+ and the Xience V coronary stents in the treatment of unselected patients with coronary artery disease.

2.1 Primary objective In a randomized study to compare the Xience V and the Cypher Select+ coronary stents by assessing SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) and EFFICACY (target vessel revascularization) after 9 months.

2.2 Secondary objective To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months and the incidence of late stent thrombosis after 12, 24 and 36 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study.

Exclusion criteria

  • The patient will not participate
  • The patient participates in other randomised stent studies
  • Expected survival < 1 year
  • Allergy to Aspirin, Clopidogrel or Ticlopidine
  • Allergy to Sirolimus or ABT-578

Treatment and study plan

Percutaneous coronary intervention (Xience V stent)

Device

Cypher Select plus coronary stent Xience V coronary stent

Other names: Cypher Select plus coronary stent, Xience V coronary stent

Primary outcomes

  1. SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) EFFICACY (target vessel revascularization)

    Time frame: 9 months, 1 year, 2 years, 3 years

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease

Acronym: SORT OUT IV

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 2, 2007
Registry last updated
Aug 13, 2009

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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