The SOURT OUT IV TRIAL

Not Applicable

Completed

• Conditions: Ischemic Heart Disease; Coronary Atherosclerosis; Percutaneous Coronary Intervention
• Interventions: Device: Percutaneous coronary intervention (Xience V stent)

• Registration Number: NCT00552877
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-11-01
• Study First Posted: 2007-11-02
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2009-08-12
• Last Update Posted: 2009-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2678

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Percutaneous coronary intervention (Xience V stent)	Cypher Select plus stent
2	Percutaneous coronary intervention (Xience V stent)	Xience V stent

Primary Outcome Measures

Name	Time	Method
SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) EFFICACY (target vessel revascularization)	9 months, 1 year, 2 years, 3 years

Trial Locations

Locations (1)

Odense University Hospital, Dept. of Cardiology; 🇩🇰 Odense, Denmark