The SOURT OUT IV TRIAL - Full Text View

Purpose

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.

Condition	Intervention
Ischemic Heart Disease Coronary Atherosclerosis Percutaneous Coronary Intervention	Device: Percutaneous coronary intervention (Xience V stent)

MedlinePlus related topics:

Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-Selected Patients With Coronary Heart Disease

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

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

Estimated Enrollment:	2678
Study Start Date:	August 2007
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: Active Comparator Cypher Select plus stent	Device: Percutaneous coronary intervention (Xience V stent) Cypher Select plus coronary stent Xience V coronary stent
2: Active Comparator Xience V stent	Device: Percutaneous coronary intervention (Xience V stent) Cypher Select plus coronary stent Xience V coronary stent

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552877

Contacts


Contact: Per Thayssen, MD DMSci	004565412681	per.thayssen@ouh.regionsyddanmark.dk

Contact: Lisette Okkels Jensen, MD PhD	004565412690	okkels@dadlnet.dk

Locations


Denmark
	Odense University Hospital, Dept. of Cardiology	Recruiting
	Odense, Denmark, 5000
	Contact: Per Thayssen, MD DMSci 004565412681 per.thayssen@ouh.regionsyddanmark.dk
	Contact: Lisette Okkels Jensen, MD PhD 004565412690 okkels@dadlnet.dk
	Principal Investigator: Per Thayssen, MD DMSci

Sponsors and Collaborators

Odense University Hospital

Investigators


Principal Investigator:	Per Thayssen, MD DMSci	Odense University Hospital, Dept. of Cardiology

More Information

Study ID Numbers:	SOIV-20070043
First Received:	October 31, 2007
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00552877
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee