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)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Coronary Artery Disease Heart Diseases

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2678
Study Start Date:	August 2007
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

Locations

Denmark
Odense University Hospital, Dept. of Cardiology
Odense, Denmark, 5000

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator:

Per Thayssen, MD DMSci

Odense University Hospital, Dept. of Cardiology

More Information

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jensen LO, Thayssen P, Christiansen EH, Tilsted HH, Maeng M, Hansen KN, Kaltoft A, Hansen HS, Bøtker HE, Krusell LR, Ravkilde J, Madsen M, Thuesen L, Lassen JF; SORT OUT IV Investigators. 2-year patient-related versus stent-related outcomes: the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) Trial. J Am Coll Cardiol. 2012 Sep 25;60(13):1140-7. doi: 10.1016/j.jacc.2012.07.004. Epub 2012 Sep 5.

Okkels Jensen L, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, Villadsen AB, Junker A, Nørregaard Hansen K, Kaltoft A, Maeng M, Pedersen KE, Kristensen SD, Bøtker HE, Ravkilde J, Sanchez R, Aarøe J, Madsen M, Sørensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV) Investigators. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012 Mar 13;125(10):1246-55. Epub 2012 Feb 3.

Jensen LO, Thayssen P, Tilsted HH, Ravkilde J, Junker A, Hansen HS, Hansen KN, Pedersen KE, Sørensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome SORT OUT IV investigators. Rationale and design of a randomized clinical comparison of everolimus-eluting (Xience v/Promus) and sirolimus-eluting (cypher select+) coronary stents in unselected patients with coronary heart disease. Cardiology. 2010 Jul;116(2):73-8. Epub 2010 Jun 3.

Responsible Party:	Per Thayssen, Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00552877 History of Changes
Other Study ID Numbers:	SOIV-20070043
Study First Received:	October 31, 2007
Last Updated:	August 12, 2009
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: Ethics Committee

Keywords provided by Odense University Hospital:

PCI
Drug-eluting stent

Additional relevant MeSH terms:

Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013

The SOURT OUT IV TRIAL (SORT OUT IV)