Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2678 participants
INTERVENTIONAL
2007-08-31
2009-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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1
Cypher Select plus stent
Percutaneous coronary intervention (Xience V stent)
Cypher Select plus coronary stent Xience V coronary stent
2
Xience V stent
Percutaneous coronary intervention (Xience V stent)
Cypher Select plus coronary stent Xience V coronary stent
Interventions
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Percutaneous coronary intervention (Xience V stent)
Cypher Select plus coronary stent Xience V coronary stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* The patient participates in other randomised stent studies
* Expected survival \< 1 year
* Allergy to Aspirin, Clopidogrel or Ticlopidine
* Allergy to Sirolimus or ABT-578
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Odense University Hospital
Principal Investigators
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Per Thayssen, MD DMSci
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital, Dept. of Cardiology
Locations
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Odense University Hospital, Dept. of Cardiology
Odense, , Denmark
Countries
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References
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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.
Jensen 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.
Antonsen 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.
Jensen 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.
Jensen 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.
Jensen 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.
Other Identifiers
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SOIV-20070043
Identifier Type: -
Identifier Source: org_study_id
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