The SOURT OUT IV TRIAL

Ischemic Heart Disease Clinical Trial

— SORT OUT IV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552877
• Other study ID #: SOIV-20070043
• Status: Completed
• Phase: N/A
• First received: October 31, 2007
• Last updated: August 12, 2009
• Start date: August 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2678
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Device:
• Percutaneous coronary intervention (Xience V stent)
Cypher Select plus coronary stent Xience V coronary stent

Locations

Country	Name	City	State
Denmark	Odense University Hospital, Dept. of Cardiology	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) EFFICACY (target vessel revascularization)		9 months, 1 year, 2 years, 3 years	Yes