The SOURT OUT IV TRIAL
SORT OUT IV
Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease
1 other identifier
interventional
2,678
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 31, 2007
CompletedFirst Posted
Study publicly available on registry
November 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedAugust 13, 2009
August 1, 2009
2 years
October 31, 2007
August 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) EFFICACY (target vessel revascularization)
9 months, 1 year, 2 years, 3 years
Study Arms (2)
1
ACTIVE COMPARATORCypher Select plus stent
2
ACTIVE COMPARATORXience V stent
Interventions
Cypher Select plus coronary stent Xience V coronary stent
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital, Dept. of Cardiology
Odense, 5000, Denmark
Related Publications (6)
Jensen LO, Thayssen P, Christiansen EH, Maeng M, Ravkilde J, Hansen KN, Hansen HS, Krusell L, Kaltoft A, Tilsted HH, Berencsi K, Junker A, Lassen JF; SORT OUT IV Investigators. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV. J Am Coll Cardiol. 2016 Feb 23;67(7):751-62. doi: 10.1016/j.jacc.2015.11.051.
PMID: 26892409DERIVEDJensen LO, Thayssen P, Maeng M, Christiansen EH, Ravkilde J, Hansen KN, Kaltoft A, Tilsted HH, Madsen M, Lassen JF; Scandinavian Organization for Randomized Trials With Clinical Outcome SORT OUT IV Investigators. Three-year outcomes after revascularization with everolimus- and sirolimus-eluting stents from the SORT OUT IV trial. JACC Cardiovasc Interv. 2014 Aug;7(8):840-8. doi: 10.1016/j.jcin.2014.02.014. Epub 2014 Jul 30.
PMID: 25086842DERIVEDAntonsen L, Thayssen P, Hansen HS, Maeng M, Tilsted HH, Botker HE, Ravkilde J, Madsen M, Sorensen HT, Thuesen L, Lassen JF, Jensen LO. Outcomes after revascularisation with everolimus- and sirolimus-eluting stents in patients with acute coronary syndromes and stable angina pectoris: a substudy of the SORT OUT IV trial. EuroIntervention. 2014 Jun;10(2):212-23. doi: 10.4244/EIJV10I2A35.
PMID: 23838425DERIVEDJensen LO, Thayssen P, Christiansen EH, Tilsted HH, Maeng M, Hansen KN, Kaltoft A, Hansen HS, Botker 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.
PMID: 22958957DERIVEDJensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, Villadsen AB, Junker A, Hansen KN, Kaltoft A, Maeng M, Pedersen KE, Kristensen SD, Botker HE, Ravkilde J, Sanchez R, Aaroe J, Madsen M, Sorensen 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. doi: 10.1161/CIRCULATIONAHA.111.063644. Epub 2012 Feb 3.
PMID: 22308301DERIVEDJensen LO, Thayssen P, Tilsted HH, Ravkilde J, Junker A, Hansen HS, Hansen KN, Pedersen KE, Sorensen 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;116(2):73-8. doi: 10.1159/000315136. Epub 2010 Jun 3.
PMID: 20523042DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Per Thayssen, MD DMSci
Odense University Hospital, Dept. of Cardiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 31, 2007
First Posted
November 2, 2007
Study Start
August 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 13, 2009
Record last verified: 2009-08