NCT00552877

The SOURT OUT IV TRIAL

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,678 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Heart Disease
• Coronary Atherosclerosis
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention (Xience V stent)	Cypher Select plus coronary stent Xience V coronary stent

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2007-11-02
• Last updated: 2009-08-13

Locations

1 site across 1 country: Denmark